Research Ethics

Overview

• Medical research Research Critical and exhaustive investigation or experimentation, having for its aim the discovery of new facts and their correct interpretation, the revision of accepted conclusions, theories, or laws in the light of newly discovered facts, or the practical application of such new or revised conclusions, theories, or laws. Conflict of Interest is essential:
  • For the advancement of knowledge
  • To promote health and to better prevent and manage illness
• However, research Research Critical and exhaustive investigation or experimentation, having for its aim the discovery of new facts and their correct interpretation, the revision of accepted conclusions, theories, or laws in the light of newly discovered facts, or the practical application of such new or revised conclusions, theories, or laws. Conflict of Interest has led to instances where researchers mistreated individuals in the name of scientific advancement. 
• Ethical oversight is required:
  • To protect participants
  • To ensure independent evaluation of the research Research Critical and exhaustive investigation or experimentation, having for its aim the discovery of new facts and their correct interpretation, the revision of accepted conclusions, theories, or laws in the light of newly discovered facts, or the practical application of such new or revised conclusions, theories, or laws. Conflict of Interest
  • To protect researchers by demonstrating external approval of the research Research Critical and exhaustive investigation or experimentation, having for its aim the discovery of new facts and their correct interpretation, the revision of accepted conclusions, theories, or laws in the light of newly discovered facts, or the practical application of such new or revised conclusions, theories, or laws. Conflict of Interest
• Publishers and funding Funding Conflict of Interest bodies require proof the research Research Critical and exhaustive investigation or experimentation, having for its aim the discovery of new facts and their correct interpretation, the revision of accepted conclusions, theories, or laws in the light of newly discovered facts, or the practical application of such new or revised conclusions, theories, or laws. Conflict of Interest proposal has received prior ethical approval.
• Carrying out research Research Critical and exhaustive investigation or experimentation, having for its aim the discovery of new facts and their correct interpretation, the revision of accepted conclusions, theories, or laws in the light of newly discovered facts, or the practical application of such new or revised conclusions, theories, or laws. Conflict of Interest without prior ethical approval has serious consequences.

Pillars of ethical research Research Critical and exhaustive investigation or experimentation, having for its aim the discovery of new facts and their correct interpretation, the revision of accepted conclusions, theories, or laws in the light of newly discovered facts, or the practical application of such new or revised conclusions, theories, or laws. Conflict of Interest:

• Autonomy Autonomy Respect for the patient’s right to self-rule. Medical Ethics: Basic Principles
• Beneficence Beneficence The state or quality of being kind, charitable, or beneficial. The ethical principle of beneficence requires producing net benefit over harm. Medical Ethics: Basic Principles
• Nonmaleficence Nonmaleficence Not acting with the intention to do harm. Medical Ethics: Basic Principles
• Justice (fair distribution of the benefits and burdens of research Research Critical and exhaustive investigation or experimentation, having for its aim the discovery of new facts and their correct interpretation, the revision of accepted conclusions, theories, or laws in the light of newly discovered facts, or the practical application of such new or revised conclusions, theories, or laws. Conflict of Interest)
• Acting in the best interest of the individual
• Fidelity Fidelity Conflict of Interest
• 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 judgment Judgment The process of discovering or asserting an objective or intrinsic relation between two objects or concepts; a faculty or power that enables a person to make judgments; the process of bringing to light and asserting the implicit meaning of a concept; a critical evaluation of a person or situation. Psychiatric Assessment of the tribunal in the Doctors’ Trial (1946–1947), one of the Nuremberg military tribunals, which exposed the atrocious experiments carried out by Nazi physicians Physicians Individuals licensed to practice medicine. Clinician–Patient Relationship and researchers on human test subjects in concentration camps.
• The underlying principle is autonomy Autonomy Respect for the patient’s right to self-rule. Medical Ethics: Basic Principles 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 (currently titled “The Physician’s Pledge”)
• Criticisms: The rights and safety of the participants remain with the investigator.

