What is the most appropriate role of institutional review boards? (discussion for EPSE 595 ~ October 10th)

From the assigned readings you should have a good sense of the history and context for the manifestation of institutional review boards as they now exist (@ UBC, the Behavioral Research Ethics Board or BREB). In large part, contemporary IRBs result from a few well known and egregious cases of unethical treatment of people (like the Tuskegee Syphilis study, Mengele’s experiments in Nazi concentration camps, Milgram’s obedience experiments, Zimbardo’s Stanford University prison experiment, and Humphrey’s Tea Room Trade). In general, the response to unethical research practices might be described as a panic response that has resulted in a rigid system of reviewing ALL research prior to its conduct using a one-size-fits most approach (although there is usually a distinction made between lower and higher risk research).

However, Dyck & Allen argue that…

Review boards responsible for vetting the ethical conduct of research have been criticised for their costliness, unreliability and inappropriate standards when evaluating some non-medical research, but the basic value of mandatory ethical review has not been questioned. When the standards that review boards use to evaluate research proposals are applied to review board practices, it is clear that review boards do not respect researchers or each other, lack merit and integrity, are not just and are not beneficent. The few benefits of mandatory ethical review come at a much greater, but mainly hidden, social cost. It is time that responsibility for the ethical conduct of research is clearly transferred to researchers, except possibly in that small proportion of cases where prospective research participants may be so intrinsically vulnerable that their well-being may need to be overseen.

[Murray Dyck and Gary Allen. “Is Mandatory Research Ethics Reviewing Ethical?” Journal of Medical Ethics (August 3, 2012), DOI: 10.1136/medethics-2011-100274.]

Within some disciplines (like history) there are questions about the relevance of IRBs to research, there are examples of ways in which the onerous task of obtaining IRB approval has truncated research efforts (such as during the SARS epidemic), and an unclear but no doubt significant influence on whether or not research is even considered.

Dyck & Allen suggest that today’s ethics review boards could be replaced by ethics boards that provide guidance and support to researchers…

Instead of promoting rote compliance with inflexible and universal rules, the role of an IRB should be to facilitate and resource the reflective practice of researchers. A simple, but significant, shift would be to move ethical review from approving a proposed project to providing guidance and feedback on submitted projects. An IRB may play a useful role in identifying ethical issues and suggesting how to deal with them, but otherwise, responsibility for research ethics needs to return to the researchers who use the feedback they receive in a reflective and project-appropriate way. Rather than policing compliance with standards that can have limited usefulness for some methods, participant populations and contexts, such an advisory review would aim to assist researchers in reflecting on the specific ethical challenges of their research.

DISCUSS WHAT YOU THINK THE ADVANTAGES AND/OR DISADVANTAGES OF FOLLOWING DYCK & ALLEN’S SUGGESTION MIGHT BE FOR YOU AS A RESEARCHER.

37 thoughts on “What is the most appropriate role of institutional review boards? (discussion for EPSE 595 ~ October 10th)

  1. If the IRB rules were to become more flexible and supportive to researchers, perhaps that could increase the diversity and quality of the research that gets conducted. The fear that I have of having less stringent rules is that researchers who behave in an unethical way would find it easier to take advantage of the system.

  2. Would the approach suggested by the authors be less stringent? Does this imply that we don’t trust researchers and that “professional” obligations to do the right thing (the sort of ethics that we assume doctors, lawyers, nurses, teachers have) does not hold with researchers?

  3. I believe Dyck and Allen’s suggestion that “today’s ethics review boards could be replaced by ethics boards that provide guidance and support to researchers”, should be considered from two different perspectives; the perspective of the researcher and the research participant.
    Last year while conducting a case study on a four year old child with Autism, I had to go through what at that point I considered to be excessively frustrating BREB application and approval process. My research participant was not only a child, but had special needs which put him in a dual vulnerable position and me being the child’s classroom teacher and the preschool’s manager, was interpreted as having “conflict of interests” by BREB. The approval process was lengthy and I had to go through multiple revisions of my proposal/application. At that point the only thing I could think of was that I was not going to harm this child whatsoever; the child had already been my student for 2 years, the family trusted me more than anyone else (as I was the person who made the referral for the diagnosis and supported them through the whole process) and if anything this research could have been beneficial to him and to children in his situation. It took months for BREB to approve my application and at multiple points I considered withdrawing from the research. At that point I truly viewed myself as a victim of BREB.

