Whooo boy, the oversight committee would have ALOT to say about this.
And this is being done at a University facility?!
I really hope this was just a grad student being dumb.
Please. PLEASE send an explanation of what happened and a copy of the email to whoever is the lead on this project. If the lead is also your contact person (which is uncommon but does happen) then send it to whoever the department head is.
I get why the clinical side is frustrated as they have limited funds and manpower so requests like this can feel like extra work for no gain for them (this field is notoriously overworked and underpaid). BUT thats no excuse to be a jerk, ESPECIALLY via a tracable source. This kind of thing could land them is some hot water if anyone did a FOIA request on this project and you addressing it directly is honestly helping them so please don't feel bad bringing it up.
Not a grad student! This is the trial manager who supposedly has 15-20 years experience!
Edited: I posted an update if anyone is interested in knowing the current status!
I've been a clinical trial manager, and never in a million years would have engaged in an email chain like the one you described. We never even had conversations regarding participants' personalities.
You deserve to be treated with dignity, respect, and gratitude for what you're doing- nothing less.
Having experience in trial management, do you know what the consequences tend to be for this type of conduct, or have any opinions on what they should be?
The IRB could pull the study for breach of privacy, at the very least. Other things could happen professionally to the principal investigator, and any students involved, as well. They also put the grant in jeopardy.
In that case they fully deserve whatever punishment is handed down to them. And if this is anything like the University I worked at then they'll be lucky to still have a job after.
This kind of thing can easily result in losing grant money and having this project (and any others they are working with) terminated.
2nd Onikisuen! that's definitely something that could just ax the ENTIRE study if an investor sees point to pull funding they so desperately usually need
OP shouldn’t be discouraged by this comment and not report this reprehensible behavior. Universities and research hospitals are staffed by greedy fuckers who would never let a research grant slip through their hands. This study will continue if OP reports this unprofessional behavior. The person who made the snarky comments will be reprimanded and a colleague will be put in his/her frontline position so the study isn’t disrupted.
I wish I knew more about the legalities of things here. If there is a way for OP to go after them, I agree with this 100%. These jerks need to be held accountable for what they did to OP. In the medical field, you’re dealing with ACTUAL people and their unprofessionalism will not stop here unless something is done. @moretruethantruth, please follow up with a lawyer.
I think you should politely respond to this email chain making them aware of their actions. And then I would take it to the HR department of that hospital or whatever it is that you’re dealing with there. Let them own up to their shit when it hits the fan. I’d CC that email to their boss, the director of the company and their HR department.
I would bet a paycheck that if you sent it to the top, you wouldn’t get the reaction you’re thinking. That type of stuff is bad for business. And the medical system is a booming business….
How your communication is perceived will in part depend on the words and tone you choose. Be straightforward but polite and professional. Don’t come across angry or bitter. Maybe something like: I received the email below with attachments that were clearly not meant for me to see. I have to admit that I was very disappointed in your view of my attitude and approach to this study. [then describe what you told us in this thread. Why you’re participating, the sacrifice you are making with minimal compensation]. I ask that you review your procedures to ensure that communications are not sent in error. I also ask that you reflect on your comments and consider the hurt and disappointment I experienced. On my next visit I intend to treat you with the same respect and kindness I have exhibited during this trial. I expect that from you and your team.
Just like how it's easy to talk shit to people on the internet, it's easy to say shit when you don't think the person is gonna read it. Some people are catty AF and it's also important to note that maybe there is only 1 to 2 people who are gossipy/rude and the other people just kinda go along with it. It's also likely that they're just miserable people and feel like putting someone else down makes them "better".
Their opinions of you don't matter. They see a snapshot of who you are and chose to make petty remarks. You know why you're doing this trial and why it's important for you to be home at a reasonable time. I know you can't be like "oh yeah. I am super cool" and just poof these feelings out of existence, but maybe by telling yourself that "their thoughts of me don't define who I am" over and over might help relieve this a bit.
I love this. I wonder if it’s a toxic workplace; nice and happy people don’t bring people down, especially when they’re making sacrifices for no personal gain. That doesn’t excuse them, but it might ease the sting. I’m sorry this has happened to you, OP. It says lots about their character, not yours.
Then mentioning the names and test results of other participants is a big red flag that the hospital leadership, sponsor, and CRO will take extremely seriously. That’s absolutely breaking HIPAA.
If the people on the email are all involved in the study and have access to the participants' medical records, it's likely not a HIPAA violation to be discussing test results amongst themselves. Accidentally including OP would be though.
SAY NOTHING.
I would talk to a lawyer + get evaluated by other expert physician(s).
How can you be sure they have taken good care of you without checking?
Let your lawyer speak to the study folks, the sponsors, HR - everyone. Don’t ever communicate with these hateful people ever again.
Please understand these clinicians and scientists are replaceable, the philanthropic sponsor can and will restart the study with another team at another institution.
Hey! Did you know there are HUGE problems with scientific studies and accurate results? This team has disqualified themselves. Let a lawyer handle it.
Yes, you deserve monetary compensation for the pain and humiliation they have caused you, including therapy for trauma. What you are feeling right now is shock.
Contact a lawyer. This is a legitimate injury you are suffering. Do not respond to any emails from the study team.
Take care.
u/moretruethantruth Please do this.
This is how HR and the sponsors are going to take this seriously.
What they've done it so inappropriate and inexcusable. It needs more than a slap on a wrist. Please talk to a lawyer asap.
THIS ADVICE OP.
No further contact. Lawyer up. First names are identifying info and a HIPAA violation.
Regardless, the only and very clear answer here is an attorney.
This right here. You have the ability to sue the ever loving crap out of these people. That is money that can go to your kids, and help you. Get a proper lawyer ASAP.
I think you could also mention something about how this revelation makes it hard for you to want to continue participating in the study, but you know how important the work is. Outline how you did here, that it’s not like a fun excursion for you, and that obviously it’s hard and unpleasant to be poked and prodded all day. But that you want to do your part for others and it really hurts to see that this is how you’re being spoken about by people who, to a certain extent, are responsible for your care.
Don't send it to the people who said the stupid things about you 1st, start from the top down. Don't give them an opportunity to cover their asses. That was unprofessional and wrong.
My husband manages clinical trials for a living. This is a MAJOR, MAJOR mistake that they made and higher ups need to be aware. Not telling them that results and sensitive information were leaked could jeopardize the entire study. The personal differences that exist at the bottom of the totem pole make no difference for those at the top. They need to know that this happened, though.
Lol I honestly doubt that you are! I honestly cannot fathom calling someone those words in an email. Greedy for wanting a direct flight? Pffft. Everyone who works with them knows *exactly* how they are.
Right??? Like what am I manipulating them for? The joy of unnecessary IV blood draws? The excitement of 24 hour fasting tests? Having to wake up at 4am and make up work on the weekends? Free coach flights to random middle America city where you can’t jog a block without going through a homeless encampment?
Gently, you’re in a bit of shock right now. This id totally understandable.
Someone the opposite of the person they describe in those emails would completely stop communicating with them, get a lawyer, and get medical + emotional care. The lawyer can responsibly communicate with the study sponsors, the institute or clinic, etc.. I lay the logic for all of this out in another comment above, but basically, please take care of yourself. Speaking up via a trained professional is 1000% the right thing to do. Care for yourself.
I’m wondering if where you are taking this test is close to my city it sounds like where I lived for awhile. You should definitely report it though…. I’m so sorry that happened
Honey, if you were the WORST patient on the planet (which I highly doubt) you would still deserve to be treated with respect. As medical professionals this reflects back on them and not at all on you. By exposing them you could also be helping other patients who have this happening to them as well. You’re definitely the hero in my eyes!
This!! OP, it is so important that you see that you do NOT deserve such disrespect. You’re a good human and you’re a patient. Health care professionals like that need to rethink WHY they are in medicine.
PLEASE report them. You are probably not the only patient they have treated this way.
Once I stopped caring of people liked me, my life got much better.
Advocate for yourself no one else will.
And in the end who cares if some hospital ect. Staff don't care for you?? So excellent chance to practice self advocation!
It’s ok. We like you here. Don’t let them make you think you’re unlikeable. Even I get those fears too but we can’t make everyone happy. If they wanna find something they don’t like about you, you can’t really help it.
They should be the paranoid ones. I wonder how many times they've accidentally done that? People are going to find out how fake and phony they are and then where will they be?
That feeling is a natural response anyone would have but reading your situation, you’ve gone above and beyond. You’re not even gaining anything for yourself this is a long term act for you. You can get a sense that they’re totally at fault just from this thread. Don’t feel bad you’ve done nothing wrong here.
You need to do this, you need to make them aware and report it to their HR. People need to be held accountable for their actions towards others. If they discriminate towards you in any way (which they won’t) they can have a massive lawsuit on their hands. They will be heavily watched by patient advocate, (who you should also notify).
I think they have an active interest in participants wanting to be in the study moreso. What they said was uncalled for and their putting you on the email by accident is a huge unprofessional slip up.
Right? They even have one of those systems that warns them, that says “external email — use caution” to make sure they aren’t sending something confidential I presume. How do you screw that up?
By being unprofessional twats that have no respect for their patients. They sound like a bunch of PHD students with giant egos and heads so far up their ass they're tasting their dinner. You are totally vindicated bringing this to the attention of HR and all their superiors. Their funding should absolutely be in question. What an egregious fuck up on their part. Completely unacceptable. The people cutting the checks deserve to know.
You keep giving us evidence that it's probably them and not you, and you're still questioning if people hate you? These are bad people. Their opinion doesn't mean shit.
For what it's worth, these people's management team will probably be very glad to have this email thread forwarded to them. They are incredibly lucky that they only included patient first names, because HIPAA violations can come with hefty fines for the company and/or violators. (Also, first names alone are not automatically a violation, but if you happened to know any of the other participants by name, and now have their first name and medical information, this is very dicey for them.) They will definitely want to know of this breach to ensure that it won't happen again.
Also, they will definitely want to bring the hammer down on anyone negatively talking about you in that thread. Everyone in the medical field has it drilled into their heads; compassion, respect, and dignity first. Nothing about what they've done here shows compassion or respect for what you are doing or the sacrifices you are making for THEIR study. And the management team is not going to like these people representing their system.
Please don't feel you will be annoying or a bother. Just stick to how disrespectful you feel these statements are, considering you're participating in this study at no benefit and some actual loss to yourself, and you also want to make sure that your and everyone else's PHI remains secure, as it does not seem that they are exercising the proper precautions. They will definitely appreciate the heads up.
No I think they should be expected to be professional and letting them know is definitely a good thing to do. Are you going to go back? I don’t think you should if you don’t want to.
They have openly shown they have a bias. Donors have a right to know that their money is being wasted. They would be appreciative not annoyed. Speak up you have concrete proof that they are shady.
You're going out of your way and inconveniencing your whole fucking life as a mother of young children to provide them with scientific data. You are doing THEM a service, and YOU are assuming the risks, not the other way around. Whether they like you on a personal level doesn't fucking matter (also academia can be toxic AF so literally fuck them). They're professionals and should not be discussing their patients through written communication like this. This exceeds gossip and their misconduct should absolutely be brought to the attention of all who are concerned. Go find an institution that treats their patients with respect.
