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After an extreme amount of effort, I am now in possession of a very large dataset of human experiments which is required for my research. However, after speaking with some of my colleagues about writing papers about it, I was told that I need to have had the IRB decide what level of consent is necessary and then had each participant sign the consent form specified by IRB... or else I can't distribute the data... to anyone (yes, I know this is country-specific, but most countries require at at least some legally-valid form of consent).

I hadn't thought about this because I was told by my supervisor to collect the data... and so I did. Now, after asking my supervisor about the ability to legally distribute the data, he agrees with my colleagues in that I need to have had them sign a consent form... but if he told me to collect the data, then methinks he could have been prudent enough to say "oh, and before you go persuade 50+ random people to participate in an experiment, don't forget to have them sign this form or else you can't share the data with anyone at all".

Are PhD supervisors responsible for telling their students about the legal requirements of their work? If not, is it expected that all "learning" done while a PhD student be from making horrible mistakes? Should I basically treat my supervisor not as a boss but as just some random person who might not actually know what I should do?

  • Comments are not for extended discussion; this conversation has been moved to chat. – eykanal Aug 2 '17 at 12:57
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Good research practice (which I would argue is not country specific), requires an independent ethical review of any research that involves human subjects. A university can make blanket determinations that certain types of research do not require individual review (e.g., interviews).

It is generally considered academic/research misconduct to not have proper ethical review and follow the recommended guidelines. Failure to obtain informed consent, when necessary, definitely falls under research misconduct. In the US and UK, it is the responsibility of the supervisor to make sure that the proper procedures are being followed.

In your case, your supervisor should have told you to get informed consent. The problem, however, sounds way bigger then you just not being able to use the data. The problem could be as large as PhD students not being properly trained regarding human subject research and faculty not following good research practice.

You need to work this out with your supervisor quickly. It should eventually escalate to your department chair and the IRB/ethics board. Not getting informed consent, when needed, is a huge deal.

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    In many cases, even interviews or other similarly "low-risk" types of research are covered by IRB. The IRB might have a simplified review process (sometimes called "exempt" review) where they essentially say "Yep, we don't need to cover this further, go ahead" - but they still have to review the protocol. Just for an example, see the guidelines from UPenn: upenn.edu/IRB/sites/default/files/… – Bryan Krause Jul 29 '17 at 19:19
  • @BryanKrause yes, that is what I was trying to get at with blanket determinations. My university has a check list process. The first part separates out research from non-research with non-research not needing approval. The second part separates human subject from non-human subject with non-human subject research not needing approval (animal work is different). The third part identifies exempt human subject research which is self approved. The final question is basically are there any reasons this research needs to be examined by the IRB. – StrongBad Aug 1 '17 at 15:53
  • Yeah, I was just pointing out that in some institutions, the blanket determinations process is still done through IRB. My institution is like that, UPenn's seems to be, I looked at a third one and saw the same language too. Basically if it involves a person, and you interact with them personally (i.e., you aren't taking data from an already-anonymized database or similar source), even if it is only an electronic survey, sometimes you still need IRB to sign off on "this does not need further review from IRB." – Bryan Krause Aug 1 '17 at 15:59
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Are PhD supervisors responsible for informing students about legal issues pertaining to research?

Yes, they definitely are. They're not called "supervisors" for nothing, after all. But - that does not mean the PhD candidates have no responsibility of their own; and the extent of that depends on the specifics of each situation.

Also - the fact they are responsible does not mean they won't try to shirk their responsibility, so it also depends on the advisor's quality of character.


Now for your specific case.

Did you get explicit oral consent from your human test subjects, and they were all aware of what you are doing and that the results go into research publications?

  • "No": In this case, you are also responsible since you should have known better than not to ask their permission at least in some form. Actually, some would argue that you should have applied due diligence and had them agree in writing to participating in the experiment regardless of anything.

  • "Yes": In this case, your own responsibility is limited; however, that does not mean you'll get to actually publish even if you are not to blame.

At any rate, you need to convince the university to give you access to their lawyers, especially in light of your advisor's negligence and the fact that you were directly instructed by him to go collect the data. You should bring up the following points when talking to the lawyer(s):

  • Perhaps the kind of experiments you carried out can be excepted from the consent form requirement?
  • Can the data be anonymized so as to avoid the requirement?
  • Can statistics/aggregates be published without constituting breaking the legal requirement?
  • Does making the data accessible to individuals under certain conditions break the legal requirement? If not, you could publish your work without the actual data, and make that data available to whoever accepts the appropriate conditons.

