Informed Consent

Lesson Progress
0% Complete

Establishing informed consent is a necessary step in conducting human subjects research.

Woman signing an informed consent sheet

Written consent to participate in a study is often required by IRBs, though verbal consent can be acquired in special circumstances.​1​ Regardless of the format, participants must be aware of all procedures involved in a study and understand that they are allowed to withdraw from the study at any time. 

While this step is routine in all human subjects research, it can be particularly challenging when working with disaster-stricken communities.​1–7​ For instance, individuals who have just been exposed to a disaster may be particularly vulnerable to experiencing negative psychological impacts from a study, especially if they experienced a highly traumatic event, such as the loss of their home or a loved one.​5​ 

Several studies suggest that disaster-affected individuals may be more prone to coercion, feel that their participation is necessary for receiving aid, or be otherwise limited in their decision-making capacity.​3,6,8,9​ Moreover, disaster contexts are inherently unstable; conditions can change rapidly, especially in the time right after an event occurs.​3​ An individual’s consent to participate in a study may be contingent on their specific circumstances, which may change throughout the duration of the study.​7​

Hazards and disaster research often requires investigators to travel to areas in which they have little cultural knowledge or familiarity.​2​ It can thus be challenging to ensure that written informed consent documents are correctly translated into the native language of the community being studied.​2,10​ It is also important to understand the social norms of obtaining consent within the culture. For instance, it may be culturally inappropriate for researchers to deal directly with community members and may therefore require the involvement of a gatekeeper to help establish informed consent.​1,2​

Ethical Dilemmas in the Field

Excerpt from Ellis et al.’s Ethical Research in Refugee Communities and the Use of Community Participatory Methods:

“Certain members of a group may be accustomed to deferring to other members in making personal decisions; for instance, men may be expected to make decisions for women, adults for children, or elders for the whole community. These ethnocultural standards may have implications for how researchers approach consent from different members of a family or community. For example, in a study of Bosnian refugee families, children stated that they would have preferred their own individual consent for the study because their parents, by and large, made the decision for the family to participate without consulting or informing their children. Alternately, many successful refugee studies employ community leaders to help engage refugees in the study. While there are many benefits to this model, it also introduces the possibility that members of a community will feel coerced or required to participate. What might it mean to refuse a community leader who asks you to participate? Individuals may feel unable to refuse the request of respected leaders, regardless of their own wishes.”​11​

In addition to individual consent, the power of communities to determine consent is becoming an increasingly prominent ethical consideration in human subjects research. When research is conducted in communities, the results may compromise or otherwise do harm to communities.​11​ This is particularly relevant for the disaster context where individual research insight from participants can impact how response and recovery resources and services are distributed in a community. 

Community Consent

Man speaking to a tribal leader

Gaining community consent has its own set of challenges. For example, it is unreasonable to expect a researcher to gain consent from all community members. It is therefore the responsibility of researchers to determine who might have the authority to speak on behalf of the community. This may involve seeking endorsements from community leaders, spokespersons, or community councils. However, in times of disaster, these individuals are often incredibly busy responding to community needs and may be especially difficult to reach. Obtaining consent from community leaders may also cause individual community members to feel as though they are required to participate in the study, leading to potential coercion.​11​

  1. 1.
    Barron Ausbrooks CY, Barrett EJ, Martinez-Cosio M. Ethical issues in disaster research: Lessons from Hurricane Katrina. Population Research and Policy Review. 2009;28(1). doi:10.1007/s11113-008-9112-7

  2. 2.
    Bruno W, Haar RJ. A systematic literature review of the ethics of conducting research in the humanitarian setting. Conflict and Health. 2020;14(1). doi:10.1186/s13031-020-00282-0

  3. 3.
    Falb K, Laird B, Ratnayake R, Rodrigues K, Annan J. The ethical contours of research in crisis settings: Five practical considerations for academic institutional review boards and researchers. Disasters. 2019;43(4). doi:10.1111/disa.12398

  4. 4.
    Ferreira RJ, Buttell F, Ferreira SB. Ethical considerations for conducting disaster research with vulnerable populations. Journal of Social Work Values and Ethics. 2015;12(1):1-29.

  5. 5.
    Fleischman AR, Wood EB. Ethical issues in research involving victims of terror. Journal of Urban Health: Bulletin of the New York Academy of Medicine. 2002;79(3). doi:10.1093/jurban/79.3.315

  6. 6.
    Jesus JE, Michael GE. Ethical considerations of research in disaster-stricken populations. Prehospital and Disaster Medicine. 2009;24(2). doi:10.1017/S1049023X00006634

  7. 7.
    Packenham JP, Rosselli RT, Ramsey SK, et al. Conducting science in disasters: Recommendations from the NIEHS Working Group for Special IRB Considerations in the Review of Disaster Related Research. Environmental Health Perspectives. 2017;125(9). doi:10.1289/EHP2378

  8. 8.
    Nuffield Council on Bioethics. Research in Global Health Emergencies. Nuffield Council on Bioethics; 2020:1-308.

  9. 9.
    Rosenstein DL. Decision-making capacity and disaster research. Journal of Traumatic Stress. 2004;17(5). doi:10.1023/B:JOTS.0000048950.36359.a2

  10. 10.
    Tansey CM, Anderson J, Boulanger RF, et al. Familiar ethical issues amplified: How members of research ethics committees describe ethical distinctions between disaster and non-disaster research. BMC Medical Ethics. 2017;18(1). doi:10.1186/s12910-017-0203-z

  11. 11.
    Ellis BH, Kia-Keating M, Yusuf SA, Lincoln A, Nur A. Ethical research in refugee communities and the use of community participatory methods. Transcultural Psychiatry. 2007;44(3):459-481. doi:10.1177/1363461507081642