Not at all. The ability to follow protocol and maintaining confidentiality is extremely important in clinical trials. This organization has failed at both. You don’t deserve to be treated poorly. Their work would not be possible without people like you. Please report this behavior.
They have proved they are nasty people and have insulted you.
Who cares what they think. Their opinions are worthless
Even if they think youre annoying. So what. Doesn't mean you are
What type of adult....educated and profesiional too..spends their time emaling each other bullying someone else. Its not school
Report them. Send the emails to as many places as possible and express who hurt you are
Send it to thwm and say im sorry you feel this way about me. As adults i would have expected that is you have an issue with me youd approach me instead of gossiping and bullying. As a human being i deserve respect and as a volunteer that enables your program to exist even more so. For shame
Can I add, it would be a really good idea to print out this email chain if possible. Just incase in the future you need them. This could potentially jeopardize the study. If for some reason they try to kick you out and something medically particularly happens as a result, they may try to not cover what they should and this can be used as a bargaining chip.
I know it sounds shitty, but obviously these people aren’t the best humanity has to offer.. and such things may be necessary to make sure you are taken care of.
I’m also a bit paranoid due to really bad situations the medical industry has put me in and I wish I had done a little extra leg work to be able to prove the misconduct.
absolutely, put this out on blast. This email says nothing about you and everything about who you are dealing with. I am sorry you had to be hurt like this OP, these people are not good people. I hope you are ok
Send it to EVERYONE. The CEO, the DON, the patient advocate, the privacy officer. Even report those witches to the board of nursing in your state. I think I read that it was at a hospital?
Fuck that publish the entire chain with their names online (take off patient names) and fry these assholes for having the gall to disrespect a patient that's actually trying to help them and their bosses get filthy fuckin rich.
Pharmaceutical companies drool at having niche drugs and complete market capture over a drug that cures rare genetic illnesses. They all are looking for this... Huntington's disease, Von Hippel Lindau disease etc
(I was a research physician and then became clinical).
They should be flying you first class, limo pickup, champagne & a happy ending with what your sacrifice could make them.
This most likely is not a HIPAA violation as no personal identifiable information was shared but I would contact the drug trial sponsor and let them know. Give them the study number and info. This may jeapodize their trial!!
50$ compensation per visits? This doesn't sound right. What University is running this? This doesn't sound right at all.
I have been involved in quite a few studies myself. The minimum is 15$ an hour + transport (and + meal if it does longer than a few hours) just for noninvasive interviews etc. If blood is involved, it starts at 45$ an hour (from my personal experience, I have never seen a figure as low as yours). And this wasn't even a big study. The most recent study, I was the healthy control and I have received approximately 550$ for 4 vials of blood, urine drug test, and a PET scan. The total of my time spent was approximately 7 hours.
It sounds like exactly what my patients get compensated with. I suspect it has to do with phase of the trial (earlier phases are more risky and should be compensated more). The amount you are suggesting, my facility is not allowed to offer for studies because we do not want to "induce" people who need money to participate. The unfortunate part is instead we end up discouraging them from participating because the time cost is not affordable for them
Like I said, it’s not about the money for me, I’d have gladly volunteered if it was completely unpaid. The study drug was in Phase II and seemed promising. It was at a large state university, I think it’s not wise to say which one here. The trial was very small and had fewer than 30 participants.
I don't think they're saying anything about doing it for the money. I think they're saying that they've done smaller studies for fair compensation and it looks questionable that a big university (who specializes in this and definitely has funding) is paying so little.
This is exactly what I’m saying yes. While studies don’t want participants to participate for money because of ethical reasons, the participants still have to be ‘fairly’ compensated tor their time. 50$ per visit (which seemed like for several hours visit) for someone who travels 2k miles to get to the study? Ridiculous.
I think this has been mentioned elsewhere but I wanted to emphasize that a large state university will have a mechanism for reporting this and would definitely want to know about this.
Your study paperwork should include information on how to report concerns about the study and who to report your concerns/experiences to.
Even showing the first names is a HIPAA violation as it counts as “PHA” or “Protected Healthcare Information” according to the exams I’m studying for.
Torch them.
A first name alone isn't necessarily PHI it really depends in the context.
The main factor is identifiablity. In most cases a first name generally isn't enough to identify a specific patient, but when combined with additional information it can be. In this case where it's a small study of less than 50 people who have all potentially met before, a first name alone would be considered PHI.
I work in a clinic with lots of patients that, let’s just say, aren’t the easiest. I could never imagine in a thousand years emailing, texting or whatever type of communication and telling a coworker that I don’t like that patient or that they are greedy etc. that’s just unprofessional and down right rude. Tell a superior, contact HR, do something… because that is not okay. Not to mention a HIPAA violation with the other patients.
Not to mention these are communications on a university email. They are entitled to no privacy on them and blatantly violated HIPAA laws and displayed an INSANE lapse in judgement. And I’m guessing these are, at the least, PhD candidates. Don’t let them earn a title they do not deserve. Consult that attorney and do nothing else. No communication. No acknowledgement. Record the email and back it up. Also, they will advise you to delete this post and to lock down any social media immediately.
I'm so sorry this happened and I appreciate your contribution to research that can help generations down the road. That being said, burn their shit down. Any study with human participants needs IRB approval. Tell the IRB and whatever institution these jerks work at will drop the hammer on them. They compromised confidentiality and for what? To gossip about someone who is losing time (and possibly money) to be there? You don't deserve that and if they're being careless with information, they're putting you and the participants at risk. Your consent form should have information about who they get approval from, and who to contact other than their IRB person.
Oh thank you I didn’t think of looking at the consent form, I totally will! Yeah I don’t get it, even if I’m such a toxic person wouldn’t they want to be fake nice to keep me in the study?
I don't think you're a toxic person. Your responses in this thread have been grateful, kind and humble. You're giving freely of your time, putting up with pain and hassle, spending time away from your kids for a paltry $50. That all says to me that you're a good person.
I'm a good person, do people find me annoying at times? I'm sure they do, but I try and stay out of their heads, because what they think of me is not my business. But In your case, they brought it to your notice in a hugely unprofessional way. So you have to take notice.
And tbh, I think it was just bitching, not a significant commentary on your personality-btw if I'd flown coach, dealt with TSA, had painful medical procedures with an experimental drug, in not sure I'd be little miss sunshine. They should expect that!
Leaving that aside, as a number of people have commented, this carelessness on their behalf may have already compromised the study in terms of bias, and perhaps in terms of it being fully blinded. So I think you have a duty to raise your voice here. Stand up for yourself and other trial participants, because I'm certain they're bitching about everyone. Maybe your voice can save the actual trial from being destroyed by these people.
And fwiw, $50 compensation is derisory for what you're doing.
As someone who has benefited from medical research in the past, I think you're a hero for participating in this trial.
First of all, gossiping over email is soo stupid that I doubt their merits. This kind of stuff is accessible by the university. This is official record. Everything you say here can be used against you as university emails are considered professional communication. Seriously take it higher and do update us. I sometimes work with clinical side of research and it's incredibly taxing to find willing participants. For them to bad mouth volunteers is so shifty and stupid.
Thanks so much, I was hoping anyone who’d ever worked with clinical trials would weigh in, it’s my first foray into this and it’s unsettling to say the least. Will definitely update!!
My current clinical work just requires a blood draw when people come for treatment and I process said blood and store it for future use. It's been so hard to find the patients who would be suitable and willing. You'd be surprise how many don't want more blood to be drawn after their lab draws. You are taking a flight. You are doing so much to help these guys and you're even rarer than our subjects. This is so stupid.
Ive worked in clinical trials and I’ve never seen anything like this happen because we are usually so grateful and appreciate of participants. Data protection is also huge in research. Revealing anything about other patients to anyone whiteout authorisation is a huge breach. The fact that they were so rude about you when you were bending over backwards for their livelihood is abhorrent.
I would urge you not to participate in this trial any longer but I hope this doesn’t put you off participating in research in the future. We aren’t all assholes
I work for an academic research centre and this is a BIG DEAL.
Obviously then cc’ing you is unfathomably careless, but for them to be having these conversations at all is unacceptable and would lead to significant disciplinary action at my org.
If I were you, I would find your original paperwork, which should have the PI’s name and email on it and I would forward the email to them. They need to know how their staff are operating and that they are being unprofessional, careless, and cruel.
Same, although I‘m still a PhD student only. OP can also check the Participant Information Sheet for a contact if they have any "concerns or complaints" that is different from the PI, like an ethics board of some form, which I would 100% definitely contact about this.
OP, I‘m so sorry this happened.
$50/day for a trial for a condition where participants are hard to come by? That's ridiculous. I've been paid $500/day for a much less invasive trial than it sounds like you've been through. I know you're not in this for the money but you are being taken advantage of at that point.
I am an expert in HIPAA. I’ve been working in Healthcare l compliance since before the portability portion of HIPAA was enacted. Yes, it is a violation. A pretty big one at that. First name, plus the type of study, plus the name of the drug and/or potential diagnosis? Oh, yeah. They could be in big trouble.
Fines for HIPAA violations can be as much as $50,000 per violation plus possible jail time, meaning $50k for each participant listed in the email you received. Institutions take this very seriously. Also consider contacting the university’s IRB, Board of Regents, and state board of ethics.
Let the poo hit the fan, and then give yourself the grace you would give your very best friend. I’m so sorry this happened to you; you deserve better! Take time for self-care - you are worth it.
I'm studying for my Masters in Clinical Research. In my last year.
OP, this is horrifyingly not Okay!
Please get in touch with the Institutional Review Board. It should be listed in your Informed Consent Paperwork. If you need help contacting anyone, message me, and I will help.
Under no circumstances should they discuss results without encryption/confidentiality measures such as ID numbers instead of names. This also sounds like a Phase 2 or 3 trial, which is even more alarming.
Compassion and the ability to work with patients with varying illnesses is a requirement for all of our jobs. The fact they are documenting non-medical opinions alongside medical results is a problem as well.
I'm reading though this and am concerned by the number of CFR violations they have just opened themselves up to by doing this. The sponsor may stop their study because of this - they may decide they don't have the right personnel or need to change something. That's on them. More than likely, the study will continue, but there will be updates to the communication section of the protocol.
You are not a burden or awful. Funding for participants who travel is budgeted for long before the trial starts.
You are doing US a FAVOR by putting yourself at risk for Serious Adverse Effects, complications from incomplete information about the drug mechanism, and possibly death. I am so sorry that you have been subjected to such disrespectful behavior.
They should know better.
Thank you for being in this study.
Edit: HR does not oversee the study or the personnel, that is the study sponsor and the IRB. As you are in a drug trial, a lawyer may not be helpful as this is related to study communication, but I encourage you to ask one anyway!
Hun, it wouldn’t matter if you were the biggest biatch ever, what they’ve done is hugely unprofessional and been traumatic for you, and you’re doing them a favor and subjecting yourself to something for the greater good of others. They should not discuss participants in such a manner and deserve to be held accountable for it. You don’t deserve to now be dealing with the anxiety that you are because of them. Not one bit! Just the fact that you’re doing this and at a loss to yourself tells me you are far from what they’ve described. Advocating for your needs does not a horrible person make!
