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Yale Bioethics

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

socio-behavioral reserach

 

Type of Institution:  Community Hospital

Type of IRB:                  Biomedical

Type of Case:                Ethical/Regulatory

Author:                           Chairman of the IRB           

 

From the Editors:

The ability of an IRB to provide effective oversight of the research being conducted at its institution depends heavily on the membership of the committee and the attendance at each meeting. This case illustrates what may happen when an IRB that is accustomed to handling biomedical research is asked to consider a socio-behavioral study. Biomedical IRB’s routinely address the potentially serious medical events that accompany oncology protocols, yet may not fully appreciate the possible non-medical adverse events associated with socio-behavioral studies in the same population.

Background

Hospital nurses occasionally submit proposals for studies that are required in their quest for advanced degrees. Such studies may be socio-behavioral in nature despite the generally biomedical character of the research brought before this IRB. In this case, the principal investigator was a staff nurse at the hospital as well as a student in a nearby Divinity School.

Study Design

The researcher planned to evaluate the ‘spiritual state’ of hospital patients who were suffering from a progressive and/or life-threatening disease such as cancer. The research design included a series of structured interviews to be conducted on several occasions during which the researcher planned to question the subjects regarding their attitudes toward God, their degree of participation in organized religious activities, their level of spiritual and/or physical comfort they derived from their religion, etc. The researcher did not precisely delineate a research hypothesis, although she was clearly interested in exploring the spiritual and religious lives of patients suffering from progressive and possibly terminal illnesses.

Outcome Measures

The research was qualitative and results of the interviews were described by the investigator in terms of the impact of the level of the subject’s ‘spiritual state’ on his or her ability to deal with the illness and the subsequent changes in his or her quality of life.

Recruitment

She planned to enroll a cohort of 15 patients who were recruited directly by hospital nursing and physician staff with the consent of the IRB.

Consent

All standard elements of informed consent were included in the consent discussion and were present on the informed consent document. Consent was obtained from patients only by the Principal Investigator after a thorough review of the purpose of the study, the nature of the questions and the time involved for participation.  

Implementation

No significant concerns were raised by the IRB at the time the study was presented for review. The study was approved with continuing review scheduled to occur one year from the date of initial study approval.

Continuing Review Discussion

When the study came before the IRB for continuing review, the researcher reported that the twelfth of 12 subjects enrolled in the study suffered an adverse event. While this subject had consented to be part of the study, once the interview began, she became agitated and demanded the researcher leave immediately. The researcher spoke with the hospital nurses and was informed that this subject had ‘fallen away’ from her prior religious involvement and had wondered if her malignancy was divine retribution for her lapse.

At the time of the continuing review discussion, the IRB recognized that the occurrence of this subject’s response to the researcher’s line of questioning might have been foreseen. Since changes in her religious observance occurred prior to her involvement in the study, this information was relevant and ascertainable by the researcher. A priori knowledge of these changes in the subject’s religious involvement could have identified the subject as someone at risk of suffering an adverse event related to study participation and possibly impacted on the researcher’s decision regarding the appropriateness of her involvement in the study. As a consequence of the researcher’s report of this adverse event, she was requested to limit her study to the dozen subjects already participating and not enroll any new ones. She was permitted to continue to follow the other subjects already enrolled for whom no adverse events had occurred. The vote was 10 in favor, one opposed.

Ethical/Regulatory Issues

At the time this proposal was initially presented to the IRB for review, no significant concerns were raised and the proposal was approved unanimously by those IRB members present at the meeting. However, at the time of continuing review, one year after initial approval, the adverse event occurrence stimulated the IRB to consider an important ethical and regulatory issue that had not been addressed previously.

  • Can a biomedical IRB provide adequate oversight of socio-behavioral research?

This socio-behavioral study was reviewed and overseen by a primarily biomedical IRB. Such organizations may not be prepared to fully appreciate the nuances of and potential for adverse events inherent in certain types of socio-behavioral research, and thereby fail to provide adequate protection for all subjects who might enroll in such a study. While this IRB was routinely accustomed to addressing the standard types of adverse medical events seen in oncology drug trials, it did not consider the possibly significant adverse psychological consequences of asking these same subjects about their religious and spiritual beliefs vis-à-vis their disease. Of note, three non-scientific members of the IRB, one of whom was a hospital chaplain, were not present at the time of initial IRB review and approval of the study, but did attend the continuing review meeting.

IRB Decision:

Given the design and conduct of the original study, in retrospect, the IRB agreed there was no opportunity a priori to prevent the one significant adverse event from occurring. The IRB also concluded it was highly unlikely for the researcher to reliably have screened and thus excluded subjects who may have been troubled by this line of questioning or to have predicted which subjects might have been at highest risk of experiencing such reactions. In addition, screening and thus excluding such patients from study participation might seriously have undermined the scientific validity of the study.

This IRB questioned, at the time of continuing review whether it was, in fact, comprised of the appropriate membership needed to adequately address all cases – biomedical as well as socio-behavioral – that might come before it. The committee felt that had the non-scientific members of the IRB, and particularly the hospital chaplain, been present at the time of initial study review, the IRB may have recognized the potential for negative non-medical consequences of study participation and dealt with this possibility at that time. The IRB noted the need to anticipate, not only the usual medical adverse events in biomedical studies with this study population but also the occurrence of non-medical events in socio-behavioral studies with the same population.

The IRB decided not to broaden the range of its membership but rather agreed to seek consultative advice in the future when faced with certain types of socio-behavioral studies. It also decided to attempt to optimize attendance of non-scientific members at IRB meetings to provide more appropriate review of socio-behavioral research. 

Comment 1: Diversity and the need for mentoring

Comment 2: Controls on novice researchers

Comment 3: Don't be afraid to ask for help

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