Resources: For Accreditation - Tip Sheets
Evaluating the Maintenance of Confidentiality of Data in Proposed ResearchDownload as PDF
Latest Update: September 1, 2012
Related Accreditation Elements: II.3.E.
A criterion for approval of research is the presence of adequate provisions to maintain the confidentiality of identifiable data collected during a research study.
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 confidentiality of data found in the relevant laws, regulations, codes, or guidance.
- Evaluation of provisions to maintain the confidentiality of identifiable data collected as
part of the research:
- Describe the types of information addressing provisions to maintain confidentiality that Researchers are asked to provide in the research protocol or plan.
- Describe the circumstances under which the IRB or EC considers provisions to maintain confidentiality to be appropriate.
- When the IRB or EC reviews provisions to maintain confidentiality of data, describe the types of issues the IRB or EC should consider in evaluating whether the provisions are adequate.
- If your IRB or EC uses a checklist, include the evaluation of provisions to maintain the confidentiality of data in the checklist or other supporting forms the IRB or EC uses.
- Include the evaluation of the maintenance of the confidentiality of data in supporting forms for Researchers, such as an application form