When can the IRB/IEC require that additional information be given to subjects as part of informed consent?

The primary responsibility of an Institutional Review Board (IRB) or Independent Ethics Committee (IEC) is to protect the rights and welfare of human research subjects. To fulfill this mandate, the IRB/IEC is granted independent authority to review, approve, require modifications to, or disapprove research. This authority includes determining the adequacy of the informed consent process and document. The IRB/IEC can require that additional information be provided to subjects whenever it judges that such information is necessary for subjects to make a truly informed decision, thereby ensuring their protection. This authority is not contingent upon the agreement of the sponsor or the investigator.

B. The IRB/IEC's authority is independent and its primary obligation is to research subjects, not the sponsor. A sponsor cannot veto an IRB/IEC requirement for subject protection.

C. An investigator must comply with the determinations of the IRB/IEC to gain and maintain approval for the research. The investigator's agreement is not a prerequisite for the IRB/IEC's decision.

D. The IRB/IEC's authority is not conditional on agreement from either the sponsor or the investigator. Its decisions are based on ethical principles and regulations for subject protection.

1. International Council for Harmonisation (ICH) Guideline for Good Clinical Practice (GCP) E6(R2), Section 3.4.1: "The IRB/IEC may require that other information, when in the IRB/IEC's judgement the information would add meaningfully to the protection of the rights, safety and/or well-being of the subjects, be given to the subjects."

2. U.S. Code of Federal Regulations, Title 21, Part 56, Section 109(a) (21 CFR 56.109(a)): This regulation grants the IRB the authority to "approve, require modifications in (to secure approval), or disapprove all research activities covered by these regulations." This establishes the IRB's power to mandate changes to the informed consent form.

3. U.S. Code of Federal Regulations, Title 45, Part 46, Section 116(c) (45 CFR 46.116(c)): This section on "Additional elements of informed consent" states, "When appropriate, one or more of the following elements of information must also be provided..." The determination of what is "appropriate" is a core function of the IRB's review and discretion.

4. Stanford University, Human Research Protection Program (HRPP) Policy Manual, Chapter 1, Section 1.2, "Authority of the IRB": "The IRB has the authority to: Approve, require modifications in (to secure approval), or disapprove all research activities overseen and conducted by the organization." This university policy reflects the federally mandated authority of the IRB.