Finally, if push comes to shove, you could think of possibilities like:

  • The university awarding your a PhD without proper publication of your thesis, with just a few examiners reading it (might not be possible).
  • Repeating the experimental work - hopefully with university funding to do so.
  • Piggy-backing a repeat of your experimental work onto that of another researcher performing continued work in the same vein. If they need your experiment + more things than you get the previous option for free (although with a time delay).
  • I'm going to disagree. "Responsibility" has legal ramifications, and researchers are not in a position to give legal counsel. It is the PI's responsibility to make sure that research in the lab follows human subject guidelines, and it is the responsibility of the University to make sure this happens. The way our university deals with this is to use a commercial online training program to certify people to work with human subjects, from PI's to techs. The PI is out of the loop – Scott Seidman Aug 1 '17 at 15:07
  • @ScottSeidman: I did actually mean "responsibility with legal ramifications"... and the fact that researchers are not lawyers does not mean they aren't legally responsible. About your university - that's an ok arrangement, in which a PI discharges this responsibility when s/he has made sure his graduate researchers have actually undergone that training. Of course, this training might not cover anything so the PIs should be aware of what that training actually comprises. – einpoklum - reinstate Monica Aug 1 '17 at 15:59
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There are two pertinent issues to address here. First, not all forms of research require consent since some data collection doesn't subject participants to any stress or other form of risk and some forms of data will not disclose identifying details of your subjects' behaviors, biomarkers, or other characteristics. In all cases, how far you are required to go in obtaining informed consent depends primarily upon how much 'risk' your participants were exposed to by agreeing to participate in your experiment. This includes 'risk' undertaken by participation and 'risk' they may be exposed to when the data becomes public in some form. If you are doing research within the US, for instance, you should have gone through an IRB process beforehand. When an IRB determines that there is some risk (even minimal) they will require a researcher to stipulate how that risk will be mitigated and may require the researcher to brief subjects about before or after the fact.

However, some forms of data and data collection pose no risk to your participants and can be exempted. If your data set includes no identifying information (including names, biomarkers, photographs, video, etc) then you may not actually have needed an ethics board (or IRB) clearance and there may be no issue with your advisor whatsoever. Online surveys, for instance, or observations of public behavior, do not require consent of any kind, and several other types of research which pose exceptionally low risk can proceed without much sign off. It is possible that obtaining verbal consent from your participants would satisfy your university, but I cannot say for sure. You will need to inquire at your university to figure out whom to consult about this. It will be different at each institution. Since you've indicated that you carried out an experiment on roughly 50 people, I'm guessing it's behavioral research you're conducting. The good news is that in many experimental studies, subjects are expected to be fully informed and give consent only after the experiment has been conducted. There is much precedent for this in psychology.

Second, your relationship with your advisor, while there are gray areas depending upon discipline and university, is not a boss-employee relationship when it comes to your own independent research. If you are getting credit for what you are doing, then you are the one who bears responsibility to make sure that what you're doing is ethical and well considered. I'd suggest that this isn't your advisor's responsibility unless it was clear that your were working on her/his behalf. However, if you and your advisor are having difficulty communicating about expectations and you're receiving little guidance on how to design and carry out research, I would suggest taking on an additional mentor, either in the form of a secondary advisor or graduate counselors at your university.

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    Some of your examples may not require consent, but they probably do require IRB approval of some kind. IRB would determine what level of consent is appropriate, all before the research is conducted. – Bryan Krause Jul 29 '17 at 19:11
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In the US, most funding agencies place responsibility on the University to make sure that all working with human subjects receive proper training. Whether the University passes that responsibility to the individual mentors is an internal decision, but as it's effectively the University that can lose it's ability to do human research, responsibility is not often passed along.

Specifically for your case, aside from legal scenarios in your country, it depends very much on what the data is. For example, if it's a simple questionairre on the usability of a device, you probably don't need consent. For many other things, you probably do need consent.

Also, aside from legal issues, journals will not publish papers that don't meet ethical standards on human subjects put forth in the Declaration of Helsinki or the Belmont Report, for Europe and the US, repectively.

