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111.13 Organization Policy on Recruitment of Study Subjects
It is the policy of the Organization that recruitment plans for research projects will ensure appropriate selection of subjects across age, gender, and ethnicity. In order to ensure equitable selection of research participants, the Organization requires that the PI provide the characteristics of the participant population, anticipated accrual, age ranges, health status, gender, and criteria for inclusion or exclusion. The JHM IRB is authorized to review the purposes of the research, the setting of the research, and whether the population to be recruited is vulnerable to coercion or undue influence. Regulatory determinations will be made if a project proposes to recruit pregnant women (45 CFR 46 Subpart B), prisoners (45 CFR 46 Subpart C), or children (45 CFR 46 Subpart D, and 21 CFR 50 Subpart D).
The JHM IRB will assess the recruitment plan to ensure that it is compliant with federal regulations as well as Organization HIPAA Privacy Policies, the JHM IRB guidance entitled “Patient Recruitment and Referral for Research”, the JHM IRB Guidances entitled “Recruiting Study Subjects” and “Reasonable Payment (Remuneration)”, Policy No. 111.4(a) “Organization Policy on Recruitment of Employees”, and Policy No. 111.4(b) "Organization Policy on Recruitment of Students".
The JHM IRB may approve recruitment methods that are referred to as “snowball recruiting”, “respondent-driven sampling” or “peer or network recruitment.” The IRBs may place monetary or numerical limits on such recruitment methods. However, the JHM IRB prohibits payments to a non-participant in exchange for the referral of a potential participant (“finder’s fees”).
All advertising or other recruitment material must be reviewed and approved by the JHM IRB before they are used. Flyers and other advertising materials must be marked as approved by the JHM IRB before distribution or posting. Letters to potential participants must be submitted to JHM IRB for review and approval prior to mailing.
When direct advertising is to be used, the IRB must review the information contained in the advertisement and the mode of its communication. The IRB must review the final copy of printed advertisements to evaluate the relative size of type used and other visual effects. The IRB may review and approve the wording of the advertisement prior to taping to preclude re-taping because of inappropriate wording and subsequently review the final taped message prepared from IRB-approved text for final approval.
The IRBs must review advertising to assure that the advertising:
- Is not unduly coercive and does not promise a certainty of cure beyond what is outlined in the consent and the protocol.
- Makes no claims, either explicitly or implicitly, that the drug, biologic, device or other research procedures are safe or effective for the purposes under investigation, or that the test article or other research procedures are known to be equivalent or superior to any other drug, biologic, device, or procedure.
- Does not use terms such as "new treatment," "new medication" or "new drug" without explaining that the test article or the research procedures are investigational or experimental.
- Does not promise "free medical treatment," when the intent is only to say subjects will not be charged for taking part in the investigation.
- Does not emphasize the payment or the amount to be paid, by such means as larger or bold type, although it may state that subjects will be paid.
Advertisement to recruit subjects should be limited to the information the prospective subjects need to determine their eligibility and interest. When appropriately worded, the following items may be included in advertisements.
- The name and address of the clinical investigator and/or research facility
- The condition under study and/or the purpose of the research
- In summary form, the criteria that will be used to determine eligibility for the study
- A brief list of participation benefits, if any (e.g., a no-cost health examination)
- The time or other commitment required of the subjects
- The location of the research and the person or office to contact for further information.