Consent and What Participants Are Told

Part of Conflict of Interest in Clinical Research: Managing and Documenting Conflicts.

About 5 minutes. Free, in your language, no account needed.

Expert review pending. CRLN wrote this lesson against the primary sources listed under References. A subject-matter expert has not yet reviewed it. Where your institution's policy or your sponsor's instructions are stricter, follow them.

Why this matters

The consent conversation is where a conflict of interest meets the participant directly. Two questions matter: what the participant is told about interests, and who does the telling. Getting either wrong can make a choice less free, even when every form is signed.

Is a conflict disclosed in the consent form?

It depends on the rules that apply and on decisions made about the specific conflict.

In the United States, the required elements of informed consent in FDA's rule (21 CFR 50.25) and in the Common Rule (45 CFR 46.116) do not list investigator financial interests. The Common Rule does include, as an additional element when appropriate, a statement that a participant's biospecimens may be used for commercial profit and whether the participant will share in it (45 CFR 46.116(c)(7)).

A conflict disclosure in consent therefore usually comes from one of these:

• a management plan: for US federally funded research, disclosure directly to participants is one of the listed management conditions (42 CFR 50.605(a)(1)(ii));
• an IRB requirement for the study or under the IRB's own policy;
• an institutional policy that requires it for certain interests.

Internationally, the Declaration of Helsinki says each potential participant must be adequately informed about, among other things, sources of funding and any potential conflicts of interest (paragraph 26). Some national laws and ethics committees follow that more closely than US federal rules do.

Whatever the source, the wording is approved by the IRB or ethics committee before use, like the rest of the consent materials. Do not add, remove or soften it on your own.

What good disclosure language does

When disclosure is required, the approved text usually says, in plain language:

• who has the interest (by role or name, as the IRB decides);
• what kind of interest it is, such as owning stock in the company, receiving consulting payments, or holding a patent that could earn money if the product is approved;
• that the interest has been reviewed and how it is being managed, for example "another doctor will check how well the treatment works";
• whom to contact with questions.

When a participant asks about it, answer honestly within the approved information and offer to have the investigator or an independent person explain further. Never brush a question aside with "it doesn't matter."

Payment information belongs in consent too

Participants' own payments are part of the same picture of influence. ICH E6(R3) says the IRB/IEC should make sure that information about payment to participants, including methods, amounts and schedule, is set out in the consent materials (Annex 1 §1.2.9), and the consent discussion covers anticipated prorated compensation and anticipated expenses (§2.8.10(j) and (k)). Make sure what you say about payment matches the approved form exactly.

Who leads the consent discussion

ICH E6(R3) says neither the investigator nor site staff should coerce or unduly influence a participant to take part or to continue (Annex 1 §2.8.3). In the United States, consent must be sought only in circumstances that minimize the possibility of coercion or undue influence (21 CFR 50.20).

A person with a conflict leading the conversation adds pressure, even unintentionally. Management plans and site practice therefore often call for independent consent: a delegated, trained team member without the interest leads the discussion. This is especially valuable when:

• the investigator has a significant financial interest in the product or sponsor;
• the investigator is also the participant's treating physician;
• the staff member is related to, supervises, or is supervised by the participant.

Independent consent is a management choice that must fit the protocol, the IRB approval and the delegation records. The person leading consent must be delegated that task and trained on the study.

Avoiding therapeutic misconception

A conflicted person may slide into talking about the study as if it were treatment. The consent discussion must cover that the trial involves research, the probability of random assignment, the reasonably expected benefits, and the alternatives (ICH E6(R3) Annex 1 §2.8.10). Plain, neutral language helps: "This is a research study. We do not know yet whether the study drug works better than the usual treatment."

In practice

A trial's consent form, approved by the IRB, states that the principal investigator owns shares in the sponsor and that a different doctor will assess the main study results. A potential participant asks the coordinator whether that means the doctor wants the drug to succeed. The coordinator explains that the interest was reviewed by the hospital and the IRB, describes the safeguard in the form, and asks whether the participant would like to speak to the independent doctor before deciding. She notes the question in the consent process record.

Key takeaways

• US federal consent elements do not require disclosure of investigator financial interests; disclosure comes from management plans, IRBs or institutional policy.
• The Declaration of Helsinki asks that potential participants be told about funding and potential conflicts.
• Disclosure wording is IRB-approved; never change it on your own.
• Independent consent by a delegated person without the interest reduces pressure.
• Use neutral language that keeps research and treatment distinct.

References

• 21 CFR 50.20 and 50.25, eCFR.
• 45 CFR 46.116, including (c)(7), eCFR.
• 42 CFR 50.605(a)(1)(ii), eCFR.
• ICH E6(R3), Step 4, 6 January 2025: Annex 1 §1.2.9, §2.8.3, §2.8.10.
• World Medical Association, Declaration of Helsinki, 2024 revision, paragraph 26.