Informed Consent Record Keeping and Documentation

The following elements are required in a consent document per 45 CFR 46.116 and 21 CFR 50.25:

  1. A statement that the study involves research, an explanation of the purpose of the research, the expected duration of participation, a description of the procedures, and identification of any experimental procedures;
  2. A description of any reasonably foreseeable risks or discomforts;
  3. A description of any benefits to the subject or to others that might be reasonably expected from the research;
  4. Disclosure of appropriate alternative treatment or courses of action, if any, which may be advantageous to the subject, including no treatment or not participating.
  5. A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained and that records may be examined by the sponsor, the IRB, the FDA, or other regulatory agencies;
  6. For research involving greater than minimal risk, an explanation as to whether compensation and/or medical treatment are available in the event of research-related injury. If so, where further information may be obtained.
  7. The informed consent form must also identify whom to contact for answers to questions about the research and research subjects’ rights, and whom to contact if the subject sustains a research-related injury;
  8. A statement that participation is voluntary, that the subject may discontinue participation at any time, and that refusal to participate or withdrawal will not involve a penalty or loss of benefits to which the subject is otherwise entitled.
The IRB, when appropriate, will also consider whether the following additional elements of informed consent are required and whether they are adequately included in the informed consent form(s):

  1. A statement that the particular procedure or treatment may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant or is a man capable of fathering a child) that are known or currently unforeseeable;
  2. Anticipated circumstances under which the subject’s participation may be terminated by the Principal Investigator without regard to the subject’s consent;
  3. Any costs, or additional costs, to the subject that may result from participation in the research, including whether such costs may be billed to a third party payor (i.e. health insurance);
  4. The consequences of the subject’s decision to withdraw from the research and procedures for safe and orderly termination of participation;
  5. A statement that significant new findings developed during the course of the research, which may relate to the subject’s willingness to continue to participate, will be provided to the subject;
  6. The approximate number of subjects involved in the study at the institution(s).
  7. Clarification whether the investigational drug, device, or biologic involved in a study will be available to a subject after the subject has completed the study, or if the study is terminated.
  8. An explanation of the payment plan, or statement that subjects will not be paid for participation.
  9. An estimate of any hazard associated with exposure to ionizing radiation as a result of participation in the study. The assessment should be in lay language and contextualize the exposure (e.g., a multiple of the background radiation to which people are exposed in one year).
  10. A statement as to whether human genetic/research testing is associated with the protocol, and if so an explanation of potential relevant risks to the subject and relatives.
The IRB has prepared an informed consent form template for research subjects. This template provides detailed information regarding elements of informed consent and provides recommended language for the document.

The consent discussion and informed consent form should be presented to a potential subject sufficiently in advance of the start of study-related procedures to ensure that a subject has adequate time to voluntarily decide whether or not to participate in a research study.

Consent must be given by a subject before any study-related procedures, including screening procedures, may take place.

Under certain circumstances, the IRB may approve a consent process that does not include, or that alters, some or all of the elements of informed consent, or may waive the requirement to obtain informed consent, provided the IRB finds and documents that all of the following requirements apply:

  1. The research involves no more than minimal risk to the subjects;
  2. The waiver or alteration will not adversely affect the rights and welfare of the subjects;
  3. The research could not practicably be carried out without the waiver or alteration; and
  4. Whenever appropriate, the subjects will be provided with additional pertinent information after participation.
Requests for alterations in, or a waiver of, informed consent requirements should be made in the study protocol and justified by addressing each of the points above in sufficient detail to substantiate requirement.
When new or additional procedures will be added to a study, or if changes are made to the protocol or informed consent form that affect the subject, or if new safety information is learned, the subject must be made aware of the change and again give consent. Such changes or new information might affect subjects’ willingness to continue participation in the study.

An investigator may not perform a procedure, etc., on a subject without first obtaining new consent if the procedure was not part of the initial consent discussion and documented in the original informed consent form.

New safety information, a change in FDA approval status of a drug or device being studied, or a new or change in alternative to participation, etc., is to be conveyed to subjects in a timely manner so that they can make an informed decision about whether or not to continue study participation. Conveying such information should not be delayed.
In the event that a study will enroll adult subjects who are temporarily or permanently incapable of giving informed consent, the subject’s legally authorized representative may provide permission for the subject to be enrolled in the study, provided the IRB has approved the enrollment of decisionally impaired subjects. Explicit IRB approval is required to enroll decisionally impaired subjects as a study population, or to enroll a single decisionally impaired subject.
When minors (less than age 18 years) will be enrolled in a study, permission (consent) must be obtained from the subject’s parent(s) or court appointed guardian(s). If the research involves greater than minimal risk but no direct benefit to the individual subject, consent must be obtained and documented in writing from either both parents or the legal guardian(s).

If minors age 7 years or older will be enrolled, the assent of the minor must be obtained if, in the judgment of the IRB, the children are capable of providing assent.

In determining whether children are capable of assenting, the IRB will 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 in accord with federal regulations. Investigators must provide specific justification for waiver of assent, which must be reviewed and approved by the IRB.
OHRP (45 CFR 46.116 and 45 CFR 46.117) and FDA (21 CFR 50.25 and 21 CFR 50.27) regulations require that information given to potential subjects or their legally authorized representative be in language understandable to the subject or the representative. Before a non-English speaking subject may be enrolled in a study, the IRB must review and approve the information before it is presented to a potential subject.
The IRB may waive the requirement to document informed consent with a signed written informed consent form for some or all subjects, provided the study is not regulated by the FDA (unless it is emergency research), if:

  1. The only record linking the subject and the research would be the informed consent form and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject would be asked whether he/she wants documentation linking him/her with the research, and his/her request will prevail. If the IRB approves a waiver of obtaining a signed informed consent form, the complete consent process must take place, including giving subjects a written informed consent form containing all required consent elements, except that the subject will have the option to not sign the informed consent form.

    OR

  2. The research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required out of the research context. If the IRB approves a waiver of the requirement to obtain a signed informed consent form based on this, investigators must completely inform potential subjects about the study, answer their questions and obtain their verbal agreement to participate in the study.