    Both as a researcher and as a research participant I welcome Dyck and Allen’s suggestion.

  4. M’s example of being a research participant is interesting. Unfortunately, what may have been approved by the IRB may not be what is happening in the actual research context. In other words, a proposal is a promise that the researcher will behave in a certain way, but there is no subsequent monitoring to insure that those promises are kept. What might this suggest about the effectiveness of an IRB?

  5. I think that Dyck and Allen’s proposal makes practical sense. The case of researching a health crisis or medical epidemic like SARS, which is referenced, really drives home the need for faster ethics approval. I can think of several other examples that are not associated with my research that would also warrant fast ethics approval in order to conduct proper research on the aftermath or immediacy of an event. These might include the recent earthquake and tsunami in Japan or democratic movements in Egypt. Especially given the role of the high-tech media and the subsequent pace of news and events on the web in the Twenty-First century, Dyck and Allen’s call for change is timely. My research, which involves Canadian national identity might be adversely affected by the slow ethics process if a particularly rich event, phenomena or movement began in Canada that referenced national identity occurred suddenly.

  6. I definitely agree with the suggestions presented by Dyck & Allen in making IRBs more applicable to the work of daily researchers. I think the advantage of their suggestion is to maintain an external reviewing body. Ideally those who work on ethics panels should bring with them experience within research (to be able to understand the pressures of academia, even it is unrealistic), combined with experience within ethics (both formal and informal knowledge, skills, and attitudes. However, the discussion above overlooks the need for academic departments/programmes to have their own, subject-specific, approaches to ethics. Discussions of ethical research should be embedded within all degree programmes, either as stand-alone courses or as threads woven into existing course content.

    It seems rather bizzare, and definitely unfortunate, that this is currently happening! I definitely am of the firm belief that our participants should understand their involvement within research; not as passive people being observed, but as active constructors of future knowledge. More concretley: instead of being given forms to simply sign-off, they should feel a degree of ownership over the data that they are helping produce.

  7. The role of an IRE that the authors are proposing sounds very reasonable to me. I would feel more confident in approaching various dilemmas, if I knew that there was a supportive body (IRE) that could provide guidance and feedback on ongoing basis. Such role is more appealing to me compared to the role that is mostly limited to approving proposed projects. Final responsibility for the research ethics should be on the researchers; however, the researchers should be able to obtain reliable guidance and advice when needed.

  8. I think to entirely deposit the ethics responsibility on researcher’s shoulders may result in ethical dilemmas without solutions. I really believe that working as a team is beneficial to the researchers as well as the research participants. However, researchers unlikely work by their own. Constantly they have to apply for grants, to review peers’ work, work collaboratively with other researcher, etc (at least that’s what I assume from my outsider’s points of view). The researcher’s work shouldn’t be in isolation, so do researchers need a control instance of their ethics decisions or rather an collaborative instance that support the solutions of the dilemmas that may come up? I do not think that IRBs only as control instance enhance the ability of researchers to do ethical research, but increase the obstacles for innovation and creativity especially in those issues regarding to allow participants in research become really co-researchers.

  9. I think one advantage of Dyck & Allen’s suggestion to shift the focus of IRB’s from approval to guidance and support is that it may shift researchers to feel more responsible for their ethical conduct. In my research on moral disengagement, I have learned that people are more inclined to relieve themselves from feeling culpable after behaving immorally when a person in authority has told them what to do. They might say, “s/he told me to do it”, even though they knew they weren’t acting in the best interest of others. I think that the shift from authoritative body to advisory committee may prevent researchers from disengaging from their moral and ethical standards.

    I can also see disadvantages to Dyke & Allen’s suggestion. In my opinion, one disadvantage would be that the process of providing ethical support and guidance may be equally onerous and lengthy. Perhaps if it is not required to obtain their advice, researchers would opt out of getting the support altogether due to time constraints, etc. Might it be the case that going through a process (even if it is onerous, rigid, and potentially unnecessary) provides researchers with a checkpoint — a time to reflect on their ethical conduct — compared to a situation where researchers may be opting out of the process altogether? I must admit, I do not think IRB’s foster a climate where researchers critically examine their ethical conduct; however, it was the only disadvantage that came to mind for now.

