General Requirements for Informed Consent

Except as provided elsewhere in this (or other) subpart, no researcher/investigator may involve a human being as a participant in research covered by these regulations unless the researcher/investigator has obtained legally effective informed consent from the participant or the participant’s legally authorized representative.

A researcher/investigator shall seek informed consent only under circumstances that provide the prospective participant (or representative) sufficient opportunity to consider whether or not to participate.  Informed consent must be presented to minimize the possibility of coercion or undue influence.  The information given to the participant (or representative) shall be written in understandable language.

No informed consent, oral or written, may include exculpatory language through which the participant (or representative) is made to waive, or appear to waive, any of their legal rights or releases or appears to release the researcher/investigator, the sponsor, the institution, or its agents from liability for negligence.

When seeking informed consent (except as per paragraph 3 of this section), the following information must be provided to each potential participant:

  1. Basic elements of informed consent:
    • A statement indicating the study involves research, including an explanation of the research aims and expected duration of participation.  Also include a description of research procedures and expectations.  Be sure to identify any experimental procedures.
    • A description detailing any foreseeable risks or discomforts to the participant, including invasion of privacy.
    • A description of any benefits to the participant or others reasonably expected from the research.
    • A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the participant.
    • A statement informing participants of their right not to participate in research that is also a teaching exercise.
    • A statement that participation is voluntary and that refusal to participate involves no penalty or loss of benefits to which the participant is otherwise entitled.  Also, indicate participants may discontinue participation, at any time, without penalty or loss of benefits to which they are otherwise entitled.
    • A statement describing the extent, if any, to which confidentiality of records identifying the participant will be maintained (e.g., confidentiality will be protected by assigned code numbers, limitations to who has access to data, data storage in locked cabinets and/or secured computer files, etc.).  Be specific.
    • For research involving more than minimal risk, an explanation regarding compensation and whether any medical treatments are available if injury occurs (if so, specify and indicate where further information may be obtained).
    • An explanation of who to contact for answers to pertinent questions about the research and research participants’ rights and who to contact in the event of a research related injury to the participant.  Include names and contact information.
  2. Additional elements of informed consent.  When appropriate, one or more of the following shall also be provided:
    • A statement that the particular treatment or procedure may involve risks to the participant (or to an embryo or fetus, if the participant is, or may become, pregnant) which are currently unforeseeable.
    • Anticipated circumstances for which participation may be terminated by the researcher/investigator without regard to participant’s consent.
    • Any additional costs the participant may incur as a result of participation.
    • The consequences of a participant’s decision to withdraw from the research including procedures for early termination by the participant.
    • A statement, which may impact the participant’s willingness to continue, indicating significant new findings developed during the course of the research.
    • The approximate number of participants involved in the study.
  3. An IRB may elect to approve an informed consent procedure not including (or altering) some (or all) elements of informed consent set forth above.  The IRB may elect to waive requirements to obtain informed consent.  If the event of either decision, the IRB must find and document (with the aid of evidence provided by the researcher) that:
    • The research involves no more than minimal risk to the participants.
    • The waiver or alteration of informed consent procedures will not adversely impact participant rights and welfare.
    • The research could not, practically, be carried out without the waiver or alteration.
    • When appropriate, participants will be provided additional pertinent information in a debriefing session after participation.
  4. The informed consent requirements in these regulations are not intended to preempt any applicable federal, state, or local laws requiring additional informed consent to be legally effective.
  5. These regulations are not intended to limit the authority of a physician to provide emergency medical care, to the extent the physician is permitted to do so under applicable federal, state, or local law.