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Yale Bioethics

IRB Case: The ability of a biomedical IRB to effectively manage

socio-behavioral reserach

Diversity and the need for mentoring

Lois S. Sadler PhD PNP-BC FAAN

This case brings to light several important ethical and research issues, many of which center around the ethical challenges that are directly embedded within specific research methods highlighted in this study. This intersection of methods and ethics is further reflected in questions about the composition and research expertise of the members of this biomedical IRB as well as the larger aims of the study and expertise of the student researcher and her mentor, who submitted this qualitative research protocol involving a vulnerable sample of interviewees i.e., individuals with progressive and/or life-threatening health conditions.

Reflections about these issues are likely clearer in a retrospective analysis of this case than they were as the protocol was being designed, reviewed and implemented. With the perspective of hindsight, it appears that with more behavioral and qualitative research expertise on the part of the researcher as well as within the IRB committee membership, the events described (the participant’s distress and the student-researcher’s abbreviated data collection) may  have been prevented. My discussion of this case includes a focus on the composition and research expertise of the IRB committee membership, the unique methodological and ethical issues inherent in the conduct of qualitative health research, and the issue of research sampling conducted by student or novice researchers, with vulnerable populations.

The expertise of different types of protection committees for human subjects is reflected not only in their charge and structure, but also by the scientific diversity of the committee membership. In larger institutions where there are multiple IRBs, or IRB subcommittees, there may be flexibility in the decisions to be made about which committee or subcommittee (biomedical or socio- behavioral) should review which type of protocols. In the case of research to be conducted within the hospital setting, there is likely less flexibility about any choice of IRB.  Representation of diverse disciplines on IRB membership rosters should include members with expertise in various research methodologies.  Researchers from nursing, divinity, social work, psychology or other backgrounds, (as well as medical researchers) commonly conduct research within medical centers and teaching hospital campus settings.  In the case of IRB members with specific expertise in socio-behavioral studies and/or qualitative research methods, they may be more attuned to the potential risks and pitfalls of  these types of studies and perhaps more attuned to the (in some cases subtle, although not always) psychological or emotional distress related to a study interview or protocol. These types of adverse reactions or distress may not be anticipated by biomedical experts who are possibly more familiar with the potential array of medical adverse outcomes in response to a clinical trial procedure or medication. This speaks to the benefits of diverse disciplines being represented on IRB committees. The social science and nursing members may be more likely to be experienced and cognizant about the non-medical but still-present psychological or emotional research-related risks for participants (Rothstein & Phuong, 2007). Participation of all IRB committee members (especially those with the research expertise pertinent to the protocols under review) at meetings, or submission of written summaries from those members not able to be present for the meeting, would help to assure adequate discussion of potential risks on the part of the review committee.

All data collection approaches with participants include some risks, but the researcher designing the socio-behavioral study needs to consider the relative risks of psychosocial interviews and ways to anticipate or reduce those risks in the conduct of the study. While some studies similar to that of the divinity student in this case might benefit from more detailed or rigorous inclusion and exclusion criteria to potentially avoid participants for whom such an interview would be too traumatic to justify their participation, the IRB decided in this case, that the tightening of inclusion and exclusion criteria would not have likely helped avoid the distressing interview that was reported. Skilled qualitative interviewing and the design of qualitative research protocols to protect vulnerable participants are two ways to possibly avoid the escalation of a difficult interview into a truly distressing event for the participant.

