IRB Member Review Resources

OHRP Resources for IRB Members

Considerations for Reviewing Human Subjects Research

OHRP Educational Resources for IRB Members and Administrators

OHRP Video Series
OHRP Simplifying Informed Consent
OHRP Quorum and Voting in IRB Meetings
OHRP What are IRBs?
OHRP What is Human Subjects Research?
OHRP Independent Review of Research

IRB Member Tip Sheets

Research Involving Medical Devices-January 2025.pdf	238 kB
Considerations for Research Involving Healthy Volunteers-November 2024.pdf	223 kB
Assent Considerations for Subjects Lacking Consent Capacity-October 2024.pdf	449 kB
Research Involving IVDs-September 2024.pdf	240 kB
IRB Review of Recruitment Plans-August 2024.pdf	234 kB
IRB Review of Protocol Modifications-May 2024.pdf	214 kB
IRB Review of studies enrolling NIH staff-April 2024.pdf	151 kB
Practical Review of Continuing Reviews-February 2024.pdf	361 kB
IRB Consideration of Possible Third-Party Research Risks-January 2024.pdf	206 kB
Waiver of Consent vs. Waiver of Consent Documentation-December 2023.pdf	218 kB
Communicating New Information to Subjects-November 2023.pdf	176 kB
IRB Review of Research Involving Deception-October 2023.pdf	172 kB
IRB Review of Multi-site Research-September 2023.pdf	251 kB
Device Software Functions and Mobile Medical Applications-August 2023.pdf	179 kB
Consent Readability Pre-review July-2023.pdf	199 kB
Payment of Research Subjects June-2023.pdf	135 kB
Secondary Genomic Findings and RoR-May 2023.pdf	171 kB
PROTECT Tip Sheet for IRB Reviewers-April 2023.pdf	210 kB
IRB Review of International Research-March 2023.pdf	164 kB
Research Involving Individuals Without Consent Capacity- Feb 2023.pdf	212 kB
IRB review of CRs in PROTECT -Jan 2023-VIDEO.mp4	165.42 MB
IRB review of CRs in PROTECT -Jan 2023.pdf	183 kB
Research w Economically or Socially Vulnerable Subjects-Dec_2022.pdf	132 kB
Research Involving Pregnant Subjects-November 2022.pdf	172 kB
IRB Member Review of Consent Forms-October 2022.pdf	175 kB
COI-What IRB Members Need to Know September 2022.pdf	138 kB
IRB Review of Possible UPs August 2022.pdf	199 kB
Research Involving Children July 2022.pdf	256 kB
Reportable Event Review Process-IRB vs. RCRC June 2022.pdf	219 kB
Consent form considerations for Early Phase research May 2022.pdf	177 kB
Data and Safety Monitoring Plans April 2022.pdf	229 kB
Equitable Selection February 2022.pdf	225 kB
Device Determinations March 2022.pdf	307 kB

IRB Member Updates

IRB Member Updates 2024-09.pdf	1.14 MB
IRB Member Updates 2023-12.pdf	781 kB
IRB Member Updates 2023-06.pdf	1.81 MB
IRB Member Updates 2022-12.pdf	1.56 MB
IRB Member Updates 2022-06.pdf	652 kB
IRB Member Update 2021-12.pdf	350 kB
IRB Member Update 2021-06.pdf	1.54 MB
IRB Member Update 2019-12.pdf	204 kB
IRB Member Update 2020-06.pdf	1.21 MB
IRB Member Update 2020-12.pdf	4.43 MB

Reference Documents

Guideline Sheet for Reviewing Return of Secondary Genomics Plans.pdf	153 kB
IRB Quick Reference Guide.pdf	809 kB
How to Receive Email Updates About FDA Drug Label Changes.docx	102 kB
CEnR CBPR Points to Consider for IRB Final_v20210809_508f.docx	37 kB
Comparison of Consent Regulations Table.pdf	694 kB
IRB member determination checklist.docx	19 kB
Initial review checklist.docx	44 kB

Presentations

IRB retreat 2022 Drs. Hull_Berkman RoR presentation.pdf	526 kB
IRB retreat 2022 Dr. Green Research with Children.pdf	1.05 MB
IRB retreat 2024 Jeff Wells- My Journey.pdf	13.06 MB
IRB retreat 2024 Heather Bridge Continuity Planning.pdf	248 kB
IRB retreat 2024 Dr. Walters THRO presentation.pdf	6.53 MB
IRB retreat 2024 Dr. Green AI_AN policy update.pdf	279 kB
IRB retreat 2024 Dr. Gilman Clinical Center Update.pdf	1.54 MB
IRB Criterion for Approval #6-Provision for Monitoring Data to Ensure the Subject Safety-Narrated.pptx.ppsx	18.46 MB
IRB Criteria for Approval 4 and 5-informed consent - Part 2 of 2 - Narrated.ppsx	30.82 MB
IRB Criteria for Approval 4 and 5-informed consent - Part 1 of 2 - Narrated.ppsx	27.57 MB
Research Involving Pregnant Women - Narrated.pptx	19.03 MB
IRB Review of UPs - Narrated.pptx	29.97 MB
IRB Criteria for Approval Criterion 1 and 2 - Narrated.pptx	27.26 MB
IRB Criterion for Approval #3-Equitable Subject Selection-Narrated.ppt	10.67 MB

IRB Review of CRs in PROTECT- Video