Research Consent Form

A Research Consent Form in the United States records a party's informed permission for a specified act, authorising it to proceed.

The current version of the Common Rule — 45 CFR Part 46, revised effective January 21, 2019 — applies to research conducted or supported by any of the 19 federal departments and agencies that have adopted the Common Rule through the Federal Policy for the Protection of Human Subjects. The Department of Health and Human Services (HHS), through the Office for Human Research Protections (OHRP), has primary responsibility for oversight and enforcement of the Common Rule. The revised Common Rule expanded the categories of research exempt from IRB review under § 46.104, introduced broad consent requirements for the storage and secondary research use of biospecimens and identifiable private information under § 46.116(d), and created new continuing review requirements.

Section 46.116 of the Common Rule enumerates eight basic elements of informed consent that every research consent form must contain: (1) a statement that the study involves research, an explanation of the purposes of the research, the expected duration of participation, and a description of the procedures to be followed; (2) a description of any reasonably foreseeable risks or discomforts; (3) a description of reasonably expected benefits to the subject or others; (4) a disclosure of alternatives to participation; (5) a statement describing the extent to which confidentiality will be maintained; (6) a statement whether compensation and medical treatment are available if injury occurs; (7) contact information for questions about the research and about participant rights; and (8) a statement that participation is voluntary and may be discontinued without penalty or loss of benefits.

Section 46.116 also lists six additional elements that must be included when applicable, including a statement that significant new findings will be communicated to participants; a statement of the approximate number of subjects enrolled in the study; and, for research involving identifiable biospecimens, a statement whether the subject's biospecimens may be used for commercial profit and whether the subject will share in commercial profits.

Institutional Review Boards (IRBs) — established under 45 CFR § 46.108 at every institution engaged in human subjects research covered by the Common Rule — must review and approve research consent forms before any participant is enrolled. IRB approval of the consent form is a prerequisite to commencing participant enrollment, and any subsequent modifications to the consent form require renewed IRB approval. Single IRBs for multi-site studies have been required for most federally funded cooperative research since January 20, 2020, under 45 CFR § 46.114(b).

A Research Consent Form is needed before enrolling any participant in human subjects research governed by the Common Rule (45 CFR Part 46), FDA regulations (21 CFR Parts 50 and 56), or institutional policy requiring IRB review.

Clinical trials of investigational drugs, biologics, and medical devices regulated by the US Food and Drug Administration (FDA) require informed consent under 21 CFR Part 50, which applies to all clinical investigations regulated by the FDA regardless of federal funding. The FDA's Guidance for IRBs, Clinical Investigators, and Sponsors (2014) and subsequent guidance documents provide detailed requirements for consent forms in FDA-regulated research, including specific language for studies involving investigational new drugs (INDs) under 21 CFR § 312.60 and investigational device exemptions (IDEs) under 21 CFR § 812.100.

Behavioral and social science research involving surveys, interviews, focus groups, or observation of human behavior requires consent forms when the research is not exempt under 45 CFR § 46.104 and when there is no IRB-approved waiver of consent under § 46.116(f). Many behavioral studies qualify for expedited IRB review under 45 CFR § 46.110, which allows review by a single experienced reviewer rather than the full IRB, but still require consent documentation.

Biospecimen and genetics research — including studies involving blood, tissue, saliva, or genetic material — requires consent forms that specifically address the storage and future use of biospecimens, the potential for re-identification of genetic data, and any incidental findings policy under 45 CFR § 46.116(b)(9). The Genetic Information Nondiscrimination Act (GINA, 42 U.S.C. § 2000ff et seq.) protects research participants from genetic discrimination in employment and health insurance, and the consent form should disclose whether the research will generate genetic information.

Pediatric research involving participants under 18 requires parental permission under 45 CFR § 46.408 and, where appropriate, assent from the child. The threshold age for assent is not specified in the regulations but is typically set by IRB policy at 7 to 12 years depending on cognitive maturity. Parental permission must be obtained from one or both parents depending on the level of risk in the study under 45 CFR § 46.408(b).

Research conducted at universities, hospitals, and research institutions with a Federalwide Assurance (FWA) on file with OHRP must comply with the Common Rule requirements for all human subjects research, regardless of federal funding, under the terms of the institution's FWA.

A complete US Research Consent Form contains the following sections required by 45 CFR § 46.116, supplemented by IRB-specific requirements and FDA requirements where applicable.

The study identification section states the title of the research study, the name and contact information of the principal investigator (PI), the name of the sponsoring institution, and the IRB protocol number under which the study has been approved. For multi-site studies using a single IRB, the reviewing IRB's name and contact information should be provided.

The introduction and voluntary participation statement confirms that the document is a research consent form (not a standard treatment consent form), that the subject has been invited to participate in research, and that participation is entirely voluntary. The statement must use the language prescribed by 45 CFR § 46.116(b)(8) confirming that refusal to participate or withdrawal at any time will involve no penalty or loss of benefits to which the subject is otherwise entitled.

The study purpose and duration section explains, in language appropriate for the target participant population (typically 6th to 8th grade reading level), why the research is being conducted, what question the researchers are trying to answer, and how long the participant's involvement will last. Federal regulations require this explanation to be distinct from the description of procedures.

The procedures description section details what will happen to the participant during the study: screening procedures, experimental interventions, study visits, sample collection, data collection methods, and any randomization or blinding procedures. For randomized controlled trials, the consent form must disclose that the participant may be assigned to a placebo or control group under 45 CFR § 46.116(b)(1).

The risks and discomforts section describes each reasonably foreseeable risk — physical, psychological, social, legal, and economic — associated with research participation. Physical risks from blood draws, biopsies, drug administration, or device use should be described specifically. Psychological risks from sensitive survey questions (trauma, substance use, mental health) and social risks from data breach or inadvertent disclosure of sensitive information should also be addressed.

The benefits section describes any direct benefits to the participant from study participation and the expected benefits to society or science. Importantly, the section must avoid overstating direct benefits in a way that constitutes undue inducement — a form of coercion under 45 CFR § 46.116 and the Belmont Report's principle of justice.

The confidentiality and data security section describes how participant data will be collected (with or without identifiers), stored (encrypted databases, secure servers), accessed (limited to research staff), and retained (retention period per funding agency and institutional policy). The section should address whether data may be shared with other researchers, the NIH, or regulatory agencies; whether a Certificate of Confidentiality has been obtained under 42 U.S.C. § 241(d); and the limitations of confidentiality (mandatory reporting laws, court orders).

The contact information section provides the PI's contact information for questions about the research, a separate contact for questions about participant rights (typically the IRB office), and an emergency contact for health-related problems arising from research participation under 45 CFR § 46.116(b)(7).

The signature block records the participant's (or legally authorized representative's) signature, the date of signing, and the researcher obtaining consent's signature. If the consent is obtained remotely (electronic consent), the form should comply with 45 CFR § 46.117(b)(2) and the FDA's 2016 guidance on electronic informed consent.