Under the US Common Rule (45 CFR 46), an informed consent document and process are built from a defined set of components: eight basic required elements (45 CFR 46.116(b)), a ninth basic element added by the 2018 revisions for research involving identifiable private information or biospecimens, and up to eight additional elements (45 CFR 46.116(c)) that apply only “when appropriate” to the specific study. This page walks through each component individually — what it requires, why it’s required, and how it typically appears in a consent document. For the broader consent process (voluntariness, comprehension, timing, waivers) see Informed Consent in Research: What It Requires and How It Works; for a working item-by-item checklist while drafting a document, see Informed Consent Checklist for Researchers; for an annotated sample form, see Informed Consent Form: A Worked Example With Annotations.
Basic elements vs. additional elements: the structural distinction
45 CFR 46.116 splits required disclosures into two tiers. Paragraph (b) sets out elements that must be included in every informed consent for research covered by the Common Rule. Paragraph (c) sets out elements that must be included only when appropriate to the specific study’s design or risks — an IRB or research ethics committee (REC) determines which additional elements a given protocol triggers. A consent document that omits a required basic element is deficient regardless of study type; a consent document that omits an additional element it doesn’t need is not deficient at all. Confusing the two tiers is a common drafting error: don’t include every additional element as boilerplate, and don’t treat any basic element as optional.
The eight basic elements (45 CFR 46.116(b)(1)-(8))
1. Research statement, purpose, duration, and procedures
A statement that the study involves research, an explanation of its purposes, the expected duration of the subject’s participation, a description of the procedures to be followed, and identification of any procedures that are experimental. This is usually the opening substantive section of a consent form — it establishes that the person is being asked to join a research study (not receive standard clinical care), what will actually happen to them and when, and how long their involvement will last.
2. Reasonably foreseeable risks or discomforts
A description of any reasonably foreseeable risks or discomforts to the subject. This covers physical, psychological, social, legal, and economic risks — not just adverse events from an experimental drug or procedure. Risk disclosure should be proportionate and specific to the study; generic boilerplate risk language is a frequent source of IRB deficiency letters.
3. Reasonably expected benefits
A description of any benefits to the subject or to others that may reasonably be expected from the research. Consent documents must not overstate benefit or imply a guarantee of personal benefit where none is reasonably expected — a common problem in early-phase trials, where the honest statement is often that there may be no direct benefit to the participant and the research is intended to benefit future patients or advance knowledge.
4. Alternative procedures or treatments
A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject. This element applies most directly to clinical/therapeutic research, where declining to participate, or withdrawing, has a real alternative (standard of care, another approved treatment, or no treatment) that the prospective subject needs to weigh against enrollment.
5. Confidentiality
A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained. This element must describe realistic limits, not just make a blanket confidentiality promise — for example, that identifiable records may be reviewed by the sponsor, the FDA, or the IRB itself, or that mandatory reporting laws (such as for suspected abuse) could require disclosure.
6. Compensation for research-related injury
For research involving more than minimal risk, an explanation of whether any compensation, and whether any medical treatments, are available if injury occurs and, if so, what they consist of or where further information may be obtained. This element is required only for greater-than-minimal-risk research — it does not apply to every study, which is why it is sometimes conflated with the additional element in 46.116(c) covering compensation more generally; the (b)(6) version is specifically about injury.
7. Contacts for questions
An explanation of whom to contact for answers to pertinent questions about the research and research subjects’ rights, and whom to contact in the event of a research-related injury. Consent documents typically list at least two separate contacts here: the study team (for questions about the research itself) and the IRB/REC or an independent office (for questions about rights or to report a concern) — deliberately not the same point of contact, so a subject with a complaint about the study team isn’t required to raise it with that same team.
8. Voluntary participation
A statement that participation is voluntary, that refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and that the subject may discontinue participation at any time without penalty or loss of benefits. This is the element most directly tied to the Belmont Report’s respect-for-persons principle and to the broader Common Rule requirement that consent be free of coercion or undue influence.
The 2018-added ninth basic element
9. Future use of identifiable data or biospecimens
For research involving the collection of identifiable private information or identifiable biospecimens, one of two statements is now required as a basic element: either that identifiers might be removed and the de-identified information or biospecimens could be used for future research without additional consent, or 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. This element did not exist before the 2018 Common Rule revisions took effect for research approved on or after January 19, 2018 — it was added specifically to address the growing use of biobanks and secondary data/specimen research, and connects to the newer regulatory category of broad consent, a single consent covering storage and future secondary use that the 2018 revisions created as a formal alternative to study-specific re-consent.