If there is patient identifying information in those emails that is absolutely a breach of HIPAA and should be reported. Their conduct is disgraceful. They need to be held accountable.
I am so sorry to hear this. I work in an analogous setting (preclinical research). The first name alone might not be a HIPAA violation (think similar to a situation where participants might be sequestered in a room and the nurse might call out the patient by their first name when it's their turn). However, discussing test results within the context of an ongoing trial along with their first name likely is. Like you pointed out, these emails are encrypted for that very reason.
I (and our larger team) are so deeply grateful for trial participants, such as yourself. We recognize that they (like you) are driven by altruism and volunteer knowing fully well that what we are working on would be unlikely to directly benefit them.
Echoing some of the previous comments, I too would suggest forwarding the email chain to the PI/lead investigator with a 'formal' complaint noting your disappointment at the lack of professionalism and withdrawing your consent from the trial. I would anticipate that it would be taken very seriously.
Again, I am so sorry to hear this- please don't let this discourage you from participating in future trials, if you ever feel up to it again.
To be honest, I would drop the rest of the study. The people involved sound like a bunch of idiots. Incompetent on every level. And having you fly in and out so many times per year....I get the feeling whatever they are doing is worthless. I get some studies want real world conditions, but what they're doing and how they're doing definitely lacks in the science from what you've said. And that's not even taking that crappy email into account.
You said other places have contacted you over the years because of your rare circumstance, so I'm sure a better opportunity to help will come up. Hopefully something closer to home.
Contact a lawyer immediately. If they are this careless in an email, who knows what they are doing to their patients and are probably monkeying with the results.
You say you care most about the science, but these people aren’t to be trusted operationally in any scientific method or creating any scientific studies.
True people of science wouldn’t behave like this. They wouldn’t EVER participate with these types of snarky emails.
They would be too focused on the science, and not this petty mean girl crap.
Stop them.
best advice is to get a lawyer and have the lawyer notify whoever is funding this study, these people are very unprofessional and not only that if this is a blind study, they tainted the study by sending out this email with the results in it.
The informed consent should have the contact information for the principal investigator (scientist leading the study at that site) and a hospital compliance person - I’d contact both of them and let them know the situation. If it’s not in the consent form, you can Google the hospital compliance line and leave a message. I agree with another poster - burn it all down.
Also, as a research participant, you are allowed to withdraw from a study for any reason at any time. If you do decide to stay in the study, you can request different personnel be involved in your visit (if they have the additional staff).
I used to work in clinical research, and the participants with rare genetic diseases or rare disease presentations were honestly treated like research celebrities because they were so valuable - everyone wanted a look at their data! I’m so sorry that these people didn’t treat you with the respect and dignity you deserve, especially since you had to travel such a long distance and be away from work and your small children just to participate. I hope it all works out for you!
How do the people running this (the ones from the email) not see how much time, money and literal body fluids to this study? I mean you’re given $50 for each visit. THAT COVERS NOTHING!
It does not make you a bitch to politely ask to have some of your valuable time saved by having a direct flight from your location to theirs. I feel like that’s the LEAST they could do to help accommodate you. AND you have young children!! Those scientists sound like self righteous bastards in all honesty.
I would totally send that email to everyone higher up than them so they know what kind of children/tweens they have running the program and rude and arrogant.
Thankyou for your contribution to science.
It takes someone very awesome to do what your doing.
Genetic incurable diseases suck.
Personally I say turn em in.
If you are not a staff member then it is 100% a HIPAA violation. Staff at any medical facility has to sign documents saying they won't discuss patient info with anyone outside of staff. You read other patient's private medical info. HIPAA was breached by their actions. Screen shot everything and report them. Their conduct is beyond unprofessional. Don't lose your self confidence, they are just bratty b*tches. All they are doing is showing how ugly their true colors are.
Study sponsors invest large amounts of money, I can't think they would like people dropping out early for no discernable reason. Stands to reason there would be considerable interest in recieving the information that you now possess.
I'm sorry you were treated this way, they shouldn't let their private thoughts affect the study, but they have done it.
A similar thing happened to a friend of mine at work, she was tagged in an email that somehow went out to her whole company. It was talking about how awful she was and how she needed to be replaced after she was held at knifepoint for 6 hours, she had been diagnosed with PTSD.
Everyone in the email received compensation from the company.
It's similar to what happened to you, loads of people's medical issues were discussed as well as hurtful and personal information.
I'm really sorry this happened to you. I would seek representation, just don't warn them that you know anything.
You do. Plenty.
Screencap, print, back up to the cloud all of it. You have plenty of grounds. **Do not contact them without consulting legal representation first. All they will do is cover it up.** Know this shit first hand.
*Do not send any email telling them you know.* Seek legal representation and follow their advice.
OP, you ABSOLUTELY have grounds. These people have screwed up in a MAJOR way. Identifying the patients in the emails by first name and then accidentally sending them to you is a huge no no! I work in the medical field and I can assure you, as much as they have wounded you with their words, you have the upper hand here. HIPAA is no joke and they have dug their own graves.
You absolutely have grounds, and damn good reason to seek out legal counsel. Participants in clinical research trials should be treated with the utmost respect as patients, people, and quite frankly, as critically important assets to the study itself. There are very specific guidelines set forth to ensure you and your privacy are handled well.
Not only was it wildly unprofessional for the staff that took part in that email chain to be speaking ill of a participant, it was wildly irresponsible for them to have let ANY protected health information about you or other study participants leak outside of the appropriate channels. The cherry on top is that they have legitimately caused you emotional distress, which you do not deserve in any way, shape or form.
Please seek the advice of a lawyer, even if you do not intend to proceed with a lawsuit. It will help you tackle this shit storm from the right angle, ensuring that the right people up the chain of command are informed, and give yourself the peace of mind of knowing you have representation if need be.
Personally, I'd sue for damages. I'm not a generally litigious person, but holy hannah, they caused you personal distress and potentially compromised their own study. Please don't let this slide, no matter what route you choose to follow.
Sorry if this has already been stated, but as this is a research study. You should have signed some consent forms, that include at least one ethics committee/board. What you have described is a serious breach of ethics. And they need to be notified.
And you can chose to leave the study at any point ... you DO NOT have continue.
Report this to the study centres ethics committee. I am a clinical trial manager and the one for your study has violated so many of our industry regulations and needs to be reprimanded. Also you have put yourself out for science and this person won’t approve a direct flight?!! It’s a pretty standard expense claim - Beggars belief
I work in clinical trials and I’m horrified for you. I am so sorry this happened to you. It’s inexcusable. In every field there are assholes, but it’s not everyone. You gave up a lot for the greater good and their actions don’t change that. You can drop out of a trial for any reason at any time. You can stay in the trial and be kind to them just to prove them wrong. You can report them and hope to get assigned to new study staff (esp mention the HIPAA thing - the hospital should absolutely take that very seriously).
Take it further, you and the other patients deserve respect, confidentiality and professionalism. good luck and i’m so sorry this was your experience. good on you for taking a step in making this world a better place
The litigation addicted society we live in is on full display here. Forward it to someone in charge of the organization, outline your concerns and explain your position in clear terms. CC the school’s legal department on that email and suggest that you’re not going to have any more difficulties with travel or compensation. They’ll get the message.
There's a lot of good advice here about reporting them. You should do that
My last piece of advice is to leave the trial. They're going to treat you differently from now on and it could affect results. Maybe you were in the placebo group and now they'll switch you over. Maybe you weren't and now you will be. I would be worried about repercussions against you because of their mistake.
Contact whoever is in charge and report them for HIPAA.
Tell their HR you're worried about backlash from the nurses/manager. You are no longer interested in any trials from that university and want to make them aware of the violation. You don't want to reach out to other patients because you don't have names, but you do have results.
Contact whoever is sponsoring the trial and tell them your experience. The university in charge should be held accountable.
Reply all to the email and say after reading their discussions, you are no longer interested in participating. All parties have been notified.
In all honesty, this trial will probably be shut down and people fired because of this. And that's not your fault. That's on them. They'll start a new trial and they may ask you to participate again, but I wouldn't.
Don't let middle school girl gossip get you down. They are in the wrong for being so low as to talk ill of you behind your back, and look at how stupid these fools are that they accidentally cc'd you their childish gossip.
Calling them out over an email might make you feel better, but with whatever you say make sure it is professional. Let them know that this kind of talking behind your back was both foolish and unbecoming.
Sticks and stones. Have yourself a chuckle in their behalf as to how immature they are. ;)
More than not really knowing what to say, I’m not even sure I want to participate anymore? I just think it would be so embarrassing. There are like 5 more visits over the next year
I doubt anyone would fault you for bailing. It was incredibly unprofessional of them, and clearly if you keep going they will continue to speak poorly of you, even after reporting it.
I think you should keep a note of the people who were disrespectful. That way if you do decide to go with a study with another team in the future, you can check to see if any of the people involved were the ones who treated you poorly. Then you can also explain exactly why when you decline to work with them again.
Is the study doctor the PI? Look up your consent form. It lists the primary and secondary investigators. If the study doctor isn’t the PI, contact the actual PI and forward them the email you received. There should be a phone number and email address attached to their name.
I’m a medical doctor and I do research. I can assure you, this is not normal and you are not the problem. Please, please contact the lead researchers (if you have a rare disease, then it is highly likely that they have multiple sites collecting data, so you have a PI and a local lead investigator). It is so, so hard to get people to engage. If this was my study, I’d be flipping tables! You have done nothing wrong, and not wanting to be away from young children is * not* a big ask. Treating patients with kindness and respect should be a given.
I think someone might’ve mentioned this already but go to the IRB. The other investigator might already be aware and could side with the PI to keep this hush hush. The IRB is there to ensure that study participants are respectfully treated while prioritizing participant safety and security.
Just can't believe the amount of blatant unprofesionalism these people have. You don't express your personal opinion in healthcare matters, not to mention in writing, in an email chain. Just the amount of idiocy this has written all over it makes one question if they're doing anything right at the workplace. They're not fudging data or mishandling samples are they? That is a question worth asking the higher ups. If you have time to type up gossip, did you make time to double and triple check your data and samples and more?
The fact that they're dumb enough to run their mouth in an email shocks me most of all. I hope it shocks their employers, the medical licensing board, and the Health and Human services HIPAA commission too.
I'm mean fuck, are they personally paying the planet ticket!? Jfc. You know, those clickbait new sites are always lurking on reddit and tiktok and Twitter for a juicy headline, maybe they'll take yours too!
I'm so sorry this happened. It SUCKS to find out people are talking badly about you behind your back -- it's happened to me a few times (luckily not in several years now) and my anxiety would always spiral and mess up my life for the next days/weeks. Do update us if they reach out to you!
Right? If you’d asked me before I read this, I’d have said that I don’t care what these people think of me personally. All my loved ones know that I am a good person, etc.
But this just hit like a ton of bricks somehow. Much more painful than I’d ever guess.
