Table 1 Ethical framework for research: benchmarks used by MSF

Collaborative Partnership

Researchers should engage in partnership with national and/or international research institutions as relevant and appropriate. Such collaboration should contribute to developing the capacity for researchers and health policymakers to become full and equal partners in the research enterprise.

May not be possible due to the absence of partners or the partisan nature of certain groups that prevent a neutral engagement. However, there should be a demonstrated effort to seek reliable partners.

Community engagement

Researchers should respect the community's values, culture, traditions, and social practices; involve the community in the design and implementation of research through a consultative process; and share fairly any financial and other rewards of the research.

Traditional community organisation may be disrupted by conflict.

Values, cultures, traditions and practices may all be disturbed by conflict.

There may be risks of bias in politically polarized environments.

Social value

Beneficiaries should be clearly specified, and importance of the health problems being investigated and the prospect of value of the research for the beneficiaries made clear.

Mechanisms to enhance the social value of the research should be established to ensure that knowledge is disseminated and ensuring the community benefits from the knowledge generated.

Efforts should be made to avoid diverting resources from health services for the conduct of research.

Transient nature of conflict prevents guarantees that research participants will benefit directly.

Scientific Validity

Research design should optimize possibilities of achieving the social value requirements. Research should be feasible given the social, political, and cultural environment and with sustainable improvements in the local health care and physical infrastructure. Finally, it should be of sufficient quality (eg of sufficient sample size) to yield reliable information.

Volatile nature of conflict can disrupt conduct research (eg sampling constrained by security; evacuations prevent achieving initial sample size)

Fair selection of participants

Study population should be selected in such a way as to ensure scientific validity of the research and minimize the risks of the research. This means formulating clear inclusion and exclusion criteria and identifying and protecting vulnerable groups.

Initial selection/recruitment may need to be adjusted due to population displacement

Favourable Harm-Benefit Ratio

Protocol should clearly assess potential harms and benefits to the study participants and the harm-benefit ratio for the community.

Given the complex cultural and political context of conflict settings, community members may need to be involved in such assessments.

Informed consent

Study community should be involved in establishing appropriate recruitment procedures and incentives for the participants.

Consent procedures should be acceptable and practical within the study community.

All information should be disclosed in culturally and linguistically appropriate formats.

Participants must fully comprehend the research objectives and procedures. This may mean allowing adequate time for discussion about the information received with members of the community or family before deciding on consent.

It should be made clear that participants are free to refuse or withdraw from the research at any stage without penalty.

The provision of incentives should be carefully considered to gain consent from vulnerable populations

Particularly important when the organisation undertaking the research is also engaged in the delivery of humanitarian assistance.

Respect for Recruited Participants and Study Communities

Procedures should be established to protect the confidentiality of recruited and enrolled participants (including biological samples). Enrolled participants should be provided with relevant new information that arises in the course of the research. Medical conditions, including research related injuries, of enrolled participants should be monitored and care provided that is at least as good as existing local norms. Participants and the study community should be informed of the results of the research. Harms and wrongs should be assessed to minimize the risk of exploiting research participants.

May be divergence between 'local' and 'acceptable' norms of care.

Conflict-related displacement of research organisation or population may prevent feedback.

Independent review

Public accountability of the research should be ensured through scientific and ethical review according to international standards. This may require the engagement of international as well as local ethics review boards.

Complicated in oppressive settings if publication research findings may cause problems to researchers or the organisation