Recruitment Materials, Payments and Conflicts of Interest

Part of Human Subjects Protection for Clinical Research Staff: Doing It Right at Your Site.

About 4 minutes. Free, in your language, no account needed.

Why this matters

Three parts of site work shape whether a person's choice to join is really free: how the study is advertised, how participants are paid, and whether anyone at the site has a stake in the outcome. Each can quietly push a person toward a yes. The IRB reviews the first two, and you will touch all three.

ICH E6(R3) is the international baseline in this course. The US federal regulations (HHS 45 CFR 46, FDA 21 CFR 50 and 56) are taught as the detailed worked example, and passages that name them are US law. Outside the United States, follow your national law and ethics committee requirements. State or local rules may add requirements.

A plain statement about recruitment

This section is education only. Recruitment materials need IRB approval before use. CRLN never recruits, matches or refers patients. This course teaches what the rules say about approval of recruitment materials so site staff know the steps. It is not a recruiting tool.

Recruitment materials need IRB approval first

The IRB/IEC reviews advertisements and information on the recruitment process (ICH E6(R3) section 1.2.2(e)). The investigator must have documented IRB/IEC approval of recruitment procedures, for example advertisements, before initiating a trial (section 2.4.2).

So a flyer, a social media post, a letter or a script used to approach people is not yours to publish because it looks accurate. The approved version is the one you use. If wording needs to change, the change goes through the IRB first. A good habit is to keep the approved copy and approval date on file next to each item in use.

Payment and the IRB

The IRB/IEC reviews both the amount and the method of payment to ensure that neither presents coercion or undue influence (sections 1.2.8, 1.2.9). Payments should be timely, prorated and not wholly contingent on completion. Reasonable reimbursement of expenses such as travel and lodging is not coercive. The payment information is set out in the consent materials.

Consent content is part of the picture. ICH E6(R3) lists anticipated prorated compensation, anticipated expenses, and compensation or treatment for trial-related injury (section 2.8.10(i) to (k)). The Common Rule requires, for research with more than minimal risk, an explanation of whether compensation and medical treatments are available if injury occurs, and it lists additional costs to the subject as an additional element (45 CFR 46.116(b)(6), (c)(3)).

At your site, that means the payment you describe must match the payment in the consent. A participant should never learn about a payment rule only from a hallway comment.

Conflicts of interest

No IRB member participates in the review of a project in which the member has a conflicting interest, except to provide information requested (45 CFR 46.107(d); 21 CFR 56.107(e)). The investigator and site staff do not take part in the IRB's decision or vote (ICH E6(R3) section 1.3.5).

At the site, a conflict can look like many things: a financial stake in the sponsor, a role in the product's development, or a personal tie to participants. This course does not describe any federal financial disclosure rule. A good habit is to follow your institution's and sponsor's disclosure procedures, to disclose early, and to ask when unsure.

In practice

A coordinator wants to post a short notice about an upcoming study. She does not write it herself and put it up. She sends the investigator's draft to the IRB office and waits for approval of that exact wording before it is used. She checks the payment line against the consent form so the amounts and timing match. The investigator, who owns shares in the sponsor's parent company, tells the institution's conflict office before enrollment begins and follows the instructions it gives.

What this looks like when it goes wrong

A site posts an eye-catching flyer that promises "$500 for completing the study." The IRB-approved consent says payment is prorated per visit. A participant leaves after two visits and is surprised to be paid only part of the amount. The flyer had not been through the IRB, its wording did not match the consent, and the promise of a large amount at the end made leaving feel costly. The site now has a complaint and has to show the IRB the flyer that was used.

Key takeaways