Historical background of human subjects’ protection
Nuremberg Military Tribunal developed the Nuremberg code in response to atrocities caused by Nazi researchers during World War II (IOM, 2022). Nuremberg code contains ten principles for any research involving humans, including mandatory, voluntary consent. Also, the U.S prohibited the involvement of vulnerable populations or special populations in research studies.
In 1966, the Public Health Service (PHS) policy in the U.S mandated investigators to always and independently review the research to protect the study subjects from harm that may arise (IOM, 2022). Later, the National Institute of Health (NIH) created the Office for Protection from Research Risks (OPRR) to protect the subjects in studies conducted by the Department of Health and Human Services (DHHS). Furthermore, in 1979, National Commission developed and published The Belmont Report identifying three ethical practices when conducting research, including justice, respect, and beneficence.
The historical incident of human subject abuse in research
Nazi medical workers forced prisoners into participating in the studies with no consent for the procedures (IOM, 2022). The inmates were involved in research designed to assist the military in developing weapons, combat situations, recovery techniques for those injured, and advancing their racial ideology.
Steps to minimize risks of the human subject in research
Firstly, I should be clear by the relevant bodies before conducting the research. Also, I will obtain consent from the subjects and fully explain to them about the study and all possible procedures to make them understand and voluntarily participate in the study. Finally, I will apply the ethical principles of conducting research, including respect, justice, beneficence, etc. to protect the study participants from harm or danger.
A vulnerable populations are ethnic or racial minorities, underinsured, socioeconomically disadvantaged, children, elderly, and those with certain medical conditions (Waisel, 2022). They are vulnerable because they can be easly exploited and their rights violated.
Appropriate ways to recruit subjects in research
The first strategy is to identify factors that would motivate study subjects to enter into the studies. Followed by providing enough written and oral information about the research (Thoma et al., 2022). Also, the study participants should be educated and well informed before asking for their consent. Finally, the researcher should take enough time to respond to questions raised by the study subjects
In obtaining consent, the researcher should fully explain the study to participants and give them the opportunity to ask questions (UCI, 2022). After the verbal explanation, the potential study participant should be given a study information sheet and afforded enough time to determine if they will participate. The investigator should be ready and able to answer questions about the research. For written consent, the investigator should obtain a written agreement, while for oral consent, the researcher gets a verbal agreement to participate or decline the study.
Elements of A Properly Executed Consent and Committee responsible for protecting rights of study subjects
A properly executed consent should have the following features, it should be voluntary, disclose information and allow the subjects to make decisions (Shah et al., 2022). The Institutional Review Board (IRB) was established to safe guard the rights and welfare of of human subjects in research.a
IOM. (2022). Introduction, Background, and Definitions. Ncbi.nlm.nih.gov. Retrieved 23 May 2022, from https://www.ncbi.nlm.nih.gov/books/NBK43592/.
Shah, P., Thornton, I., Turrin, D., & Hipskind, J. (2022). Informed Consent. Ncbi.nlm.nih.gov. Retrieved 23 May 2022, from https://www.ncbi.nlm.nih.gov/books/NBK430827/#:~:text=Valid%20informed%20consent%20for%20research,voluntary%20nature%20of%20the%20decision.
Thoma, A., Farrokhyar, F., McKnight, L., & Bhandari, M. (2022). How to optimize patient recruitment. PubMed Central (PMC). Retrieved 23 May 2022, from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2878987/.
UCI. (2022). Informed Consent – UCI Office of Research. UCI Office of Research. Retrieved 23 May 2022, from https://research.uci.edu/human-research-protections/research-subjects/informed-consent/.
Waisel, D. (2022). Vulnerable populations in healthcare. Retrieved 23 May 2022, from. https://pubmed.ncbi.nlm.nih.gov/23385323/#:~:text=Vulnerable%20populations%20include%20patients%20who,exacerbated%20by%20unnecessarily%20inadequate%20healthcare.
- Based on the “Case Study: Healing and Autonomy” and other required topic study materials, you will complete the “Applying the Four Principles: Case Study” document that includes the following
- German case study Irish case study
- African-American case study #2 Appalachian case study #1
- Case Study 1 Follow The Instructions Below Case Study 1
- Case Study: A System Approach Review The Case Study In The Article, Texas Health Harris Methodist-Cleburne: A System Approach To Surgical Improvement
- Chinese case study #1 Japanese case study
- Discussion About A Case Study . Case Study Attached Two References APA Format
- You will complete Part 1 of a case-study activity that you will continue to address next week. The case study is a true-to-life example of an ethical dilemma related to patient right to refuse care. It will provide you with an opportunity to practice application of selected decision-making models for identification and resolution of dilemma.
- You will complete Part 1 of a case-study activity that you will continue to address next week. The case study is a true-to-life example of an ethical dilemma related to patient right to refuse care.
- Review the Episodic note case study your instructor provides you for this week’s Assignment. Please see the “Course Announcements” section of the classroom for your Episodic note case study.
- Assess three families using the “Heritage Assessment Tool.” In 1,000-1,500 words discuss the usefulness of applying a heritage assessment to evaluate the needs of families and develop plans for health maintenance, health protection, and health restoration.
- How would you decide the best way to honor a patient’s autonomy in a nursing home and what will you decide?
- ETHICS:Follow both of the following links and read the brief articles. In the first article: General Motors Misled Grieving Families on a Lethal Flaw, identify the key ethical issues and the accountability issues from an OD point of view. In the second article: As Mary Barra Returns To D.C., Can GM’s Culture Really Change?, describe the challenges ahead of Mary Barra. Families Misled by GM, Mary Barra Returns. In your response, also incorporate how and where mission, vision and values come into play. Respond to two classmates’ posts.
- Discuss you educational and professional goals, short term and long term, and address how earning the Doctor of Nursing Practice (DNP) will help you reach these goals.
- Explain, in your own words, the terms “mission,” “vision,” “goals,” and “values” statements. What is the practical purpose of a statement of organizational values?
- Develop a research question from ONE of these health themes: – Mothers and babies – Children and families – Acute care settings – Older people – Mental health – Rural and remote health
- Assess the health, health care, and preparedness needs of a population in order to identify sub-populations, families, and individuals who would benefit from health promotion
- Decide, as a Learning Team, on a chronic health issue that affects the aging population.
- What changes in the U.S. health care delivery system would you suggest to actually make it a system in order to address the health needs of veterans and their families, e.g. post-traumatic stress, brain injury, post-deployment depression, and other visible and invisible wounds of war?