Ethical Issues to Consider in Developing, Evaluating, and Conducting Research Post-Disaster
Disasters, whether unintentional acts of nature or human-made, can have profound effects on those who experience them. Although the physical dangers inherent in disasters are obvious, such events, including terrorism and bioterrorism, are a grave threat to mental health as well.
This document offers guidance to investigators, Institutional Review Board (IRB) representatives, public health officials, local officials, and others focused on ensuring that research in the aftermath of a disaster is conducted in a safe and ethical manner. Suggestions included in this summary were derived from a 2003 meeting jointly sponsored by The New York Academy of Medicine and the National Institute of Mental Health.
A diverse group of individuals contributed to this meeting and the summary, including mental health professionals, trauma researchers, public health officials, ethicists, IRB representatives, as well as family members and first responder representatives from the Oklahoma City and World Trade Center disasters.
Federal regulations (The Common Rule - 45 CFR 46, subpart A) provide the framework for the protection of the human subjects of research. These regulations and additional subparts B through D define the standards for the ethical conduct of research, including the process for proposal review through IRBs. The regulations describe the process of voluntary informed consent and note that additional protections should be afforded vulnerable subjects such as children, prisoners, fetuses, the decisionally impaired, and the economically and educationally disadvantaged (Federal Policy for the Protection of Human Subjects, 45 CFR §46.111, 1991). Nevertheless, beliefs and knowledge about the potential of research to cause additional and significant distress for participants varies greatly among those involved in developing, evaluating and conducting disaster mental health research. Thus, there is a need for investigators, IRBs, and public health and government officials to have access to data-informed guidance 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.
There is broad agreement that research post-disaster is extremely important and that it can be performed in an ethical manner. Among the many complex considerations for research after disaster, four areas of critical importance to development, evaluation, and conduct of research protocols post-disaster are addressed here: decisional capacity of potential participants, vulnerability of research subjects, risks and benefits of research participation, and informed consent.
The following guidance is offered as points to be considered in research post-disaster. Citations found at the end of this overview point to valuable sources of more detailed discussion on these points of consideration.
- 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 of the competent prospective participant.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- The setting for the explanation of the research should be a safe, controlled environment conducive to making an informed decision about participation.
- Provisions for confidentiality of the data and protection of the privacy of the participants should be an explicit part of the research plan.
- 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.
- Participants in research post-disaster should be informed of the results of studies in which they have participated.
- Coordination and collaboration among researchers and IRBs may help minimize redundant research and 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.
For a summary of considerations for institutional review board members, see: Collogan LK, Tuma F, and Fleischman A. Research with Victims of Disaster: IRB Considerations. IRB: Ethics & Human Research. 2004 Jul-Aug;26(4):9-11. PMID: 15449409
The Journal of Traumatic Stress dedicated a special section to ethical issues in disaster research: 2004 Oct;17(5):361-448.
Kilpatrick DG. The ethics of disaster research: A special section. J Trauma Stress. 2004 Oct;17(5):361-2. PMID: 15633914
Collogan LK, Tuma F, Dolan-Sewell R, Borja S, Fleischman AR. Ethical issues pertaining to research in the aftermath of disaster. J Trauma Stress. 2004 Oct;17(5):363-72. PMID: 15633915
Rosenstein DL. Decision-making capacity and disaster research. J Trauma Stress. 2004 Oct;17(5):373-81. PMID: 15633916
Newman E, Kaloupek DG. The risks and benefits of participating in trauma-focused research studies. J Trauma Stress. 2004 Oct;17(5):383-94. PMID: 15633917
Levine C. The concept of vulnerability in disaster research. J Trauma Stress. 2004 Oct;17(5):395-402. PMID: 15633918
Updated September 2007