Informed Consent Checklist for Researchers

This is a working checklist for the researcher or study coordinator drafting an informed consent process and document — not a legal definition of what informed consent is (see the informed consent dictionary entry for that) and not a walk-through of a finished sample form (see Informed Consent Form: A Worked Example With Annotations for that). Use it while you are building or revising a consent document and process, before submission to your IRB or research ethics committee (REC), to confirm every required element under 45 CFR 46.116 is actually present.

For the full regulatory reasoning behind each item — why the form is not the same as consent, how waivers work, and what special populations require — see the companion guide Informed Consent in Research: What It Requires and How It Works. This page is the condensed, checklist version meant to be worked through item by item.

Before you start: process checklist, not just document checklist

Confirm which regulatory framework applies — US federally funded or federally regulated human subjects research falls under the Common Rule (45 CFR 46); FDA-regulated trials layer on 21 CFR 50; non-US or multi-site trials typically also need to satisfy ICH E6 Good Clinical Practice and/or the Declaration of Helsinki.
Confirm the study’s risk level and consent pathway — whether it needs full IRB review, expedited review, or falls into an exemption category (most exemption categories still expect disclosure to participants; exemption is not a waiver of the ethical obligation). See exempt human subjects research and CASRAI’s IRB/REC approval process guide.
Identify whether any participant population needs additional protections before drafting a single document — children, prisoners, pregnant women/fetuses/neonates, or adults with diminished decision-making capacity each trigger extra Common Rule subparts (see the population-specific section below).
Decide early whether documentation itself can be waived under §46.117(c) (a separate question from whether the consent process can be waived under §46.116(f)) — this determines whether you’re drafting a signature document at all or an information sheet plus a verbal-consent script.

The basic elements checklist (45 CFR 46.116(b))

Every consent process and document for non-exempt, more-than-minimal-risk human subjects research must disclose all of the following. Treat each line as a required element to check off, not a suggestion:

Research statement. A statement that the study is research (not standard clinical care), its purpose(s), the expected duration of the participant’s involvement, and a description of the procedures to be followed, with any experimental procedures identified as such.
Reasonably foreseeable risks or discomforts. Described specifically enough that a reasonable person could weigh them — not just “there may be risks.”
Reasonably expected benefits. To the participant or to others; if there is no direct benefit to the participant, say so explicitly rather than implying one.
Disclosure of appropriate alternative procedures or courses of treatment, if any — particularly important where participation could be mistaken for, or substitute for, standard care.
Confidentiality statement. A statement describing the extent, if any, to which confidentiality of records identifying the participant will be maintained — what will be collected, how it will be stored, and who can access it.
Compensation and medical treatment for research-related injury (required only where the research involves more than minimal risk): an explanation of whether any compensation exists, and whether medical treatments are available if injury occurs, and if so, what they consist of or where further information can be obtained.
Contact information. Who to contact with questions about the research and participants’ rights, and who to contact in the event of a research-related injury.
Voluntary participation statement. An explicit statement that participation is voluntary, that refusal to participate involves no penalty or loss of benefits to which the participant is otherwise entitled, and that the participant may discontinue participation at any time without penalty or loss of benefits.

Additional elements — check if applicable to your study

45 CFR 46.116(c) lists elements that must be included only when they apply to the specific study design. Screen for each:

A statement that a particular treatment or procedure may involve risks to the participant (or to an embryo or fetus, if the participant is or may become pregnant) that are currently unforeseeable.
Anticipated circumstances under which the participant’s participation may be terminated by the investigator without the participant’s consent.
Any additional costs to the participant that may result from participation.
The consequences of a participant’s decision to withdraw from the research, and procedures for orderly termination of participation.
A statement that significant new findings developed during the course of the research that may relate to the participant’s willingness to continue participating will be provided.
The approximate number of participants involved in the study.
Since the 2018 Common Rule revisions: for research involving the collection of identifiable private information or identifiable biospecimens, either a statement that identifiers might be removed and, after removal, the information/biospecimens could be used for future research without additional consent, or a statement that the participant’s information/biospecimens will not be used for future research even after identifiers are removed.
Whether clinically relevant research results, including individual research results, will be disclosed, and under what conditions.
For research involving biospecimens, whether the research will (or might) include whole genome sequencing.

