The University of Texas at Dallas

Policies and Guidance

Researchers

Institution Policies

Institutional Review Board Policies

IRB Policy Library
1. Authority & Institutional Commitment

1.1 Assurance Roles and Responsibilities
1.2 Activities Subject to IRB Jurisdiction

2. Conducting Research

2.1 Research Involving Performance Sites
2.2 Offsite Research, Cooperative Research, and Unaffiliated Research
2.3 Biospecimens and Data
2.4 Human Subject Research Determination
2.5 Subject Privacy and Confidentiality
2.6 International Research
2.7 Internet Research
2.8 DoD Funded Studies

3. Records and Documentation

3.1 IRB Records and Documentation

4. Committee Roles & Responsibilities

4.1 Composition of the IRB
4.2 IRB Committee Member COI
4.3 IRB Relationships to Institutional Committees

5. IRB Review Process

5.1 IRB Determinations
5.2 IRB Review – Minimal Review
5.3 IRB Review – Expedited Review
5.4 IRB Review – Full Board
5.5 Risk-Benefit Analysis

6. Researcher Responsibilities

6.1 Modifications
6.2 Continuing Review
6.3 Reportable Events
6.4 Study Closures

7. Informed Consent

7.1 Participant Compensation
7.2 Advertisement and Recruitment
7.3 Prospective – Legally Obtained Consent
7.4 Documentation of Consent
7.5 Waiver of Consent
7.6 Assent – Children or Cognitively Impaired
7.7 Approval or Expiration of Consent Forms
7.8 Role of a Witness

8. Vulnerable Participants

8.1 Children
8.2 Prisoners
8.3 Pregnant Women
8.4 Persons with Intellectual Disabilities
8.5 UTD Students and Employees

9. Investigational Devices

9.1 Investigational Devices

10. Education & Training

10.1 Education and Training of PI and Study Personnel
10.2 Education and Training of IRB Members

11. Post Monitoring and Quality Assurance

11.1 Research Non-Compliance
11.2 Concerns and Complaints
11.3 Post-Monitoring Program
11.4 Hold, Suspension, and Termination of IRB Approval
11.5 Protocol Deviation
11.6 Reporting to the Appropriate Institutional Officials

Federal Regulations

HHS Frequently Asked Questions

General Guidance and Helpful Information

Belmont Report

The Belmont Report sets forth basic ethical principles for the conduct of research involving human subjects. Those principles, respect for persons, beneficence, and justice, have been formally adopted by UTD through its Federalwide Assurance, for all research at UTD involving human subjects. Belmont is the foundation of the U.S. human subjects regulatory system.

Certificates of Confidentiality

Certificates of Confidentiality are issued by the National Institutes of Health (NIH) to protect identifiable research information from forced disclosure. The certificates may be granted for studies collecting information that, if disclosed, could have adverse consequences for subjects or damage their financial standing, employability, insurability, or reputation. A Certificate of Confidentiality will allow the researcher and others who have access to research records to refuse to disclose identifying information on individual research participants in civil, criminal, administrative, legislative, or other proceedings, whether at the federal, state, or local level.

Certificates of Confidentiality may be secured for any sensitive research, regardless of the funding source, so long as the research is relevant to the mission of the NIH/DHHS. In fact, the research does not have to be funded.

OHRP Resources

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