Research policy

Guide for writing a Research Protocol for research involving human participation

Most WHO departments have their own procedures for supporting research in priority areas - these vary from requesting letters of intent to issuing a call for proposals to commissioning research. If you wish to know how you can get involved with research supported by WHO, consult the website of the specific departments that you wish to work with. For more information on WHO supported research activities, click on any of the links provided in the inset.

The WHO-ERC defines "research involving human participants" as any social science, biomedical, behavioral, or epidemiological activity that entails systematic collection or analysis of data with the intent to generate new knowledge; in which human beings (i) are exposed to manipulation, intervention, observation, or other interaction with investigators either directly or through alteration of their environment, or (ii) become individually identifiable through investigators’ collection, preparation, or use of biological material or medical or other records.

All research involving human participants that is supported by WHO undergoes final review by the WHO Research Ethics Review Committee (ERC). ERC does not accept proposals directly from the investigators. They are submitted to the ERC by the WHO responsible technical officers who work closely with the Principal Investigators and are in-charge of that particular project.

This section provides the format for a research protocol recommended by the ERC. Investigators should ensure that each of the items included in the format is addressed in their submission to the technical unit they collaborate with. This guidance is complementary to any information and advice provided by the technical unit or available on the department specific website. It is provided not only to ensure the highest quality in the research protocol, but also to ensure that the ethics review procedure at WHO is efficient and timely.