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Policies

Institution Policies

Office of Human Subjects Protections Policies and Procedures

OHSP Policy and Procedure 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
2.9 Data and Safety Monitoring

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 – Exempt
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. Clinical Trials & FDA – Regulated Research

9.1 – SOP for ClinicalTrials.gov PRS
9.2 – SOP for Investigational New Drug (IND)
9.3 – SOP for Investigational Device Exemption (IDE)

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

The list below represents a few of the federal agencies from which UTD receives support for human subjects research. The links below reference federal websites or documents that contain policies, explain specific provisions, and provide links to resources for that agency.

U.S. Department of Health and Human Services (HHS)

Protection of Human Subjects (45 CFR Part 46)
The Common Rule
2018 Common Rule Update
Information about regulatory changes effective January 21, 2019 guidance on implementation at UTD

Food and Drug Administration (FDA) Regulations

Department of Defense

Data Protection Policies

FERPA (Family Education Rights and Privacy Act)
Protects the privacy of student education records and establishes guidelines for accessing records

GDRP (General Data Protection Regulation)
Mandates standards for handling certain personal data of residents of the European Union (EU) and non-EU citizens located in the EU.

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.