Specifically, the Tufts Health Sciences IRB complies with 45 CFR 46, 21 CFR 50, 21 CFR 56, 21 CFR 312, 21 CFR 812, and 45 CFR 164.508-514.  The ethical and regulatory requirements of the HRPP apply to all research involving human participants conducted on behalf of Tufts (regardless of funding or lack thereof) and to all individuals and components of the institution.

Federal and state regulations and institutional guidelines and policies govern human subject research. These regulations and guidelines exist to protect the rights and welfare of human subjects. If an investigator is engaged in research, IRB review and approval is required.

All Studies

• 45 CFR 46
• Categories of Research That May Be Reviewed by the IRB Through an Expedited Review Procedure
• Comparison of FDA and HHS Human Subject Protection Regulations
• OHRP Guidance on Reviewing and Reporting Unanticipated Problems Involving Risks to Subjects or Others and Adverse Events
• OHRP Guidance by Topic

Studies Using Investigational Drugs, Devices, or Biologics

• 21 CFR 50
• 21 CFR 56
• 21 CFR 312 (IND studies)
• 21 CFR 312.2(b) (IND Exemption Criteria)
• 21 CFR 812 (IDE studies)
• FDA Guidance
• FDA Guidance, Informed Consent
• FDA Device Advice – Comprehensive Regulatory Information Regarding Medical Devices
• FDA Guidance for Clinical Investigators, Sponsors, and IRBs:  Adverse Event Reporting to IRBs — Improving Human Subject Protection (Issued January 2009)
• FDA Guidance for Industry and Investigators:  Safety Reporting Requirements for INDs and BA/BE Studies  (Issued December 2012)
• FDA Guidance for Sponsors, IRBs, Clinical Investigators, and FDA Staff:  Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that Are Not Individually Identifiable (Issued April 2006)

International Research

• International Compilation of Human Research Protections (OHRP) – listing laws, regulations, and guidelines on human subjects research in over 100 countries, and standards from international and regional organizations

HIPAA Regulations

• 45 CFR 160, 162, and 164 (combined regulation text)
• HIPAA guidance

Department of Defense (DoD) Supported Research

• Department of Defense (DoD) policies and links to the DoD Components policies may be found here. See especially DoD Directive (DoDD) 3216.02 “Protection of Human Subjects and Adherence to Ethical Standards in DoD-Supported Research.”
• 32 CFR 219: Department of Defense Protection of Human Subjects
• Department of Defense Instruction – Protection of Human Subjects and Adherence to Ethical Standards in DoD-Supported Research
• Department of the Navy (DON) Training

Vulnerable Populations

Vulnerable populations identified in federal laws are pregnant women, fetuses and neonates, prisoners, and children (subpart B, C and D respectively).

The Commonwealth of Massachusetts General Laws (MGL) address experimentation on human research subjects. Specifically, MGL Chapter 112, Section 12J addresses research conducted on human fetuses. This is commonly referred to as the Massachusetts Fetal Research Statute.

While there are no specific federal regulations addressing research involving incompetent or cognitively impaired persons, the highest ethical standards should be followed when conducting research with this vulnerable population. The OHRP IRB Guidebook addresses “special classes of subjects,” including fetuses and human in vitro fertilization, women, children and minors, prisoners, the terminally ill, the elderly, minorities, students, employees, and the cognitively impaired.

Informed Consent

Specific federal regulations dictate the required elements of informed consent: 21 CFR 50 and 45 CFR 46. The IRB has developed informed consent form (ICF) templates.

A waiver or alteration of informed consent can be requested in accordance with 45 CFR 46.116(d) and 45 CFR 46.117. Those regulations allow for a waiver or alteration of the requirement for a signed ICF in certain minimal risk studies and when the principal risk is a breach of confidentiality. The FDA does not permit waivers of documentation of consent (see 21 CFR 50.23, 50.24). Please also note that a waiver of parental permission is not allowed for any FDA regulated research. To help determine if your research qualifies for a waiver or alteration of informed consent, call the IRB office at ext. 6-7512 or consult the Human Subject Decision Charts.