Sharing Data and Specimens
Sharing Data and Specimens
- Decision Trees for Sharing from NIH Protocols (OHSRP, 3/12/19)
- OHSRP Education Series Presentation: When IRB Approval is Necessary and How to Complete the New Investigator Attestation for Tech Transfer Agreements (3/18/19) Slides and Videocast
- Investigator Attestation: Addressing the Protection of Human Subjects for MTAs/DTAs (OHSRP, 3/19/19)
- NIH GDS Policy - Flowchart for Informed Consent Expectations
- Using or Sharing Data or Biospecimens for Research: When is IRB Approval Needed? (OHSRP, 4/13/20)
Unanticipated Problems
- FDA Guidance for Clinical Investigators, Sponsors, and IRBs Adverse Event Reporting to IRBs — Improving Human Subject Protection
- How to Complete A Reportable Event Form (REF) In iRIS
- IRB Member Considerations When Evaluating Reported Events as Possible Unanticipated Problems (Narrated PowerPoint)
- OHRP Reporting to OHRP: Unanticipated Problems (2020)
- OHRP Unanticipated Problems Involving Risks & Adverse Events Guidance (2007)
- OHRP Videos Related to Incident Reporting and Compliance
- OHSRP Education Series presentation: Reporting Research Events and Non-compliance in Human Subjects Research (Slides and Videocast)
- OHSRP Education Presentation: Two Years Since Release of the “NEW” OHSRP Research Related Event Reporting Policies: How is the IRP Doing? (5/4/2021) Slides and Videocast
- Policy 801 Reporting Research Events and Guidance for Reporting Research Events and Noncompliance
Additional Guidance
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