Research Ethics

Ethics Ethics Medical ethics are a set of moral values that guide the decision-making of health care professionals in their daily practice. A sense of ethical responsibility has accompanied the profession of medicine since antiquity, and the Hippocratic oath was the 1st document to codify its core ethical principles. Basics of Medical Ethics is the field of study dealing with moral principles. Since the beginning, ethics has guided the practice of medicine. The core set of directives is based on the assumptions that all human life has intrinsic value and must be preserved, and all actions of the physician must be congruent with curing disease and in the best interest of the individual. Medical research also operates under these assumptions when seeking better alternatives of care to benefit individuals.

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Editorial responsibility: Stanley Oiseth, Lindsay Jones, Evelin Maza

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Overview

  • Medical research is essential: 
    • For the advancement of knowledge
    • To promote health and to better prevent and manage illness
  • However, research has led to instances where researchers mistreated individuals in the name of scientific advancement. 
  • Ethical oversight is required: 
    • To protect individuals 
    • To ensure independent evaluation of the research
    • To protect researchers by demonstrating external approval of the research
  • Publishers and others who fund research require proof the research proposal has received prior ethical approval. 
  • Carrying out research without prior ethical approval has serious consequences.

Pillars of ethical research:

  • Autonomy
  • Beneficence
  • Nonmaleficence
  • Justice
  • Acting in the best interest of the individual
  • Fidelity
  • Trustfulness
  • Confidentiality Confidentiality Confidentiality is a set of rules that dictates the protection of health information shared by a patient with a physician. In general, this information should only be used to dictate medical decision-making steps and can only be disclosed to a 3rd party with the patient's express consent. Patient-Doctor Confidentiality

Important Documents in Medical Research Ethics

The Nuremberg Code

  • A 10-point statement introduced as the final judgement of the tribunal in the 1947 Nuremberg trials, which exposed the atrocious experiments carried out by Nazi physicians and researchers on human test subjects in concentration camps
  • The underlying principle is autonomy or voluntariness (the ability to make choices based on an individual’s self-determined principles).
  • Criticisms: Risk of life is permissible as long as the investigator is subject to the same risk.

The Declaration of Geneva

  • The Declaration of Geneva was adopted in September 1948 by the 2nd General Assembly of the World Medical Association in Geneva, Switzerland. 
  • Modernization of the Hippocratic Oath
  • Criticisms: The rights and safety of the participants remain with the investigator.

The Belmont Report

  • Issued by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research after the passing of the Research Act of 1974
  • A response to ethical controversies in biomedical research in the 1960s and 1970s (particularly the Tuskegee Syphilis Syphilis Syphilis is a bacterial infection caused by the spirochete Treponema pallidum pallidum (T. p. pallidum), which is usually spread through sexual contact. Syphilis has 4 clinical stages: primary, secondary, latent, and tertiary. Syphilis Study (1932–1972))
  • Distinguishes therapeutic medicine from research
  • Established core principles: 
    • Respect for individuality 
    • Beneficence (always seeking to do good)
    • Justice (treating all people the same)
    • Informed consent (agreement to be experimented upon)
    • Assessments of risks and benefits
    • Selection of subjects
  • Criticisms: Ethnic, gender, or cultural differences are not considered and no principle is prioritized over another.

The Declaration of Helsinki

  • Published by the World Medical Association, the Declaration of Helsinki was 1st adopted in 1964 as a set of guidelines for human experimentation.
  • Considered one of the most important documents in bioethics (continues to be regularly updated)
  • Highlights the differences of a therapeutic relationship between a physician and an individual, and between a researcher and a test subject
  • Pillars:
    • Principlism (respect for an individual’s autonomy)
    • Beneficence (seeking to do good)
    • Nonmaleficence (seeking to not do harm)
    • Justice (treating cases alike): rejection of racism, sexism, classism, etc.
    • Best interest (to act in the best interest of the individual)
  • Criticisms: offers no guideline to prioritize one pillar over another

Common Issues in Medical and Research Ethics

Informed consent is the free and prior expression of agreement made by a capable individual to carry out a medical procedure or disclose protected information. 

  • Underlying principle: autonomy, specifically voluntariness (to exercise autonomy free of external influence)
  • Both an ethical and a legal obligation of medical professionals
  • Represents collaborative decision-making between the clinician and the individual regarding the steps to be followed in the individual’s care

In the Nuremberg Code:

Consent is a mandatory requirement for research on human beings to protect dignity and freedom.

In the Helsinki Declaration:

  • A physician must seek the subject’s freely given informed consent.
  • In medical research, consent must be given for the collection, analysis, storage and/or reuse of data.

Prerequisites: 

  • Disclosure to the individual of adequate, relevant, and complete medical information needed regarding condition, name and purpose of treatment or intervention, consequences of refusing treatment, potential risks and benefits, and alternatives
  • Capacity of the individual to make medical decisions is determined by the attending physician.

Related videos

Research Ethics Boards (REBs)

Research Ethics Ethics Medical ethics are a set of moral values that guide the decision-making of health care professionals in their daily practice. A sense of ethical responsibility has accompanied the profession of medicine since antiquity, and the Hippocratic oath was the 1st document to codify its core ethical principles. Basics of Medical Ethics Boards are bodies within institutions (e.g., universities, hospitals) that assess the ethical soundness of a study to ultimately indicate if the study can be carried out without ethical liability. 

Research Ethics Ethics Medical ethics are a set of moral values that guide the decision-making of health care professionals in their daily practice. A sense of ethical responsibility has accompanied the profession of medicine since antiquity, and the Hippocratic oath was the 1st document to codify its core ethical principles. Basics of Medical Ethics Boards protect the rights and welfare of research subjects by ensuring:

  • Risks are minimized.
  • Risks are acceptable in light of possible benefits. 
  • Informed consent documentation is accurate and complete.
  • The study is conducted in an ethical manner.

Additional Research Ethics Ethics Medical ethics are a set of moral values that guide the decision-making of health care professionals in their daily practice. A sense of ethical responsibility has accompanied the profession of medicine since antiquity, and the Hippocratic oath was the 1st document to codify its core ethical principles. Basics of Medical Ethics Boards

  • Institutional review board (IRB)
  • Independent ethics committee (IEC)
  • Ethical review board (ERB)
  • Research ethics committee (REC)

Elements reviewed by Research Ethics Ethics Medical ethics are a set of moral values that guide the decision-making of health care professionals in their daily practice. A sense of ethical responsibility has accompanied the profession of medicine since antiquity, and the Hippocratic oath was the 1st document to codify its core ethical principles. Basics of Medical Ethics Boards

  • Scientific value to be gained from research
  • Fair selection or recruitment of participants 
  • Favorable risk-benefit ratio 
  • Protection of research participants
  • Proper informed consent and degree of anonymity/confidentiality
  • Appropriateness of the researchers and support staff
  • Appropriateness of the supporting information
  • Independent review

Actions taken by Research Ethics Ethics Medical ethics are a set of moral values that guide the decision-making of health care professionals in their daily practice. A sense of ethical responsibility has accompanied the profession of medicine since antiquity, and the Hippocratic oath was the 1st document to codify its core ethical principles. Basics of Medical Ethics Boards

  • Prior to the start of research:
    • Scrutinize ethical standards of the research proposal
    • Observe and notify the investigators to modify proposals if needed
    • Approve or reject proposals
  • During research:
    • Monitor investigators to ensure research conforms to approved protocol.
    • Terminate if participants are exposed to greater risk than the approved protocol.

References

  1. Guraya, S. Y., London, N. J. M., & Guraya, S. S. (2014). Ethics in medical research. Journal of Microscopy and Ultrastructure, 2(3), 121–126.
  2. Wong, Y. W., & Schulman, K. A. (2013). Chapter 4. Ethics of Clinical Research: An Overview and Emerging Issues. In R. D. Lopes & R. A. Harrington (Eds.), Understanding Clinical Research. New York, NY: The McGraw-Hill Companies. Retrieved from http://accessmedicine.mhmedical.com/content.aspx?aid=57835286
  3. Barrow J. M., Brannan G. D., Khandhar P. B. Research Ethics. [Updated 2021 Aug 28]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2021 Jan. Available from: https://www.ncbi.nlm.nih.gov/books/NBK459281/
  4. Hajar R. (2017). The Physician’s Oath: Historical Perspectives. Heart views: the official journal of the Gulf Heart Association, 18(4), 154–159. https://doi.org/10.4103/HEARTVIEWS.HEARTVIEWS_131_17
  5. World Medical Association. (2017, October). WMA Declaration of Geneva – WMA – The World Medical Association. Retrieved June 10, 2021, from https://www.wma.net/policies-post/wma-declaration-of-geneva/ 
  6. The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. (1979, April 18). The Belmont Report | HHS.gov. Retrieved June 10, 2021, from https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/read-the-belmont-report/index.html 
  7. World Medical Association. (1964, June). WMA Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects. Retrieved June 10, 2021, from https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/

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