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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 Research Subjects Consenting Non-English Speaking Subjects How to Fill Out the Forms IRB Reportable Events Data Storage and Security CITI Training HIPAA Regulations Clinical Trials Regulation on Human Subject Research

Other Key Information and Guidelines

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

Forms and "How-to-Submit"

IRB Submission IRB Forms IRB Meetings IRB Review Schedule

Training for UNTHSC Human Subject Researchers

Training Requirements Training Policy CITI FAQs CITI Course

Resources

Policies and Procedures OPHS and IRB Contacts On-line Resources Research Glossary

Office for the Protection of Human Subjects

Institutional Review Board

Vision:

OPHS at UNTHSC will be the premier regional human research protection program and a leading innovator in education, training, and positive "value-added" investigator-IRB relationships.

Mission:

Protect research participants, serve the community, and enhance the human research enterprise at UNTHSC.

The University of North Texas Health Science Center (UNTHSC) operates a University-wide human research protection program to review and approve all research involving human subjects. This program has two important components: the Office for the Protection of Human Subjects (OPHS), and the Institutional Review Board (IRB).

Reporting to the Vice President for Research, the Office for the Protection of Human Subjects is an administrative staff department that oversees human subjects' protections through program oversight, education, policy setting, and outreach. The OPHS conducts initial review for all research projects involving human subjects and refers their findings and recommendation to the UNTHSC IRB for formal in-depth review and approval. Further, on behalf of the IRB, OPHS is authorized to monitor all research involving human subjects under their Federal Wide Assurance (FWA) jurisdiction. OPHS provides administrative support to the IRB committees, provides assistance to investigators who are preparing IRB applications, and maintains records of IRB reviews and approvals for investigators.

The IRB is a volunteer member review committee at UNTHSC that is empowered to review all human subjects research proposals - funded or not - which are conducted by UNTHSC faculty, staff, or students, as well as designated community research partners. IRB members are appointed by the Institutional Official (in our case, the Vice President for Research) and serve 3-year terms on the Board (renewable). Note that the IRB is essentially an "independent committee" of the University and must follow federal regulations as well as university policy in evaluating the scientific and ethical merits of human subject research.

The University of North Texas Health Science Center is committed to conducting its biomedical and behavioral research involving human subjects under rigorous ethical principles. The OPHS and the IRB have been established to comply with existing regulations of the federal government in accordance with U.S. Department of Health and Human Services (DHHS) regulations in 46 CFR 46, with the Food and Drug Administration (FDA) regulations set forth in 21 CFR 50, 56, and with Federal Wide Assurance (accepted by the DHHS, Office for Human Research Protections (OHRP)).

Further, the University has agreed to adhere to the statement of ethical principles as described in The Belmont Report: Ethical Principles and Guidelines for the Human Subjects of Research found in the Report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research; and the IRB is cognizant of the International Conference on Harmonization Good Clinical Practice Consolidated Guidelines regarding organization and operation of Institutional Review Boards (IRBs).

This fundamental commitment to the protection of human subjects applies to all UNTHSC research involving human subjects regardless of whether the research is funded through government, non-profit or industry sponsors, through University funds, or not funded at all, and regardless of the location of the research.

Before any human subject research project is initiated, it must be reviewed and approved by the OPHS and where appropriate, the IRB. While the principal investigator has primary responsibility for the conduct of the study, the UNTHSC OPHS and IRB are responsible for protecting the rights and welfare of study subjects under FWAs granted by DHHS to the University. The University and its researchers adhere to federal, Texas, and local regulations and laws as appropriate. Ethical and procedural guidelines by recognized professional organizations are also used for achieving best practices.

Research