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. 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. 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: : 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?

In the given case study, the Centers for Disease Control and Prevention (CDC) funded five health departments to develop and implement programs aimed at providing HIV prevention and referral services to HIV-infected individuals. The project objectives were focused on increasing the proportion of infected persons who know their HIV serostatus, providing prevention services to reduce the risk of transmission, and assisting infected individuals in accessing needed services. While the CDC considered the program to be non-research, some participating health departments sought Institutional Review Board (IRB) oversight, leading to delays and confusion.

The potential ethical considerations in this scenario are numerous. First and foremost, the protection of human subjects is imperative. Ethical considerations include ensuring the informed consent of participants, considering the risks and benefits of participation, and actively protecting participants from harm. In this case, program recipients are HIV-infected persons, who may already be vulnerable due to their health condition. Therefore, extra caution must be taken to safeguard their rights and well-being.

One of the main risks for participants in the program is the potential breach of confidentiality. HIV infection is often stigmatized, and participants may fear discrimination or disclosure of their status. This risk highlights the need for strict confidentiality protocols to protect the privacy of program participants.

Another ethical consideration is the potential impact on participants’ behaviors, attitudes, and trust if the evaluation of the program is deemed research and informed consent is obtained. If participants perceive the program as a research study, they may be more cautious or skeptical about engaging in the program’s activities. Additionally, informed consent procedures that involve sharing personal information may further exacerbate their concerns about confidentiality. This can lead to a decrease in program participation and hinder the achievement of desired outcomes.

Conversely, labeling the evaluation as non-research may have unintended consequences as well. It may diminish the importance and rigor of the evaluation, potentially resulting in incomplete or biased data collection. Without the oversight and ethical scrutiny associated with research, there is a risk of compromising the validity and reliability of the evaluation findings. This can ultimately impact the program’s effectiveness and impede future program planning and implementation.

Moreover, by categorizing the evaluation as non-research, the opportunity to generate generalizable knowledge and lessons learned may be missed. If the evaluation is conducted with proper research oversight, the findings can contribute to the broader field of HIV prevention and inform future program development in other settings. However, if the evaluation is not seen as research, the potential for knowledge transfer is limited, and valuable insights might not be shared.

In conclusion, this case study highlights the importance of carefully discerning between research and non-research activities during program implementation and evaluation. Ethical considerations surrounding participant protection, informed consent, and confidentiality must be adequately addressed. The potential risks to participants, as well as the unintended consequences of labeling the evaluation as research or non-research, need to be thoroughly examined to ensure the ethical and effective delivery of public health interventions.