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Resources: For Accreditation - Evaluation Instrument
Table of Contents
- The time and place where they give information.
- The nature of the information they give.
- The nature of the experiences that are given to them.
- Who receives and can use the information.
Regulatory and guidance references
- DHHS: 45 CFR 46.111(a)(7)
- DOE: 10 CFR 745, DOE Order 443.1C (November 2019)
- FDA: 21 CFR 56.111(a)(7)
- VA: 38 CFR 16.111(a)(7), VHA Handbook 1200.05, 10, 12, 17
- AAHRPP Tip Sheet: Evaluating Protections of Privacy Interests of Participants in Proposed Research
- AAHRPP Tip Sheet: Sufficient Information to Determine Whether the Criteria for Approval are Met
Required written materials
- Essential requirements:
- Applications include a description of provisions to protect the privacy interests of participants.
- In order to approve research, policies and procedures have the IRB or EC determine that the research protocol or plan contains adequate provisions to protect the privacy interests of participants.
- When following DOE requirements:
- Personally identifiable information collected and/or used during human participant research projects must be protected in accordance with the requirements of DOE Order 206.1, Department of Energy Privacy Program
- Any breach involving Personally Identifiable Information must be reported:
- Immediately upon a finding of a suspected or confirmed data breach involving Personally Identifiable Information (PII) in printed or electronic form, the incident must be reported to the DOE-Cyber Incident Response Capability in accordance with the requirements of DOE O 206.1.
- Within 48 hours the DOE or NNSA HSP Program Manager must also be notified of any corrective actions taken and consulted regarding the plan for any remaining corrective actions.
Common types of materials that may be used to meet the element
- Application form
- Reviewer checklist
- IRB or EC members understand the concept of privacy.
- IRB or EC members determine that the research protocol or plan contains adequate provisions to protect the privacy interests of participants.