Re: Topic 2 DQ 2
To provide a balance between respect for persons, potential benefits and burdens of the research, and justice, proper adherence to research guidelines and regulations should be performed. In 1976, a conference was held by the National Commission for the Protection of Human Subjects in Biomedical and Behavioral Research at the Smithsonian’s Belmont Conference Center. This was the start of the development of the Belmont Report that emphasizes the fundamental principles of research along with the Nuremberg Code of 1947 and the Helsinki Declaration of 1964 (Tappen, 2016). Another way to balance principles, the study must be approved by a hospital based institutional review board (IRB) and before it is approved, the IRB may ask for it to be revised and can even be rejected. IRBs vary across research and healthcare institutions therefore requirements vary. Some commonly requested information for IRBs to request in their applications include conflicts of interest, investigational drugs, environmental concerns, participant safety, and data monitoring (Tappen, 2016).
To balance respect for persons in my study It would be helpful to use various modalities for participant education and informed consent in addition to offering all material in the participant’s language of choice (Tappen, 2016). Providing various forms of the educational material about the study prior to the official informed consent helps improve comprehension to ensure participants are positioned to optimally understand the components of the study and informed consent (Lindsley, 2019). While providing educational material and answering any participant questions I would also deliver the information in a simple, objective, thorough, and truthful manner (Tappen, 2016).
To balance justice within the study, I would create clear inclusion and exclusion criteria for participants based upon the objectives of the study (The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 1979).
To balance the benefits and burdens of research, I would first do as much research as I could to determine the consequences or potential risks/harms of research on participants through evaluating previous studies and other factual resources (The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 1979). Study design would then attempt to minimize the known risks to participants. I would also obtain IRB approval to ensure the study benefits justify the potential risks from an unbiased perspective (Tappen, 2016).
Lindsley, K. A. (2019). Improving quality of the informed consent process: Developing an easy-to-read, multimodal, patient-centered format in a real-world setting. Patient Education and Counseling, 102(5), 944–951. https://doi.org/10.1016/j.pec.2018.12.022
National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. (1979). The Belmont report: Ethical principles and guidelines for the protection of human subjects of research. Retrieved from http://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/
Tappen, R. M. (2016). Advanced nursing research from theory to practice. Jones & Bartlett Learning.