General Requirements for Informed Consent

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General Guidelines for the Protection of Human Research Participants

General Requirements for Informed Consent

No investigator may involve a human being as a participant in research covered by this policy unless the investigator has obtained the legally effective informed consent of the participant or the participant’s legally authorized representative. An investigator shall seek such consent only under circumstances that provide the prospective participant or the representative sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence. The information that is given to the participant or the representative shall be in language understandable to the participant or the representative. No informed consent, whether oral or written may include any exculpatory language through which the participant or the representative is made to waive or appear to waive any of the participant’s legal rights, or releases or appears to release the investigator, the sponsor, the institution, or its agent from liability for negligence.

See sample Informed Consent Form and Checklist. It contains the basic and additional elements to include, as described below. (Sample Informed Consent Form and Checklist)

Basic elements of informed consent

(1) A statement that the study involves research, an explanation of the purposes of the research, the expected duration of the subject's participation, a description of the procedures to be followed; identification of any procedures which are experimental

(2) A description of any reasonably foreseeable risks or discomforts to the participant

(3) A description of any benefits to participant or others which may reasonably be expected from the research

(4) A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the participant

(5) A statement describing the extent, if any, to which confidentiality of records identifying the participant will be maintained

(6) For research involving more than minimal risk, an explanation as to whether any compensation, and an explanation as to whether any medical treatments are available, if injury occurs and, if so, what they consist of, or where further information may be obtained

(7) An explanation of whom to contact for answers to pertinent questions about the research and research participants' rights, and whom to contact in the event of a research-related injury to the participant

(8) An explanation of whom to contact for answers to pertinent questions about the research and research participants' rights, and whom to contact in the event of a research-related injury to the participant

(9) A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the participant is otherwise entitled, and the participant may discontinue participation at any time without penalty or loss of benefits, to which the participant is otherwise entitled

Additional elements of informed consent

When appropriate, one or more of the following elements of information shall also be provided to each participant.

(1) A statement that the particular treatment or procedure may involve risks to the participant (or to the embryo or fetus, if the participant is or may become pregnant), which are currently unforeseeable

(2) Anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's consent

(3) Any additional costs to the participant that may result from participation in the research

(4) The consequences of a participant's decision to withdraw from the research and procedures for orderly termination of participation by the participant

(5) A statement that significant new findings developed during the course of the research, which may relate to the participant's willingness to continue participation, will be provided to the participant

(6) The approximate number of participants involved in the study

Documentation of Informed Consent

The informed consent s hall be documented by the use of a written consent form approved by the IRB and signed by the participant or the participant’s legally authorized representative. A copy shall be given to the person signing the form.

The informed consent form may be either of the following:

(1) A written consent document that embodies elements of informed consent. The investigator shall give either the participant or the representative adequate opportunity to read it before it is signed; or

(2) A short form written consent document stating that the elements of informed consent have been presented orally to the participant or the participant’s legally authorized representative. When this method is used, there shall be a witness to the oral presentation. Also, the IRB shall approve a written summary of what is to be said to the subject or the representative.

(3) Any variation of the above procedure must be approved by the IRB.

Prepared by the University of the District of Columbia Institutional Review Board (UDC IRB) with reference to the Institutional Review Board Guidebook (http://www.hhs.gov/ohrp/irb/irb_guidebook.htm ). The UDC IRB acknowledges the assistance of the College of Charleston, which shared its web materials, on which UDC’s materials are based. The UDC IRB is also indebted to many other fine university web sites which it has visited in the course of preparing these materials, and in particular commends the design and content of the University of Maryland Baltimore Campus website.