  10. I am definitely not a fan of my own experience, or those of other friends in the lab, with pre-ethical approval of research. There is even a sense of paranoia among faculty at times about submitting amendments over changes in research with no ethical repercussions at all in my opinion. For instance I was forced to submit an amendment because I was planning to administer part of my study online and instead of signing a consent form, I was asking people to check a box indicating they read the consent form (pretty normal). The committee replied saying I must ask participants to sign, and I had to submit another amendment saying it is an online study on the computer so people cannot physically sign, which was already explained in the original submission (it is still confusing why I had to explain this twice). This meant I could not do anything in that study for weeks until this completely ethic-less issue got resolved. I was strictly forbidden to proceed by faculty in the department as well.

    I am on board with changing this system as per Dyck and Allen’s suggestion. I think dropping the requirement of pre-approval is a prospect for that, or the approval process could be further decentralized and delegated to research departments in lieu of institutions. For instance, instead of having a UBC-wide REB, there could be REB members in different departments who are ethically “trained” and who better understand ethical issues relevant to research in their respective departments.

    One thing I don’t fully agree with is Dyck and Allen’s confidence in the individual moral compass of researchers, which I don’t mean to insult. However, an assumption like this might be too naive in the sense that it decentralizes ethical responsibility further than what I think is reasonable.

  11. @Shathel… there are no doubt alternatives that might combine the Dyck & Allen’s suggestions with some institutional oversight. But it does beg the question of the extent to which serious ethical violations do occur that (and this is important) are actually avoided by IRBs. There is plenty of chicanery in medical research, for example, that is sponsored by drug companies, often conducted by drug companies and the journals articles ghost written but attributed to medical faculty.

  12. … this is a really interesting example as it suggests how IRBs fulfill a bureaucratic function, but not the supposed primary intention of protecting research participants.

  13. M, your example of being a research participant is frightening (and also enlightening). It demonstrates that obtaining “ethical approval” from an IRB is not effective in predicting/regulating a researcher’s (or group of researchers) ethical behaviour. I wonder how the researchers perspective might shift if they engaged with you and your colleagues on a regular basis? Perhaps if a relationship was formed between you and the researcher (like the relationship between you and your student), they would feel more compelled to act in your best interest?

  14. I whole-heartedly agree that it would be more desirable to have a supportive ethics body to help researchers. I did find the whole ethics process to be somewhat patronizing in the sense that very minor details sometimes took on ridiculous proportions. I was reminded of these issues in our reading this week. In my study I had to get parental consent even though many of my students were 16 years or older. In a separate, but related issue, I once had to get parental consent to take a student on a field trip. The student was a father himself, about 20 years old, with the power to give consent on behalf of his child, but not for himself. He did not even live with his parents. So sometimes I feel like the whole parental consent issue can quickly spiral beyond the scope of common sense.

    Despite my reservations about our current ethics system, would a supportive ethics body be able to limit unscrupulous research from occurring? Dr. Mathison raised the point about other professionals such as teachers or doctors having the final decision about their work, but each of these professions also have structures and professional colleges or associations that they must (even in a marginal way) be accountable to. In the education system, for example, I was observed multiple times by in-school and external administration. In addition, my teaching was constantly informally monitored by the students, parents, paraprofessionals, and the community at large. To whom is the researcher accountable? Perhaps some kind of peer governing body would then be in order to provide appropriate checks and balances?

  15. I think that Ellen’s comment that IRBs do not foster a climate where researchers critically examine their ethical conduct is an important one, as I think what is key to ethical research is that researchers are able to reflect at all points in their research about whether what they are doing is ethical or not, not just when submitting to an IRB. Having a board as suggested by Dyck and Allen might provide a good resource for researchers to check in with – but that would require that researchers actually do check in if they have questions about the ethics of a situation. I do not think it is a question of whether or not “most” people will act ethically. Rather, I think any board is likely to need time to give ethical advice on issues, which researchers would know, and perhaps not be inclined to check with if they know it is going to slow them down or they are going to hear advice they don’t want to hear. From Maryam’s example, it seems that there might need to be some appeals or complaints process for participants so they can inform the institution supporting the research if they feel they have been treated unethically. I wonder how this would affect how researchers approach a situation – would this cause them to be more reflective, or just unnecessarily scare people off of doing important research?

