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Posted: January 30th, 2023
Explore the Ethical Standards for Conducting Medical Research
Explore the Ethical Standards for Conducting Medical Research
Medical research is essential for advancing human health and improving the prevention, diagnosis and treatment of diseases. However, medical research also involves ethical challenges and risks for the participants and the researchers. Therefore, it is important to follow certain ethical standards and principles that ensure the respect, safety and well-being of all parties involved in medical research.
Ethical Standards and Principles for Medical Research
According to the National Institutes of Health (NIH), ethical guidelines are established for clinical research to protect patient volunteers and to preserve the integrity of the science. NIH Clinical Center researchers published seven main principles to guide the conduct of ethical research:
– **Social and clinical value**: The research question should be important enough to justify asking people to accept some risk or inconvenience for others. The answer should contribute to scientific understanding of health or improve our ways of preventing, treating, or caring for people with a given disease.
– **Scientific validity**: The study should be designed in a way that will get an understandable answer to the research question. The research methods should be valid and feasible, and the study should be conducted with accepted principles, clear methods, and reliable practices.
– **Fair subject selection**: The recruitment of participants should be based on the scientific goals of the study, not on vulnerability, privilege, or other unrelated factors. Specific groups of participants should not be excluded from the research opportunities without a good scientific reason or a particular susceptibility to risk.
– **Favorable risk-benefit ratio**: The risks and benefits of the research should be assessed and balanced. Everything should be done to minimize the risks and inconvenience to research participants and to maximize the potential benefits. The potential benefits should be proportionate to, or outweigh, the risks.
– **Independent review**: The study should be reviewed by an independent committee, such as an institutional review board (IRB), that can ensure that the study is ethical and that the rights and welfare of the participants are protected.
– **Informed consent**: The participants should be informed about the purpose, procedures, risks, benefits, and alternatives of the research, and they should voluntarily agree to participate without coercion or undue influence. They should also have the right to withdraw from the research at any time without penalty or loss of benefits.
– **Respect for potential and enrolled subjects**: The participants should be treated with respect and dignity throughout the research process. Their privacy and confidentiality should be protected, and their feedback and concerns should be addressed.
These principles are consistent with other sources of guidance for ethical research, such as the Declaration of Helsinki, the Belmont Report, and the Good Clinical Practice guidelines. They provide a framework for conducting medical research that is ethical, rigorous, and beneficial for society.
Bibliography
: NIH Clinical Center. (2021). Guiding Principles for Ethical Research | National Institutes of Health (NIH). Retrieved October 30, 2023 from https://www.nih.gov/health-information/nih-clinical-research-trials-you/guiding-principles-ethical-research
: World Medical Association. (2018). WMA Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects. Retrieved October 30, 2023 from https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/
: U.S. Department of Health & Human Services homework help – write my religious studies thesis. (1979). The Belmont Report | HHS.gov. Retrieved October 30, 2023 from https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/index.html
: International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). (2016). ICH Harmonised Guideline Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2). Retrieved October 30, 2023 from https://database.ich.org/sites/default/files/E6_R2_Addendum.pdf
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