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Informed Consent & Assent

In most research activities, the investigator must obtain informed consent from each subject or the subject's legally authorized representative (e.g., parent, guardian or legal 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. In situations where full disclosure of the purpose of the research is not possible because it could bias the outcome, the investigator has the responsibility to debrief subjects concerning the purpose of the research.

Basic elements of informed consent that must be communicated in clear, non-technical and age appropriate language that subjects can understand:

  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.

  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.

When appropriate, one or more of the following elements shall 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.

  6. The approximate number of subjects involved in the study.

Sample Consent Forms: (files are Word documents)

There are two procedures, which may be used to obtain informed consent, written and orally.

  1. A written consent document that embodies the elements of informed consent set forth above. This form may be read to the subject or the subject's legally authorized representative, but in any event, the investigator should give either the subject or the representative adequate opportunity to read it before it is signed.

  2. A short form written consent document, stating that the elements of informed consent, set forth above, have been presented orally to the subject or the subject'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. Only the short form itself is to be signed by the subject or the representative. However, the witness shall sign both the short form and a copy of the summary, and the person actually obtaining consent shall sign a copy of the summary. A copy of the summary shall be given to the subject or the representative, in addition to a copy of the short form.

Informed Consent Waivers:

An IRB may approve a consent procedure which does not include, or which alters, some or all of the elements of informed consent set forth above, or waive the requirement to obtain informed consent. An IRB may also approve a consent procedure that waives the requirement for investigators to obtain a signed consent form for some or all subjects. An investigator must complete the appropriate form and submit it to the IRB for approval, if they wish to alter consent, waive the requirement to obtain consent or waive the requirement for a signed consent.

Assent of Children and Permission by Parents:

IRB shall determine that adequate provisions are made for soliciting the assent of children, when in the judgment of the IRB the children are capable of providing assent. In determining whether children are capable of assenting, the IRB shall take into account the ages, maturity, and psychological state of the children involved. This judgment may be made for all children to be involved in research under a particular protocol, or for each child, as the IRB deems appropriate. If the IRB determines that the capability of some or all of the children is so limited that they cannot reasonably be consulted or that the intervention or procedure involved in the research holds out a prospect of direct benefit that is important to the health or well-being of the children and is available only in the context of the research, the assent of the children is not a necessary condition for proceeding with the research. Even where the IRB determines that the subjects are capable of assenting, the IRB may still waive the assent requirement under circumstances in which consent may be waived.

The federal regulations do not specify the age at which written assent from children is required. For children who are too young to read and sign an assent form, but who would be capable of understanding an oral explanation, an oral explanation can be provided. Investigators should remember that the assent process should take into account, in both oral and written communication, the child's age, maturity and level of understanding. The assent form does not replace a thoughtful discussion with the child regarding participation in the research. Ultimately, the assent process should illustrate respect for the child and convey the essential information the child requires, in a manner the child can understand, in order to make a decision about participating in the research.

The IRB may find that the permission of one parent is sufficient for research not involving greater than minimal risk or research involving greater than minimal risk but presenting the prospect of direct benefit to the individual subjects. For the following research, both parents must give their permission, unless one parent is deceased, unknown, incompetent, or not reasonably available, or when only one parent has legal responsibility for the care and custody of the child: 1) research involving greater than minimal risk and no prospect of direct benefit to individual subjects, but likely to yield generalizable knowledge about the subject's disorder or condition; and 2) research not otherwise approvable which presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children.

If the IRB determines that a research protocol is designed for conditions or for a subject population for which parental or guardian permission is not a reasonable requirement to protect the subjects (for example, neglected or abused children), it may waive the consent requirements, provided an appropriate mechanism for protecting the children who will participate as subjects in the research is substituted, and provided further that the waiver is not inconsistent with federal, state, or local law. The choice of an appropriate mechanism would depend upon the nature and purpose of the activities described in the protocol, the risk and anticipated benefit to the research subjects, and their age, maturity, status, and condition.

Sample Assent: (Word document)