  16. I find the notion that ?a proposal is a promise that the researcher will behave in a certain way, but there is no subsequent monitoring to insure that those promises are kept? to be very interesting when looking at the effectiveness of IRBs. It seems in the case of SFU?s research that Maryam mentioned that the IRB was more of a bureaurocratic hoop then effective measure taken to ensure ethical research. To this end, I appreciate Dyck and Allen?s suggestions that ?instead of promoting rote compliance with inflexible and universal rules, the role of an IRB should be to facilitate and resource the reflective practice of researchers?. Such a reflective process would help ensure and facilitate ethical research.

  17. @Maryam ’s case as a research ‘participant’ is definitely interesting and does seem to highlight the points made by Dyck & Allen. I hope I understand this correctly when I say, the effectiveness of the IRB may be questionable because there is no further monitoring to ensure what is being done is what was initially proposed to the research council. I believe a ‘good’ researcher would naturally seek out the advice of others to ensure that they were staying true to their proposal. It is interesting that researchers, when compared to other professions like teachers, are not considered professionals in their own right. Many seem to pay the price for a few unethical researchers, dealing with extreme cases. I like the idea of switching from approval to guiding and supporting researchers through the entire process. Hopefully this would help research become more timely, efficient and researchers wouldn’t have to go through so much red tape to pursue projects, that with minor revision are deemed acceptable (like the research example of @shathel).

  18. using M’s example again (thanks for the discussion fodder!) it should be the case that research participants can question researchers and the institutional review board… most written consent forms include a contact number of the university IRB. what is clear here though is that even those rudimentary practices were not followed, but much worse is that punitive actions can be taken for not complying!

  19. @ Nikki
    Even though various professions such as doctors, teachers, etc. have professional colleges or associations that they must be accountable to, the cases of professional malpractice happen all the time…

  20. The question of IRB functioning as an ethics gatekeeper viz Dyck & Allen’s suggestion for decentralized ethics review by the researcher reminds me of the issues surrounding state-wide standardized testing vs local assessment by the teachers of student learning, whether of the summative or formative nature.

    I’m of the view that any form of de-centralization of ethics approval (or assessment of student learning in the analogy of standardized testing) will not totally remove the practice of having an external body assess the individual researcher (or student in the analogy), but shifts the pattern of review/approval to to a more localized context, say the researcher’s university or local district. Even if this assessment function of the external body is removed and replaced by a function of providing guidance and advice, I think it may be a matter of time before problems that research participants face (e.g., like what Maryam’s experienced), or the public who catch wind of unorthodox practices of researchers, may cause people to demand for stronger accountability of researchers.

    I do agree with Dyck & Allen’s view that the individual researcher’s professionalism is key to that kind of accountability, but unfortunately, I think structure drives behavior – and if there is a lack of accountability structure, people tend to cut corners when push comes to shove, and there may need to be some form of monitoring (which the current IRBs are not able to perform because they are so removed from the researchers). Monitoring at the local context (university or district) may however add additional undue pressure – I feel that there are always trade-offs between either complete trust in the professionalism of your researchers, and having some form of structure/process to monitor for accountability.

  21. As discussed in the reading, some critiques of regulation of social science research include its relevance to social science ? specific research contexts or purpose of research and its narrow conception of research. In other words, I think the potential problem with the role of IRB lays in its dogmatic application to different kinds of research whose contexts, purposes, and the researchers? epistemological stances vary. Therefore, Dyck & Allen?s argument on the supportive and guiding role of IRB makes sense because it doesn?t start from a rigid rule; rather it takes into consideration varying and complicated natures of different types of research while respecting researchers? capacity to be reflective on their practices. At the same time, to me, the two roles of IRB ? policing vs. guiding are understood as a continuum rather than a dichotomy. While facilitating researchers? understanding on ethical issues that may rise at any stages in their research process, the board may also play an important role by suggesting any possible breaching parts which the researcher may have paid less attention.

  22. @Joanna… IRBs are at the university level, which doesn’t mean they are very connected to individual researchers.

  23. It would be advantageous for IRB rules to be more based on facilitating the ethical standards of researchers, rather than focusing on a “goal-orientated” approach of the research ethics board to be simply a bureaucratic hoop to jump through. I agree that a team approach would be more useful, as a researcher might be more likely to approach the ethics board if any problems/concerns arose if the board’s role was as facilitator, rather than as “the heavy.” By establishing a relationship of trust between the researcher and ethics board, I think there could be more honesty and transparency, rather than a researcher viewing the board as “a heavy,” or as a force that can delay, obstruct, or annul an entire project. Researchers do not all have the same moral compass, but neither do teachers and doctors.

