Federal Regulations Related to Human Subjects Research
There are a variety of federal regulations and state laws that apply to human subjects research. In addition, the Office of Human Research Protections (OHRP) and the US Food and Drug Administration (FDA) have issued guidance documents and other materials that reflect their agency's current thinking. This page provides quick links to the most commonly accessed regulations and guidance documents.
|Office of Human Research Protections|
|45 CFR 46||The regulations that govern all research funded by the federal government; also known as the Common Rule.|
|Comparison of the FDA regs vs. the Common Rule*||A useful side by side comparison highlighting where the two sets of regulations differ.|
|Final Rule: Federal Policy for the Protection of Human Subjects||Final Rule issued January 19, 2017 to update the Common Rule and taking effect January 2018. 45 CFR 46: January 19, 2017 version includes the revised regulations without the preamble explanatory materials.|
|45 CFR 164||The Privacy Rule or HIPAA|
|Food and Drug Administration|
|21 CRF 50||Regulations for informed consent (Part 50), Financial Disclosure (Part 54) and for IRB committees (Part 56|
|21 CRF 56||Regulations for IRB committees (Part 56|
|21 CRF 50 Subpart D||Subpart D additional safeguards for children in clinical investigations of FDA-regulated products under 21 CFR 50 and 56|
|21 CFR 312||Drug Regulations: IND Regulations including IND format, reporting requirements, sponsor responsibilities and investigator responsibilities|
|21 CFR 812||Device Regulations: IDE regulations including IDE content, format, reporting requirements, sponsor responsibilities and investigator responsibilities|
|21 CFR 601||Applications for approval of a Biologic license|
|Department of Defense|
|10 USC 980||Limitation on use of humans as experimental subjects in studies funded by the DoD|
|32 CFR 219||Department of Defense version of the Common Rule|
|DoD Directive 3216.02||The Directive outlines DoD's requirements for the protection of human subjects and adherence to ethical standards in DoD-supported research|
|DoD and HSRRB||DOD and Human Subjects Research Review Board (HSRRB) - Unique Requirements|
Office of Human Research Protections (OHRP)
- OHRP: OHRP's site contains resources and guidance germane to human subjects research and the regulatory process.
- Expedited Review Categories: Categories of federally funded minimal risk research that is approvable using expedited review. The research must fall into 1 of the first 7 categories enumerated in this guidance.
- FDA Information Sheets: The FDA maintains amongst the most helpful websites for explaining the regulations. The Information Sheets provide answers to many FAQs related to GCP conduct of clinical trials and humans subjects research topics.
- FDA Guidances, Information Sheets, and Notices and Clinical Trial Guidance Documents: Guidance documents express the current thinking of a regulatory agency. These two pages contain essential resources for investigators conducting clinical trials, especially FDA-regulated research. Some of the guidance documents available via this page include:
- Guidance for Industry. Investigator Responsibilities — Protecting the Rights, Safety,and Welfare of Study Subjects
- Guidance for Industry. Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring
- Guidance for Clinical Trial Sponsors: Establishment and Operation of Clinical Trial Data Monitoring Committees
- Guidance for Clinical Investigators, Sponsors, and IRBs: Adverse Event Reporting to IRBs: Improving Human Subject Protection
- Guidance for Clinical Investigators, Sponsors, and IRBs: IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites, and the Determination of Whether an IND/IDE is Needed
- Guidance for Clinical Investigators, Sponsors, and IRBs. Investigational New Drug Applications (INDs) — Determining Whether Human Research Studies Can Be Conducted Without an IND
- Information Sheet Guidance For IRBs, Clinical Investigators, and Sponsors. Significant Risk and Nonsignificant Risk Medical Device Studies
- Guidance for IRBs, Clinical Investigators, and Sponsors. IRB Continuing Review after Clinical Investigation Approval
- Guidance for Industry – Using a Centralized IRB Review Process in Multicenter Clinical Trials
- Guidance for Clinical Investigators, Sponsors, and IRBs. Considerations when Transferring Clinical Investigation Oversight to Another IRB
- Financial Relationships and Interests in Research Involving Human Subjects: Guidance for Human Subjects Protection
- Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identifiable
International Conference on Harmonisation (ICH)
The ICH Guidelines are international standards for the conduct of pharmaceutical trials. They serve as official FDA Guidance documents covering Quality, Efficacy, Safety, and Multidisciplinary topics. Selected ICH Guidelines are listed below.
ICH E4:Dose-Response Information to Support Drug Registration. (Many early translational studies submitted to the IRB for review use dose-response designs.)
ICH E6: Good Clinical Practice: Consolidated Guidance. Summarizes good clinical practice (GCP) standards for conduct of clinical trials
ICH E8: General Considerations for Clinical Trials
ICH E9: Statistical Principles for Clinical Trials
ICH E10: Choice of Control Group and Related Issues in Clinical Trials
ICH E11: Clinical Investigation of Medicinal Products in the Pediatric Population
Miscellaneous Guidance Resources
NIH Gene Transfer: A vital website for those doing recombinant DNA and gene transfer research.
AAHRP: The Association for Accreditation and Human Research Protection Programs maintains standards and principles for IRB accreditation.
Consent to Treatment and Confidentiality Provisions: The Juvenile Legal Center (JLC) has a nice summary of the rights of minors to in the state of Pennsylvania.
Other Ethics Resources
Belmont Report: An essential document which articulates the fundamental ethical principles which provide the foundation for the DHHS and FDA regulations. This is an essential document to read for all who conduct human subjects research.
Declaration of Helsinki: The first consensus statement articulating ethical principles to guide the conduct of human subjects research. The WMA has updated the Declaration numerous times, most recently in October 2008.
International Ethical Guidelines for Biomedical Research Involving Human Subjects: The Council for International Organizations of Medical Sciences (CIOMS) Guidelines. This is the link to the pre-publication version of the November 2016 guidelines which cover the conduct of international research. Major changes include an added emphasis on scientific validity and social value, updates to research in low resource environments, changes to the sections addressing the collection, storage and future use of biological specimens, and the sections dealing with pregnant and lactating women. An overview of the update is available at the CIOMS website.
Ethical Considerations for Children: The European Union/European Medicines Agency (EMEA) guidance on ethical conduct of clinical research involving children in pharmaceutical trials.
Video Presentations About Research — Designed for Parents
Children and Clinical Studies: The National Institutes of Health (NIH) has a wonderful website with a host of information and video presentations about children in research. There are videos interviews with children and parents about deciding to take part in a study and information on questions to ask before deciding to take part. The NIH also has prepared a Newsletter that can be read online that outlines the information available on their website.
NIH Division of Bioethics: For those who wish to learn more about the ethics of clinical research, the NIH Division of Bioethics has archived videos of past lectures going back to 2000. There are many topics that could be of interest to parents including talks on Ethical Issues in Research Involving Children; Risks and Benefits; and IRB Review.
Boston Children's Hospital Website: The Boston Children's Hospital also has several video presentations about clinical research that may be of interest to parents of participants.