The selection of subjects should be equitable and free of any coercion, both explicit and implied. The IRB will consider the purpose of the research and the setting of the research. The IRB will closely examine research involving vulnerable subject populations, such as children, prisoners, subjects with cognitive disorders, or economically or educationally disadvantaged subjects. Researchers should detail any extra precautions taken to safeguard the rights and welfare of subject populations.

The IRB is required to review the method for prospective identification and recruitment of subjects, to include the means of identifying and contacting potential subjects and the methods for ensuring the subjects' privacy and confidentiality. Researchers will include plans for ensuring the privacy and confidentiality of subjects in their applications for IRB approval.

Whenever appropriate, the IRB will require a research plan to make adequate provisions for monitoring the data collected to ensure the safety of subjects. The IRB will review who has been identified in the protocol as having the primary responsibility for analyzing and responding to subject safety issues and will determine whether the study should be modified to minimize risk to current or future research subjects.

The IRB may determine that a project requires more than annual review and may require an appropriate monitoring procedure that could include monitoring of the consent process, observation of the research procedures, formulation of a data and safety monitoring plan, and review of research related records.

Reasons for requiring IRB review more frequently than annually may include but are not limited to: securing the confidentiality of sensitive information, monitoring the safety of subjects, and ensuring participants are free from undue influence or coercion.

Surveys, questionnaires, focus group and interview questions, and related materials should be reviewed to ensure that they adequately reflect the purpose and procedures in the study and handle sensitive issues appropriately. If the materials ask for information that, according to local law, would require reporting (e.g., elder, spouse, or child abuse), the consent form should explain this exception to the promise of subject confidentiality. There are, however, a variety of psychological and other measures which are considered “standard” and, while they cannot be modified, reviewers should still indicate if use of a