IX. ADVERTISING, SOLICITING FOR AND SELECTING STUDY SUBJECTS
9.1 Advertising
Advertisements used to recruit study subjects are an extension of the informed consent and subject selection process. As part of its responsibility for assuring equitable selection of research subjects, all advertisements will be submitted to the IRB for review and action. Generally, any advertisement for subject recruitment, written or verbal, should be limited to:
- Name and address of Principal Investigator
- Purpose of the research and a summary of eligibility criteria that will be used to admit subjects into the study.
- An Honest and direct description of the benefits (i.e. payments for participation, study related medication and/or diagnostic evaluations and/or office visits at no charge.)
- Location of research, name of contact person and phone number for additional information.
No claims should be made or implied that the drug, device or procedure is safe or effective for the purposes under investigation, or that the drug, device or procedure is in any way equivalent or superior to any other drug, device or procedure. Misleading representations are a violation of FDA regulations concerning the promotion of investigational drugs (21 CFR 312.7 (a) and 21 CFR 812.7 (d)).
9.2 Medical Records
Researchers shall at all times respect the confidentiality of patient medical records and shall not review or cause others to review medical records or disclose the contents as a means of identifying potential subjects without appropriate prior consent from the affected patient or an IRB waiver. Principal Investigators are responsible for review and reason for reviewing the medical record.
9.3 Coercion
Researchers must at all times avoid any behavior that may be interpreted as coercive of the potential subject or as a result of undue influence. Potential subjects must be assured that refusal to participate in research will not affect their care or deny them access to non-experimental treatment.
9.4 Compensation
Compensating subjects for participating in research includes cash payments, free health care products or services, or other benefits. Where compensation is being offered to potential subjects, the terms and amount of compensation offered must not be so great or structured in such a way that the compensation may be considered coercive of the subject or where it biases the selection of subjects.
9.5 Reasonable Amount
9.5.1 Payments
Payments made to subjects for their participation in research shall be limited to a reasonable and fair amount that is related to the expenses or harms incurred by the subject. This can include reimbursement for travel expenses, lost wages, inconvenience caused to their life style, pain caused or other disabilities caused by the study.
9.5.2 Pro-Rata System
Payments shall be given within reasonable period of time from when the services of the subject are used. In the event of research that takes place over a period of time, payments will be pro-rated and delivered over time and not withheld until the completion of the subject's participation. If a completion bonus is offered for patients completing the full protocol, it will be limited to a reasonable amount to avoid the possibility of coercing the patient to continue. Subjects shall not be financially penalized for withdrawing form research
9.6 Non-Exploitation of the Poor
In any protocol involving payment, the IRB must consider whether or not the payment will tend to target the poor or disadvantaged in the community who might be compelled to participate in order to earn the compensation offered.
9.7 Women and Minority Subjects
Researchers are expected to enroll women and members of minority groups and their subpopulations must be in all research projects involving human subjects, unless a clear and compelling rationale and justification establishes to the satisfaction of the IRB that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research.
The inclusion of women and members of minority groups and their subpopulations must be addressed in developing a research design appropriate to the scientific objectives of the study. The research plan should describe the composition of the proposed study population in terms of sex/gender and racial/ethnic group, and provide a rationale for selection of such subjects. Such a plan should contain a description of the proposed outreach programs for recruiting women and minorities as participants. (NIH Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research, 8/1/2002)
