Recruitment

Before beginning recruitment:

• Obtain IRB approval for your protocol, recruitment plan, and recruitment materials.
• Design recruitment activities that are fair and equitable.
• Minimize coercion and undue influence, particularly for vulnerable populations.
• Protect the privacy and confidentiality of potential participants.
• NIH investigators may not provide or receive finder's fees (payments for referrals).
• Describe the use of any third-party recruitment vendors in your protocol.

The recruitment plan is the section of your protocol that describes the who, what, where, when, and how of your recruitment activities.

Your recruitment plan should:

• Identify the population you intend to recruit and explain why it is appropriate for the study.
• Describe who will conduct recruitment.
• Explain how potential participants will be identified and contacted.
• Describe where recruitment will occur (for example, clinics, community settings, websites, or social media).
• Explain when and how potential participants will be approached.

The recruitment plan should support the scientific objectives of the study while ensuring that no population is unfairly targeted or excluded.

When planning recruitment:

• The individual contacting potential participants should be knowledgeable about the study and able to answer questions or refer participants to someone who can.
• Avoid cold-calling individuals based on private information unless specifically justified and approved.
• Protect privacy when recruiting family members by using IRB-approved recruitment methods. Passive approaches, where participants voluntarily share information with family members, are generally preferred.
• Consider language, literacy, cultural, and social factors that may affect recruitment of diverse populations.

Recruitment activities are considered part of the informed consent process and should support voluntary, informed decision-making.

Recruitment methods vary depending on the study population and setting.

Direct Recruitment

Investigators may discuss research opportunities with their own patients. Whenever feasible, someone other than the treating clinician should introduce the study to minimize the possibility of undue influence.

Referrals

Clinicians who are not members of the study team may inform patients about a study and provide IRB-approved recruitment materials. Interested individuals should contact the study team directly.

With the participant's authorization, clinicians may share contact information with the study team so investigators can contact the individual directly.

Recruitment Letters

Recruitment letters should explain:

• How the individual was identified
• Why they may be eligible
• How to obtain additional information about the study

Websites and Social Media

Recruitment websites and social media should be described in the protocol.

Public websites that provide only basic descriptive information about a study (such as ClinicalTrials.gov) do not require IRB review. Websites or social media that actively recruit participants or include information beyond basic study facts generally require IRB review before use.

Medical Record Review

Medical records may be reviewed to identify potential participants when described in the protocol and conducted in accordance with applicable privacy requirements.

Recruitment materials include anything that potential participants may see or hear about the study.

Examples include:

• Flyers, posters, and brochures
• Print, radio, television, and social media advertisements
• Emails and recruitment letters
• Telephone or in-person recruitment scripts
• Videos
• Public service announcements
• Presentations used to recruit participants
• Third-party recruitment platforms

If you are unsure whether recruitment material requires IRB review, contact the IRB Office before using it.

Recruitment materials should be:

• Clear and easy to understand
• Accurate and consistent with the protocol
• Balanced and not misleading
• Appropriate for the intended audience

They should provide enough information for someone to decide whether they are interested in learning more, but should not replace the informed consent process.

Recruitment materials generally should include:

• Study title or identifier
• A statement that the activity involves research
• The purpose of the study
• Basic eligibility criteria
• What participation involves
• Study location
• Principal Investigator name and NIH Institute or Center
• Contact information

When appropriate, they should also include compensation information and a brief description of important risks or potential benefits.

Recruitment materials should not:

• Promise or imply guaranteed benefits.
• Suggest that an investigational product is safe or effective.
• Emphasize payment as a benefit of participation.
• Use the word ‘free’ as in ‘free treatment’
• Use catchy/persuasive hooks like ‘exciting opportunity’
• Include language that waives or appears to waive participant rights.

Recruitment materials for FDA-regulated studies must also:

• Identify investigational drugs, biologics, or devices as investigational.
• Avoid statements suggesting the investigational product is safe, effective, or superior to available treatments.
• Avoid misleading statements regarding free medical care when only study-related procedures are provided without charge.

If recruitment materials include QR codes:

• Follow applicable NIH social media policies.
• Link QR codes to ClinicalTrials.gov or another IRB-approved study webpage.
• If the webpage is not available at the time of IRB submission, provide screenshots or other representative content for IRB review.

When using medical records, registries, or databases to identify potential participants:

• Limit access to information necessary for recruitment.
• Protect participant privacy and confidentiality.
• Follow applicable Privacy Act, HIPAA and Common Rule requirements.

When working with external HIPAA-covered institutions, authorization or Privacy Board approval may be required before information is shared with NIH investigators.

Screening is part of the recruitment process and should be described in your protocol.

For additional guidance on screening activities and informed consent requirements, see:

Recruitment should be planned carefully, described clearly in your protocol, and approved by the IRB before recruitment begins. Recruitment activities and materials should be fair, respectful, scientifically appropriate, and designed to protect participant privacy while minimizing coercion and undue influence.

If you have questions about recruitment strategies, recruitment materials, or screening procedures, contact OHSRP before submitting your protocol.

FDA Information Sheet: Screening Tests Prior to Study Enrollment

FDA Information Sheet: Recruiting Study Subjects: Guidance for Institutional Review Boards and Clinical Investigators

OHRP: Guidance on Institutional Review Board Review of Clinical Trial Websites