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Categories of Review

Introduction to Categories of IRB Review Exempt Review Expedited Review Full Board Review Continuing Review-Progress Report Protocol Amendments and Modifications

Guidance or "How-to-pages"

What is Human Subject Research?Designing Research Protocols IRB Protocol Synopsis Designing Research-Supporting Documents Consenting Non-English Speaking Subjects IRB Application Submission IRB Reportable Events Data Storage and Security HIPAA Regulations Regulation on Human Subject Research

Other Key Information and Guidelines

Informed Consent-HIPAA Guidelines OPHS-IRB Question and Answer NIH Pre-review IRB Membership Roster-FWA version

Forms

IRB Forms IRB Meetings IRB Review Schedule

Training for UNTHSC Human Subject Researchers

Training Requirements Training Policy CITI FAQs CITI Course

Resources

On-line Resources OPHS and IRB Contacts Research Glossary

NOTE: This pre-review option applies ONLY to the "human subject" section of an NIH grant application- NOT the entire protocol.

NIH building

PRE-REVIEW FOR NATIONAL INSTITUTE OF HEALTH (NIH) GRANT

The Office for the Protection of Human Subjects (OPHS) currently offers "pre-review" of NIH Grant Applications which include a human subject component. This service is part of OPHS' vision to provide exceptional guidance to human subject research investigators as well as to enhance research at UNTHSC.

Investigators may request a "pre-review" from Dr. Brian Gladue, OPHS Director and IRB Chairman for UNTHSC, before submitting a grant proposal. Dr. Gladue serves on several NIH review panels and is a seasoned NIH reviewer and human subject researcher. His extensive experience provides investigators with a unique perspective in evaluating human subject research for grant applications. If you are interested in having a pre-review done, please contact Dr. Gladue via email at bgladue@hsc.unt.edu.

In order to receive an effective review, please submit all appropriate research and grant-related documents well before the grant submission deadline. Grant writing is often a time consuming process and may require several revisions. Therefore, OPHS recommends that investigators request a "pre-review" in a timely manner, usually 3-4 weeks before grant submission, to ensure reviewer availability and time to complete any recommended modifications.

If you have any questions about this unique service, please contact 817-735-0409.

Compass_Guidance for NIH Grants NIH Reviewer Grant Money