Recruitment

1. Recruitment Activities as Part of Informed Consent: Consider recruitment activities as part of the informed consent process.
2. IRB Approval: Do not start recruiting subjects before you get IRB approval of the research protocol.
3. Use of NIH Logo: Make sure any use of the NIH logo is allowed and follows NIH policies.
4. Third-Party Vendor Usage: If you plan to use a third-party vendor for recruiting, describe this in your protocol.
5. Finder's Fees Prohibition: NIH investigators, or their supporting Institute or Center (IC), cannot provide or receive finder's fees (payment for referrals of prospective research subjects, sometimes called "recruitment incentives") from any source for research conducted by the NIH.

The recruitment plan is a section in your protocol which describes the “who, what, where, when and how” details of your planned recruitment process. In your plan:

• Clearly describe the recruitment plan in the protocol, including intended populations/cohorts and recruitment methods.
• Ensure the recruitment plan reflects the populations that have the disease or condition under study.
  • Ensure you are not unfairly targeting or excluding a specific population
• Verify that recruitment materials directed at prospective subjects only include the information needed to determine subject eligibility and interest in participation.

The following information should be included in any recruitment material that you develop:

• Research title or identifier
• Identify that the study is a research study (must include the word “research”)
• Purpose of the study
• Summary of eligibility criteria
• What is involved (e.g., study duration and location, number of visits, procedures and, if applicable, research intervention(s))
• If compensation will be provided
• Name of the investigator and their NIH IC affiliation
• Who to contact for more information
• Technical specifications: NIH/IC logo unless prohibited by 3rd party; footer with protocol #, version and date; and pagination, if applicable
• If applicable, brief lists of significant risks and possible benefits as well as compensation information

If your protocol is FDA regulated, in addition to the above, any recruitment materials must meet these requirements:

• State that the test article (drug, biologic, or device) being studied is investigational.
• Do not claim, either explicitly or implicitly, that the test article is safe or effective.
• Do not claim that the test article is known to be equivalent or superior to any other drug, biologic, or device.
• Do not promise "free medical treatment or care" if you only intend to inform subjects that they will not be charged for participating in the study.

For more information, refer to the FDA information sheet, Recruiting Study Subjects - Guidance for Institutional Review Boards and Clinical Investigators.

Direct Recruitment:

• You can discuss the study directly with your own patients.
• It's better for a knowledgeable investigator from the study team, who isn't directly providing care to the patient, to contact the potential subject. This helps avoid any undue influence or pressure from the physician-patient relationship.

Recruitment Letters:

• Communications sent to prospective subjects should clearly indicate how you identified the individual.
• Include detailed information about the study and provide contact details for someone who can give more information.

Referrals:

• Potential subjects can directly contact the NIH investigator (self-referral).
• Clinicians not involved in the research can inform prospective subjects about the availability of the research and give their patients IRB-approved recruitment materials or letters.
• Clinicians not part of the study team cannot answer detailed questions about the study or obtain informed consent from potential subjects. These responsibilities belong to the study investigators or authorized study team members.
• With the patient's authorization, clinicians can share the patient's contact information and relevant health data with investigators, allowing investigators to reach out directly.

Websites:

• IRB review and approval are not required for clinical trial website postings that provide only basic descriptive information. However, if the information includes more than basic descriptive information, IRB review and approval are required.
• Before creating a website, submit a mockup of the proposed website for prospective IRB review.
• According to OHRP guidance, if the website collects identifiable private information, the IRB should review the plans for protecting the confidentiality of this information.
• The website must clearly explain how identifiable private information might be used to ensure transparency and protect subject confidentiality.

Submit all recruitment materials to the reviewing IRB via the electronic IRB system for review and approval, either at the time of initial submission or as a modification if new materials are added. This includes any type of material that you develop, such as flyers, advertisements, some website postings, letters, emails, social media posts, and scripts for television or radio ad.

FDA Information Sheet: Screening Tests Prior to Study Enrollment

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