VCOM Institutional Policy and Procedure Manual

VCOM Policy and Procedure

Policy #R004

the information is not misleading to subjects. Any advertisement to recruit subjects should state clearly that the project is human subjects research and must include: • The name and contact information of the investigator; • The purpose of the research, and, in summary form, the eligibility criteria that will be used to admit subjects into the study; • A straightforward and truthful description of the incentives to the subject for participation in the study (e.g., payment); • The location of the research and the person to contact for further information; and • For flyers, an indication that the advertisement and the study described therein have been reviewed by the appropriate IRB. If a study involves investigational drugs or devices, no claims should be made, either explicitly or implicitly, that the drug or device is safe or effective for the purposes under investigation, or that the drug or device is in any way equivalent or superior to any other drug or device. Such representation would not only be misleading to subjects but would also violate FDA regulations concerning the promotion of investigational drugs and investigational devices. The FDA specifically discourages the use of terms such as “new treatment”, “new medication” or “new drug” without explaining that the test article is investigational and that its effectiveness has not been proven. 16.2. Direct Solicitation Generally, researchers at VCOM may not solicit by direct appeal to students, employees or trainees in that researcher’s department or class in an effort to recruit subjects for a study. Such direct solicitation (which should be distinguished from the dissemination of information) takes place within a power dynamic that could be construed as coercive by the potential subjects being solicited. The IRB should evaluate the proposed method of recruitment as it would be applied to students, employees or trainees to make sure that recruitment materials are not presented in a manner that could suggest that their decision regarding research participation could have an effect on their relationship with instructors, mentors or employers (see Section 17. Vulnerable Subjects). The use of email or campus mail to distribute “Dear Colleague” letters intended to solicit the help of professional peers in recruiting subjects should be reviewed by the IRB and will be considered on a case-by-case basis. Direct solicitation or surveying of employees or students must first obtain administrative approvals prior to the submission of an IRB application package. See also VCOM PolicyU023: VCOM Policy on Solicitations, Surveys, and the Use of College Outcomes. 16.3. Payments to Research Subjects Subjects may be paid for their participation in research. However, the IRB should review the amount and type of payment and the proposed method of disbursement in the context of the proposed subject population to assess that undue influence is avoided. Rewards such as course credit or goods with local monetary value should be considered to be forms of payment to study participants. Problems with undue influence might occur, for example, if the entire payment were to be contingent upon completion of a longitudinal study or if the payment were unusually large. The

VCOM Institutional Review Board Policies and Procedures

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