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Latest from HRP Consulting Group

• Navigating the Complexities of Exception from Informed Consent (EFIC) in Research
  A growing area of research involves exception from informed consent, also known as planned emergency research. Under certain conditions, in an emergency setting, participants can be enrolled in a trial without their consent. This article summarizes the podcast hosted by CITI Program with guest Michael Linke, PhD from the University of Cincinnati and the host Justin Osborne from The HRP Consulting Group where they discussed the… Read more: Navigating the Complexities of Exception from Informed Consent (EFIC) in Research
• Comparison of Common Rule_FDA_Revised FDA_May 2024
  Comparison of Common Rule_FDA_Revised FDA_May 2024 The FDA Regulations cited in this table are primarily from 21 CFR 50 and 56 as these regulations refer to human subject protection and institutional review boards (IRBs). The proposed FDAchanges cited in this table are from FDA proposed rules Protection of Human Subjects and Institutional Review Boards and Institutional Review Boards; Cooperative Research.
• FDA Final Rule – Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations
  FDA 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 Update
  HRP 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 IRBs
  HRP 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 Requirement
  HRP 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