Sample Policy for the Participation of Students and Employees in Research

I. To What Does This Policy Apply:

This policy defines the standards and parameters for the involvement of students and employees in biomedical, behavioral and social science research. This policy applies to students recruited as subjects in instructor-initiated research (includes faculty and graduate student instructors) and employees recruited for employer-initiated/sponsored research. This organization will consider such individuals as vulnerable to coercion and, therefore, will apply additional safeguards to protect their rights and welfare (45 CFR 46.111(b)).

II. Policy Statement:

This organization will ensure that all students and employees enrolled in research will be treated in a manner commensurate with their special status and that their participation in research will be ethical and in compliance with the federal regulations for the protection of human subjects, specifically 45 CFR 46.111(b).

Students and employees recruited as research subjects are vulnerable to coercion because of the possibility that they may perceive grades, employment or other benefits as dependent upon their participation in research. Investigators should be mindful of their ability to influence others when directly recruiting their own students /employees, as such individuals may feel pressure to participate because of their relationship with the investigator. It is preferable that, whenever students/employees participate in research, they approach the research team and initiate enrollment on their own behalf. In such cases, the enrollment and consent process may not be conducted by the investigator, but must be conducted by someone on the research team who is at "arm's length" to the potential subjects. Under no circumstances will an investigator's own students and/or staff be recruited as a matter of convenience sampling.

A student may not be compelled to participate in instructor-initiated research as part of a course requirement. Similarly, an employee may not be required to participate in employer-initiated research as a condition of employment. This organization will not conduct or facilitate such employer-initiated research.

Investigators recruiting students in research will:

• Make sure that subjects know that they may choose not to participate in the research and that their decision will not affect their grade/class standing.
• Limit the use of extra credit as compensation; it should not significantly increase a student's overall grade.
• Avoid using class time to recruit or engage in the research.
• Provide students with an equal alternative to participation, which should be comparable in terms of effort, time commitment and credit given.

Investigators recruiting employees in research will:

• Engage in recruitment and consent activities outside of the presence of the employee's supervisor(s).
• Make sure that subjects know that they may choose not to participate in the research and that their decision will not affect their employment or performance evaluation.
• Make sure that all data given to the employer is either in the aggregate or is stripped of all identifiers so that the employee subject's identity is protected.
• Make sure that steps are taken to avoid identifying employees who decline participation and whenever possible the research procedures should be conducted out of sight of other employees. For example, surveys or questionnaires could be given to the employee subjects to complete at home and be mailed back to the investigators instead of asking all employee subjects to convene in a room on site, which would identify them to their superiors and co-workers as well as identify those who have chosen not to participate.

DEPARTMENT: Yale University
POLICY NUMBER:
SECTION: IRB Policies for Research Affiliate Institutions
REVIEW RESPONSIBILITY: IRB Leadership and Research Collaborators
ORIGINAL CREATION DATE: April 14, 2005
REVISION DATES: April 21, 2005, August 13, 2005

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