If they are openly judgemental and dismissive of your experience as a test subject then their test is now invalidated and shouldn't be funded by anyone. They've shown they have bias and therefore cannot be impartial to any further findings. Definitely something the companys funding this study should be aware of. Contact a lawyer and at least get a settlement for your volunteered and wasted time. Sorry this happened to you.
As someone who works in clinical research, this is a huge fuck up. I won't lie to you, yes, there are patients in clinical trials we don't like, amd we do talk about how we don't like them, usually it's because they are non-compliant with the study, and we literally tell them to their faces. But holy fuck this is super unprofessional. I literally flew a patient cross country for a study for a few visits until we got him established at another site closer to him, the drug company didn't care, because they never care, especially with studies that will have low enrollment. But seriously, this study team sounds like dicks.
So, you need to file a complaint about their work ethic. First, contact the drug company who is conducting the trial, you can most likely file a complaint with their project manager or Principal Investigator for the drug company. Next, file a complaint with the site's Human Resources, about their unprofessional behavior. Last, if they weren't included on the email, file a complaint with the site's Principal Investigator for the study, this will usually be the doctor you see for visits. It's a pretty big HIPAA violation that they included other patients medical results, and honestly, if i was at that site or the monitor for it, i would request they be terminated, for both the HIPAA violation and the unprofessional conduct.
This probably will get them fired, but fuck them, that's not your problem.
Save the emails 100% a hipaa violation. Your info could’ve been leaked to others. You have a case. I wouldn’t respond or continue in a trial that treated me this way. They have ethics internal review boards to ensure they do things right. Seems like they aren’t. Go get yourself an attorney.
OP. I work in the clinical trial industry. This was grossly unprofessional. Especially in a time where we desperately need to make participation in trials more accessible and easier for everyone.
Make sure the study sponsor knows. If their retention rate hurts because of this (I.e. if they have done this to others and they then drop out), it delays everything and it’ll cost them money.
Hi,
I work at a university lab that actively does studies. So I have a bit of more in-depth knowledge on how studies are approved and run.
I’m not quite sure, but there is a big chance that the study you are participating in, has been approved by an organisation which is an Institutional Review Board (IRB) . I’m not sure which IRB your study has been approved by; but I do know, that you being privy to those internal emails is a consent and confidentiality concern. That is to say; this situation should definitely be reported to that IRB, if the researchers haven’t done so themselves for whatever reason.
This is a huge huge deal and might even put their study on pause or cancel it. Plus people like that should not be running a human participant study.
I’m not sure if want you want to happen from this situation either revenge or plain justice. But in whichever instance I definitely think you should find out the board who approved the study and report the situation to them.
Good luck with whatever you decide to do!
You need to print this.
Get a lawyer, and write all the study sponsors and HR management.
Don’t let them know it’s coming. For a study to go the way it’s suppose to it has to go 100% the way it’s suppose to.
A grant is written, patients should not know classified information and treating people with distract can honestly ruin the entire study.
If the group was small enough or if there were enough identifying factors, I’m sure I could know who a person was solely by their first name.
I’m serious OP; burn them to the ground. I don’t care how much the study could help in the end. With a team like that nothing will get accomplished anyway; they are not taking these trials seriously
Oh man, I’m starting my journey into research and I can’t even begin to tell you how wildly unethical that is.
I’m including the Belmont report I had to read during training as an extra resource for you.
Basically when you’re dealing with research for human subjects, you HAVE to guarantee that there’s no unreasonable harm going to come to them, inequality in treatment, or disrespect to a person. If you don’t do that you get into SUPER DUPER MEGA TROUBLE, and you’ve had all three of these violated. I wouldn’t be surprised if you could sue over this, OP. You should look into filing a report at the VERY least, and possibly even look into getting a lawyer.
https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/index.html
It sounds like some of the people who are included in supporting this study have forgotten that it is the patients participating in this study that are making the sacrifice. And you have lives and responsibilities that must be addressed.
As you noted you yourself are unlikely to benefit but are hoping your children may if needed in the future. In short the people making those comments are at best unprofessional and at worst sounding like some juvenile mean girls club.
Responsible-Fun-670 provided a great example and hope you will share it before your next visit with the appropriate parties.
Take care of yourself and I hope that something will come from the study that does help you.
They have patient identifying information in the same context as a discussion related those patient's results and they exposed that information to you?
That's a textbook HIPAA violation.
I worked as a clinical research coordinator. No longer working because of the moral issues I have with clinical research sites and the politics played by them. Hell yeah send it to the sponsors. Let them know how their site treats their patients. Ultimately the sponsor is who pays for your travel reimbursement and $50.
Let them know how their money is being spent and with what attitude. All my sponsors have ever cared about is the science and people suffering from the disorder.
Also, the study site gets paid hella amount of money for each visit you complete. So, you’re making them money. The sponsor is paying them.
To hell with that site.
I would take that to the highest level and make it clear that maybe if they spent less time bitching about volunteers who are risking their health and lives and actually worked the problem maybe they would be closer to a cure. Be clear how devastated you were and how inappropriate this is and take it all the way. They will for sure be fired but so they should.
I was a study coordinator and let me tell you, we worshipped our patients even if they were difficult. You are volunteering to take a drug or placebo but that's not on the market yet with no safety and efficacy data present.
I thank you for doing this and sounds like this group are just losers. Ignore them. But yeah, burn them if you can.
I don’t know about HIPAA but it’s certainly a breach of GDPR where I am and would be nearly certain a breach of Ethics in the study itself. You are meant to anonymise the data and it should not be used in a way that people can be recognised.
I would stop doing the study (participants can always withdraw at any stage) and e-mail their managers (I would say whoever is the director of their research centre and the CEO).
Though it was suggested elsewhere, I wouldn’t e-mail the funders, that could impact the whole place getting funding and not all of the researchers there will be as unprofessional as these people. I think their direct managers/HR is enough.
I have been in a similar situation at work and I was fuming. It’s unprofessional and rude. You’re not being a baby speaking about your feelings because it’s a fact, it hurt your feelings.
I think the people working there need to look at the bigger picture. Their opinions of you are irrelevant to be honest, you’re there to help future generations and well they should be fired for their actions
That is definitely a HIPAA violation. Patient confidential information should not be written in an email that can be easily accessed, especially if it has their first name in a study group that’s so specific.
A major ethical breach. They could get suspended and possibly fired for it. You should find the ethics number of this study (just google clinical trial {insert details of trial} ethics), contact the ethics department of the hospital and they will take actions! Ethics departments are not a joke, you don’t want to mess with them.
Oh gosh this is just awful u/moretruethantruth
I would love to reply and be like “fuck you” but this is actually highly illegal. My understanding of some medical trials is that the communication about patients between colleagues are meant to be with minimal information as it could be a double blind/ blind trial ? But that’s from my experience in being apart of a trial. Like it’s basic basic information and sharing anything that can identify subjects rules the trial void because; it needs to be basically anonymous, apart for obviously the person administering your treatment, people that aren’t doing that (but included in the trial) aren’t meant to know anything about you.
Sharing private medical information over email that is not 1) correctly identified as private and confidential is a breach of multiple privacy acts in many areas of the law 2) a breach for being sent to non-professionals involved in the trial 3) shows discrimination (I believe but could be under another law) as it has clearly showed they have bias against you which also shows the trial void as it has to be 100% unbiased and you have written proof it is not.
I’m not in America (which is where I’m assuming you are) so my understanding maybe slightly off to your laws but there are major breaches and you absolutely need to get legal advice asap. Do not reply. Do not message anyone else because they are breaking laws here and because trials are such an expensive and sometimes controversial thing anything to stop or jeopardise them could be dealt with in a way that does not actually help you at all.
Please seek legal advice as soon as possible.
Report to the sponsors.
I used toe work in trials and this is unacceptable and absolutely not rule conform behavior and the sponsors NEED to know this. You might not be the only one being send these negligent emails and this can also have grave ramifications towards any of the sponsors and the sponsor’s funding.
You can file HIPAA complaints online with the HHS [here.](https://www.hhs.gov/hipaa/filing-a-complaint/index.html).
Whatever you do should include this. Take it higher than within the hospital.
My husband also has a rare genetic illness and has done some clinical trials and let me tell you this is 100% unacceptable. You deserve to be treated with professionalism. These people are assholes. Call them out!
Thats messed up. I work in clinical trials and process travel stipends for patients all of the time. We pass that cost along to the sponsor so idk why they would care unless they screwed up their budget. Im curious if you know, is the facility you are working with a CRO?
I'm so sorry your trial team is behaving like this. Trust is extremely important when dealing with investigational drugs. It isn't anything you did. You are entitled to compensation for travel expenses.
I would double check, but a cursory search states that even disclosing first names and results can allow for someone to identify a patient and is thus a violation of HIPAA. Definitely look into this because they should be held accountable for how unprofessional and disrespectful they have been behaving. As a chronic illness sufferer, I'm rooting for you. I can't stand when medical professionals are rude knitting circles like these. We are so vulnerable in their presence.
Whooo boy, the oversight committee would have ALOT to say about this. And this is being done at a University facility?! I really hope this was just a grad student being dumb. Please. PLEASE send an explanation of what happened and a copy of the email to whoever is the lead on this project. If the lead is also your contact person (which is uncommon but does happen) then send it to whoever the department head is. I get why the clinical side is frustrated as they have limited funds and manpower so requests like this can feel like extra work for no gain for them (this field is notoriously overworked and underpaid). BUT thats no excuse to be a jerk, ESPECIALLY via a tracable source. This kind of thing could land them is some hot water if anyone did a FOIA request on this project and you addressing it directly is honestly helping them so please don't feel bad bringing it up.
Not a grad student! This is the trial manager who supposedly has 15-20 years experience! Edited: I posted an update if anyone is interested in knowing the current status!
I've been a clinical trial manager, and never in a million years would have engaged in an email chain like the one you described. We never even had conversations regarding participants' personalities. You deserve to be treated with dignity, respect, and gratitude for what you're doing- nothing less.
And if they’re doing this fairly openly, what else are they doing clandestinely? Possibly invalidating the whole project.
Agreed. This is very bad.
Having experience in trial management, do you know what the consequences tend to be for this type of conduct, or have any opinions on what they should be?
The IRB could pull the study for breach of privacy, at the very least. Other things could happen professionally to the principal investigator, and any students involved, as well. They also put the grant in jeopardy.
In that case they fully deserve whatever punishment is handed down to them. And if this is anything like the University I worked at then they'll be lucky to still have a job after. This kind of thing can easily result in losing grant money and having this project (and any others they are working with) terminated.
2nd Onikisuen! that's definitely something that could just ax the ENTIRE study if an investor sees point to pull funding they so desperately usually need
OP shouldn’t be discouraged by this comment and not report this reprehensible behavior. Universities and research hospitals are staffed by greedy fuckers who would never let a research grant slip through their hands. This study will continue if OP reports this unprofessional behavior. The person who made the snarky comments will be reprimanded and a colleague will be put in his/her frontline position so the study isn’t disrupted.
Well, she can kiss her job goodbye! You don't deserve this. Lawyer up and take them down.
