Human Subjects Approval

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Human Subjects Approval is done to protect the rights and welfare of the human subjects in a research project.

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All impact evaluations must be fully compliant with both local and international Institutional Review Boards (IRB). Local IRB approvals vary by country; research local regulations when the impact evaluation is designed. IRB approval is required for:

  • Studies interacting with human subjects for the purposes of research
  • Studies collecting data on individuals including personally identifying information
  • Studies using data collected from individuals that includes personally identifying information

All researchers should be certified in conducting ethical research on human subjects. All surveys require informed consent from every respondent.

Human Subjects Research Certification

Who must be certified

All members of the research team who manage surveys and work with personally identified data must complete training on conducting research with human subjects. This can include, for example, principal investigators, research assistants, field coordinators, and survey firm staff.

How to obtain Human Subjects Research certification

Ethics certification is usually a prerequisite for IRB approval. Specific requirements vary, but two commonly accepted sources of certification are:

The courses cover the historical development of human subject protections, discuss the ethical issues involved in this type of research, and present the principles and regulations governing it. They are divided in modules, where reading material is provided, followed by a quiz. A minimum score is required to pass each module. Learners may complete the modules at their own pace. Certificates usually have expirations and must be renewed. The CITI certificate must be renewed every 3 years, whereas the expiration of the NIH depends. Note that the IRBs can also define a date past which the certificates are considered invalid.

Additional Resources

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MIT's Committee on the Use of Humans as Experimental Subjects (COUHES) offers examples of IRB applications, informed consent, and authorization forms: