As Part of the Consent Process, What Do Federal Regulations Require Researchers To Do?
Federal regulations (45 CFR 46.116) require researchers to provide potential subjects with information in language understandable to them, at an appropriate reading level. Consent must be plain and comprehensible, not legalese, and must genuinely inform the person's voluntary decision.
The answer
Under the U.S. federal regulations governing human-subjects research, specifically 45 CFR 46.116 (part of the Common Rule), the consent process requires researchers to present information in language that is understandable to the subject, at a reading level the potential participant can actually comprehend. Guidance commonly recommends writing consent materials at roughly a sixth-to-eighth-grade reading level. The purpose of informed consent is not to collect a signature that protects the institution, it is to enable a genuine, voluntary, informed decision by the participant. That is only possible if the person can understand what they are agreeing to.
On CITI Program quizzes, this is the correct choice, and the distractors are things the regulations do not require. The regulations do not require researchers to list the names of every IRB member, to write the form in technical or legal language, or to include a clause waiving the subject's legal rights. In fact, exculpatory language, any wording through which the subject waives or appears to waive legal rights or releases the researcher from liability, is explicitly prohibited.
Why the other options are wrong
- "Include a list of the IRB members" / "institutional details": Consent must tell subjects whom to contact with questions about the research and about their rights, but naming the individual board members is not a required element.
- "Use precise legal/technical language": This is the opposite of what the rule demands. Legalese defeats comprehension; the standard is plain, understandable language.
- "Include a statement that the subject waives their legal rights": Prohibited. No consent process may ask a subject to waive legal rights or release the investigator, sponsor, or institution from liability for negligence.
- "Guarantee benefits to the subject": Consent must describe reasonably expected benefits honestly, and must not overstate or promise them.
The bigger picture: the required elements of consent
45 CFR 46.116 lists the basic elements every consent process must generally convey. These include: (1) a statement that the study involves research, its purpose, expected duration, and the procedures; (2) any reasonably foreseeable risks or discomforts; (3) any benefits reasonably expected; (4) alternatives to participation; (5) how confidentiality of records will be maintained; (6) for more-than-minimal-risk research, whether compensation or medical treatment is available for injury; (7) whom to contact for questions about the research and about subjects' rights, and whom to contact in case of injury; and (8) a statement that participation is voluntary, refusal carries no penalty, and the subject may withdraw at any time without loss of benefits.
The 2018 revised Common Rule added a requirement that consent begin with a concise, focused presentation of key information to help the person decide, reinforcing the same theme: consent is a comprehension-driven process, not a paperwork formality. Understanding that everything in 46.116 serves the subject's ability to make a free, informed choice is what separates a correct exam answer from a memorized one.
- 1
State it's research
Explain the study's purpose, expected duration, and the procedures involved, and that participation is research.
- 2
Disclose risks
Describe any reasonably foreseeable risks or discomforts honestly.
- 3
Describe benefits
State benefits reasonably expected, without overstating or guaranteeing them.
- 4
Offer alternatives
Explain appropriate alternative procedures or courses of treatment, if any.
- 5
Protect confidentiality
Explain how records identifying the subject will be kept confidential.
- 6
Address injury (if >minimal risk)
State whether compensation or medical treatment is available if injury occurs.
- 7
Give contacts
Provide whom to contact about the research, about subjects' rights, and in case of injury.
- 8
Affirm voluntariness
State that participation is voluntary and the subject may refuse or withdraw at any time without penalty, all in understandable language.
Frequently asked
What are the eight required elements of informed consent under 45 CFR 46.116?
They are: a statement that it is research with purpose and procedures; foreseeable risks; expected benefits; alternatives; confidentiality protections; whether compensation/treatment for injury is available (for more-than-minimal-risk studies); whom to contact; and a statement that participation is voluntary and may be withdrawn at any time.
At what reading level must consent forms be written?
Regulations require language understandable to the subject; standard guidance recommends roughly a sixth-to-eighth-grade reading level. The goal is genuine comprehension, so technical or legal jargon should be avoided in favor of plain, clear wording.
What is the difference between consent and assent in research?
Consent is the legally effective agreement given by an adult with decision-making capacity (or a legally authorized representative). Assent is a child's or decisionally impaired person's affirmative agreement to participate, obtained alongside a parent's or guardian's permission, since they cannot legally consent themselves.
Can a subject waive their legal rights in a consent form?
No. 45 CFR 46.116 prohibits exculpatory language, so no consent process may ask a subject to waive or appear to waive any legal rights, or release the investigator, sponsor, or institution from liability for negligence.