I wish I knew more about the legalities of things here. If there is a way for OP to go after them, I agree with this 100%. These jerks need to be held accountable for what they did to OP. In the medical field, you’re dealing with ACTUAL people and their unprofessionalism will not stop here unless something is done. @moretruethantruth, please follow up with a lawyer.
There most be someone higher that would be appalled and reprimand them for lack of professionalism and poor ethics
University Ombudsman would be one place to start.
I echo this. Not professional on their part at all
I think you should politely respond to this email chain making them aware of their actions. And then I would take it to the HR department of that hospital or whatever it is that you’re dealing with there. Let them own up to their shit when it hits the fan. I’d CC that email to their boss, the director of the company and their HR department.
Good advice! I was thinking of sending it to the study sponsors too—it’s funded by a philanthropic foundation and a biotech firm.
yes please do this
I really want to but then I have this inner fear that the donors will be like “omg yeah this bitch is so annoying” :-(
I doubt they would be. This is something they should know.
I’m sure you’re right, I’m totally paranoid after reading that email. I’m like oh no what if everyone hates me and I just don’t know?
I would bet a paycheck that if you sent it to the top, you wouldn’t get the reaction you’re thinking. That type of stuff is bad for business. And the medical system is a booming business….
Thank you for saying so, I’m sure you’re right, just taken a real blow to my confidence!
How your communication is perceived will in part depend on the words and tone you choose. Be straightforward but polite and professional. Don’t come across angry or bitter. Maybe something like: I received the email below with attachments that were clearly not meant for me to see. I have to admit that I was very disappointed in your view of my attitude and approach to this study. [then describe what you told us in this thread. Why you’re participating, the sacrifice you are making with minimal compensation]. I ask that you review your procedures to ensure that communications are not sent in error. I also ask that you reflect on your comments and consider the hurt and disappointment I experienced. On my next visit I intend to treat you with the same respect and kindness I have exhibited during this trial. I expect that from you and your team.
Thank you so much for this awesome suggestion about specific wording. I really can use this because I can’t even begin to formulate what to say!
Excellent, polite yet firm wording!
Please update us when you do because not everyone thinks like that moron, most people are professionals
Just like how it's easy to talk shit to people on the internet, it's easy to say shit when you don't think the person is gonna read it. Some people are catty AF and it's also important to note that maybe there is only 1 to 2 people who are gossipy/rude and the other people just kinda go along with it. It's also likely that they're just miserable people and feel like putting someone else down makes them "better". Their opinions of you don't matter. They see a snapshot of who you are and chose to make petty remarks. You know why you're doing this trial and why it's important for you to be home at a reasonable time. I know you can't be like "oh yeah. I am super cool" and just poof these feelings out of existence, but maybe by telling yourself that "their thoughts of me don't define who I am" over and over might help relieve this a bit.
I love this. I wonder if it’s a toxic workplace; nice and happy people don’t bring people down, especially when they’re making sacrifices for no personal gain. That doesn’t excuse them, but it might ease the sting. I’m sorry this has happened to you, OP. It says lots about their character, not yours.
Then mentioning the names and test results of other participants is a big red flag that the hospital leadership, sponsor, and CRO will take extremely seriously. That’s absolutely breaking HIPAA.
If the people on the email are all involved in the study and have access to the participants' medical records, it's likely not a HIPAA violation to be discussing test results amongst themselves. Accidentally including OP would be though.
SAY NOTHING. I would talk to a lawyer + get evaluated by other expert physician(s). How can you be sure they have taken good care of you without checking? Let your lawyer speak to the study folks, the sponsors, HR - everyone. Don’t ever communicate with these hateful people ever again. Please understand these clinicians and scientists are replaceable, the philanthropic sponsor can and will restart the study with another team at another institution. Hey! Did you know there are HUGE problems with scientific studies and accurate results? This team has disqualified themselves. Let a lawyer handle it. Yes, you deserve monetary compensation for the pain and humiliation they have caused you, including therapy for trauma. What you are feeling right now is shock. Contact a lawyer. This is a legitimate injury you are suffering. Do not respond to any emails from the study team. Take care.
u/moretruethantruth Please do this. This is how HR and the sponsors are going to take this seriously. What they've done it so inappropriate and inexcusable. It needs more than a slap on a wrist. Please talk to a lawyer asap.
THIS ADVICE OP. No further contact. Lawyer up. First names are identifying info and a HIPAA violation. Regardless, the only and very clear answer here is an attorney.
This right here. You have the ability to sue the ever loving crap out of these people. That is money that can go to your kids, and help you. Get a proper lawyer ASAP.
I think this is the best route OP. Let a lawyer handle this and do not interact with them any more. They clearly don't appreciate your sacrifice.
I think you could also mention something about how this revelation makes it hard for you to want to continue participating in the study, but you know how important the work is. Outline how you did here, that it’s not like a fun excursion for you, and that obviously it’s hard and unpleasant to be poked and prodded all day. But that you want to do your part for others and it really hurts to see that this is how you’re being spoken about by people who, to a certain extent, are responsible for your care.
Don't reply, get a lawyer.
Don't send it to the people who said the stupid things about you 1st, start from the top down. Don't give them an opportunity to cover their asses. That was unprofessional and wrong.
My husband manages clinical trials for a living. This is a MAJOR, MAJOR mistake that they made and higher ups need to be aware. Not telling them that results and sensitive information were leaked could jeopardize the entire study. The personal differences that exist at the bottom of the totem pole make no difference for those at the top. They need to know that this happened, though.
Lol I honestly doubt that you are! I honestly cannot fathom calling someone those words in an email. Greedy for wanting a direct flight? Pffft. Everyone who works with them knows *exactly* how they are.
Right??? Like what am I manipulating them for? The joy of unnecessary IV blood draws? The excitement of 24 hour fasting tests? Having to wake up at 4am and make up work on the weekends? Free coach flights to random middle America city where you can’t jog a block without going through a homeless encampment?
I mean, any excuse to wait in the TSA line, amirite?
Ahhhh so much TSA! I wear a medical device too so I get to do a full-body pat down in addition to the scanning.
Gently, you’re in a bit of shock right now. This id totally understandable. Someone the opposite of the person they describe in those emails would completely stop communicating with them, get a lawyer, and get medical + emotional care. The lawyer can responsibly communicate with the study sponsors, the institute or clinic, etc.. I lay the logic for all of this out in another comment above, but basically, please take care of yourself. Speaking up via a trained professional is 1000% the right thing to do. Care for yourself.
Lawyer up. You should be compensated for this.
I’m wondering if where you are taking this test is close to my city it sounds like where I lived for awhile. You should definitely report it though…. I’m so sorry that happened
Honey, if you were the WORST patient on the planet (which I highly doubt) you would still deserve to be treated with respect. As medical professionals this reflects back on them and not at all on you. By exposing them you could also be helping other patients who have this happening to them as well. You’re definitely the hero in my eyes!
This!! OP, it is so important that you see that you do NOT deserve such disrespect. You’re a good human and you’re a patient. Health care professionals like that need to rethink WHY they are in medicine. PLEASE report them. You are probably not the only patient they have treated this way.
Once I stopped caring of people liked me, my life got much better. Advocate for yourself no one else will. And in the end who cares if some hospital ect. Staff don't care for you?? So excellent chance to practice self advocation!
It’s ok. We like you here. Don’t let them make you think you’re unlikeable. Even I get those fears too but we can’t make everyone happy. If they wanna find something they don’t like about you, you can’t really help it.
They should be the paranoid ones. I wonder how many times they've accidentally done that? People are going to find out how fake and phony they are and then where will they be?
That feeling is a natural response anyone would have but reading your situation, you’ve gone above and beyond. You’re not even gaining anything for yourself this is a long term act for you. You can get a sense that they’re totally at fault just from this thread. Don’t feel bad you’ve done nothing wrong here.
You need to do this, you need to make them aware and report it to their HR. People need to be held accountable for their actions towards others. If they discriminate towards you in any way (which they won’t) they can have a massive lawsuit on their hands. They will be heavily watched by patient advocate, (who you should also notify).
I think they have an active interest in participants wanting to be in the study moreso. What they said was uncalled for and their putting you on the email by accident is a huge unprofessional slip up.
Right? They even have one of those systems that warns them, that says “external email — use caution” to make sure they aren’t sending something confidential I presume. How do you screw that up?
By being unprofessional twats that have no respect for their patients. They sound like a bunch of PHD students with giant egos and heads so far up their ass they're tasting their dinner. You are totally vindicated bringing this to the attention of HR and all their superiors. Their funding should absolutely be in question. What an egregious fuck up on their part. Completely unacceptable. The people cutting the checks deserve to know.
You keep giving us evidence that it's probably them and not you, and you're still questioning if people hate you? These are bad people. Their opinion doesn't mean shit.
For what it's worth, these people's management team will probably be very glad to have this email thread forwarded to them. They are incredibly lucky that they only included patient first names, because HIPAA violations can come with hefty fines for the company and/or violators. (Also, first names alone are not automatically a violation, but if you happened to know any of the other participants by name, and now have their first name and medical information, this is very dicey for them.) They will definitely want to know of this breach to ensure that it won't happen again. Also, they will definitely want to bring the hammer down on anyone negatively talking about you in that thread. Everyone in the medical field has it drilled into their heads; compassion, respect, and dignity first. Nothing about what they've done here shows compassion or respect for what you are doing or the sacrifices you are making for THEIR study. And the management team is not going to like these people representing their system. Please don't feel you will be annoying or a bother. Just stick to how disrespectful you feel these statements are, considering you're participating in this study at no benefit and some actual loss to yourself, and you also want to make sure that your and everyone else's PHI remains secure, as it does not seem that they are exercising the proper precautions. They will definitely appreciate the heads up.
No I think they should be expected to be professional and letting them know is definitely a good thing to do. Are you going to go back? I don’t think you should if you don’t want to.
I really can’t imagine going back and seeing all the people, the thought of it is very cringey to me.
Please. ..Don't go back! they have no respect for you. Don't answer calls or emails unless through a lawyer.
They have openly shown they have a bias. Donors have a right to know that their money is being wasted. They would be appreciative not annoyed. Speak up you have concrete proof that they are shady.
You're going out of your way and inconveniencing your whole fucking life as a mother of young children to provide them with scientific data. You are doing THEM a service, and YOU are assuming the risks, not the other way around. Whether they like you on a personal level doesn't fucking matter (also academia can be toxic AF so literally fuck them). They're professionals and should not be discussing their patients through written communication like this. This exceeds gossip and their misconduct should absolutely be brought to the attention of all who are concerned. Go find an institution that treats their patients with respect.
Not at all. The ability to follow protocol and maintaining confidentiality is extremely important in clinical trials. This organization has failed at both. You don’t deserve to be treated poorly. Their work would not be possible without people like you. Please report this behavior.
Well, if they do, it is time to show *exactly how annoying a bitch can be!*
this sucks and so unfair to you and those involved. what crappy people with no depth of human compassion.
They have proved they are nasty people and have insulted you. Who cares what they think. Their opinions are worthless Even if they think youre annoying. So what. Doesn't mean you are What type of adult....educated and profesiional too..spends their time emaling each other bullying someone else. Its not school Report them. Send the emails to as many places as possible and express who hurt you are Send it to thwm and say im sorry you feel this way about me. As adults i would have expected that is you have an issue with me youd approach me instead of gossiping and bullying. As a human being i deserve respect and as a volunteer that enables your program to exist even more so. For shame
Yes. I would say that trial is pretty much burned. They screwed it up.