Often, qualitative research approaches are seen as a better match with the study of sensitive issues or with vulnerable samples, however, this assumption implies that the researcher is skilled in interviewing about sensitive topics and has anticipated participant distress and built into the protocol various ways to help participants de-brief or in other ways, handle their distress (Marshall & Rossman, 2006; Morris, 2001; Patton, 2002).  Interviewing techniques in qualitative research include good listening skills as well as careful attention to the content, pacing and sensitive nature of the interview questions. The qualitative interview is like a guided conversation that is carefully planned by the researcher to begin with familiar content and to gradually build up to the difficult or sensitive questions, and then finish with easier, less charged questions (Patton, 2002). The researcher may want to “normalize” particularly sensitive questions, such as, “…something that many if not all cancer survivors think about is the following...have you ever had this type of thought?” During the interview, the researcher listens and observes the participant to be able to monitor the level of discomfort or distress, and to determine if the participant wants to slow down, stop or continue. The researcher should have an a priori protocol in place (for during and after the interview) to accommodate participants who become upset or may reveal symptoms of depression, anxiety, etc during the research interview (Patton, 2002). These protocols are similar to those in studies where information may be disclosed by subjects about potentially harmful information for self or others during the interview process, or when the researcher is surveying or interviewing about known health risk areas (e.g. depression, suicidal ideation and potential child abuse).

The third issue in this case concerns the novice researcher conducting (qualitative) research with a uniquely vulnerable population of participants (DeChesnay et al., 2008; Michaels & Moffet, 2008). While it is not known how well this student researcher was prepared to conduct this set of qualitative interviews, it is not uncommon for novice researchers to assume that qualitative research is easy to do by simply asking questions and noting participant responses. While the student may have been a competent clinician, quite used to interviewing patients in her nursing role, she may not have had preparation and experience as a research interviewer, nor have been knowledgeable about the preliminary signs of distress in a study participant and ways to head off or diminish the distress during the interaction (DeChesnay et al., 2008;  Kavanaugh & Ayres, 1998; Morris, 2001). Qualitative research with vulnerable populations should responsibly include specific safeguards to protect the participants as noted previously

The research mentor (as the first line- reviewer) as well as IRB committee reviewers need to consider this student’s research project in light of their evaluation of the relative risks and benefits to the participants, and the potential contribution to the state of the science.  These considerations should be aside from the benefit to the student of completing a degree requirement. Especially when the research study includes a vulnerable or potentially vulnerable study sample (such as individuals with a terminal health condition), the benefit of the study and findings need to favorably balance with the potential for distress and/or risks or inconvenience to participants. In the description of this research study, the focus of the research appeared to be descriptive, (exploring the level of the participant’s spiritual state as related to the ability to deal with illness and changes in quality of life). There were no specific aims reported that indicated that clinical approaches or interventions would be developed as a result of the study and no apparent direct benefit to the participants.  In addition, it was unclear as to how the student was being supervised, the extent of the role of the research mentor, and how experienced that individual was in the specific method or approach of the student’s project.

References

DeChesnay, M., Murphy, P., Harrison, L. & Taualii, M. (2008). Methodological and ethical issues in research with vulnerable populations. In M. DeChesnay & B. Anderson (Eds.), Caring for the vulnerable: Perspectives in nursing theory, practice and research (pp.155-170), Sudbury, MA: Jones & Bartlett.

 Kavanaugh, K., & Ayres, L. (1998). Not as bad as it could have been: Assessing and mitigating harm during research interviews on sensitive topics. Research in Nursing and Health, 21, 91-97.

Marshall, C. & Rossman, G. (2006). Designing qualitative research (4th Ed.). Thousand Oaks, CA: Sage.

Michaels, C. & Moffet, C. (2008). Rethinking vulnerability. In M. DeChesnay & B. Anderson (Eds.), Caring for the vulnerable: Perspectives in nursing theory, practice and research (pp.15-37), Sudbury, MA: Jones & Bartlett.

Morris, S. (2001). Joint and individual interviewing in the context of cancer. Qualitative Health Research, 11, 553-567.

Patton, M. Q. (2002). Qualitative research and evaluation methods. Thousand Oaks, CA: Sage.

Rothstein , W.& Phuong, L. (2007). Ethical attitudes of nurse, physician and unaffiliated members of institutional review boards. Journal of Nursing Scholarship, 39, 75-81.

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