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Federal Regulations

The field of human subjects research is governed by several sets of regulations. Links to relevant sections of the code of federal regulations (CFR) and a brief description of the purpose of the regulation are provided below. The IRB forms and checklists are designed to address the requirements of these regulations and aid investigators and study personnel in ensuring compliance.

45 CFR  46 – Protection of Human Subjects (Office for Human Research Protections)
Subpart A of this regulation is often referred to as The Common Rule because several agencies abide by it. Subpart A is titled Basic HHS Policy for Protection of Human Research Subjects. Some of the key elements addressed within 45 CFR 46 include the following:

  • IRB membership
  • IRB functions and operations
  • IRB review of research
  • Expedited review procedures
  • Criteria for IRB approval
  • General requirements for informed consent
  • Documentation of informed consent

Subparts B, C and D address the additional protections required for vulnerable populations. Subpart B addresses additional protections for pregnant women, human fetuses and neonates. Subpart C addresses additional protections for prisoners. Subpart D addresses additional protections for children.  The requirements of this regulation apply to all non-exempt federally funded human subject research.  At UConn Health this regulation is also the guiding premise for approval of non-exempt, non-federally funded research that is not subject to FDA regulations.

21 CFR 50 – Protection of Human Subjects (Food and Drug Administration (FDA))
This regulation applies to all clinical investigations regulated by the Food and Drug Administration under sections 505(i) and 520(g) of the Federal Food, Drug and Cosmetic Act, as well as clinical investigations that support applications for research or marketing permits for products regulated by the Food and Drug Administration, including foods, including dietary supplements, that bear a nutrient content claim or a health claim, infant formulas, food and color additives, drugs for human use, medical devices for humans use, biological products for human use and electronic products. This regulation consists of Subparts A, B and D. Subpart A addresses general provisions of the regulation, e.g. scope and definitions. Subpart B addresses informed consent of human subjects. Subpart D address the additional protections for children. Some of the key elements addressed within Subpart B include the following:

  • General requirements of informed consent
  • Exceptions from the general requirements
  • Exceptions from informed consent requirements for emergency research
  • Elements of informed consent
  • Documentation of informed consent

21 CFR 56 – Institutional Review Boards (FDA)
This regulation addresses several of the same key elements as 45 CFR 46, including:

  • IRB membership
  • IRB functions and operations
  • IRB review of research
  • Expedited review procedures
  • Criteria for IRB approval

21 CFR 54 – Financial Disclosure by Clinical Investigators (FDA)
The requirements in this part apply to any applicant who submits a marketing application for a human drug, biological product, or device and who submits covered clinical studies. The applicant is responsible for making the appropriate certification or disclosure statement where the applicant either contracted with one or more clinical investigators to conduct the studies or submitted studies conducted by others not under contract to the applicant. Some of the key elements addressed include:

  • Certification and disclosure requirements
  • Agency evaluation of financial interests
  • Recordkeeping and record retention

21 CFR 210 and -211 – Good Manufacturing Practices (FDA)
These regulations set forth the minimum standard for manufacturing, processing, packing or holding of drugs.

21 CFR 312 – Investigational New Drug Application (FDA)
This regulation applies to all clinical investigations of products that are subject to section 505 of the Federal Food, Drug, and Cosmetic Act or to the licensing provisions of the Public Health Service Act. Key elements addressed within the regulation include:

  • Subpart A – General Provision (e.g. Scope, Applicability, Definitions, Labeling etc.)
  • Subpart B – Investigational New Drug Applications
  • Subpart C – Administrative Actions
  • Subpart D – Responsibilities of Sponsors and Investigators
  • Subpart E – Drugs Intended to Treat Life-threatening or Severely Debilitating Illnesses
  • Subpart I – Expanded Access to Investigational Drugs

21 CFR 314 – Application for FDA Approval to Market a New Drug (FDA)
This part of the regulations sets forth procedures and requirements for the submission to, and the review by, the Food and Drug Administration of applications and abbreviated applications to market a new drug under section 505 of the Federal Food, Drug, and Cosmetic Act, as well as amendments, supplements, and postmarketing reports to them

21 CFR 812– Investigational Device Exemptions (FDA)
This regulation applies to clinical investigations of devices to determine safety and effectiveness. Key elements addressed within the regulation include:

  • Subpart A – General Provision (e.g. Scope, Applicability, Definitions, Labeling etc.)
  • Subpart B – Application and Administrative Action
  • Subpart C – Responsibilities of Sponsors
  • Subpart D – IRB Review and Approval
  • Subpart E – Responsibilities of Investigators
  • Subpart G – Records and Reports

21 CFR 803 – Medical Device Reporting (FDA)
This part establishes requirements for medical device reporting. Under this part, device user facilities, importers, and manufacturers, as defined in § 803.3, must report deaths and serious injuries to which a device has or may have caused or contributed, must establish and maintain adverse event files, and must submit to FDA specified followup and summary reports.

21 CFR 814 – PreMarket Approval of Medical Devices (FDA)
This part provides procedures for the premarket approval of medical devices intended for human use.

21 CFR 600 – Biological Products General (FDA)

21 CFR 601 – Licensing (FDA)

45 CFR 160 and 164 – Health Insurance Portability and Accountability Act (Office of Civil Rights)
The Privacy Rule establishes a foundation of Federal protections for the privacy of protected health information.

20 U.S.C. § 1232h; 34 CFR Part 98 – Protection of Pupil Rights Amendment, (U.S. Dept., of Education)
The Protection of Pupil Rights Amendment ((PPRA) (20 U.S.C. § 1232h; 34 CFR Part 98) applies to programs that receive funding from the U.S. Department of Education (ED). PPRA is intended to protect the rights of parents and students by ensuring that 1) schools and contractors make instructional materials available for inspection by parents if those materials will be used in connection with an ED-funded survey, analysis, or evaluation in which their children participate and 2) schools and contractors obtain written parental consent before minor students are required to participate in any ED-funded survey, analysis, or evaluation that reveals sensitive and/or private information.