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Informed Consent

The Health Sciences Institutional Review Boards Office provides the following list of useful tips on writing consent forms.

This page lists the federally required elements of consent under the Common Rule's 2018 Requirements, effective 1/21/19. These requirements appear in the Code of Federal Regulations, 45 CFR 46.116.

General requirements for informed consent
  • Before involving a human subject in research covered by this policy, an investigator shall obtain the legally effective informed consent of the subject or the subject’s legally authorized representative (LAR). 
  • An investigator shall seek informed consent only under circumstances that provide the prospective subject or the LAR sufficient opportunity to discuss and 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 LAR shall be in language understandable to the subject or LAR. 
  • The prospective subject or the LAR must be provided with the information that a reasonable person would want to have in order to make an informed decision about whether to participate, and an opportunity to discuss that information. 
  • Informed consent must begin with a concise and focused presentation of the key information that is most likely to assist a prospective subject or LAR in understanding the reasons why one might or might not want to participate in the research. This part of the informed consent must be organized and presented in a way that facilitates comprehension. 
  • Informed consent as a whole must present information in sufficient detail relating to the research, and must be organized and presented in a way that does not merely provide lists of isolated facts, but rather facilitates the prospective subject’s or LAR’s understanding of the reasons why one might or might not want to participate. 
  • No informed consent may include any exculpatory language through which the subject or the LAR 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. General requirements for informed consent, whether written or oral.
Basic elements of informed consent
Informed consent must include these elements unless an IRB approves consent that omits some, or alters some or all, of these element
  • 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
  • A description of any reasonably foreseeable risks or discomforts to the subject
  • A description of any benefits to the subject or to others which may be reasonably be expected from the research
  • A disclosure of appropriate alternative procedures to courses of treatment, if any, that might be advantageous to the subject
  • A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained
  • 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
  • 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
  • A statement that participation in 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
  • One of the following statements about any research that involves the collection of identifiable private information or identifiable biospecimens:
    • A statement that identifiers might be removed from the identifiable private information or identifiable biospecimens and that, after such removal, the information or biospecimens could be used for future research studies or distributed to another investigator for future research studies without additional informed consent from the subject or the LAR, if this might be a possibility; or
    • A statement that the subject’s information or biospecimens collected as part of the research, even if identifiers are removed, will not be used or distributed for future research studies.

Additional elements of consent 
One or more of the following elements of information, when appropriate, shall also be provided to each subject or LAR: 
  • A statement that the particular treatment or procedures may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant) that are currently unforeseeable
  • Anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's or LAR’s consent
  • Any additional costs to the subject that may result from participation in the research
  • The consequences of a subject's decision to withdraw from the research and procedures for orderly termination of participation by the subject
  • A statement that significant new findings developed during the course of the research that may relate to the subject's willingness to continue participation will be provided to the subject
  • The approximate number of subjects involved in the study
  • A statement that the subject’s biospecimens (even if identifiers are removed) may be used for commercial profit and whether the subject will or will not share in this commercial profit
  • A statement regarding whether clinically relevant research results, including individual research results, will be disclosed to subjects, and if so, under what conditions
  • For research involving biospecimens, whether the research will (if known) or might include whole genome sequencing (i.e., sequencing of a human germline or somatic specimen with the intent to generate the genome or exome sequence of that specimen)

*Note regarding broad consent* 
Informed consent regulations allow “broad consent” for the storage, maintenance, and secondary research use of identifiable private information or identifiable biospecimens.  Broad consent is permitted under the regulations as an alternative to the informed consent requirements above and has requirements specific to this type of consent.  At this time, however, UW-Madison is not implementing broad consent.  Investigators may obtain informed consent for storage, maintenance, and secondary use of data and biospecimens as part of specific studies, registries, and repositories. 

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Keywords:ICF, CF, elements of consent, wizard, template   Doc ID:18665
Owner:Monica E.Group:Health Sciences IRBs
Created:2011-05-26 19:00 CDTUpdated:2019-02-15 17:43 CDT
Sites:Health Sciences IRBs
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