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    This doesn't answer OP's question. – Dan Romik Jul 30 '17 at 14:33
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Yes! Without a shadow of a doubt. The ethical issues around human data collection and use are an absolutely critical aspect of research. Data should not be collected without approval by a local ethics committee. The protocol that they will approved will contain a detailed description of the informed consent, your plans for data management, anonymisation and use.

Critical question: you say 'dataset of human experiments', do you mean 1. data that you generated - ie experiments that you performed - OR 2. a dataset of data collected by others from experiments that they did. If the former, you are screwed, if the latter you need to find out the circumstances under which the data was collected, there may be a way that your use of the data can be covered by the original consent and ethical approvals. But under those circumstances, whoever gave you the data had a responsibility to ensure that your intended use was consistent with the original approvals.

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In the US, the institution where the data is collected is responsible for providing appropriate training about data collected from human subjects, working with Institutional Review Boards (IRBs), an all things related to the Health Insurance Portability and Accountability Act (HIPAA).

It seems to me that you are getting secondary data. If the data was collected here in the US, then, in compliance with HIPAA, the experimental protocol was reviewed by an IRB, and all subjects should have signed a consent form if the IRB deemed it necessary. The IRB might have also deemed it not necessary. It depends on the risks associated with the study.

Your adviser might be as clueless as you on how to deal with the data copyright (so to speak). The question is, then: from where did you obtain the data? If you obtained it from another researcher, who collected it, then he should know. Get your adviser involved by contacting that person. If you obtained it from a public data repository, then the rules of the repository apply.

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I am a Ph.D. Professer and graduate student adviser at a university with graduate programs...

No, there is no "responsibility" on the adviser in a legal sense. (people who say otherwise are simply expressing their opinion on how they want the legal landscape to be, not how it actually is.)

Should the Ph.D. adviser be knowledgeable about such things, monitor the student's behavior and correct/educate them when they do something wrong? Certainly. If they can't or won't then the student should have picked a better, more competent, adviser.

But if the student does something illegal or unethical it is 100% the student's responsibility. There will be no legal consequences or repercussions for the adviser as the adviser has no legal responsibility. It is entirely up to the student to make sure they know what they are doing and what is allowed. Any transgression is their fault, not the adviser. The adviser is simply an academic resource and not legally liable for the student's behavior or product.

So, as you asked... yep. just some random dude that might not actually know what you should do. (a pretty good rule to think about every human in existence, including your parents and yourself actually.)

Yes, I know that as an adviser I sound like I'm just covering my ass and trying to avoid responsibility but that is not the case. I have a business obligation to be competent and educate my students well but this does not constitute a legal responsibility for a student's behavior which is what your question is specifically asking about (since there are state and federal legal requirements concerning human and animal test subjects.) It is not the faculty members responsibility that you know them or follow them, though I strongly believe he should know them and make sure that you do too before you embark on your thesis. But ultimately any legal responsibility for the outcome rests with the student.

Should a driving instructor teach students not to speed? Certainly. Is he legally liable for their speeding tickets... nope. Same sort of relationship.

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    The question is not whether a driving instructor is liable but whether he/she should have taught the student not to speed. – Just Saying Jul 29 '17 at 20:14
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    I appreciate the input, but a more appropriate metaphor would be to tell me to drive through a nature reserve without telling me I need a permit first... And then tells me after I come out the other side. – errantlinguist Jul 29 '17 at 21:11
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    This is a poor analogy, in my opinion. Moreover, the question asks about responsibility of PhD supervisors -- which can be viewed in ethical and professional senses -- and your answer seems to be overly focused on legal liability – Yemon Choi Jul 29 '17 at 23:19
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    Uh, there definitely is a certain degree of responsibility in the legal sense - liability. Advising a PhD candidate is not some "business transaction". I suggest you start making that assumption, lest you'll find yourself in administrative procedures, or even in court... I believe your position is based merely on wishful thinking, unless you can provide some legal basis for your very strong claim of 0% liability. – einpoklum - reinstate Monica Jul 30 '17 at 9:38
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    I don't know how driving licenses are obtained in every country. But I know that at least in some countries you first have to pass a theoretical test before you can learn to drive a car. So that means you should know that speeding is forbidden. Furthermore I asked my driving instructor once when I learned to drive: during lessons, they are responsible (and have to pay the speeding tickets) since students are allowed to make mistakes. – Willem Van Onsem Jul 30 '17 at 20:59

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