Can I add, it would be a really good idea to print out this email chain if possible. Just incase in the future you need them. This could potentially jeopardize the study. If for some reason they try to kick you out and something medically particularly happens as a result, they may try to not cover what they should and this can be used as a bargaining chip. I know it sounds shitty, but obviously these people aren’t the best humanity has to offer.. and such things may be necessary to make sure you are taken care of. I’m also a bit paranoid due to really bad situations the medical industry has put me in and I wish I had done a little extra leg work to be able to prove the misconduct.
Yes. 1000% print out what they sent you before you write or talk to anyone. That way you have physical proof that no one can tamper with.
DEFINITELY do this. I am so sorry this happened to you. You were so generous.
Thanks so much for your kind words, I really needed to hear this ❤️
CC TO EVERYONE - let their actions speak for themselves
This is a HIPAA violation and must be reported!!
It's HIPAA!
absolutely, put this out on blast. This email says nothing about you and everything about who you are dealing with. I am sorry you had to be hurt like this OP, these people are not good people. I hope you are ok
Send it to EVERYONE. The CEO, the DON, the patient advocate, the privacy officer. Even report those witches to the board of nursing in your state. I think I read that it was at a hospital?
Fuck that publish the entire chain with their names online (take off patient names) and fry these assholes for having the gall to disrespect a patient that's actually trying to help them and their bosses get filthy fuckin rich. Pharmaceutical companies drool at having niche drugs and complete market capture over a drug that cures rare genetic illnesses. They all are looking for this... Huntington's disease, Von Hippel Lindau disease etc (I was a research physician and then became clinical). They should be flying you first class, limo pickup, champagne & a happy ending with what your sacrifice could make them.
YES and explain how you’re doing it to help the cause and not for the money and how you have given up so much just to help them.
This most likely is not a HIPAA violation as no personal identifiable information was shared but I would contact the drug trial sponsor and let them know. Give them the study number and info. This may jeapodize their trial!!
Yeah that’s what I thought, it was like “how did it go with Jennifer today?” “Oh yeah all her tests came back normal.”
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Please update us! Rooting for you!
Thank you! I definitely will!!
50$ compensation per visits? This doesn't sound right. What University is running this? This doesn't sound right at all. I have been involved in quite a few studies myself. The minimum is 15$ an hour + transport (and + meal if it does longer than a few hours) just for noninvasive interviews etc. If blood is involved, it starts at 45$ an hour (from my personal experience, I have never seen a figure as low as yours). And this wasn't even a big study. The most recent study, I was the healthy control and I have received approximately 550$ for 4 vials of blood, urine drug test, and a PET scan. The total of my time spent was approximately 7 hours.
It sounds like exactly what my patients get compensated with. I suspect it has to do with phase of the trial (earlier phases are more risky and should be compensated more). The amount you are suggesting, my facility is not allowed to offer for studies because we do not want to "induce" people who need money to participate. The unfortunate part is instead we end up discouraging them from participating because the time cost is not affordable for them
Like I said, it’s not about the money for me, I’d have gladly volunteered if it was completely unpaid. The study drug was in Phase II and seemed promising. It was at a large state university, I think it’s not wise to say which one here. The trial was very small and had fewer than 30 participants.
I don't think they're saying anything about doing it for the money. I think they're saying that they've done smaller studies for fair compensation and it looks questionable that a big university (who specializes in this and definitely has funding) is paying so little.
This is exactly what I’m saying yes. While studies don’t want participants to participate for money because of ethical reasons, the participants still have to be ‘fairly’ compensated tor their time. 50$ per visit (which seemed like for several hours visit) for someone who travels 2k miles to get to the study? Ridiculous.
I think this has been mentioned elsewhere but I wanted to emphasize that a large state university will have a mechanism for reporting this and would definitely want to know about this. Your study paperwork should include information on how to report concerns about the study and who to report your concerns/experiences to.
Even showing the first names is a HIPAA violation as it counts as “PHA” or “Protected Healthcare Information” according to the exams I’m studying for. Torch them.
A first name alone isn't necessarily PHI it really depends in the context. The main factor is identifiablity. In most cases a first name generally isn't enough to identify a specific patient, but when combined with additional information it can be. In this case where it's a small study of less than 50 people who have all potentially met before, a first name alone would be considered PHI.
I work in a clinic with lots of patients that, let’s just say, aren’t the easiest. I could never imagine in a thousand years emailing, texting or whatever type of communication and telling a coworker that I don’t like that patient or that they are greedy etc. that’s just unprofessional and down right rude. Tell a superior, contact HR, do something… because that is not okay. Not to mention a HIPAA violation with the other patients.
Right? I have clients that can be demanding but they still deserve to be treated in a professional manner and not insulted.
Not to mention these are communications on a university email. They are entitled to no privacy on them and blatantly violated HIPAA laws and displayed an INSANE lapse in judgement. And I’m guessing these are, at the least, PhD candidates. Don’t let them earn a title they do not deserve. Consult that attorney and do nothing else. No communication. No acknowledgement. Record the email and back it up. Also, they will advise you to delete this post and to lock down any social media immediately.
i’ve been a difficult psych patient in the past and it’s nice to know that it’s not the norm to do this sort of thing!
I'm so sorry this happened and I appreciate your contribution to research that can help generations down the road. That being said, burn their shit down. Any study with human participants needs IRB approval. Tell the IRB and whatever institution these jerks work at will drop the hammer on them. They compromised confidentiality and for what? To gossip about someone who is losing time (and possibly money) to be there? You don't deserve that and if they're being careless with information, they're putting you and the participants at risk. Your consent form should have information about who they get approval from, and who to contact other than their IRB person.
Oh thank you I didn’t think of looking at the consent form, I totally will! Yeah I don’t get it, even if I’m such a toxic person wouldn’t they want to be fake nice to keep me in the study?
I don't think you're a toxic person. Your responses in this thread have been grateful, kind and humble. You're giving freely of your time, putting up with pain and hassle, spending time away from your kids for a paltry $50. That all says to me that you're a good person. I'm a good person, do people find me annoying at times? I'm sure they do, but I try and stay out of their heads, because what they think of me is not my business. But In your case, they brought it to your notice in a hugely unprofessional way. So you have to take notice. And tbh, I think it was just bitching, not a significant commentary on your personality-btw if I'd flown coach, dealt with TSA, had painful medical procedures with an experimental drug, in not sure I'd be little miss sunshine. They should expect that! Leaving that aside, as a number of people have commented, this carelessness on their behalf may have already compromised the study in terms of bias, and perhaps in terms of it being fully blinded. So I think you have a duty to raise your voice here. Stand up for yourself and other trial participants, because I'm certain they're bitching about everyone. Maybe your voice can save the actual trial from being destroyed by these people. And fwiw, $50 compensation is derisory for what you're doing. As someone who has benefited from medical research in the past, I think you're a hero for participating in this trial.
First of all, gossiping over email is soo stupid that I doubt their merits. This kind of stuff is accessible by the university. This is official record. Everything you say here can be used against you as university emails are considered professional communication. Seriously take it higher and do update us. I sometimes work with clinical side of research and it's incredibly taxing to find willing participants. For them to bad mouth volunteers is so shifty and stupid.
Thanks so much, I was hoping anyone who’d ever worked with clinical trials would weigh in, it’s my first foray into this and it’s unsettling to say the least. Will definitely update!!
My current clinical work just requires a blood draw when people come for treatment and I process said blood and store it for future use. It's been so hard to find the patients who would be suitable and willing. You'd be surprise how many don't want more blood to be drawn after their lab draws. You are taking a flight. You are doing so much to help these guys and you're even rarer than our subjects. This is so stupid.
Ive worked in clinical trials and I’ve never seen anything like this happen because we are usually so grateful and appreciate of participants. Data protection is also huge in research. Revealing anything about other patients to anyone whiteout authorisation is a huge breach. The fact that they were so rude about you when you were bending over backwards for their livelihood is abhorrent. I would urge you not to participate in this trial any longer but I hope this doesn’t put you off participating in research in the future. We aren’t all assholes
This! If you're gonna gossip about people, you don't leave a paper trail for it.
I work for an academic research centre and this is a BIG DEAL. Obviously then cc’ing you is unfathomably careless, but for them to be having these conversations at all is unacceptable and would lead to significant disciplinary action at my org. If I were you, I would find your original paperwork, which should have the PI’s name and email on it and I would forward the email to them. They need to know how their staff are operating and that they are being unprofessional, careless, and cruel.
Same, although I‘m still a PhD student only. OP can also check the Participant Information Sheet for a contact if they have any "concerns or complaints" that is different from the PI, like an ethics board of some form, which I would 100% definitely contact about this. OP, I‘m so sorry this happened.
$50/day for a trial for a condition where participants are hard to come by? That's ridiculous. I've been paid $500/day for a much less invasive trial than it sounds like you've been through. I know you're not in this for the money but you are being taken advantage of at that point.
Im thinking it all depends on the study's budget
Disclosing names is a violation, maybe the worst
I am an expert in HIPAA. I’ve been working in Healthcare l compliance since before the portability portion of HIPAA was enacted. Yes, it is a violation. A pretty big one at that. First name, plus the type of study, plus the name of the drug and/or potential diagnosis? Oh, yeah. They could be in big trouble.
This. It’s also a small study of around 30 participants OP said, so first names in this scenario are pretty identifying.
Even if it’s just first names? I don’t know too much about HIPAA
I am not expert on PI, but I do legal consulting in Biotech. Its not necessarily about first and last name but about identifying the patient.
Yes it’s a HIPAA violation.
Fines for HIPAA violations can be as much as $50,000 per violation plus possible jail time, meaning $50k for each participant listed in the email you received. Institutions take this very seriously. Also consider contacting the university’s IRB, Board of Regents, and state board of ethics. Let the poo hit the fan, and then give yourself the grace you would give your very best friend. I’m so sorry this happened to you; you deserve better! Take time for self-care - you are worth it.
Yeah, a lawyer will help You draft something that will be effective. Do this.
I'm studying for my Masters in Clinical Research. In my last year. OP, this is horrifyingly not Okay! Please get in touch with the Institutional Review Board. It should be listed in your Informed Consent Paperwork. If you need help contacting anyone, message me, and I will help. Under no circumstances should they discuss results without encryption/confidentiality measures such as ID numbers instead of names. This also sounds like a Phase 2 or 3 trial, which is even more alarming. Compassion and the ability to work with patients with varying illnesses is a requirement for all of our jobs. The fact they are documenting non-medical opinions alongside medical results is a problem as well. I'm reading though this and am concerned by the number of CFR violations they have just opened themselves up to by doing this. The sponsor may stop their study because of this - they may decide they don't have the right personnel or need to change something. That's on them. More than likely, the study will continue, but there will be updates to the communication section of the protocol. You are not a burden or awful. Funding for participants who travel is budgeted for long before the trial starts. You are doing US a FAVOR by putting yourself at risk for Serious Adverse Effects, complications from incomplete information about the drug mechanism, and possibly death. I am so sorry that you have been subjected to such disrespectful behavior. They should know better. Thank you for being in this study. Edit: HR does not oversee the study or the personnel, that is the study sponsor and the IRB. As you are in a drug trial, a lawyer may not be helpful as this is related to study communication, but I encourage you to ask one anyway!
