Ethical Considerations.

  Last week, you explored practice problems at the local level. This week, we’ll take that knowledge a step further—you’ll have the opportunity to examine the protection of individuals who volunteer to participate in research studies. What ethical principles are researchers held to as they design a sampling plan that includes recruitment, informed consent, and protection of human subjects throughout the duration of the study, including the dissemination of research study findings? Why is a researcher’s ethical responsibility to human subjects relevant to your exploration of a practice problem? The Office for Human Research Protections (OHRP) provides leadership in the protection of the rights, welfare, and wellbeing of human subjects involved in research conducted or supported by the U.S. Department of Health and Human Services (HHS).  I’m sure you’re ready to find answers to these questions, so let’s get started! 

Translation of a research-based intervention to practice involves a critical review of numerous published research studies to discern if individuals – research subjects – were treated according to the ethical values and principles as defined by the Code of Federal Regulations (CFR). Reflect upon your selected practice problem (lung cancer) and the eventual research-based intervention you select for your practice change project and address the following.

• What are the potential benefits and harms related to your selected practice problem(lung cancer) when considering a research-based intervention for your practice change project?
• Are there competing personal or professional values related to this research-based intervention that might impact the implementation of this intervention in your practice setting?
• What types of objections might be raised? How will you explain your decision to key stakeholders to address these objections?  
• Utilize ethical considerations and theories relevant to translation science.    

Instructions:

Use an APA style and a minimum of 200 words. Provide support from a minimum of at least three (3) scholarly sources. The scholarly source needs to be: 1) evidence-based, 2) scholarly in nature, 3) Sources should be no more than five years old (published within the last 5 years), and 4) an in-text citation. citations and references are included when information is summarized/synthesized and/or direct quotes are used, in which APA style standards apply. 

• Textbooks are not considered scholarly sources. 

• Wikipedia, Wikis, .com website, or blogs should not be used.

*Resources available to support your learning and work in our discussions this week are:

https://www.hhs.gov/ohrp/regulations-and-policy/regulations/common-rule/index.html 

http://www.ihi.org/education/IHIOpenSchool/resources/Pages/Activities/Bates-Reducing-Harm-Important-To-Patient-Safety.aspx

https://www.govinfo.gov/content/pkg/CFR-2016-title45-vol1/pdf/CFR-2016-title45-vol1-part46.pdf

https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/index.html

 U.S. Department of health and Human Services. (2017, October 25). The Belmont report: Basic ethical principles and their application [Video]. YouTube. https://www.youtube.com/watch?v=M6AKIIhoFn4&feature=youtu.be 

Resnik, D. B. (2020, August 25). National Institute of Environmental Health Sciences: Research ethics timeline (1932-Present). https://www.niehs.nih.gov/research/resources/bioethics/timeline/index.cfm (Links to an external site.)
 

Centers for Disease Control and Prevention. (2016). U.S. public health service syphilis study at Tuskegee. http://www.cdc.gov/tuskegee/timeline.ht

Dang, D., & Dearholt, S. (2018). Johns Hopkins nursing evidence-based practice model and guidelines (3rd ed.). Sigma Theta Tau International.

U.S. Department of Health & Human Services. (n.d.). Human subjects research. http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html

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