Ethics

Experimental trials can carry risks, often greater than other types of studies. However, any type of research may result in burden: a loss of privacy and the time spent completing interviews and examinations. It is also possible there are adverse psychological effects -such as enhanced grief or false expectations.

In the environments where MSF works, research work can notably create false expectations in the therapeutic or philanthropic nature of the work. These risks are of particular concern in vulnerable populations. Benefits are often societal in nature, such as obtaining new information about the causes of disease or identifying health disparities across groups defined by ethnicity or other factors.

This is a key consideration for Epicentre and MSF, which evokes the principle of justice broadly. These obligations to the community are multiple: active participation in the research, collaborative partnerships, sharing and access to the results from the research. In addition, research obliges the communication results of studies at the earliest possible time after appropriate scientific review so that the widest possible audience stands to benefit from the information. 

Informed consent (most often but not exclusively written) ensures that participants have voluntarily chosen to participate, free from coercion or undue inducement. Free and informed consent ensures the research adheres to international norms and is a legal requirement in some cases. This necessitates the provision of information on which to base decisions regarding participation in the research and includes the purpose, risks, and the right to refuse.

Exceptionally, informed consent may be waived by an ethical review committee, if it considers there is minimal risk, social value or that it is really impossible in practice to obtain consent. Issues with informed consent for vulnerable populations include the misinterpretation that study participation constitutes health care; in addition, study participants may not feel they can opt out if a person of authority is requesting consent. 

Regulations to protect the privacy of participants and confidentiality of health records must be adhered to and followed. Notably, the protection of any individual-level study data, including their secure retention, transmission, or transfer, is essential for participants' privacy. In short, the system hosting such data should be secured to prevent unauthorized access and the movement of any individual-level data must be encrypted.