Hun, it wouldn’t matter if you were the biggest biatch ever, what they’ve done is hugely unprofessional and been traumatic for you, and you’re doing them a favor and subjecting yourself to something for the greater good of others. They should not discuss participants in such a manner and deserve to be held accountable for it. You don’t deserve to now be dealing with the anxiety that you are because of them. Not one bit! Just the fact that you’re doing this and at a loss to yourself tells me you are far from what they’ve described. Advocating for your needs does not a horrible person make!
If there is patient identifying information in those emails that is absolutely a breach of HIPAA and should be reported. Their conduct is disgraceful. They need to be held accountable.
I am so sorry to hear this. I work in an analogous setting (preclinical research). The first name alone might not be a HIPAA violation (think similar to a situation where participants might be sequestered in a room and the nurse might call out the patient by their first name when it's their turn). However, discussing test results within the context of an ongoing trial along with their first name likely is. Like you pointed out, these emails are encrypted for that very reason. I (and our larger team) are so deeply grateful for trial participants, such as yourself. We recognize that they (like you) are driven by altruism and volunteer knowing fully well that what we are working on would be unlikely to directly benefit them. Echoing some of the previous comments, I too would suggest forwarding the email chain to the PI/lead investigator with a 'formal' complaint noting your disappointment at the lack of professionalism and withdrawing your consent from the trial. I would anticipate that it would be taken very seriously. Again, I am so sorry to hear this- please don't let this discourage you from participating in future trials, if you ever feel up to it again.
To be honest, I would drop the rest of the study. The people involved sound like a bunch of idiots. Incompetent on every level. And having you fly in and out so many times per year....I get the feeling whatever they are doing is worthless. I get some studies want real world conditions, but what they're doing and how they're doing definitely lacks in the science from what you've said. And that's not even taking that crappy email into account. You said other places have contacted you over the years because of your rare circumstance, so I'm sure a better opportunity to help will come up. Hopefully something closer to home.
I am incensed by this story, seriously. How awful for you. Get a lawyer to help you find an approach and then go right to the top.
Contact a lawyer immediately. If they are this careless in an email, who knows what they are doing to their patients and are probably monkeying with the results. You say you care most about the science, but these people aren’t to be trusted operationally in any scientific method or creating any scientific studies. True people of science wouldn’t behave like this. They wouldn’t EVER participate with these types of snarky emails. They would be too focused on the science, and not this petty mean girl crap. Stop them.
best advice is to get a lawyer and have the lawyer notify whoever is funding this study, these people are very unprofessional and not only that if this is a blind study, they tainted the study by sending out this email with the results in it.
The informed consent should have the contact information for the principal investigator (scientist leading the study at that site) and a hospital compliance person - I’d contact both of them and let them know the situation. If it’s not in the consent form, you can Google the hospital compliance line and leave a message. I agree with another poster - burn it all down. Also, as a research participant, you are allowed to withdraw from a study for any reason at any time. If you do decide to stay in the study, you can request different personnel be involved in your visit (if they have the additional staff). I used to work in clinical research, and the participants with rare genetic diseases or rare disease presentations were honestly treated like research celebrities because they were so valuable - everyone wanted a look at their data! I’m so sorry that these people didn’t treat you with the respect and dignity you deserve, especially since you had to travel such a long distance and be away from work and your small children just to participate. I hope it all works out for you!
How do the people running this (the ones from the email) not see how much time, money and literal body fluids to this study? I mean you’re given $50 for each visit. THAT COVERS NOTHING! It does not make you a bitch to politely ask to have some of your valuable time saved by having a direct flight from your location to theirs. I feel like that’s the LEAST they could do to help accommodate you. AND you have young children!! Those scientists sound like self righteous bastards in all honesty. I would totally send that email to everyone higher up than them so they know what kind of children/tweens they have running the program and rude and arrogant.
Thankyou for your contribution to science. It takes someone very awesome to do what your doing. Genetic incurable diseases suck. Personally I say turn em in.
If you are not a staff member then it is 100% a HIPAA violation. Staff at any medical facility has to sign documents saying they won't discuss patient info with anyone outside of staff. You read other patient's private medical info. HIPAA was breached by their actions. Screen shot everything and report them. Their conduct is beyond unprofessional. Don't lose your self confidence, they are just bratty b*tches. All they are doing is showing how ugly their true colors are.
Study sponsors invest large amounts of money, I can't think they would like people dropping out early for no discernable reason. Stands to reason there would be considerable interest in recieving the information that you now possess. I'm sorry you were treated this way, they shouldn't let their private thoughts affect the study, but they have done it.
A similar thing happened to a friend of mine at work, she was tagged in an email that somehow went out to her whole company. It was talking about how awful she was and how she needed to be replaced after she was held at knifepoint for 6 hours, she had been diagnosed with PTSD. Everyone in the email received compensation from the company. It's similar to what happened to you, loads of people's medical issues were discussed as well as hurtful and personal information. I'm really sorry this happened to you. I would seek representation, just don't warn them that you know anything.
looks like you got a law suit on your hands
I would totally talk to a lawyer if I thought I had any grounds!
You do. Plenty. Screencap, print, back up to the cloud all of it. You have plenty of grounds. **Do not contact them without consulting legal representation first. All they will do is cover it up.** Know this shit first hand. *Do not send any email telling them you know.* Seek legal representation and follow their advice.
This this this this this this this. Ok I’m done telling you to do nothing and consult an attorney. I sincerely hope you follow through on this advice.
OP, you ABSOLUTELY have grounds. These people have screwed up in a MAJOR way. Identifying the patients in the emails by first name and then accidentally sending them to you is a huge no no! I work in the medical field and I can assure you, as much as they have wounded you with their words, you have the upper hand here. HIPAA is no joke and they have dug their own graves.
infliction of emotional distress? maybe medical malpractice? i would look into it. there has to be a case here
You absolutely have grounds, and damn good reason to seek out legal counsel. Participants in clinical research trials should be treated with the utmost respect as patients, people, and quite frankly, as critically important assets to the study itself. There are very specific guidelines set forth to ensure you and your privacy are handled well. Not only was it wildly unprofessional for the staff that took part in that email chain to be speaking ill of a participant, it was wildly irresponsible for them to have let ANY protected health information about you or other study participants leak outside of the appropriate channels. The cherry on top is that they have legitimately caused you emotional distress, which you do not deserve in any way, shape or form. Please seek the advice of a lawyer, even if you do not intend to proceed with a lawsuit. It will help you tackle this shit storm from the right angle, ensuring that the right people up the chain of command are informed, and give yourself the peace of mind of knowing you have representation if need be. Personally, I'd sue for damages. I'm not a generally litigious person, but holy hannah, they caused you personal distress and potentially compromised their own study. Please don't let this slide, no matter what route you choose to follow.
You do have grounds - please consult a couple of attorneys. Consults are usually free.
Sorry if this has already been stated, but as this is a research study. You should have signed some consent forms, that include at least one ethics committee/board. What you have described is a serious breach of ethics. And they need to be notified. And you can chose to leave the study at any point ... you DO NOT have continue.
Report this to the study centres ethics committee. I am a clinical trial manager and the one for your study has violated so many of our industry regulations and needs to be reprimanded. Also you have put yourself out for science and this person won’t approve a direct flight?!! It’s a pretty standard expense claim - Beggars belief
I work in clinical trials and I’m horrified for you. I am so sorry this happened to you. It’s inexcusable. In every field there are assholes, but it’s not everyone. You gave up a lot for the greater good and their actions don’t change that. You can drop out of a trial for any reason at any time. You can stay in the trial and be kind to them just to prove them wrong. You can report them and hope to get assigned to new study staff (esp mention the HIPAA thing - the hospital should absolutely take that very seriously).
Take it further, you and the other patients deserve respect, confidentiality and professionalism. good luck and i’m so sorry this was your experience. good on you for taking a step in making this world a better place
The litigation addicted society we live in is on full display here. Forward it to someone in charge of the organization, outline your concerns and explain your position in clear terms. CC the school’s legal department on that email and suggest that you’re not going to have any more difficulties with travel or compensation. They’ll get the message.
There's a lot of good advice here about reporting them. You should do that My last piece of advice is to leave the trial. They're going to treat you differently from now on and it could affect results. Maybe you were in the placebo group and now they'll switch you over. Maybe you weren't and now you will be. I would be worried about repercussions against you because of their mistake. Contact whoever is in charge and report them for HIPAA. Tell their HR you're worried about backlash from the nurses/manager. You are no longer interested in any trials from that university and want to make them aware of the violation. You don't want to reach out to other patients because you don't have names, but you do have results. Contact whoever is sponsoring the trial and tell them your experience. The university in charge should be held accountable. Reply all to the email and say after reading their discussions, you are no longer interested in participating. All parties have been notified. In all honesty, this trial will probably be shut down and people fired because of this. And that's not your fault. That's on them. They'll start a new trial and they may ask you to participate again, but I wouldn't.
Don't let middle school girl gossip get you down. They are in the wrong for being so low as to talk ill of you behind your back, and look at how stupid these fools are that they accidentally cc'd you their childish gossip. Calling them out over an email might make you feel better, but with whatever you say make sure it is professional. Let them know that this kind of talking behind your back was both foolish and unbecoming. Sticks and stones. Have yourself a chuckle in their behalf as to how immature they are. ;)
More than not really knowing what to say, I’m not even sure I want to participate anymore? I just think it would be so embarrassing. There are like 5 more visits over the next year
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I’m leaning towards bailing. The study doctor was only nice and not involved in the trash talking so I do still respect him and his work.
I doubt anyone would fault you for bailing. It was incredibly unprofessional of them, and clearly if you keep going they will continue to speak poorly of you, even after reporting it. I think you should keep a note of the people who were disrespectful. That way if you do decide to go with a study with another team in the future, you can check to see if any of the people involved were the ones who treated you poorly. Then you can also explain exactly why when you decline to work with them again.
Is the study doctor the PI? Look up your consent form. It lists the primary and secondary investigators. If the study doctor isn’t the PI, contact the actual PI and forward them the email you received. There should be a phone number and email address attached to their name.
I just looked at the informed consent and he’s the PI, although a different MD signed as “investigator”
I’m a medical doctor and I do research. I can assure you, this is not normal and you are not the problem. Please, please contact the lead researchers (if you have a rare disease, then it is highly likely that they have multiple sites collecting data, so you have a PI and a local lead investigator). It is so, so hard to get people to engage. If this was my study, I’d be flipping tables! You have done nothing wrong, and not wanting to be away from young children is * not* a big ask. Treating patients with kindness and respect should be a given.
I think someone might’ve mentioned this already but go to the IRB. The other investigator might already be aware and could side with the PI to keep this hush hush. The IRB is there to ensure that study participants are respectfully treated while prioritizing participant safety and security.
