Table 11: Some documents to be submitted to ERCs

Cover letter briefly describing the research protocol and ethical issues involved, if any.

Full research protocol including rationale, research problem, literature review, methodology, data collection tools, procedures, budget and expected outcomes.

Analysis of potential risks and benefits, including protection of privacy and confidentiality.

Detailed human subject/participant recruitment process and target population.

Informed consent or assent for minors available in the local language.

Process of communicating the research findings to participants and communities.

Plan for addressing post-study obligations, such as:

improvements in health care and facilities;
provision of new-proven interventions to participants;
long-term surveillance;
strengthening of local research expertise.

Curriculum vitae of the team leader/principal investigator and the other research team members.

Proposed dissemination of the study results.