Informed Consent Checklist

Guidelines

Required Elements

  • 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 (i.e., not standard of care)
  • A description of any reasonably foreseeable risks or discomforts to the subject (ideally subdivided by frequency and severity)
  • A description of any benefits to the subject or to others which may reasonably be expected from the research
  • A disclosure of appropriate alternative procedures or 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 research subjects' rights, about the research and in the event of research-related injury.
  • 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
  • Include clinicaltrials.gov language
  • FDA-regulated clinical investigations: Subjects must be informed that the FDA may inspect the records of the study.
  • Concise summary
  • One of the following statements about any research that involves the collection of identifiable private information or identifiable biospecimens:
    1. 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 legally authorized representative, if this might be a possibility; or
    2. 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

  • 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
  • Anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject'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
  • 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
  • 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)

For bio-specimen collection consider including the following in the informed consent documents

  • A clear description of the operation of the bio-specimen resource. This description could include details that may be of interest to human research participants, such as whether identifiable information will be maintained by the bio-specimen resource and/or whether research results will be linked to the bio-specimen.
  • The conditions under which samples and data will be released to recipient investigators.
  • Procedures for protecting the privacy of human research participants and confidentiality of data.
  • Specific descriptions of the nature and purpose of the research.
  • Information about the consequences of DNA typing if human genetic research is anticipated.

HIPAA Authorization for Research

The HIPAA Privacy Rule establishes national standards to protect individuals' medical records and other personal health information. The Rule requires appropriate safeguards to protect the privacy of personal health information, and sets limits and conditions on the uses and disclosures that may be made of such information without patient authorization.

A HIPAA Privacy Rule Authorization is an individual's signed permission to allow a covered entity to use or disclose their protected health information (PHI) that is described in the Authorization for the purpose(s) and to the recipient(s) stated in the Authorization. An Authorization may be combined with an informed consent document or it may be a separate document.

HIPAA Authorization Core Elements:

  • Specific and meaningful description of the PHI to be used or disclosed.
  • The name or other specific identification of the person, or class of persons, authorized to make the requested use or disclosure.
  • The name or other specific identification of the person, or class of persons, who may use the PHI or to whom the covered entity may make the requested disclosure.
  • A description of each purpose of the requested use or disclosure. Researchers should note that this element must be research study specific, not for future unspecified research.
  • An expiration date/expiration event that relates to the individual or the purpose of the use or disclosure. The terms "end of the research study" or "none" may be used for research, including for the creation and maintenance of a research database or repository.
  • The date and signature of the individual or the individual's personal representative. If the authorization is signed by a personal representative, include a description of the representative's authority to act for the patient.

HIPAA Authorization Required Statements:

  • Statement regarding the right of the individual to revoke the authorization in writing, the limits of that right, and instructions on how to exercise such right.
  • Statement regarding ability or inability to condition treatment, payment, enrollment or eligibility for benefits on the Authorization and, if applicable, consequences of refusing to sign the Authorization.
  • Re-disclosure Statement - Information disclosed to others not subject to the Privacy Rule may be re-disclosed by them without the Privacy Rule protections (cannot promise that information will definitely be protected).
Disclaimer
This information is designed to provide general guidance to you on the elements of human research consent. Always follow the specific requirements/forms/documents of the IRB to which you are planning to submit your proposal.