Week 3: Health-Related Research and Regulations How do you balance the need to advance health-related research to cure disease with the requirement to protect the patient and “do no harm”? This is the challenge at the root of all advances in health. Health researchers who are exploring new cutting-edge therapeutic procedures, developing medications, and engineering advanced medical devices are constantly working on this delicate balance. In Week 2, you were introduced to the doctrine of informed consent and the role that it plays in allowing professionals to ethically and legally treat patients. This week, you will expand on that information and consider the critically important role that informed consent plays in health-related research. You will also continue to explore how decisions are made concerning who will receive scarce and expensive medical care. Learning Objectives Students will: Analyze the components of informed consent Identify key terms and concepts related to privacy, confidentiality, and liability Identify key ethical and legal terms associated with health-related research, regulation, and the allocation of scarce healthcare resources Learning Resources Required Readings Judson, K., & Harrison, C. (2019). Law and ethics for the health professions (8th ed.). New York: McGraw-Hill. Chapter 13, “Health Care Trends and Forecasts, (pp. 342-374) American Medical Association. (n.d.). Informed consent. Retrieved September 5, 2018 from https://www.ama-assn.org/delivering-care/informed-consent National Institutes of Health. (2018). Patient recruitment: Ethics in clinical research. Retrieved from https://clinicalcenter.nih.gov/recruit/ethics.html Scheunemann, L. P. & White, D. B. (2011). The ethics and reality of rationing in medicine. Chest. 140(6), 1625 1632. doi: 10.1378/chest.11-0622 Shamoo, A. E. (2016). U.S. military medical ethics guidelines in limbo. Retrieved from https://www.thehastingscenter.org/u-s-military-medical-ethics-guidelines-in-limbo/ National Institutes of Health. (n.d.). Medical research with animals (NIH Publication Number 08-6436). Retrieved September 5, 2018, from http://grants.nih.gov/grants/policy/air/AnimalResearchFS06.pdf Document: Week 3 Discussion Scenarios (PDF) Required Media Laureate Education. (n.d.). Virtual philosopher. [Interactive Media]. Baltimore, MD: Author. This interactive media activity asks a series of question to determine your beliefs, then gives you various situations that test your personal ethics. Optional Resources U.S. Department of Health and Human Services, Office for Human Research Protections. (2016). The Belmont report: Ethical principles and guidelines for the protection of human subjects of research. Retrieved from https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/index.html Read the full text of the Belmont Report and watch the accompanying video Discussion: Informed Consent in Practice and Research To prepare for this Discussion: Review this week’s Learning Resources, paying particular attention to the AMA article Informed Consent and Chapter 7 in the Judson and Harrison textbook. Download the Week 3 Discussion Scenarios (located in the Learning Resources). Choose two scenarios for your Discussion. By Day 4 Post a comprehensive response to the following: For each scenario, decide if informed consent was obtained properly. If it was, then explain why you think it was. Be specific. If it was not, then explain wherein the informed consent process a procedure was not followed. Be specific. For each scenario, explain how you would improve the informed consent process to make sure consent to treat a patient is obtained correctly. Be specific and provide examples. Imagine yourself as a health provider (like the providers in the scenarios). What would you do to make sure that informed consent to treat is always done correctly? Note: Initial postings must be 250-350 words (not including references). Support your Discussion and peer responses with in-text citations and references from specific Learning Resources. Read a selection of your colleagues’ postings. By Day 6 Respond to at least two of your colleagues’ by addressing the following: Expand further on why informed consent was or was not properly obtained in the scenario and offer additional recommendations for obtaining proper informed consent. Offer additional recommendations for providers to ensure that proper informed consent is obtained in all circumstances. In addition, you may also respond as follows (optional): Offer and support an opinion Validate an idea with your own experience Make a suggestion or comment that guides or facilitates the discussion Submission and Grading Information Grading Criteria To access your rubric: Week 3 Discussion Rubric Post by Day 4 and Respond by Day 6 To participate in this Discussion: Week 3 Discussion
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