Content created by Office for Human Research Protections (OHRP)
March 22, 2023 - March 23, 2023
Materials may be accessed at Regulations.gov, links to an external website, docket # HHS-OASH-2023-0003.
Agenda
Wednesday, March 22, 2023
| Time | Agenda Item |
|---|---|
| 11:00 am - 11:15 am | Welcome Doug Diekema, MD SACHRP Chair Julie Kaneshiro Acting Director, OHRP |
| 11:15 am – 11:30 pm | Overview of Government Accounting Office (GAO) Report #GAO-23-104721 Institutional Review Boards: Actions Needed to Improve Federal Oversight and Examine Effectiveness Shannon Legeer Assistant Director Health Care Team, GAO Toni Harrison Senior Analyst Health Care Team, GAO |
| 11:30 pm- 12:30 pm | Speaker Panel: Defining Stakeholders and Evaluating HRPP/IRB Quality and Effectiveness Emily E. Anderson, PhD, MPH Associate Professor, Neiswanger Institute for Bioethics Stritch School of Medicine Loyola University Chicago Holly Fernandez Lynch, JD, MBe Assistant Professor of Medical Ethics and Law Perelman School of Medicine University of Pennsylvania Ann Johnson, PhD, MPH Director, Institutional Review Board University of Utah |
| 12:30 pm – 1:15 pm | SACHRP Discussion with Panelists Moderator- Douglas Diekema, MD SACHRP Chair |
| 1:15 pm – 1:45 pm | BREAK |
| 1:45 pm – 3:00 pm | SACHRP Charge and Recommendation on GAO Report Recommendation #4 David Forster, J.D. Co-chair Subcommittee on Harmonization Susan Kornetsky, MPH Subpart A Subcommittee |
| 3:00 pm - 4:15 pm | Recommendations on Draft FDA Guidance: Ethical Considerations for Clinical Investigations of Medical Products Involving Children Guidance for Industry, Sponsors, and IRBs David Borasky, MPH Subpart A Subcommittee Co-chair |
| 4:15 pm - 4:30 pm | Public Comment |
| 4:30 pm | Adjournment Doug Diekema, MD SACHRP Chair |
Thursday, March 23, 2023
| Time | Agenda Item |
|---|---|
| 11:00 am - 11:15 am | Welcome Doug Diekema, MD SACHRP Chair Julie Kaneshiro Acting Director, OHRP |
| 11:15 am – 1:00 pm | Recommendations on Draft FDA Guidance: Ethical Considerations for Clinical Investigations of Medical Products Involving Children Guidance for Industry, Sponsors, and IRBs David Borasky, MPH Subpart A Subcommittee Co-chair |
| 1:00 pm – 1:30 pm | BREAK |
| 1:30 pm – 2:30 pm | Recommendations on Draft FDA Guidance: Ethical Considerations for Clinical Investigations of Medical Products Involving Children Guidance for Industry, Sponsors, and IRBs David Borasky, MPH Subpart A Subcommittee Co-chair |
| 2:30 pm – 4:00 pm | Reserved |
| 4:00 pm – 4:15 pm | Public Comment |
| 4:15 pm – 4:30 pm | Adjournment Doug Diekema, MD SACHRP Chair |