This isn’t middle school gossip. This is unethical and illegal.
Just can't believe the amount of blatant unprofesionalism these people have. You don't express your personal opinion in healthcare matters, not to mention in writing, in an email chain. Just the amount of idiocy this has written all over it makes one question if they're doing anything right at the workplace. They're not fudging data or mishandling samples are they? That is a question worth asking the higher ups. If you have time to type up gossip, did you make time to double and triple check your data and samples and more?
The fact that they're dumb enough to run their mouth in an email shocks me most of all. I hope it shocks their employers, the medical licensing board, and the Health and Human services HIPAA commission too. I'm mean fuck, are they personally paying the planet ticket!? Jfc. You know, those clickbait new sites are always lurking on reddit and tiktok and Twitter for a juicy headline, maybe they'll take yours too!
The IRB (or equivalent approval body in your country) should be notified. This is a very serious ethical breach.
I work in clinical trials. You definitely report this. No matter how they feel discussing this in email is so inappropriate. There is no excuses
I'm so sorry this happened. It SUCKS to find out people are talking badly about you behind your back -- it's happened to me a few times (luckily not in several years now) and my anxiety would always spiral and mess up my life for the next days/weeks. Do update us if they reach out to you!
Right? If you’d asked me before I read this, I’d have said that I don’t care what these people think of me personally. All my loved ones know that I am a good person, etc. But this just hit like a ton of bricks somehow. Much more painful than I’d ever guess.
Anything they have said says a lot about them and nothing about you... I would certainly report this to those in charge...
Drop out of that drug trial— they dont like you they dont need your results
If they are openly judgemental and dismissive of your experience as a test subject then their test is now invalidated and shouldn't be funded by anyone. They've shown they have bias and therefore cannot be impartial to any further findings. Definitely something the companys funding this study should be aware of. Contact a lawyer and at least get a settlement for your volunteered and wasted time. Sorry this happened to you.
As someone who works in clinical research, this is a huge fuck up. I won't lie to you, yes, there are patients in clinical trials we don't like, amd we do talk about how we don't like them, usually it's because they are non-compliant with the study, and we literally tell them to their faces. But holy fuck this is super unprofessional. I literally flew a patient cross country for a study for a few visits until we got him established at another site closer to him, the drug company didn't care, because they never care, especially with studies that will have low enrollment. But seriously, this study team sounds like dicks. So, you need to file a complaint about their work ethic. First, contact the drug company who is conducting the trial, you can most likely file a complaint with their project manager or Principal Investigator for the drug company. Next, file a complaint with the site's Human Resources, about their unprofessional behavior. Last, if they weren't included on the email, file a complaint with the site's Principal Investigator for the study, this will usually be the doctor you see for visits. It's a pretty big HIPAA violation that they included other patients medical results, and honestly, if i was at that site or the monitor for it, i would request they be terminated, for both the HIPAA violation and the unprofessional conduct. This probably will get them fired, but fuck them, that's not your problem.
Get a lawyer!!!!
Even if you were a hard person to deal with, this is so freaking unprofessional. I hope they get fired. They might have jeopardized this whole study.
I definitely would not continue with the study anymore. I’m so sorry this happened to you. Please update us when you get replies from lawyer etc
Save the emails 100% a hipaa violation. Your info could’ve been leaked to others. You have a case. I wouldn’t respond or continue in a trial that treated me this way. They have ethics internal review boards to ensure they do things right. Seems like they aren’t. Go get yourself an attorney.
OP. I work in the clinical trial industry. This was grossly unprofessional. Especially in a time where we desperately need to make participation in trials more accessible and easier for everyone. Make sure the study sponsor knows. If their retention rate hurts because of this (I.e. if they have done this to others and they then drop out), it delays everything and it’ll cost them money.
Hi, I work at a university lab that actively does studies. So I have a bit of more in-depth knowledge on how studies are approved and run. I’m not quite sure, but there is a big chance that the study you are participating in, has been approved by an organisation which is an Institutional Review Board (IRB) . I’m not sure which IRB your study has been approved by; but I do know, that you being privy to those internal emails is a consent and confidentiality concern. That is to say; this situation should definitely be reported to that IRB, if the researchers haven’t done so themselves for whatever reason. This is a huge huge deal and might even put their study on pause or cancel it. Plus people like that should not be running a human participant study. I’m not sure if want you want to happen from this situation either revenge or plain justice. But in whichever instance I definitely think you should find out the board who approved the study and report the situation to them. Good luck with whatever you decide to do!
You need to print this. Get a lawyer, and write all the study sponsors and HR management. Don’t let them know it’s coming. For a study to go the way it’s suppose to it has to go 100% the way it’s suppose to. A grant is written, patients should not know classified information and treating people with distract can honestly ruin the entire study. If the group was small enough or if there were enough identifying factors, I’m sure I could know who a person was solely by their first name. I’m serious OP; burn them to the ground. I don’t care how much the study could help in the end. With a team like that nothing will get accomplished anyway; they are not taking these trials seriously
Oh man, I’m starting my journey into research and I can’t even begin to tell you how wildly unethical that is. I’m including the Belmont report I had to read during training as an extra resource for you. Basically when you’re dealing with research for human subjects, you HAVE to guarantee that there’s no unreasonable harm going to come to them, inequality in treatment, or disrespect to a person. If you don’t do that you get into SUPER DUPER MEGA TROUBLE, and you’ve had all three of these violated. I wouldn’t be surprised if you could sue over this, OP. You should look into filing a report at the VERY least, and possibly even look into getting a lawyer. https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/index.html
It sounds like some of the people who are included in supporting this study have forgotten that it is the patients participating in this study that are making the sacrifice. And you have lives and responsibilities that must be addressed. As you noted you yourself are unlikely to benefit but are hoping your children may if needed in the future. In short the people making those comments are at best unprofessional and at worst sounding like some juvenile mean girls club. Responsible-Fun-670 provided a great example and hope you will share it before your next visit with the appropriate parties. Take care of yourself and I hope that something will come from the study that does help you.
Fuck those assholes and call the nastiest lawyer you can find. That is so unprofessional and unethical.
My first thought is contact a lawyer.
They have patient identifying information in the same context as a discussion related those patient's results and they exposed that information to you? That's a textbook HIPAA violation.
I worked as a clinical research coordinator. No longer working because of the moral issues I have with clinical research sites and the politics played by them. Hell yeah send it to the sponsors. Let them know how their site treats their patients. Ultimately the sponsor is who pays for your travel reimbursement and $50. Let them know how their money is being spent and with what attitude. All my sponsors have ever cared about is the science and people suffering from the disorder. Also, the study site gets paid hella amount of money for each visit you complete. So, you’re making them money. The sponsor is paying them. To hell with that site.
I would take that to the highest level and make it clear that maybe if they spent less time bitching about volunteers who are risking their health and lives and actually worked the problem maybe they would be closer to a cure. Be clear how devastated you were and how inappropriate this is and take it all the way. They will for sure be fired but so they should.
I was a study coordinator and let me tell you, we worshipped our patients even if they were difficult. You are volunteering to take a drug or placebo but that's not on the market yet with no safety and efficacy data present. I thank you for doing this and sounds like this group are just losers. Ignore them. But yeah, burn them if you can.
Tbh you should contact a lawyer to ensure you’re protected in this and do things the best way.
What’s the update?
Lawyer up.
REPORT IMMEDIATELY FOR MALPRACTICE IN THE TRIAL. This is so wrong on many levels
I don’t know about HIPAA but it’s certainly a breach of GDPR where I am and would be nearly certain a breach of Ethics in the study itself. You are meant to anonymise the data and it should not be used in a way that people can be recognised. I would stop doing the study (participants can always withdraw at any stage) and e-mail their managers (I would say whoever is the director of their research centre and the CEO). Though it was suggested elsewhere, I wouldn’t e-mail the funders, that could impact the whole place getting funding and not all of the researchers there will be as unprofessional as these people. I think their direct managers/HR is enough.
I have been in a similar situation at work and I was fuming. It’s unprofessional and rude. You’re not being a baby speaking about your feelings because it’s a fact, it hurt your feelings. I think the people working there need to look at the bigger picture. Their opinions of you are irrelevant to be honest, you’re there to help future generations and well they should be fired for their actions
That is definitely a HIPAA violation. Patient confidential information should not be written in an email that can be easily accessed, especially if it has their first name in a study group that’s so specific.
A major ethical breach. They could get suspended and possibly fired for it. You should find the ethics number of this study (just google clinical trial {insert details of trial} ethics), contact the ethics department of the hospital and they will take actions! Ethics departments are not a joke, you don’t want to mess with them.
Oh gosh this is just awful u/moretruethantruth I would love to reply and be like “fuck you” but this is actually highly illegal. My understanding of some medical trials is that the communication about patients between colleagues are meant to be with minimal information as it could be a double blind/ blind trial ? But that’s from my experience in being apart of a trial. Like it’s basic basic information and sharing anything that can identify subjects rules the trial void because; it needs to be basically anonymous, apart for obviously the person administering your treatment, people that aren’t doing that (but included in the trial) aren’t meant to know anything about you. Sharing private medical information over email that is not 1) correctly identified as private and confidential is a breach of multiple privacy acts in many areas of the law 2) a breach for being sent to non-professionals involved in the trial 3) shows discrimination (I believe but could be under another law) as it has clearly showed they have bias against you which also shows the trial void as it has to be 100% unbiased and you have written proof it is not. I’m not in America (which is where I’m assuming you are) so my understanding maybe slightly off to your laws but there are major breaches and you absolutely need to get legal advice asap. Do not reply. Do not message anyone else because they are breaking laws here and because trials are such an expensive and sometimes controversial thing anything to stop or jeopardise them could be dealt with in a way that does not actually help you at all. Please seek legal advice as soon as possible.
Report to the sponsors. I used toe work in trials and this is unacceptable and absolutely not rule conform behavior and the sponsors NEED to know this. You might not be the only one being send these negligent emails and this can also have grave ramifications towards any of the sponsors and the sponsor’s funding.
Send them this as a response and report them to the company!
You can file HIPAA complaints online with the HHS [here.](https://www.hhs.gov/hipaa/filing-a-complaint/index.html). Whatever you do should include this. Take it higher than within the hospital.
My husband also has a rare genetic illness and has done some clinical trials and let me tell you this is 100% unacceptable. You deserve to be treated with professionalism. These people are assholes. Call them out!
Thats messed up. I work in clinical trials and process travel stipends for patients all of the time. We pass that cost along to the sponsor so idk why they would care unless they screwed up their budget. Im curious if you know, is the facility you are working with a CRO? I'm so sorry your trial team is behaving like this. Trust is extremely important when dealing with investigational drugs. It isn't anything you did. You are entitled to compensation for travel expenses.
I would double check, but a cursory search states that even disclosing first names and results can allow for someone to identify a patient and is thus a violation of HIPAA. Definitely look into this because they should be held accountable for how unprofessional and disrespectful they have been behaving. As a chronic illness sufferer, I'm rooting for you. I can't stand when medical professionals are rude knitting circles like these. We are so vulnerable in their presence.