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