Process quality checklist — beyond what’s on the page

A form that lists every required element can still fail to produce valid consent. Check the process itself, not only the document:

Language and literacy. Is the document written in language understandable to the specific population being enrolled — avoiding jargon, at an appropriate reading level, and translated (with a qualified translation, not a machine translation alone) for non-English-speaking participants?
Time and setting. Does the process give participants sufficient opportunity to consider participation and ask questions, in a setting that minimizes the possibility of coercion or undue influence — not, for example, a group setting where declining is visible to peers, or immediately before a clinical procedure the participant feels dependent on?
Comprehension check, not just disclosure. Does the process actually confirm understanding (inviting questions, teach-back, or a comprehension check) rather than assuming a signature implies comprehension?
Version control. Does the consent form’s version number and date match the currently IRB/REC-approved version, and does it match the protocol version it supports? Mismatched versions are one of the most common findings in monitoring visits and audits.
Re-consent triggers identified in advance. Have you specified what would trigger re-consent — a protocol amendment that changes risk, or a significant new finding — rather than treating consent as obtained once and never revisited? See When Should Informed Consent Be Obtained? Timing, Re-Consent, and the Emergency Exception for the timing rules in detail, including the exception from informed consent (EFIC) framework for emergency research where consent cannot practicably be obtained in advance.

Special populations — check whether extra protections apply

Children/minors (Subpart D). Consent alone is not sufficient — confirm your document and process separately capture parental/guardian permission and, where the IRB determines the child capable, the child’s own assent. Assent is an affirmative agreement; silence or non-objection does not count. See the assent dictionary entry and the comparison page Informed Consent vs. Assent — What’s the Difference? for how the two documents differ and when each is required.
Adults with cognitive or decisional impairment. Confirm whether your protocol requires assessment (and, if capacity fluctuates, reassessment) of decision-making capacity, and whether a legally authorized representative’s consent is needed instead of or in addition to the participant’s own.
Prisoners (Subpart C). Confirm additional IRB composition and research-category constraints apply — incarceration itself can compromise voluntariness.
Pregnant women, fetuses, and neonates (Subpart B). Confirm whether additional safeguards apply given potential risk to a fetus or neonate who cannot themselves consent.
Emergency research where advance consent is not possible. Confirm whether your study qualifies for the EFIC exception and, if so, that community consultation and public disclosure requirements (not just an IRB waiver) have been planned — see the timing guide linked above.

Documentation checklist (45 CFR 46.117)

Documentation is regulated separately from the consent process itself. Check:

Does the study need a signed form at all, or does it qualify for a documentation waiver under §46.117(c) — either because the signed form would be the only record linking the participant to the study and the principal risk is a confidentiality breach, or because the research is minimal risk and involves no procedures normally requiring written consent outside a research context?
If a signature is required, does the process for obtaining and storing it (wet-ink, electronic signature platform, or witnessed oral consent with a short-form document) match what your IRB approved?
Is there a plan for retaining signed consent documents for the period required by your institution, funder, and applicable regulation?

Frequently asked questions

Is this checklist a substitute for my IRB’s consent template?

No. Every institution’s IRB or research ethics committee maintains its own required template, house style, and locally mandated clauses that supersede a general checklist. Use this list to confirm nothing required by 45 CFR 46.116 is missing before submission — not as a replacement for institutional guidance.

What’s the difference between this checklist and the informed consent dictionary entry?

The informed consent entry defines the concept — what makes an agreement to participate count as informed consent. This page is a practical, item-by-item checklist for researchers actually drafting a consent process and document, built around the specific regulatory elements they need to include.

Do all consent forms need every element on the basic elements list?

The eight basic elements under 45 CFR 46.116(b) are required for essentially all non-exempt human subjects research consent processes, with the injury/compensation element required specifically where the research involves more than minimal risk. The additional elements under §46.116(c) apply only where relevant to the specific study design — screen for each rather than including all by default.

Can an IRB waive some of these required elements?

Yes, under §46.116(f), but only where the research involves no more than minimal risk, the waiver won’t adversely affect participants’ rights and welfare, the research couldn’t practicably be carried out without it, and participants will be given additional pertinent information after participation where appropriate. That is a separate provision from §46.117(c), which waives only the signed-documentation requirement while the underlying consent process still has to occur. See Informed Consent in Research for the full distinction.

Where do I find the actual text of 45 CFR 46.116?

The current regulatory text is maintained at the Electronic Code of Federal Regulations, Title 45 Part 46. HHS’s Office for Human Research Protections (OHRP) also publishes consent-related guidance, including a longstanding informed consent checklist researchers and IRBs commonly reference alongside institution-specific templates.