This policy and procedure may stand alone or be part of an umbrella policy and procedure addressing criteria for approval.

• Cite or repeat the criterion for approval pertaining to privacy interests of participants found in the relevant laws, regulations, codes, or guidance.
• Evaluation of protections of privacy interests of participants:
  • Describe the types of information addressing provisions to protect privacy interests of participants that Researchers are asked to provide in the research protocol or plan.
  • Describe the circumstances under which the IRB or EC considers the provision of protections of privacy interests of participants to be appropriate.
  • When the IRB or EC reviews provisions to protect the privacy interests of participants, describe the types of issues the IRB or EC should consider in evaluating whether the provisions are adequate.

Other suggestions

• If your IRB or EC uses a checklist, include the evaluation of provisions for protecting privacy interests of participants in the checklist or other supporting forms the IRB or EC uses.
• Include the evaluation of privacy interests of participants in supporting forms for Researchers, such as an application form.