Federal Regulations and Resources

Federal regulations and ethical standards exist to ensure research involving people is conducted safely, responsibly and ethically. These guidelines protect the rights, privacy, and welfare of all research participants.

The current system of human subjects protections emerged largely in response to historical abuses and unethical research practices. High-profile ethical breaches prompted the creation of clear guidelines and oversight mechanisms. As a result, institutions like UTSA now have Institutional Review Boards (IRBs) responsible for reviewing and approving research to ensure compliance with ethical and regulatory standards.

The following links provide information concerning the ethical principles, codes and federal regulations that govern the protection of human subjects in research. Please notify the Office of the IRB at irb@utsa.edu of any links that are not functioning.

Resources

Resources
Federal Policy for the Protection of Human Subjects (45 CFR 46) This is the core federal regulation governing human subjects research in the U.S. It outlines the ethical principles and compliance requirements institutions must follow to ensure the safety, rights and welfare of research participants.
Exempt Categories under the Common Rule This section outlines specific categories of research that may be exempt from full IRB review under federal guidelines. These exemptions still require a determination by the IRB but are considered lower-risk and subject to fewer regulatory requirements.
Expedited Review Categories This guidance describes types of research that involve no more than minimal risk and may qualify for an expedited IRB review process. While still requiring IRB oversight, these studies don’t need full board review, helping streamline approval for qualifying projects.
Family Educational Rights and Privacy Act (FERPA) FERPA is a federal law that protects the privacy of student education records. It gives students and parents certain rights over access to and disclosure of academic information.
Title 34 CFR Part 99 This section of the Code of Federal Regulations provides the full legal language and detailed implementation rules for FERPA, including definitions, enforcement and conditions for data sharing in research.
FDA Regulations for Human Subjects Research For studies involving drugs, biologics or medical devices, researchers must follow additional FDA regulations to protect participants and ensure compliance.
21 CFR Part 50 – Protection of Human Subjects This regulation outlines the requirements for informed consent in FDA-regulated research. It ensures participants are fully informed before agreeing to take part in studies involving drugs, biologics or medical devices.
21 CFR Part 56 – Institutional Review Boards This section defines how IRBs must be structured and operated for FDA regulated studies. It covers IRB membership, review procedures and responsibilities to protect human subjects in clinical investigations.

Definitions

UTSA’s Handbook of Operating Procedures (HOP) outlines official definitions and institutional policies related to human subjects research. This includes what qualifies as human subjects research and when IRB review is required.

Foundations of Ethical Research Oversight

Ethical oversight in human subjects research exists because history has shown what can go wrong without it. These foundational documents and international codes were developed to ensure that research involving people is conducted with transparency, accountability, and care. They continue to shape modern standards for protecting participants and guiding responsible research practices.

Information
The Belmont Report Issued in 1979 by the U.S. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, the Belmont Report outlines three core principles that guide ethical research with human participants: respect for persons, beneficence and justice. These principles remain central to how IRBs evaluate research today.
The Nuremberg Code Developed in 1947 during the Doctors' Trial following World War II, the Nuremberg Code established ten principles for ethical human experimentation, emphasizing voluntary consent and the necessity of avoiding unnecessary harm in research. It serves as a cornerstone in the history of clinical research ethics.
Declaration of Helsinki Adopted by the World Medical Association in 1964, the Declaration of Helsinki provides internationally recognized ethical guidance for research involving human participants, especially in medical and clinical contexts. It reinforces the importance of independent review, participant welfare and transparency.

Guidance from Oversight Agencies

Research involving human participants is regulated by a network of federal and international agencies that provide detailed guidance on compliance, ethics and participant protections. The resources below help researchers navigate expectations from key oversight bodies.

Agencies
Office for Human Research Protections (OHRP) OHRP, part of the U.S. Department of Health and Human Services, provides leadership and regulatory guidance on the protection of human subjects in research. It supports institutions in implementing the Common Rule and offers educational tools, FAQs and policy updates.
Food and Drug Administration (FDA) – Human Subject Protection The FDA regulates clinical investigations involving drugs, biologics and medical devices. It offers detailed guidance on informed consent, IRB operations, and good clinical practice (GCP) to ensure ethical and scientifically sound studies.
U.S. Department of Health & Human Services – Office for Civil Rights (OCR) OCR enforces federal civil rights laws that apply to programs receiving HHS funding. It provides guidance on nondiscrimination, privacy and accessibility, including protections under HIPAA, Section 504, and other key regulations that support equitable access to research and healthcare.
National Institutes of Health (NIH) Human Subjects Research NIH provides comprehensive policy and training resources for researchers conducting federally funded human subjects research. This includes guidance on ethical conduct, data protections, certificates of confidentiality and participant inclusion policies.
NIH – Privacy Rule and Research This site explains how the HIPAA Privacy Rule applies to research involving health information. It offers case studies, FAQs and regulatory guidance for researchers working with identifiable health data.