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Documents

IRB Member Resources - TIP Sheets

Below are the monthly TIP sheets that are reviewed at IRB meetings.

Showing all documents

List of documents

Assent Considerations for Subjects Lacking Consent Capacity
  • October 1, 2024
  • 448.6 KB
COI-What IRB Members Need to Know
  • September 1, 2022
  • 137.8 KB
Component Analysis and IRB Review of Research Involving Children
  • May 1, 2026
  • 292.0 KB
Consent form considerations for Early Phase research
  • May 1, 2022
  • 177.0 KB
Consent Readability Pre-review
  • July 1, 2023
  • 198.7 KB
Considerations for Research Involving Healthy Volunteers
  • November 1, 2024
  • 223.0 KB
Data and Safety Monitoring Plans
  • April 1, 2022
  • 228.8 KB
Device Determinations
  • March 1, 2022
  • 307.4 KB
Device Software Functions and Mobile Medical Applications
  • August 1, 2023
  • 179.3 KB
Enrollment of NIH Staff or Family Members in NIH Research
  • July 1, 2025
  • 192.7 KB
Equitable Subject Selection
  • February 1, 2022
  • 225.1 KB
IRB Consideration of Possible Third-Party Research Risks
  • January 1, 2024
  • 206.1 KB
IRB Member Review of Consent Forms
  • October 1, 2022
  • 175.3 KB
IRB Membership and Meeting Requirements
  • November 1, 2026
  • 230.6 KB
IRB review of CRs in PROTECT
  • January 1, 2023
  • 183.4 KB
IRB Review of International Research
  • March 1, 2023
  • 164.2 KB
IRB Review of Multi-site Research
  • January 1, 2026
  • 266.4 KB
IRB review of New Information Being Communicated to Participants
  • February 2, 2026
  • 189.2 KB
IRB Review of Possible Unanticipated Problems
  • August 1, 2022
  • 198.8 KB
IRB Review of Protocol Modifications
  • May 1, 2024
  • 213.6 KB
IRB Review of Recruitment Plans
  • August 1, 2024
  • 234.1 KB
IRB Review of Reportable Events
  • July 1, 2026
  • 179.4 KB
IRB Review of Research Involving Deception
  • October 1, 2023
  • 172.4 KB
IRB Review of studies enrolling NIH staff
  • April 1, 2024
  • 151.0 KB
IRB Waiver of Informed Consent and Waiver of Documentation of Consent
  • September 1, 2025
  • 258.2 KB
IRB Waiver or Alteration of Informed Consent and Waiver of Documentation of Consent
  • October 1, 2026
  • 88.9 KB
Payment of Research Subjects
  • June 1, 2023
  • 134.8 KB
Practical Review of Continuing Reviews
  • February 1, 2024
  • 361.4 KB
Preparing for the 2026 AAHRPP Accreditation Site Visit
  • June 1, 2026
  • 106.5 KB
PROTECT Tip Sheet for IRB Members
  • April 1, 2023
  • 206.2 KB
Reportable Event Review Process-IRB vs. RCRC
  • June 1, 2022
  • 218.6 KB
Research Involving Individuals Without Consent Capacity
  • February 1, 2023
  • 212.4 KB
Research Involving IVDs
  • September 1, 2024
  • 240.1 KB
Research Involving Medical Devices
  • March 1, 2026
  • 183.3 KB
Research Involving Pregnant Subjects
  • November 1, 2022
  • 172.2 KB
Research with Adults Who Lack Consent Capacity
  • May 1, 2025
  • 155.5 KB
Research with Economically or Socially Vulnerable Subjects
  • December 1, 2022
  • 162.8 KB
Reviewing Community-Based Participatory Research (CBPR)
  • April 1, 2026
  • 100.8 KB
Review of Consent Forms in PROTECT
  • September 1, 2026
  • 366.0 KB
Review of Research Including Pregnant Women
  • April 1, 2025
  • 123.8 KB
Secondary Genomic Findings and Return of Results
  • August 1, 2026
  • 165.6 KB
Updated PROTECT Tip Sheet for IRB Members
  • August 5, 2025
  • 289.4 KB