Nuremberg Code (1947)
10-point statement delimiting permissible medical experimentation on human subjects.
The Subject
1. Consent
2. Comprehension and sufficient knowledge of what may occur
3. Voluntariness – no coercion, deceit, fraud
● The right to stop at any time
Researchers
4. No delegation with impunity of the ethical responsibility
5. Responsible to stop if they suspect injury, disability, or death to the experimental subject may occur.
6. Qualified
The Research
7. May not be random and unnecessary in nature
8. Avoid all unnecessary physical and mental suffering and injury
9. Risks should be managed and never be higher than importance
10. No experiment should be conducted where there is an a priori reason to believe that death or disabling injury will occur; except, perhaps, in those experiments where the experimental physicians also serve as subjects.
Declaration of Helsinki (1964)
A set of ethical principles regarding human experimentation developed for the medical community by the World Medical Association (WMA)
“Interest of science and society should NEVER take precedence over considerations related to the wellbeing of the subject.”
Principles:
1) Duty of Physician to protect life, health, dignity, integrity, right to self-determination, privacy and confidentiality
2) Conform generally accepted scientific practices and current literature
3) Clearly formulated and is reviewed by an independent body in an experimental protocol- should always contain ethical considerations
4) Conducted by qualified persons (research and medical)
5) Objective’s importance is proportional to the risk- assessment done to compare risks/burdens to benefits
● Don’t move forward with research subjects unless this has been done
6) Subject’s interest must always prevail over the interests of science and society
7) Minimize research impact on subjects Covers biomedical research, medical research, clinical research (treatment)
8) Hazards - believed to be predictable and never outweigh benefits
9) No publishing results that have not complied with this declaration
10) Consenting is a process- subjects should be adequately informed of the aims and methods of the study
11) Be aware of possible coercion when consenting
12) The concept of assent and consent, especially written, is used whenever possible- if subject is unable to consent then proper steps are followed using legally authorized representative
13) The protocol should reflect the principles in this declaration
National Research Act (July 12, 1974)
Created the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.
The Commission was charged with the following task:
● identify the basic ethical principles
● develop guidelines to be followed
● specifically consider the following areas:
○ the boundaries between research and medicine (the conflict)
○ criteria for what is considered appropriate of risk vs. benefit (the debate)
○ define what is informed consent in various research
Requires each entity to establish a board (to be known as an ‘Institutional Review Board’) to review biomedical and behavioral research involving human subjects conducted at or sponsored by such entity in order to protect the rights of the human subjects of such research.
Belmont Report (1979)
A cornerstone document of ethical principles and guidelines for research involving human subjects.
The boundaries between research and medicine generated the following definitions:
● Research – to contribute to generalize knowledge
● Practice – interventions, with the reasonable expectation of success, to enhance well-being of the patient. The purpose is providing diagnosis, preventative or reactive care
● “Experimental” – Something that is untested. This does not mean something is automatically research. It is the responsibility of the medical committees to insist radical new procedures to be tested by formal research first.
Resulted in Respect for Persons, Beneavelence, Justice
Justice
● who ought to receive the benefits of research and bear its burdens
● maximize possible benefits and minimize possible harms
○ to each person an equal share,
○ to each person according to individual need
○ to each person according to individual effort
○ to each person according to societal contribution, and
○ to each person according to merit.
Beneficence
(the cause of the current debate: knowledge vs. regulations.)
● do no harm
● maximize possible benefits and minimize possible harms
Respect for Persons
● to acknowledge autonomy (a choice)
● to protect those with diminished autonomy (e.g. vulnerable populations)
