IRB Resources

Code of Federal Regulations for the Protection of Human Subjects

Title 45, Part 46, Title 21 CFR Part 50, Title 21 CFR Part 56

United States Department of Health and Human Services

Office for Human Research Protections (OHRP)
Website: http://www.hhs.gov/ohrp

United States Food and Drug Administration

Website: http://www.fda.gov/

Federal Policy for the Protection of Human Subjects

Website: http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html

The Belmont Report

Website: http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html

Clinical Study Registry and Results Database

Website: https://clinicaltrials.gov/

ClinicalTrials.gov is a web-based resource that provides patients, their family members, health care professionals, researchers, and the public with easy access to information on publicly and privately supported clinical studies on a wide range of diseases and conditions. The Web site is maintained by the National Library of Medicine (NLM) at the National Institutes of Health (NIH). Information on ClinicalTrials.gov is provided and updated by the sponsor or principal investigator of the clinical study. Studies are generally submitted to the Web site (that is, registered) when they begin, and the information on the site is updated throughout the study. In some cases, results of the study are submitted after the study ends. This Web site and database of clinical studies is commonly referred to as a "registry" and "results database." In October 2008, the 59th World Medical Association (WMA) General Assembly amended the Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Subjects. In particular, paragraph 19 requires prospective trial registration, as follows: "Every clinical trial must be registered in a publicly accessible database before recruitment of the first subject." Paragraph 30 promotes the public disclosure of study results as an ethical obligation and states, in part, "Authors have a duty to make publicly available the results of their research on human subjects and are accountable for the completeness and accuracy of their reports. They should adhere to accepted guidelines for ethical reporting. Negative and inconclusive as well as positive results should be published or otherwise made publicly available." The ClinicalTrials.gov registration requirements were expanded after Congress passed the Food and Drug Administration Amendments Act of 2007 (FDAAA). Section 801 of FDAAA (FDAAA 801) requires more types of trials to be registered and additional trial registration information to be submitted. The law also requires the submission of results for certain trials.