The Belmont Report

• Issued in 1979 by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research Research Critical and exhaustive investigation or experimentation, having for its aim the discovery of new facts and their correct interpretation, the revision of accepted conclusions, theories, or laws in the light of newly discovered facts, or the practical application of such new or revised conclusions, theories, or laws. Conflict of Interest after the passing of the National Research Research Critical and exhaustive investigation or experimentation, having for its aim the discovery of new facts and their correct interpretation, the revision of accepted conclusions, theories, or laws in the light of newly discovered facts, or the practical application of such new or revised conclusions, theories, or laws. Conflict of Interest Act of 1974
• A response to ethical controversies in biomedical research Research Critical and exhaustive investigation or experimentation, having for its aim the discovery of new facts and their correct interpretation, the revision of accepted conclusions, theories, or laws in the light of newly discovered facts, or the practical application of such new or revised conclusions, theories, or laws. Conflict of Interest 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), now designated by the CDC as the U.S. Public Health Service Untreated 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 at Tuskegee).
• Distinguishes therapeutic medicine from research Research Critical and exhaustive investigation or experimentation, having for its aim the discovery of new facts and their correct interpretation, the revision of accepted conclusions, theories, or laws in the light of newly discovered facts, or the practical application of such new or revised conclusions, theories, or laws. Conflict of Interest
• Established core principles:
  • Respect for individuality 
  • Beneficence Beneficence The state or quality of being kind, charitable, or beneficial. The ethical principle of beneficence requires producing net benefit over harm. Medical Ethics: Basic Principles (maximizing possible benefits and minimizing possible harms)
  • Justice (fairness in the distribution of the burdens and benefits of research Research Critical and exhaustive investigation or experimentation, having for its aim the discovery of new facts and their correct interpretation, the revision of accepted conclusions, theories, or laws in the light of newly discovered facts, or the practical application of such new or revised conclusions, theories, or laws. Conflict of Interest)
• Corresponding applications:
  • Informed consent Informed consent Informed consent is a medicolegal term describing the documented conversation between a patient and their physician wherein the physician discloses all relevant and necessary information to a patient who is competent to make an informed and voluntary decision regarding their care. Competency, disclosure, and voluntariness are the key elements upon which IC is based. Informed Consent (voluntary agreement to participate after adequate disclosure and comprehension)
  • Assessments of risks and benefits
  • Selection Selection Lymphocyte activation by a specific antigen thus triggering clonal expansion of lymphocytes already capable of mounting an immune response to the antigen. B cells: Types and Functions of subjects
• Criticisms: Ethnic, gender Gender Gender Dysphoria, 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 research Research Critical and exhaustive investigation or experimentation, having for its aim the discovery of new facts and their correct interpretation, the revision of accepted conclusions, theories, or laws in the light of newly discovered facts, or the practical application of such new or revised conclusions, theories, or laws. Conflict of Interest participant
• Pillars:
  • Autonomy Autonomy Respect for the patient’s right to self-rule. Medical Ethics: Basic Principles (respect for an individual’s self-determination)
  • Beneficence Beneficence The state or quality of being kind, charitable, or beneficial. The ethical principle of beneficence requires producing net benefit over harm. Medical Ethics: Basic Principles (seeking to do good)
  • Nonmaleficence Nonmaleficence Not acting with the intention to do harm. Medical Ethics: Basic Principles (seeking to not do harm)
  • Justice (treating cases alike): rejection of racism, sexism, classism, etc ETC The electron transport chain (ETC) sends electrons through a series of proteins, which generate an electrochemical proton gradient that produces energy in the form of adenosine triphosphate (ATP). Electron Transport Chain (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 Informed consent Informed consent is a medicolegal term describing the documented conversation between a patient and their physician wherein the physician discloses all relevant and necessary information to a patient who is competent to make an informed and voluntary decision regarding their care. Competency, disclosure, and voluntariness are the key elements upon which IC is based. 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 Autonomy Respect for the patient’s right to self-rule. Medical Ethics: Basic Principles, specifically voluntariness (to exercise autonomy Autonomy Respect for the patient’s right to self-rule. Medical Ethics: Basic Principles free of external influence)
• Both an ethical and a legal obligation of medical professionals
• Represents collaborative decision-making between the clinician Clinician A physician, nurse practitioner, physician assistant, or another health professional who is directly involved in patient care and has a professional relationship with patients. Clinician–Patient Relationship 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 Research Critical and exhaustive investigation or experimentation, having for its aim the discovery of new facts and their correct interpretation, the revision of accepted conclusions, theories, or laws in the light of newly discovered facts, or the practical application of such new or revised conclusions, theories, or laws. Conflict of Interest on human beings to protect dignity and freedom.

In the Helsinki Declaration:

• A physician must seek the participant’s freely given informed consent Informed consent Informed consent is a medicolegal term describing the documented conversation between a patient and their physician wherein the physician discloses all relevant and necessary information to a patient who is competent to make an informed and voluntary decision regarding their care. Competency, disclosure, and voluntariness are the key elements upon which IC is based. Informed Consent.
• In medical research Research Critical and exhaustive investigation or experimentation, having for its aim the discovery of new facts and their correct interpretation, the revision of accepted conclusions, theories, or laws in the light of newly discovered facts, or the practical application of such new or revised conclusions, theories, or laws. Conflict of Interest, consent must be given for the collection, analysis, storage and/or reuse of data and biological material.

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 (capacity is a clinical determination; legal competence Legal competence Competency, or competence, is a legal term defined as the ability of an individual to participate in legal proceedings, which includes their ability to make medical decisions. Determinations of competence are made by a judge and not by a physician. Decision-making Capacity and Legal Competence is determined by a court).