  24. Summarizing the previous comment seems to be the thread that IRBs only are (?marginally) effective from the outset, and not as effective while the research is in progress.

    In that case, is there a mechanism other than IRBs with which we can promote, encourage, and ensure everyone complies with ethical principles?

  25. Apologies for the butchered grammar! The first sentence should have read: “Summarizing the threads within the previous comments, it seems that IRBs are only […]”

  26. I was reflecting on the Ethics Case #2, and was thinking that even my own practice as a researcher has changed after reading that story (and reflecting on how my research might compare). I think perhaps an Ethics roundtable–a semi-frequent meeting where researchers discuss potential dilemmas or dilemmas they experienced–would be more helpful than submitting a BREB. This approach would be more consistent with Dyck & Allen’s suggestion for an advisory-approach to ethics than the current /dominant IRB approval approach.

  27. @Sandra: Perhaps an even more localized level of accountability in labs/ by direct supervisors is required? Then it seems like the issue of small supervisor-to-researcher ratio (akin to small teacher-to-student ratio) may help. But as I said there are trade-offs to flexibility and adminstrative load when such monitoring structures are added.

  28. That’s true Gordana, but then their practice becomes restricted. And I think there is a sense of justice for people who have been victimized. So like all aspects of justice, there is a component of deterrence, punishment, and vindication. Although not enough to prevent all undesirable situations from occurring.

  29. Would simply changing the placement/proximity of the authority (from University to Advisor) make a difference? I think the call by Dyck & Allen suggests that researchers need to reframe the way they consider “ethics”, rather than change the way they are monitored.

  30. I appreciate the challenges in the current structure of institutional review boards(IRBs) identified by Dyck and Allen (2012); however, I do not believe removing the “approval” function of the IRBs would facilitate more ethical and diverse research. Like others who have commented, I believe that once the requirement of ethical approval is removed then many researchers may not use the consultative body/process as intended. My belief is that the people whose research may be most scrutinized by an IRB are also those who are most likely to skip the consultation. As others have highlighted, researchers can find loop holes and grey areas that will allow them to pass ethical review. I think the quantity of research may increase, I am doubtful that the quality of research would increase.
    I do understand that the current IRB structure causes delays and the guidelines are applied generically. My suggestion would be to modify, rather than remove, the current structure. I agree with the idea of localizing IRBs, in fact, I would move away from an Institutional Review board and make something more specialized, perhaps at the faculty level. This may allow for the development of ethical guidelines with a greater understanding of the likely subject matter and more specialized knowledge of the reviewers. Hopefully this would reduce the detail related mistakes and may allow for the development of an expedited procedure as needed. Also, by having smaller case load it may reduce the time required for approval. My suggestion would likely result in greater costs to the university (unless it was a volunteer board, which has its own complications). One further benefit of having a faculty specific review board is that follow up (ensuring that these proposal promises are kept) may be more feasible at that level.

  31. IRBs are faculty members who do the work as part of their service to their university and profession… so the current system relies on ‘volunteers.’ One of the saving graces of having an IRB at the University level is that there may be less personalized reviews of research than might occur at say a Faculty level.

  32. I was suggesting the move from university to a more proximal level (e.g. advisor or Faculty-level as some of you have suggested) in lieu of integrating both Dyck and Allen’s suggestion to move to a more consultative/guidance relationship, but also to facilitate better monitoring because we have agreed that approvals by IRBs do not necessarily lead to ethical carry-through of the plan. So could this decentralizing to the faculty help to achieve that? Does making it a more “personalized” reviewing threaten the researcher, or compromise on the ethical standards that are to be maintained?

  33. In terms of the structure of IRBs at the University level, are there any rules that require that all the faculties are represented, i.e., that the members come from various disciplines?

  34. probably not, the requirement for institutions to have IRBs is determined externally… in Canada that is by the Tri-Councils. Any institution that accepts Tri-Council funding must review all research (whether it is funded or not). In the USA it is required by federal law, also connected to funding.

  35. Ok, so changing the structure of the IRB would be a process from the top (Tri-Council) downward. The connection of ethics to funding is an interesting piece to consider, especially given that some of the unethical research (as mentioned in the bio-medical/pharmaceutical field) is often connected with increasing profits for someone.

Leave a Reply

Your email address will not be published.