Latest from HRP Consulting Group
- FDA Final Rule – Waiver or Alteration of Informed Consent for Minimal Risk Clinical InvestigationsFDA Final Rule – Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations Fast Facts On December 21, 2023, the Food and Drug Administration (FDA) published a Final Rule “Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations” (Federal Register: Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations). Background: The rule implements changes… Read more: FDA Final Rule – Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations
- Single IRB UpdateHRP recently had a very helpful email dialogue with OHRP regarding the cooperative review (single IRB) provisions in the revised Common Rule. OHRP has graciously provided permission for us to disseminate the information they provided and have asked that we remind everyone to please check in with the funding agency when uncertain whether the mandate applies because the funding agency may have a definition of support that is more strict or different than OHRP’s…Read more
- Is it time to rethink the IRB roster?We’re all eagerly watching the evolving ethical and regulatory landscape in research, with updated guidance from several agencies and organizations, the unknown implications of AI and the increasing dependency on technology to conduct our trials. For those who have been in the research industry for a while, this is a lot of change in a short amount of time, and it often feels like we’re being… Read more: Is it time to rethink the IRB roster?
- IND Safety Reports and IRBsHRP recently engaged in extensive correspondence with the FDA regarding the following statements that appeared in one of the later iteration’s of the FDA’s guidance document “Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency”: Where an IND safety report is required to be submitted to FDA under 21 CFR 312.32, the investigator must [emphasis added] also send that IND safety report… Read more: IND Safety Reports and IRBs
- Exception Process for Revised Common Rule Single IRB RequirementHRP recently sought clarification from NIH and OHRP regarding the process for organizations to request exceptions from the revised Common Rule requirement for single IRB for cooperative research. While NIH was previously able to grant exceptions from its own single IRB policy, it is unable to grant exceptions to the revised Common Rule requirement. HHS interprets the regulatory text (see excerpt below) to mean that exceptions… Read more: Exception Process for Revised Common Rule Single IRB Requirement