Research Ethics Boards (REBs)

Research Research Critical and exhaustive investigation or experimentation, having for its aim the discovery of new facts and their correct interpretation, the revision of accepted conclusions, theories, or laws in the light of newly discovered facts, or the practical application of such new or revised conclusions, theories, or laws. Conflict of Interest 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. Medical Ethics: Basic Principles 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 Research Critical and exhaustive investigation or experimentation, having for its aim the discovery of new facts and their correct interpretation, the revision of accepted conclusions, theories, or laws in the light of newly discovered facts, or the practical application of such new or revised conclusions, theories, or laws. Conflict of Interest 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. Medical Ethics: Basic Principles Boards protect the rights and welfare of research Research Critical and exhaustive investigation or experimentation, having for its aim the discovery of new facts and their correct interpretation, the revision of accepted conclusions, theories, or laws in the light of newly discovered facts, or the practical application of such new or revised conclusions, theories, or laws. Conflict of Interest participants by ensuring:

• Risks are minimized.
• Risks are acceptable in light of possible benefits. 
• Informed consent Informed consent Informed consent is a medicolegal term describing the documented conversation between a patient and their physician wherein the physician discloses all relevant and necessary information to a patient who is competent to make an informed and voluntary decision regarding their care. Competency, disclosure, and voluntariness are the key elements upon which IC is based. Informed Consent documentation Documentation Systematic organization, storage, retrieval, and dissemination of specialized information, especially of a scientific or technical nature. It often involves authenticating or validating information. Advance Directives is accurate and complete.
• The study is conducted in an ethical manner.

Other Names for Research Research Critical and exhaustive investigation or experimentation, having for its aim the discovery of new facts and their correct interpretation, the revision of accepted conclusions, theories, or laws in the light of newly discovered facts, or the practical application of such new or revised conclusions, theories, or laws. Conflict of Interest 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. Medical Ethics: Basic Principles Boards

• Institutional review board (IRB)
• Independent 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. Medical Ethics: Basic Principles committee (IEC)
• Ethical review board (ERB)
• Research Research Critical and exhaustive investigation or experimentation, having for its aim the discovery of new facts and their correct interpretation, the revision of accepted conclusions, theories, or laws in the light of newly discovered facts, or the practical application of such new or revised conclusions, theories, or laws. Conflict of Interest 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. Medical Ethics: Basic Principles committee (REC)

Elements reviewed by Research Research Critical and exhaustive investigation or experimentation, having for its aim the discovery of new facts and their correct interpretation, the revision of accepted conclusions, theories, or laws in the light of newly discovered facts, or the practical application of such new or revised conclusions, theories, or laws. Conflict of Interest 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. Medical Ethics: Basic Principles Boards

• Scientific value to be gained from research Research Critical and exhaustive investigation or experimentation, having for its aim the discovery of new facts and their correct interpretation, the revision of accepted conclusions, theories, or laws in the light of newly discovered facts, or the practical application of such new or revised conclusions, theories, or laws. Conflict of Interest
• Fair selection Selection Lymphocyte activation by a specific antigen thus triggering clonal expansion of lymphocytes already capable of mounting an immune response to the antigen. B cells: Types and Functions or recruitment Recruitment Skeletal Muscle Contraction of participants 
• Favorable risk-benefit ratio 
• Protection of research Research Critical and exhaustive investigation or experimentation, having for its aim the discovery of new facts and their correct interpretation, the revision of accepted conclusions, theories, or laws in the light of newly discovered facts, or the practical application of such new or revised conclusions, theories, or laws. Conflict of Interest participants
• Proper informed consent Informed consent Informed consent is a medicolegal term describing the documented conversation between a patient and their physician wherein the physician discloses all relevant and necessary information to a patient who is competent to make an informed and voluntary decision regarding their care. Competency, disclosure, and voluntariness are the key elements upon which IC is based. Informed Consent and degree of anonymity/ 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
• Appropriateness of the researchers and support staff
• Appropriateness of the supporting information
• Independent review

Actions taken by Research Research Critical and exhaustive investigation or experimentation, having for its aim the discovery of new facts and their correct interpretation, the revision of accepted conclusions, theories, or laws in the light of newly discovered facts, or the practical application of such new or revised conclusions, theories, or laws. Conflict of Interest 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. Medical Ethics: Basic Principles Boards

• Prior to the start of research Research Critical and exhaustive investigation or experimentation, having for its aim the discovery of new facts and their correct interpretation, the revision of accepted conclusions, theories, or laws in the light of newly discovered facts, or the practical application of such new or revised conclusions, theories, or laws. Conflict of Interest:
  • Scrutinize ethical standards of the research Research Critical and exhaustive investigation or experimentation, having for its aim the discovery of new facts and their correct interpretation, the revision of accepted conclusions, theories, or laws in the light of newly discovered facts, or the practical application of such new or revised conclusions, theories, or laws. Conflict of Interest proposal
  • Observe and notify the investigators to modify proposals if needed
  • Approve or reject proposals
• During research Research Critical and exhaustive investigation or experimentation, having for its aim the discovery of new facts and their correct interpretation, the revision of accepted conclusions, theories, or laws in the light of newly discovered facts, or the practical application of such new or revised conclusions, theories, or laws. Conflict of Interest:
  • Monitor investigators to ensure research Research Critical and exhaustive investigation or experimentation, having for its aim the discovery of new facts and their correct interpretation, the revision of accepted conclusions, theories, or laws in the light of newly discovered facts, or the practical application of such new or revised conclusions, theories, or laws. Conflict of Interest conforms to approved protocol.
  • Terminate if participants are exposed to greater risk than the approved protocol.