ETHICAL PRINCIPLES IN CLINICAL RESEARCH
WHAT IS ETHICS?
• The word 'ethics' is derived from the Greek word, ethos, which means custom or character.
• Ethics is the systematic study of values, so as to decide what is right and what is wrong.
ETHICS:
• Ethics is a subject that deals with values, principles, beliefs, and opinions.
• Not a natural science but a creation of the human mind that opens to the influence of time, place, and situation.
• A framework to determine what is right and wrong regarding human action, character, and behavior.
• Comes from within, unlike law which regulates external behavior.
CLINICAL RESEARCH:
• Human subject research is a systematic investigation that can be either research or clinically oriented and involves the use of human subjects in any capacity.
MORAL PROBLEM IN CLINICAL RESEARCH:
• The goal of clinical research is the generation of useful knowledge about human health and illness.
• Benefit to participants is not the purpose of the research.
• People are the means to developing useful knowledge; and are thus at risk of exploitation.
ETHICS REQUIRED IN CLINICAL RESEARCH?
• Value-enhancements of health or knowledge must be derived from the research.
• Scientific validity-the research must be methodologically rigorous.
• Fair subject selection-scientific objectives, not vulnerability or privilege, and the potential for and distribution of risks and benefits, should determine communities selected as study sites and the inclusion criteria for individual subjects.
• Favorable risk-benefit ratio-within the context of standard clinical practice and the research protocol, risks must be minimized, potential benefits enhanced, and the potential benefits to individuals and knowledge gained for society must outweigh the risks.
• Independent review-unaffiliated individuals must review the research and approve, amend, or terminate it.
• Informed consent-individuals should be informed about the research and provide their voluntary consent.
• Respect for enrolled subjects-subjects should have their privacy protected, the opportunity to withdraw, and their well-being monitored.
CORE PRINCIPLES OF CLINICAL TRIAL ETHICS:
Three basic principles:
• Justice
• Respect for Persons
• Beneficence and non-maleficence
- Maximize benefits
- Minimize harms and wrongs
- Do no harm
HISTORY:
• The Nuremberg Code (1947).
• The Declaration of Helsinki (1964).
• U.S. Code of Federal Regulations (1974).
• The National Research Act and the IRB System (1974).
• The Belmont Report (1979).
• ICMR Guidelines (2000, 2006).
THE NUREMBERG CODE (1947):
The Nuremberg Code is a set of research ethics principles for human experimentation set as a result of the Subsequent Nuremberg Trials at the end of the Second World War.
The ten points of the Nuremberg Code:
• Voluntary consent is essential
• The results of any experiment must be for the greater good of society
• Human experiments should be based on previous animal experimentation
• Experiments should be conducted by avoiding physical/mental suffering and injury
• No experiments should be conducted if it is believed to cause death/disability
• The risks should never exceed the benefits
• Adequate facilities should be used to protect subjects
• Experiments should be conducted only by qualified scientists
• Subjects should be able to end their participation at any time
• The scientist in charge must be prepared to terminate the experiment when injury, disability, or death is likely to occur2.
THE DECLARATION OF HELSINKI (1964):
• 1964 - Adopted by the 18th World Medical Assembly (latest version 2008).
• A notable change from the Nuremberg Code was a relaxation of the conditions of consent.
• Obtain consent if at all possible.
• Introduced the concept of oversight by an 'independent committee" Or ethics committees.
• All protocols must be submitted to an ethics committee for review, which must be independent of the investigator, the sponsor or any other kind of undue influence".
U.S. CODE OF FEDERAL REGULATIONS (1974):
• The Code of Federal Regulations (CFR) is the codification of the general and permanent rules published in the Federal Register by the executive departments and agencies of the Federal Government.
• It is divided into 50 titles that represent broad areas subject to Federal regulation.
• Each volume of the CFR is updated once each calendar year and is issued on a quarterly basis.
THE NATIONAL RESEARCH ACT AND THE IRB SYSTEM (1974):
• Due to the publicity from the Syphilis Study, the National Research Act of 1974 was passed,
• The National Research Act was created by the National Commission for the Protection of Human subjects of biomedical and behavioural research.
• The Commission's charge was to identify the basic ethical principles that should underlie the conduct of biomedical and behavioural research involving human participants and to develop guidelines which should be followed to assure that such research is conducted in accordance with those principles.
THE BELMONT REPORT (1979):
• National Commission for the Protection of Human Subjects of Biomedical and Behavioural Research created "Belmont Report":
• Respect for persons: treating people as autonomous agents and protecting those with diminished autonomy
• Beneficence: minimizing potential harms and maximizing benefits of participation
• Justice: distributing benefits/risks fairly
ICMR (INDIAN COUNCIL OF MEDICAL RESEARCH)
GUIDELINES (2000, 2006):
Statement of General Principles in Biomedical Research Involving Human Participants.
This statement of Ethical Guidelines for Biomedical Research on Human Participants shall be known as the ICMR Code and shall consist of the following:
• Statement of General Principles on Research using
Human Participants in Biomedical Research
• Statement of Specific Principles on Research using Human Participants in specific areas of Biomedical Research
FACTORS INFLUENCING VIOLATION OF PRINCIPLES IN CLINICAL RESEARCH:
Here are some of the main factors that contribute to the abuse of subjects participating in clinical trials:
• Paternalism.
• Improper use of informed consent.
• Lack of strict ethical supervision.
• Pressure exerted by health institutions to increase the production of scientific material.
• Absence of legislation regarding ethics in terms of health care and research.
REFERENCES:
• https://pubmed.ncbi.nlm.nih.gov/28190696/
• https://pubmed.ncbi.nlm.nih.gov/10819955/
• https://pubmed.ncbi.nlm.nih.gov/23241478/
• Mass device, The Nuremberg Code and its impact on clinical research [Internet] [Cited on 09-04-2019].Available from URL
https://www.massdevice.com/the-nuremberg-code-and-its-impact-on-clinical-research/
• https://www.britannica.com/topic/Declaration-of-Helsinki
• The Belmont report[Internet][Cited on 18-14-1979].Available from the URL
https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/read-the-belmont-report/index.html
• Image Available from URL: https://images.app.goo.gl/KUzTxrXKqmmLrYhi9
• Milestones for the evolution of ethics for clinical research. Image available from the URL: https://images.app.goo.gl/54jeQUw45P8p9g3H7
• Research Ethics: Definition, Principles and Advantages. Image available from the URL: https://images.app.goo.gl/5ej4JyTeNhoHUt5d8
Written by: Vandana Reddy
Qualification: PHARM D
Student ID: 171/0922
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