Did You Know
Best Practices for Stamped Consent Forms
April 7, 2025
OHRE implemented date stamping of consent forms in May 2024. Since that time, we have noted some instances where the stamp fails to be placed or is obscured by other
How do I submit my Investigatorʼs Brochure (IB) update to the IRB?
June 27, 2022
Investigator’s Brochures are essential regulatory documents requiring IRB submission and review, but should these documents be submitted as a Modification or as Promptly Reportable Information (PRI)? It depends… IBs are
Department routing of IRB submissions
February 23, 2021
A department’s approval in IRBIS is attesting that the study personnel have the appropriate expertise (e.g., credentialing, licensure, privileges, training), experience (e.g. previous research studies conduct and role in relation
Changes to Multi-Site Screening Question
January 25, 2021
With the most recent IRBIS update, the application logic rules were changed regarding the Multi-Site Screening question (#6 on the Screening Questions page). The original purpose of the question was
Meeting Dates and Deadlines for 2021
January 25, 2021
The IRB Meetings and Deadlines Calendar has been published for 2021 on the OHRE website. With the restructuring of the boards to remove the designations of Biomedical, Non-biomedical, and Safety
What information should be in recruitment materials?
January 25, 2021
In order to assure recruitment procedures adequately protect the rights and welfare of prospective subjects, the IRB must review and approve all advertisement and recruitment materials for research conducted under
How do I describe my Consent Process?
July 28, 2020
Informed consent is more than a just a form for the subject to sign, it is a verbal and written process by which the investigator provides adequate and appropriate information
What should be in my Concise Summary?
June 26, 2020
All initial studies approved on or after January 20, 2019 are governed by new IRB regulations (the Revised Common Rule). One of the new requirements is the addition of a
Updates to CITI Human Subjects Protection training requirements for study personnel
May 21, 2020
Collaborative Institutional Training Initiative (CITI) is a web-based training package on issues relating to human subjects research. The program contains modules on topics like informed consent, vulnerable populations, ethical principles,
De-identified, Coded, or Anonymous? How do I know?
May 1, 2020
These can be confusing adjectives when referring to study data. Included below is a mini-glossary to help you with your IRB applications. [list][li]Coded Data are coded when a link will exist between