United States Regulations

Regulations

Department of Health and Human Services (HHS)

• Title 42 CFR 50, Part F – Promoting Objectivity in Research (i.e., Financial Conflict of Interests) – August 2011
• Title 42 CFR 94 – Responsible Prospective Contractors

Center for Medicare and Medicaid Services

• ​Title 42 CFR 405, Subpart B – Medical Services Coverage Decisions That Relate to Health Care Technology (last amended 8/25/2025)

Food and Drug Administration

• Title 21 CFR 11 – Electronic Records; Electronic Signatures
• Title 21 CFR 50 – Informed Consent
  • ​​Parts 50 and 56:  Additional Safeguards for Children in Clinical Investigations of Food and Drug Administration-Regulated Products March 2013
  • Informed Consent Elements (…clinical trials include a specific statement that clinical trial information will be entered in a databank) March 2011
  • Medical Devices; Exception from General Requirements for Informed Consent – June 2006
• Title 21 CFR 54 – Financial Disclosure by Clinical Investigators
• Title 21 CFR 56 – Institutional Review Board (IRB)
• Title 21 CFR 210 – Subpart C (Drugs) – Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; General
• Title 21 CFR 312 – Investigational Drug Application
• Title 21 CFR 316 – Orphan Drugs
• Title 21 CFR 361.1 – Radioactive Drugs for Certain Research Uses
• Title 21 CFR 600 – Biologics Products – General
• Title 21 CFR 606 – Subpart F (Biologics) – Current Good Manufacturing Practice for Blood and Blood Components
• Title 21 CFR 812 – Investigational Device Exemption
• Title 21 CFR 809 - In Vitro Diagnostic Products for Human Use
• Title 21 CFR 814 – Subpart H (Medical Devices) – Humanitarian Use Devices
• Title 21 CFR 820 – Subpart H (Medical Devices) – Quality System Regulation

• FDA Form 1571
• FDA Form 1572

Office for Civil Rights

• Title 45 CFR 160 and 164 – HIPAA-Privacy Rule – Final Rule -January 2013

Office for Human Research Protections (OHRP)

• Title 45 CFR 46 – Protection of Human Subjects from Research Risks

Office for Research Integrity (ORI)

• 42 CFR Part 93 – Public Health Service Policies on Research Misconduct – May 2005

Department of Defense

• 32 CFR 219 – Protection of Research Subjects
• DoD Directive 3216.02 – Protection of Human Subjects and Adherence to Ethical Standards in DoD-Supported Research​
• Department of the Navy – Assurance Information

Department of Education

• Protection of Human Subjects in Research (Office of the Chief Financial Officer)
• 34 CFR 98 – Students Rights in Research, Experimental Programs, and Testing
  • Protection of Pupil Rights Amendment (PPRA) – Summary on Department of Education website
• 34 CFR 99 – Family Educational Rights and Privacy Act (FERPA)
  • Family Educational Rights and Privacy Act (FERPA) – Summary on Department of Education website
• 34 CFR 350 – Excerpt from Disability and Rehabilitation Research Projects and Center Program & 34 CFR 356 – Excerpt from Disability and Rehabilitation Research:  Research Fellowships

Department of Justice

   Bureau of Prisons (BOP)

• 28 CFR 512 – Research
• Program Statement – May 1999

   National Institute of Justice (NIJ)

• 28 CFR 22 – Confidentiality of Identifiable Research and Statistical Information