MSF Ethics Review Process

The MSF Ethics Review Board (ERB) is an independent ethics review board (ERB) that evaluates all research proposals involving MSF. All research involving human subjects must be submitted for review through the ERB entry point unique to each operational center (OC).

Contact your research advisor for OC-specific information.

Learn more about the MSF ERB and view the profiles of the ERB members

First submission

The ERB submission package requires the documents listed below. All documents should be clearly named.

Completed ERB research template form - click here for the template
Study protocol, annexes, and supporting material (such as consent forms, data collection tools, risk mitigation plan, SOPs)
Short (2 page) CVs of all study investigators
Local ethics review committee approval (if applicable)
Material transfer agreements (if applicable; drafts are acceptable)
For clinical trials, insurance certificate if available at the time of submission

If the research is being done collaboratively with other institutions or individuals, the following forms are also needed:

Data sharing agreement

All materials should be sent to your operational center research advisor, and will be submitted to the ERB by the medical director. The ERB reviews the application to assess risks to participants, benefits, confidentiality, and informed consent. Review takes approximately 6 weeks. The application will be accepted, rejected, or have revisions requested.

Revisions

The ERB may request revisions be made to the documents. If so, all of the following documents should be re-submitted:

Revised protocol, with tracked changes
Revised protocol, clean with all changes made
Point-by-point response to ERB review (all comments should be responded to, even is just requiring an acknowledgment)

Amendments

Amendments are any significant changes that are made to an ERB-approved protocol.

These changes may be classified as major or minor. Examples or major amendments include changes in the research design or methodology, changes in the study site(s), adjustments in the sample size, among others. Examples of minor amendments include adjustments in the study schedule, changes in the research staff other than the principal investigator, among others. Click here for more information about amendments

If an amendment is needed for your study, please fill out the template for requesting amendment approval.

Definition and examples of amendments SOP for amendment review

Study completion/termination

When the study is complete or is terminated for any reason, the following documents should be submitted to the ERB:

Final report for completed studies
Completed declaration of end of study form - Click here for the template
Any additional documents (journal articles/manuscripts, copies of presentations)

Congratulations on completing your research study! A key part of conducting research is responsibly disseminating findings to contribute to the body of scientific evidence.

MSF investigators, find information specific to your OC:

OCA OCB OCBA OCG OCP

MSF ERB Exemption

Under certain conditions, research can be exempted from full ERB review.

Review exemption applies to routine program implementation and assessment related work. Monitoring and evaluation as a part of normal project implementation does not need ethical review.

Exemption from full ERB review does not mean the ERB process can be ignored. An exemption application must be submitted to the ERB and approved. This exemption process applies only to MSF ERB review, local ERBs may not exempt studies. Local ethics review may still be required, even if the study is exempt from MSF ERB review.

A posteriori analyses of routinely collected clinical data

If your study meets certain criteria, MSF Medical Directors can take responsibility for research ethics oversight and the research does not have to undergo full review. Some of the criteria are: