Regulations and Regulatory Guidance

Department of Health and Human Services

• The Belmont Report
• Title 45 Code of Federal Regulations Part 46 Protection of Human Subject
• Research That May Be Reviewed Through an Expedited Procedure
  
  

Office for Human Subject Research Protection (OHRP)

• IRB Guidebook
• OHRP Guidance (listed by topic)
• OHRP Compliance Oversight Procedures

Food and Drug Administration (FDA)

General

• 21 CFR 50- Protection of Human Subjects
• 21 CFR 54- Financial Disclosure by Clinical Investigators
• 21 CFR 56 - Institutional Review Boards
• FDA Good Clinical Practice
• FDA Guidance Documents from FDA Centers and Commissioner
• FDA Guidance and Information Sheets on Good Clinical Practice in FDA-Regulated Clinical Trials
• Information Sheet Guidances Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors

Devices

• 21 CFR 812 - Investigational Device Exemptions (IDE's)
• FAQs about Medical Devices in Research
• Humanitarian Use Devices
• Significant Risk and Nonsignificant Risk Medical Device Studies

Drugs Products

• FDA Regulations: 21 CFR 312 – Investigational New Drug Application
• FDA Information Sheet Guidance: “Off Label” and Investigational Use of Marketed
  Drugs, Biologics, and Medical Devices
• FDA Information Sheet Guidance: Emergency Use IND
• FDA Information Sheet Guidance: Treatment IND
• FDA FAQs: Frequently Asked Questions on Drug Development and Investigational New Drug Applications
• FDA Instructions: Information for Sponsor-Investigators Submitting IND Applications
• FDA Forms: 1571 Investigational New Drug Application and 1572 Statement of Investigator

Biological Products

• FDA Instructions: Information on Submitting an Investigational New Drug Application for a Biological Product
• FDA FAQs: Center for Biologics Evaluation and Research (CBER) Frequently Asked Questions

Botanical Products in Research

• FDA Guidance: Guidance for Industry, Botanical Drug Products
• FDA FAQs: Frequently Asked Questions on Botanical Drug Product Development
  

FDA Inspections

• FDA Information Sheet Guidance: FDA Inspections of Investigators
• FDA Warning Letters
  
  

Commonwealth of Massachusetts

Relevant State Statutes and Codes

• M.G.L. c. 94C §8 (Controlled Substances in Research)
• 105 C.M.R. 700.009 (Controlled Substances in Research)
• M.G.L. ch. 111L (Human Embryonic Stem Cell Research)
  • 105 C.M.R. 960.000 (Human Embryonic Stem Cell Research)
• M.G.L. ch. 111, §70E (Patients Rights/Informed Consent)
• M.G.L. c.111 § 70F (Consent to HIV/AIDS Testing)
• M.G.L. c.111 § 70G (Genetic Privacy)
• M.G.L. c.112, §12F (Consent by Minors)
• M.G.L. c.112, §12J (Experimentation on Fetuses)
• M.G.L. c.201, §§6-6B (Guardianships)
  • Section 6. Mentally ill persons
  • Section 6A. Mentally retarded persons
  • Section 6B. Persons unable to make or communicate informed decisions
• M.G.L. c.201D,6; 2-1-2 to 201-4 (Health Care Proxies)
• 104 C.M.R. 31.00 (Department of Mental Health Research)
• 115 C.M.R. 10.00 (Department of Mental Retardation Research)