2021
November/December: Articulating Satisfaction of the IRB Review Criteria_Board Education
Tip_Sheet_20_Sufficient_Information_to_Determine_Whether_the_Criteria_for_Approval_are_Met
IRB Member Recommended article:Contraception Requirements in Clinical Trials Considerations From Studies on Sexually Transmitted Infections
October: OHRE SOP 1401 Update_Promptly Reportable Information_October Meetings
September: No education session
August: Child Assent August 2021
July: Pregnant Research Subjects & Xrays
Additional resource: X-Rays, Pregnancy and You https://www.fda.gov/radiation-emitting-products/medical-x-ray-imaging/x-rays-pregnancy-and-you
WCG-IRB-Annonymous-versus-de-identified-data
June: Reviewer Worksheet Process PPT
Tip Sheet Documenting Discussions and Decisions on Research Studies and Activities
May: OHRP Continuing Review Guidance
Primary Review Presentation for Continuing Reviews
April: Tip Sheets on Study Deferral & Stipulations
March: 111 Criteria #8 Vulnerable Populations PPT
February: 111 Criteria # 7 Privacy & Confidentiality PPT
Attachment A – NIH Data Sharing Policy, Implications of the NIH Draft Policy for Data Management and Sharing on Data Derived from Human Participants
January: 111 Criteria # 6 Monitoring for Safety Plan PPT; OHRP Independent Review of Research