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In This Section Texas Health Research & Education Institute
Institutional Review Board

Human Subject Research Regulations and Guidelines

All Studies

45 CFR 46
45 CFR 46 is a federal policy, enforced by the U.S. Department of Health and Human Services (HHS), for the protection of human subjects. This policy applies to any human subject research supported by any of the 17 agencies of the federal government that support human subject research. The policy also includes additional protections for vulnerable subjects such as pregnant women, human fetuses and neonates, prisoners and children. This policy is also known as the "Common Rule."

OHRP Guidance by Topic
This page provides guidance from the Office for Human Research Protection (OHRP) of the HHS on various topics such as adverse events, certificates of confidentiality, and conflicts of interest.

Categories of Research That May Be Reviewed by the IRB Through an Expedited Review Procedure
This page explains and defines the nine categories of expedited review.

OHRP Guidance on Reviewing and Reporting Unanticipated Problems Involving Risks to Subjects or Others and Adverse Events
This guidance represents OHRP's current thinking on the reviewing and reporting of unanticipated problems and adverse events.  It should be viewed as recommendations unless specific regulatory requirements are cited.

Comparison of FDA and HHS Human Subject Protection Regulations
This guidance discusses the similarities and differences between the U.S. Food and Drug Administration's (FDA) 21 CFR 56 and OHRP's 45 CFR 46.


Studies Using Investigational Drugs, Devices, or Biologics

21 CFR 50
21 CFR 50, enforced by the FDA, codifies the requirements for informed consent. This regulation is almost identical to the regulations set forth by the DHHS's "Common Rule."

21 CFR 56
21 CFR 56, enforced by the FDA, codifies the requirements for Institutional Review Boards (IRBs). This regulation is almost identical to the regulations set forth by the HHS's "Common Rule".

21 CFR 312 (IDE studies)
21 CFR 312, enforced by the FDA, describes the procedures and requirements governing the use of investigational new drugs (INDs), including procedures and requirements for the submission to, and review by, the FDA.

21 CFR 812 (IDE studies)
21 CFR 812, enforced by the FDA, encourages the discovery and development of useful devices intended for human use, and establishes an ethical freedom for scientific investigators in their pursuit of this purpose. It provides procedures for the conduct of clinical investigations of devices. An investigational device exemption (IDE) permits a device, that would otherwise be required to comply with performance standards or to have premarket approvals, to be shipped lawfully for the purpose of conducting investigations of that device.

FDA Guidances, Information Sheets, and Notices
These guidances and information sheets represent the FDA's current guidance on good clinical practice (GCP) and the conduct of clinical trials.

FDA Guidance for Clinical Investigators, Sponsors, and IRBs
Adverse Event Reporting to IRBs -- Improving Human Subject Protection (issued January 2009).

FDA Guidance for Sponsors, IRBs, Clinical Investigators, and FDA Staff
Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that Are Not Individually Identifiable (issued April 2006).


HIPAA Regulations

45 CFR 160, 162, and 164
45 CFR 160, 162 and 164, enforced by the Office for Civil Rights, is also known as the HIPAA Privacy Rule.  It establishes national standards to protect individuals' medical records and other personal health information and applies to health plans, health care clearinghouses, and those health care providers that conduct certain health care transactions electronically.


Conflict of Interest (COI) Regulations & Guidelines

Food and Administration (FDA) Regulations
This guidance represents the Food and Drug Administration's current thinking on this topic.

Public Health Service (PHS) Regulations

Association of American Medical Colleges (AAMC) Guidance
Policy and Guidelines for the Oversight of Individual Financial Interests in Human Subjects Research.


Other IRB-Related Guidance

Belmont Report
The Belmont Report was created as a result of the 40-year U.S. Public Health Service Syphilis Study at Tuskegee, in which syphilis subjects were denied treatment for their disease. This legislation, which was passed in 1974, created regulations to protect human subjects and created a National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research to examine ethical issues related to human subject research. 

Nuremberg Code
The Nuremburg Code was created as a result of the atrocities committed against humans during World War II. It addressed the significance of obtaining informed consent, of ensuring that this consent was voluntary and of ensuring that any individual "who initiates, directs, or engages in the experiment" bears responsibility for the quality of consent.

Declaration of Helsinki
The significances of the Nuremberg Code were further articulated and expanded in the Declaration of Helsinki, which was originally set forth in 1964. The Declaration's significance was that it called for prior approval and ongoing monitoring of research by independent ethical review committees.



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