Laws

Best Pharmaceuticals for Childrens Act – Public Law 107-109 – January 2002

Federal Food, Drug, and Cosmetic Act – Public Law 113-115 – March 2013

For Historical Purposes:

Food, Drug, and Cosmetic Act – Public Law 75-717 – 1938

Kefauver-Harris Amendment to the Food, Drug, and Cosmetic Act – Public Law 87-781 – October 1962

Genetic Information Nondiscrimination Act (GINA) – Public Law 110-233 – May 2008

National Research Act – Public Law 93-348 – July 1974

Orphan Drug Act – Public Law 97-414 – January 1983

Pediatric Research Equity Act (PREA) of 2007

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 – December 2013

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 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 – April 2002​
• 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 – Addendum to the Federalwide Assurance

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

Environmental Protection Agency (EPA)

• 40 CFR 26 – Protection of Human Subjects
• Protection for Subjects in Human Subjects Research with Pesticides (Final Amendement’s to EPA’s 2006 Rule)

Office of Management and Budget (OMB)

• Circular A-21, Cost Principles for Educational Institutions – May 2004
• Circular A-110, Uniform Administrative Requirements for Grants and (Cooperative) Agreements with Institutions of Higher Education, Hospitals, and Other Non-Profit Organizations – September 1999
• Circular A-133, Audits of States, Local Governments, and Non-Profit Institutions – June 2003