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How to Review the Consent Document

Important Points:

In general, no investigator may involve a human being as a subject in research covered under federal regulations unless the investigator has obtained the legally effective informed consent of the subject or the subject's legally authorized representative. 

An investigator shall seek such consent only under circumstances that provide the prospective subject 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 subject or the representative shall be in language understandable to the subject or the representative.

No informed consent, whether oral or written, may include any exculpatory language through which the subject or the representative is made to waive or appear to waive any of the subject's legal rights, or releases or appears to release the investigator, the sponsor, the institution or its agents from liability for negligence.

Basic elements of informed consent:

In seeking informed consent the following information must be provided to each subject:

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

(2) a description of any reasonably foreseeable risks or discomforts to the subject;

(3) a description of any benefits to the subject or to 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 subject;

(5) a statement describing the extent, if any, to which confidentiality of records identifying the subject 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 subjects' rights, and whom to contact in the event of a research-related injury to the subject; and

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

Additional elements of informed consent:

When appropriate, one or more of the following elements of information should also be provided to each subject:

(1) a statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject 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 subject that may result from participation in the research;

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

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

(6) the approximate number of subjects involved in the study.

The informed consent requirements are not intended to preempt any applicable Federal, State, or local laws which require additional information to be disclosed in order for informed consent to be legally effective.

Nothing in the regulations is 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.

Other components/statements for inclusion in the consent document:

When appropriate, one or more of the following additional statements should be included in the consent form.

(1) The researcher should include the name, department and contact information of the Lead Researcher and any Co-investigators involved in the informed consent process. The study title, location of the research, anticipated sample size and funding source should also be listed. If this is a multi-site study, include the number of subjects at UCI and the total number nationally/internationally

(2) In the Procedures section of the consent document, the researcher should detail the inclusion/exclusion criteria. Consider whether the subject would benefit from the addition of a procedures table.

(3) Standard non-alterable UCI Compensation for Injury statement to describe the provision for subject injury incurred as a result of this study should be included if there is a potential for harm.

(4) Compensation for participation. Compensation (usually in the form of monetary compensation or extra credit) should accrue as the study progresses and not be contingent upon the subject completing the entire study. If a study is completed in one session or only last a few days, the IRB may find it appropriate to allow a single payment at the end of the study as opposed to paying out over time during the course of a longitudinal study. All information concerning payment, including the amount and schedule of payment(s), should be explained in the informed consent document.

(5) In the Other Considerations section if a research team member has a significant financial interest in the outcome of this particular study or research program, a statement to that effect must be inserted at the requirement of the COI Oversight Committee. If the study involves collection of specimens, appropriate standard language should be included.

(6) Signature lines should be included for the subject and for the researcher obtaining informed consent. A “Legally-Authorized Representative” signature line should be included if the researcher is requesting to obtain surrogate consent or parental permission (consent for enrollment of a minor in research. A researcher may obtain the assent of a minor ages 13-17 (as well as parental permission) using one form – a combined consent/assent form. A “Witness” signature line must be included for clinical research studies involving more than minimal risk and may be required by the IRB for other studies.

Before the full Committee Meeting:

First, read the consent for general information about the study;

  • Can you clearly describe the study after reading the Consent Form?
  • For studies involving medical treatments, can you distinguish standard-of-care from research procedures?

Read it for readability (6th – 8th grade level);

  • Did it seem easy, or did you have to re-read for understanding?
  • Could a junior-high school student explain the study after reading the consent form?

 Finally, read it for content

  • Are the required elements of informed consent included in the form?
  • Does the researcher include the appropriate additional elements of consent?
  • Resist the urge to make minor wording changes to the consent form unless it will influence human subjects protection.
  • Make changes to the consent form or note questions for the researcher to address on the reviewer’s checklist.
  • If substantive changes need to be made to the consent form such as adding or categorizing risks or removing possible benefits please provide a rationale for the change.

* Adapted from "Institutional Review Board Member Handbook" by Robert Amdur, MD Jones and Bartlett Publishers, 2003

 

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