Overview: All students will read the following HPE case study related to discerning between research and non-research during program implementation.

Overview: All students will read the following HPE case study related to discerning between research and non-research during program implementation. There are many blurred lines between research and evaluation, so careful consideration of research and non-research activity is essential to ensure ethical practices are carried out at the onset of the program implementation and evaluation process.

Case Study: The CDC funded 5 health departments to develop programs to provide HIV prevention and referral services to HIV-infected persons. The project objectives included increasing the proportion of HIV-infected persons who know their HIV serostatus as early as possible after infection, providing HIV prevention services to infected persons to reduce the risk of transmission to others, and assisting HIV-infected persons in accessing medical and other needed services. Grantees were encouraged to tailor their interventions to local circumstances, and the funding supported local evaluations of the effectiveness of the interventions in each site.

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The grantees provided an array of services to a mix of target populations based on their location. The CDC’s perspective was that the primary intent of the program was to provide services targeted to local community needs, and the primary intent of the evaluations was to improve those services. Thus, the project was deemed to represent non-research by the CDC. However, it was anticipated that, as a secondary benefit, the projects also would provide information—or lessons learned—that might be useful elsewhere.

Although the CDC did not consider the evaluation component of the program to constitute research, some participating health departments differed in this assessment and sought institutional review board (IRB) oversight. At sites where local IRB review was invoked, implementation was delayed up to 1 year. Confusion over whether the program constituted human subjects research resulted in the loss of formative pilot data at 1 site when a local IRB determined that appropriate approvals were not in place. Also read: HIV Rates in Black Men

Assignment: After reading the case study, write a discussion that addresses the following:

· What are the potential ethical considerations in this scenario? What are the main risks for participants in the program?

· Explain the unintended consequences that may occur from the participants’ perspective if the evaluation of the program is deemed research and informed consent is obtained? How might this change impact the participants’ behaviors, attitudes, and/or trust in the program?

· What are the unintended consequences of labeling this evaluation as non-research? How might this impact the program or future programming?

· Which entity was correct in their assessment of the evaluation’s research status (i.e. was this research or non-research)?

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