The additional elements (45 CFR 46.116(c)) — required only when appropriate
An IRB determines, protocol by protocol, which of the following apply. None of them is universal.
1. Unforeseeable risks
A statement that the particular treatment or procedure may involve risks to the subject (or to an embryo or fetus, if the subject is or may become pregnant) that are currently unforeseeable. Relevant to novel interventions, early-phase drugs, or procedures with limited safety history.
2. Investigator-initiated termination
Anticipated circumstances under which the subject’s participation may be terminated by the investigator without the subject’s consent — for example, if a safety threshold is crossed, or if the subject becomes ineligible partway through the study.
3. Additional costs
Any additional costs to the subject that may result from participation — costs not covered by insurance, travel, or study-related procedures billed outside the research budget. This is a distinct concern from research-related injury compensation in (b)(6).
4. Consequences of withdrawal
The consequences of a subject’s decision to withdraw from the research, and procedures for orderly termination of participation — relevant where withdrawal mid-study has real implications, such as an ongoing drug taper or a procedure that cannot simply be stopped.
5. New findings during the study
A statement that significant new findings developed during the course of the research that may relate to the subject’s willingness to continue participating will be provided to the subject.
6. Approximate number of subjects
The approximate number of subjects involved in the study, which can be relevant context for a prospective participant weighing a study’s scale and design.
7 & 8. Biospecimens research results and whole-genome sequencing
Two further elements were added by the 2018 revisions for research specifically involving biospecimens: whether clinically relevant research results, including individual research results, will be disclosed to subjects, and under what conditions; and, when applicable, a statement regarding whether the research will (or might) include whole genome sequencing.
Where these components fit relative to the rest of the consent process
The components above answer the question “what information must be disclosed.” They are not the whole of 45 CFR 46.116 — the surrounding general requirements govern how that information must be conveyed: in language understandable to the subject, without exculpatory language that waives the subject’s legal rights, with adequate opportunity to consider participation, and free of coercion. Nor do these components cover documentation: 45 CFR 46.117 regulates the signed consent form separately from the consent process itself, which is the basis for the distinction covered in Informed Consent in Research between the process and the paperwork. Special-population protections — parental permission and child assent under Subpart D, additional protections for pregnant women, fetuses, and neonates under Subpart B, and for prisoners under Subpart C — layer additional requirements on top of, not instead of, the components above; see Informed Consent vs. Assent for how the child-assent requirement differs from adult consent. Where a study qualifies for a full or partial waiver of one or more elements, that determination runs through the separate four-part test in 46.116(f), not through simply omitting elements at the drafting stage.
Frequently asked questions
What are the components of informed consent?
Under 45 CFR 46.116, the components are eight basic required elements — research/purpose/duration/procedures, risks, benefits, alternatives, confidentiality, compensation for research-related injury (where relevant), contacts, and voluntary participation — plus a ninth basic element (future use of identifiable data/biospecimens) added in 2018, and up to eight additional elements required only when a specific study’s design or risk profile calls for them.
Are all the elements required for every study?
No. The eight (now nine) basic elements in 46.116(b) are required for every Common Rule-covered study. The elements in 46.116(c) are required only “when appropriate” — the reviewing IRB or REC determines which apply to a given protocol based on its design and risks.
What’s the difference between the required elements and a consent form?
The required elements are the content that must be disclosed during the consent process. A consent form is one way of documenting that the process occurred, regulated separately under 46.117. An IRB can, in narrow circumstances, waive the signed-form requirement without waiving the underlying consent process or its required elements.
Does FDA-regulated research use the same elements?
FDA’s own human subjects regulations (21 CFR 50.25) closely parallel the Common Rule’s basic and additional elements, and institutions conducting both federally funded and FDA-regulated research typically design a single consent document that satisfies both. This page covers the Common Rule (45 CFR 46.116) framing; always confirm which regulation(s) actually govern a specific protocol.
How is this different from the ethical principles behind informed consent?
The components on this page are the specific regulatory disclosure requirements a consent document and process must satisfy. The ethical principles behind them — respect for persons, beneficence, and justice, as articulated in the Belmont Report — are a separate, related question about why these requirements exist rather than what they require line by line.
