IRB Ready

Writing Informed Consent Forms for IRB

Required elements under 45 CFR 46.116, plain-language guidance, sample consent language for adults, minors, and waivers, and common errors.

The informed consent document is the participant's contract with your study. It is also the single most scrutinized attachment in your IRB application. Reviewers read it line by line, comparing every procedure and risk against your protocol. This guide covers the required elements under 45 CFR 46.116, plain-language writing, sample passages for adults and minors, and the waiver process.

What consent actually is

Informed consent is not a signature. It is a process: a reasonable opportunity to understand the study, ask questions, weigh the decision, and agree without coercion. The document is the record of that process. Under the revised Common Rule, the consent form must begin with a concise summary of the key information a reasonable person would want in order to decide.

Required elements under 45 CFR 46.116

Every IRB-approved consent form must include the basic elements listed in 45 CFR 46.116(b):

  • Statement that the study involves research, plus the purpose, expected duration, and procedures
  • Description of reasonably foreseeable risks or discomforts
  • Description of benefits to the participant or others
  • Disclosure of appropriate alternative procedures or treatments, when relevant
  • Confidentiality statement describing how records will be kept
  • For greater-than-minimal-risk research: whether compensation or medical treatment is available if injury occurs
  • Contact information for research questions and for research-participant rights
  • Statement that participation is voluntary, refusal involves no penalty, and the participant may withdraw at any time

Additional elements under 45 CFR 46.116(c) apply when relevant: unforeseen risks, circumstances under which participation may be terminated, additional costs, consequences of withdrawal, notification of significant new findings, approximate number of participants, and statements about future use of identifiable data or biospecimens.

The concise key information summary

The 2018 Common Rule requires that consent begin with a concise, focused presentation of the information most important to decision-making (45 CFR 46.116(a)(5)). This is not a legal abstract — it is a plain-language summary.

Sample key information summary

You are being asked to take part in a research study. Here is a quick summary of the study so you can decide if you want to learn more.

  • Purpose: We are studying how graduate students manage stress during their first year of doctoral training.
  • What you will do: Complete one 30-minute online survey and, if you agree, one 45-minute video interview.
  • Risks: You may feel uncomfortable discussing stressful experiences. You can skip any question.
  • Benefits: You will not directly benefit. Findings may help universities improve student support.
  • Time: About 75 minutes total over two weeks.
  • Compensation: A $25 digital gift card after the interview.
  • Voluntary: You can stop at any time with no penalty.

This summary covers purpose, procedures, risks, benefits, time commitment, compensation, and the voluntary nature of participation — in under 150 words.

Plain-language guidance

Consent forms must be written at a level a prospective participant can actually read. Most IRBs target an 8th-grade reading level. Use the plain-language principles below.

  • Use short sentences. One clause per sentence is a good rule.
  • Use the second person. "You will complete a survey" reads better than "Participants will complete a survey."
  • Replace jargon. "Randomized" becomes "assigned by chance, like flipping a coin."
  • Explain acronyms on first use. PI, IRB, HIPAA are not universally known.
  • Avoid conditional fog. "In the event that" becomes "if."
  • Name the study team. Participants deserve to know who is asking them to take part.

Sample consent sections

Risks section (adult interview study)

Talking about stressful experiences can sometimes bring up difficult feelings. You can skip any question or stop the interview at any time. If you feel distressed during or after the interview, you can contact your campus counseling center at [phone number] or call or text 988 to reach the Suicide and Crisis Lifeline.

Names the psychological risk, states mitigation (skip/stop), and provides concrete resources. Do not list risks without mitigation.

Assent section (ages 12–17)

We are doing a study about how middle schoolers deal with stress at school. If you want to be in the study, you will answer some questions on a tablet for about 20 minutes. Some questions are about feelings you have had. You do not have to answer any question you do not want to, and you can stop at any time. Nothing bad will happen if you say no or stop. Do you want to take part?

Written for middle-school reading level. Permission from a parent or guardian is still required in addition to this assent. Read the special populations guide for rules under 45 CFR 46 Subpart D.

Waiver of documentation (anonymous survey)

By clicking "I agree" below, you indicate that you have read this information and agree to take part in the study. Because this survey is anonymous, we are not asking you to sign a consent form — your agreement here is your consent.

Under 45 CFR 46.117(c), an IRB may waive the requirement for a signed consent form if the only record linking the participant to the study would be the signature and the principal risk is breach of confidentiality, or if the research is minimal risk and involves procedures not normally requiring written consent outside the research context.

Waivers of consent

Under 45 CFR 46.116(f), an IRB may waive or alter consent requirements if the IRB finds all of the following:

  • The research involves no more than minimal risk
  • The research could not practicably be carried out without the waiver
  • If identifiable private information or biospecimens are used, the research could not practicably be carried out without using them
  • The waiver will not adversely affect the rights and welfare of participants
  • Whenever appropriate, participants will be provided with pertinent information after participation

Common waiver scenarios include retrospective chart reviews, research using existing de-identified records, and some classroom observation studies.

Common consent form errors

Reading-level inflation

Consent forms written by researchers default to graduate-level prose. Run a Flesch-Kincaid or SMOG score and aim for grade 8 or below. Shorter sentences alone usually solve the problem.

  • Missing elements. The voluntary-participation statement and the rights-of-participants contact are the most commonly omitted elements.
  • Conflicting information. The consent form says 30 minutes; the protocol says 45 minutes. Reviewers catch this every time.
  • Undersell or oversell benefits. "This study will benefit society" without specificity is hollow. So is "There is no benefit" when the study examines a clinical population.
  • Omitting video/audio recording details. State explicitly what is recorded, where it is stored, who has access, and how long it is retained.
  • Pressuring language. "We hope you will participate" or "Your help is essential" is coercive. Keep it neutral.
  • No separate assent. Children are not miniature adults. Assent forms must be written for the child's developmental level.

Consent form quality checklist

  • Begins with a key information summary
  • All required elements under 45 CFR 46.116(b) present
  • Written at grade 8 or below
  • Uses "you" consistently
  • All procedures match the protocol exactly
  • All named risks have named mitigations
  • Compensation amount and schedule are clear
  • Two sets of contact information: PI for study questions, IRB for participant-rights questions
  • Voluntary participation and right to withdraw stated plainly

Next, strengthen the data security language that underpins your confidentiality claims — see the data management guide. If your study involves children, prisoners, or pregnant participants, the special populations guide covers additional consent requirements.