Human Research Protection Program

March 4, 2024
IRB Noncompliance – Lapse in Approval and Past Due Progress Reports

February 5, 2024 and February 16, 2024
Reviewing Audit Study & AI Research

January 8, 2024 and January 19, 2024
Protocol Assistance and Compliance Team (PACT) Services

November 6, 2023 and November 17, 2023
Subject Matter Expert (SME) Review

October 2, 2023 and October 20, 2023
Screening Process

September 11, 2023 and September 22, 2023
IRB Meeting Conduct

July 10, 2023 and July 14, 2023
NIH Policy Application

June 5, 2023 and August 18, 2023
Vulnerable Participants

May 19, 2023
Moving STUDY to PROJECT and Memory Review

May 1, 2023
Moving STUDY (Portal Old System) to PROJECT (Portal New System)

April 3, 2023 and April 14, 2023
Identifying Student Research in the Portal and Consent Documents

March 13, 2023 and March 17, 2023
TMS Safety Protocol

February 17, 2023
What is Undue Influence in Research?

December 9, 2022
Device Software Functions and Mobile Medical Applications

November 2, 2022 and November 18, 2022
Reviewing Studies with Medical Device

October 5, 2022 and October 21, 2022
Reviewing Recruitment Process and Materials

September 7, 2022 and September 16, 2022
IRB Member Portal Training

August 19, 2022
Important Considerations in Conducting In-Home Research

July 15, 2022 and August 3, 2022
An Unethical Experiment

June 1, 2022
Increased Vigilance in the IRB Protocol Application Reviews

April 15, 2022
ResearchMatch.org Overview

October 6, 2021
Return of Results, CLIA, and HIPAA

July 7, 2021 and December 8, 2021
Modifications Required to Secure Approval

May 21, 2021
Non-compliance Determinations

June 19, 2020
FDA Regulations for Medical Device Studies

October 2, 2019
Conflict of Interest, Coercion, and Undue Influence

September 4, 2019
Studies Involving Persons with HIV and Reporting Requirements

August 7, 2019
Minimal Risk vs. Greater than Minimal Risk

June 5, 2019 and July 19, 2019
Risk Determination

May 17, 2019
Levels of IRB Review and Risk Assessment

August 15, 2019
EULA

January 18 and February 6, 2019
Final Rule Discussion: Changes to Consent

December 5, 2018
Final Rule Discussion: Overview of Changes

July 20, 2018
Deception in Research

March 7, 2018
Financial Conflict of Interest

February 7, 2018
HUD Overview

July 21, 2017
New Common Rule Overview

June 28, 2017
Determining Minimal Risk

May 19, 2017
Subpart D

February 17, 2017
Subpart C

January 20 & 25, 2016
Scientific and Scholarly Validity

December 9, 2016
RNIs and Non-Compliance: What is the role of the IRB?

November 30, 2016
Guidance on FDA: HCT/P and INDs.

October 26, 2016
Approval Criteria – Informed consent presentation.

September 16, 2016
What is Exempt Research?

August 19, 2016
Getting Back to Basic-Approval Criteria

July 15, 2016
Risk Determinations and Research with Children

June 17, 2016
Determining Minimal Risk

May 20, 2016
Fully Informed Consent and Healthcare Literacy