Federal Regulations and Policies

US federal regulations are in place to safeguard the well-being and rights of research participants, maintain ethical standards, and ensure the credibility of scientific research while promoting trust in the research process. When a research protocol is federally funded or supported, and/or falls under the FDA’s purview, researchers should be aware of the requirements of these departments and agencies. The following is a listing of the commonly applied federal regulations and policies.

Please contact the Office of Regulatory Services at regulatoryservices@uta.edu with questions about the applicability of federal regulations to proposed or approved research.

The Revised Common Rule

In 1991, The Department of Health and Human Services (HHS) published “The Federal Policy for the Protection of Human Subjects”, which contained several subparts (A-D). The first section (Subpart A) was called the Common Rule because it was simultaneously adopted by numerous Federal departments and agencies when it was first published. The Common Rule was revised in 2018 and is now called the Revised Common Rule.

• Subpart A - Basic HHS Policy for Protection of Human Research Subjects

Also known as The Revised Common Rule. This subpart includes requirements for:

• IRB review of research
• Criteria for IRB approval of research
• Cooperative Research
• General Requirements for Informed Consent
• Documentation of Informed Consent

• Subpart B — Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research
• Subpart C — Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects
• Subpart D — Additional Protections for Children Involved as Subjects in Research

Federal funders normally require the application of the Revised Common Rule to human subjects research they fund or support. A list of those US departments and agencies that have adopted the Revised Common Rule and require compliance for the conduct of human subject research can be found here.

Food and Drug Administration (FDA) Regulations

Human subjects research is regulated by the FDA when it involves the development and testing of products that fall under the FDA’s purview. The FDA primarily regulates research related to the following areas:

• Drug development
• Medical devices
• Biologics
• Food Safety
• Tobacco Products
• Dietary supplements (depending on the study purpose)

Like many federal departments and agencies, the FDA has regulations for the protection of human subjects. These are similar to the Revised Common Rule and its other subparts, but have some differences in consideration of the distinct nature of the development of products under the FDA’s purview. When a research protocol is determined to be FDA-regulated the following regulations are applied by the IRB upon review:

• Protection of Human Subjects (Informed Consent) (21 CFR Part 50)
• Institutional Review Boards (21 CFR Part 56)

Additionally, when the research involves a drug, medical device, and/or biologic, one or more of the following regulations will be applied by the IRB upon review:

• Investigational New Drug Application (21 CFR Part 312)
• Bioavailability and Bioequivalence Requirements (21 CFR Part 320)
• Applications for FDA Approval of a Biologic License (21 CFR Part 601)
• Investigational Device Exemptions (21 CFR Part 812)
• Premarket Approval of Medical Devices (21 CFR Part 814)

When electronic records and electronic signatures are used in lieu of traditional paper records and handwritten signatures, requirements found at Electronic Records; Electronic Signatures (21 CFR Part 11) apply. It is the investigator’s responsibility to develop processes and procedures to be compliant with these requirements.

As part of a marketing application for a drug, device, or biologic, the FDA requires adherence to

Financial Disclosure by Clinical Investigators (21 CFR Part 54). The sponsor submitting the marketing application is responsible for compliance. The IRB does not review these disclosures but any financial interest that could be a potential conflict of interest should be disclosed in the IRB protocol application.

The most commonly applied regulations have been listed above, but a full listing of FDA regulations and guidance documents can be found here.

Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule

The Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule applies to research that involves the use or disclosure of individually identifiable health information (protected health information or PHI).  UTA is not a Covered Entity, but the HIPAA Privacy Rule may apply to UTA research in certain circumstances. More information can be found at the HIPAA and Research page.

The HIPAA Privacy Rule is located at 45 CFR Part 160 and Subparts A and E of Part 164. 

Family Educational Rights and Privacy Act (FERPA)

The Family Educational Rights and Privacy Act (FERPA) primarily applies to educational records and safeguarding the privacy of students' educational information. In the context of human subjects research, FERPA may intersect with research activities when the research involves educational records or data, examples include:

• Consent and Authorization: When educational records or personally identifiable information (PII) from educational records are used in research, obtaining appropriate consent or authorization from students or their parents (if minors) is necessary.
• Data Security: Researchers must implement appropriate data security measures to protect educational records and PII in compliance with FERPA. This includes safeguarding against unauthorized access and breaches.
• Data Sharing: Sharing educational records or data with other researchers or institutions should be done in accordance with FERPA regulations. Data sharing agreements or similar arrangements may be necessary to ensure compliance.

More information about FERPA requirements in human subjects research can be found in the UTA IRB SOPs.

Protection of Pupil Rights Amendment (PPRA)

Protection of Pupil Rights Amendment (PPRA) is aimed to protect the rights of parents and students in programs that receive funding from the Department of Education. PPRA specifically addresses surveys, questionnaires, and evaluations that are administered to students. PPRA is designed to prevent the collection of sensitive or personal information from students and families without their knowledge and consent.

More information about PPRA requirements in human subjects research can be found in the UTA IRB SOPs.

Public Health Service (PHS) Policy- Promoting Objectivity in Research

The Public Health Service (PHS) policy Promoting Objectivity in Research, often referred to as the PHS Financial Conflict of Interest (FCOI) regulations, aims to ensure the integrity and objectivity of research by managing and mitigating financial conflicts of interest. In the context of human subjects research, this involves researchers disclosing any significant financial interests that could potentially bias their research or compromise the welfare of human subjects. Such financial interests should be described in the IRB protocol application as it relates to the specific research protocol.

Additionally, significant financial interests should also be disclosed in the Research Conflict of Interest Disclosure process described here, as applicable.

Several non-PHS agencies and organizations have adopted the PHS FCOI policy, like the American Heart Association, so compliance with the policy will be implemented when required by the sponsor or funder.

National Science Foundation-Responsible Conduct of Research

For NSF funded researchers, Responsible and Ethical Conduct of Research (RCR) training is required as outlined in the Proposal & Award Policies & Procedures Guide (PAPPG). The training covers the responsible and ethical conduct of research. More information about UTA RCR training can be found here.

DHHS Office of Research Integrity- Research Misconduct

Every investigator is responsible for research integrity when conducting human subjects research. Specifically, the research must conducted free of fabrication, falsification, or plagiarism. For PHS funded researchers, the Federal Research Misconduct Policy will be followed when allegations of research misconduct are reported. More information about research misconduct can be found here.

National Institutes of Health (NIH)- Policies

For researchers receiving NIH funds or support, there are numerous NIH-specific requirements for research involving human subjects. These requirements cover the conduct, monitoring, and reporting of the research. The UTA IRB has specific guidance for the Data Sharing and Management Policy and Reliance agreements in compliance with the NIH Management and Sharing Policy and NIH Single IRB policy, respectively. The NIH also has a Genomic Data Sharing Policy, which applies to certain types of genomic research.

FDAAA, Section 801, and the Final Rule (42 CFR Part 11)- Clinicaltrials.gov

Section 801 of the Food and Drug Administration Amendments Act (FDAAA 801) and the subsequent regulation found at 42 CFR Part 11 established the requirement for the registration and reporting of information on “applicable clinical trials” on Clinicaltrials.gov. More guidance on researcher’s responsibilities can be found at the UTA guidance document for Clinicaltrials.gov.

NIH Certificates of Confidentiality Policy

Certificates of Confidentiality are automatically issued for NIH-funded research that collects or uses identifiable, sensitive information.