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Informed consent

Rooted in the ethical principle of Respect for Persons from the Belmont Report, state regulations (DHS 94.03; DHS 94.14; DHS 94.01(2)), and Federal regulations (45 CFR 46.116; 21 CFR 50.20), unless appropriately waived by an Institutional Review Board, any human subject participating in research must first provide their voluntary agreement to do so - this is called informed consent.

Obtaining vs. documenting informed consent

Obtaining informed consent

Obtaining informed consent is on ongoing process in which the potential subject, or their legally authorized representative (LAR), is presented with information about the research and he or she voluntarily agrees to participate. This agreement must be free from any coercion, undue influence, or other incentive that could affect the voluntary nature of the subject's agreement to take part in the research.
  • Coercion occurs when an overt or implicit threat of harm is intentionally presented by one person to another in order to obtain compliance.
  • Undue influence, by contrast, often occurs through an offer of an excessive or inappropriate reward or other overture in order to obtain compliance.
Information about the research must be presented to a potential subject in a way that allows him or her to fully understand to what they are agreeing, in accordance with 45 CFR 46.116, 21 CFR 50.25. This means not only presenting all the required elements of informed consent, but also that any consent forms or other material used must be written in a language understandable to the subject. This relates to consenting non-English speaking subjects as well as the overall readability of the document. Fully informed consent includes discussion of:
  • the purpose of the research
  • how many subjects are anticipated
  • how long participation is expected to last
  • circumstances in which participation would be ended regardless of consent
  • the process for voluntary withdrawal at any time and assurance this will not affect care or bring penalties
  • foreseeable potential risk of harm and potential benefits that may be experienced
  • financial risk or additional cost subject may incur as a result of participation
  • what alternatives to participating in the research are available
  • how confidentiality and privacy will be protected during participation
  • what the subject's overall experience will be (medications, procedures, testing or surveys, number of visits, etc)
  • what happens if a subject is injured or harmed in the course of their participation
  • communication of significant findings from the research that may affect their willingness to continue to participate
  • who to contact for questions and concerns about the research and their participation
  • assurance that their participation is voluntary
Subjects should be given sufficient time to ask questions, process the information presented, and give thoughtful consideration to whether they choose to participate, both at the time of the initial discussion and throughout their participation in the research. Investigators should plan on mechanisms to regularly and continually assess subject understanding of the research and continued agreement to remain in the study.

Documenting informed consent

Documenting consent is the process of getting a subject's signature, or the signature of their legally authorized representative (LAR), on a currently IRB approved written informed consent document in accordance with 45 CFR 46.117. The consent document must also contain all the required elements of informed consent (45 CFR 46.116; 21 CFR 50.25) and is typically used as the basis for the discussion in which consent is obtained.

Resources for writing consent documentation

Other resources

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