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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.