Ethical Issues Pertaining to Research in the Aftermath of Disaster

January 13-14, 2003
New York

| Meeting Attendees (PDF file, 2 pages) |

On January 13 and 14, 2003, The New York Academy of Medicine and the National Institute of Mental Health sponsored a meeting entitled "Ethical Issues Pertaining to Research in the Aftermath of Disaster." The attendees included 37 mental health professionals, trauma researchers, public health officials, ethicists, Institutional Review Board (IRB) representatives, as well as family members and first responder representatives from the Oklahoma City and World Trade Center disasters.

The purpose of the meeting was to examine evidence concerning the impact of research on trauma-exposed participants, review the applicable ethical principles and policies concerning protection of human subjects, and offer guidance to investigators, IRBs, public health and local officials, and others interested in assuring that research in the aftermath of a disaster is conducted in a safe and ethical manner.

Four areas of critical importance to development, evaluation, and conduct of research protocols post disaster were identified by the planners of the meeting: decisional capacity of potential participants, vulnerability of research subjects, risks and benefits of research participation, and informed consent. Each topic was the subject of a discussion at the meeting. Moderators of each discussion were asked to review the literature in the field, examine evidence directly related to research post-disaster, and define those areas that required further study.

Attendees agreed that research post-disaster is extremely important and that it can be performed in an ethical manner. They all agreed that there is a need for investigators, IRBs, and public health and government officials to have access to discussions of this type in the event of future disasters in order to assure that important research can be expeditiously reviewed and conducted in a manner that protects the interests of the participants.

The attendees concluded that the following guidance could be offered as points to be considered in research post-disaster:

1. It should be assumed that, as a group, individuals affected by a disaster have the capacity to provide meaningful and voluntary informed consent to participation in research. When questions arise, individual assessments should be conducted. The decision to participate or not participate in research is entirely the purview at the competent prospective participant.

2. Capacity assessment tools exist and should be utilized and capacity might need to be monitored over time; the level of risk of the research should determine the level of concern about capacity.

3. Disaster-affected populations should not necessarily be considered "vulnerable" in the regulatory sense. However, research proposals should address the individual psychological state of potential participants and have explicit mechanisms available for timely referral of subjects in need of mental health consultation, including training of investigators and research staff to recognize emotional problems in research participants.

4. Specific research proposals should be scrutinized based on the level of risk, the novel nature of the research, and the uncertainty of the risk-benefit ratio; such scrutiny may result in the need for additional procedural safeguards for that specific proposal.

5. There is a critical need for additional research on the risks and benefits of participation in disaster-related research. It is important to study the effect of the research itself on participants and whether their experience of participation was what they had expected based on the enrollment process.

6. Ideally, representatives of the community who will be participants of the research should have some level of involvement in the planning and implementation of the research.

7. Information for potential participants about a research project should make clear whether there is therapeutic intent. Informed consent procedures should reduce the likelihood of participants mistaking research for clinical services.

8. The setting for the explanation of the research should be a safe, controlled environment conducive to making an informed decision about participation.

9. Provisions for confidentiality of the data and protection of the privacy of the participants should be an explicit part of the research plan.

10. Proposals should have explicit plans for the training and support of research staff who will be exposed to the emotional challenges faced by research participants.

11. Participants in research post-disaster should be informed of the results of studies in which they have participated.

12. Coordination and collaboration among researchers and IRBs may help minimize participant burden; various models should be considered to facilitate such coordination without unduly impeding research.

The research community that has focused its attention on assessing and minimizing the impact of terror and disaster on affected individuals and communities, has made major contributions to enhancing knowledge, services, and outcomes for countless victims and their families. This community can continue to serve victims and survivors of traumatic events by maintaining sensitivity to the needs of this population and striving to understand more about the effects of trauma and trauma-focused research participation while continuing with their important work.