Subject 'Pools' for Future Research Recruitment A subject pool is, in a sense, a form of "Data Repository," though for a different purpose. Some subject pools only contain contact information, while others are a complex hybrid of recruitment and data repository. As such, some recruitment subject pools require HRPP or IRB review, while others do not. Please refer to the "Bank or Repository (of Data or Samples)" Special Topic for detailed information. It is important to remember that participation in research is voluntary, including participation in a subject pool.42 When setting up the subject pool, please ensure that you clearly communicate to participants, such as in a 'Subject Pool consent' document, that inclusion in the subject pool does not require participation in future projects. Please also note that in the management of a student subject pool, imposing penalty credits on students who fail to show up for scheduled appointments with investigators without cancelling by a specified deadline violates the requirement of Department of Health and Human Services (HHS) regulations at 45 CFR part 46.116(a)(8). Regardless of the management system being used, including commercial web-based systems such as SONA SYSTEMS' Experiment Management System, please ensure that it is configured so as to not use a penalty function. Additional requirements can be found in OHRP Correspondences (from January 8, 2010 and January 11, 2010). In the same vein, students cannot be required to be a subject in a research study in order to pass a course. Any course that offers credit for research participation must offer an alternative method for students to learn and obtain credit without being a subject in a research study. The alternative to participation must also be comparable to the research (in time, effort, etc.), so that students are not unduly influenced to be a subject in a research study. Finally, a subject pool that includes any information about students may also require compliance with the Family Educational Rights and Privacy Act (FERPA) regulations. Please see the Special Topic titled, "Research Involving Students - FERPA and PPRA" for detailed information. References: http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html http://www.hhs.gov/ohrp/policy/Correspondence/sonasystems20100108letter.html http://www.hhs.gov/ohrp/policy/Correspondence/ohrp20100108.html

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The Belmont Report states that respect for persons demands that subjects enter into the research voluntarily and with adequate information. The federal regulations at 45 CFR 46.116(a)(8) state that participation in research must be voluntary and refusal to participate must involve no penalty or loss of benefits to which the subject is otherwise entitled.

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