National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research was the first public national body to shape bioethics policy in the United States.
Formed in the aftermath of the Tuskegee Experiment scandal, the commission was created in 1974 as Title II of the National Research Act. It was part of the United States Department of Health, Education, and Welfare (DHEW) until 1978.
On July 12, 1974, the United States National Research Act (Pub. L. 93-348) was signed into law, there-by creating the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. One of the charges to the Commission was to identify the basic ethical principles that should underlie the conduct of biomedical and behavioral research involving human subjects and to develop guidelines which should be followed to assure that such research is conducted in accordance with those principles. In carrying out the above, the Commission was directed to consider: (i) the boundaries between biomedical and behavioral research and the accepted and routine practice of medicine, (ii) the role of assessment of risk-benefit criteria in the determination of the appropriateness of research involving human subjects, (iii) appropriate guidelines for the selection of human subjects for participation in such research and (iv) the nature and definition of informed consent in various research settings.
The Belmont Report (1976) is a formal statement by the United States government regarding the ethical standards and accepted legal norms regarding the use of human subjects in medical, behavioral or scientific experimentation. The Belmont Report summarizes the basic ethical principles identified in 4 days of deliberations supplemented by the monthly deliberations held over a period of nearly four years. It is a statement of basic ethical principles and guidelines to consider in the use of human subjects in research. It was published in the Federal Register so it could become ethical guidance for U.S. researchers, scientists, governmental employees and Institutional Review Boards (IRB).
The Belmont Report identifies three basic ethical principles that are particularly relevant to the ethics of research involving human subjects: the principles of respect of persons, beneficence and justice.
Purposes and objectives of the U.S. Congress regarding human rights:
International Human Right Treaties signed and ratified by the United States clearly are a statement of the U.S. Congress’s purposes and objectives in regard to human rights.
The International Covenant on Civil and Political Rights (ICCPR) is a multilateral treaty that commits nations to respect the civil and political rights of individuals, including the right to life, freedom of religion, freedom of speech, freedom of assembly, electoral rights and rights to due process and a fair trial. It was adopted by United Nations General Assembly Resolution 2200A (XXI) on 16 December 1966 and entered into force on 23 March 1976 after its thirty-fifth ratification or accession. As of June 2024, the Covenant has 174 parties and six more signatories without ratification, most notably the People’s Republic of China and Cuba; North Korea is the only state that has tried to withdraw.
Thus, an interpretation of the United States obligations under the International Covenant on Civil and Political Rights (ICCPR), in conjunction with the ethical and legal standards of the United States Constitution and the U.S. Bill of Rights a natural person and citizen of the U.S.A., has the right to bring a petition to the Inter-American Commission on Human Rights in support of his/her human rights as defined under International Human Rights law and the customary human rights norms.
Certain rights, such as the right to freedom from torture and freedom from non-consensual experimentation, are non-derogable, and as such, cannot be suspended even in times of national emergency. Human rights such as the prohibition against crimes against humanity, torture and non-consensual scientific or medical experimentation are considered to be absolute. There are implied erga omnes duties for the United States to prohibit non-consensual experimentation and torture.
The principle of the prohibition against non-consensual experimentation to be fundamentally norm-creating character and the widespread practice of protecting human subjects is considered legally or morally obligatory – Opinio Iuris.
The United States Congress has clearly indicated through the ratification of the ICCPR, (Article 7) that it is the purpose and the intent of Congress to protect persons from non-consensual experimentation.
The United States Congress has also implemented Article 7 of the ICCPR in domestic legislation to protect human subjects from non-consensual experimentation – The Common Rule (45 CFR Part 46). The United States Congress has made its intent clearly evident by 1) ratifying the ICCPR (including Article 7), 2) Holding extensive discussions regarding the ethical need for human subjects protections, 3) publishing The Belmont Report and 4) legislating The Common Rule.
The Common Rule (45 CFR Part 46) is federal legislation drafted and entered in force under proper constitutional procedures and thus it is enforceable by the Court.
By legislating The Common Rule through a thorough and detailed political process the United States federal government has expressed the political will of the people to protect and defend the rights of persons against non-consensual experimentation.
The Right to freedom from torture or cruel, inhuman or degrading treatment or punishment and freedom from medical or scientific experimentation is a human rights principle that has the status of jus cogens, and thus is ipso facto entrenched against treaty amendment or repeal.
Article 53 of Vienna Convention on The Law of Treaties (Signed at Vienna 23 May 1969), stated that “For the purposes of the present Convention, a peremptory norm of general international law is a norm accepted and recognized by the international community of States as a whole as a norm from which no derogation is permitted and which can be modified only by a subsequent norm of general international law having the same character.”
The United States has signed and ratified the International Covenant on Civil and Political Rights (ICCPR) and The Convention against Torture and Other Cruel, Inhuman or Degrading Treatment or Punishment (the United Nations Convention against Torture or CAT). Both treaties delineate the prohibition against torture. The ICCPR specifically identifies non-consensual experimentation within Article 7 of the ICCPR.
“No one shall be subjected to torture or to cruel, inhuman or degrading treatment or punishment. In particular, no one shall be subjected without his free consent to medical or scientific experimentation.”
Art. 2 of the ICCPR states that ‘[e]ach State Party… undertakes to respect and to ensure to all individuals within its territory and subject to its jurisdiction the rights recognized in the present Covenant …’
The ICCPR contains no provision on termination or withdrawal, and the Human Rights Committee in General Comment 26 of 1997 declared that there was no such intention so that a state may not withdraw from it.
Finally, Article 103 of the UN Charter provides that ‘[i]n the event of a conflict between the obligations of the Members of the United Nations under the present Charter and their obligations under any other international agreement, their obligations under the present Charter shall prevail’.
The ICCPR treaty should be interpreted in good faith and with liberal interpretation in order to protect the human rights of vulnerable persons. The canon of good faith stipulates that treaties “are to be kept in most scrupulous good faith,” and that a treaty “should be interpreted . . . in a manner to carry out its manifest purpose.”
If a treaty such as the ICCPR has the status of supreme federal law, and it creates or protects individual rights, then an individual whose rights under the treaty have been violated is entitled to a domestic judicial remedy. The Supremacy Clause supplements international law mechanisms for enforcing treaties by adding domestic mechanisms. The Supremacy Clause causes treaties to be assimilated treaties to federal statutes and the Constitution (the national legal system), thus obviating the differences in enforcement mechanisms that would otherwise exist between these forms of law. Among other things, the Supremacy Clause makes treaties enforceable in court at the request of individuals. Because it refers to “Judges,” the Supremacy Clause clearly contemplates that courts will enforce treaties, and, indeed, “[t]he province of the court is, solely, to decide on the rights of individuals.”
Chief Justice Marshall in Foster v. Neilson recognized that our Constitution, specifically the Supremacy Clause, establishes the general rule that treaties are enforceable in U.S. courts, just as the Constitution and federal statutes are.
Human subject research includes experiments and observational studies in basic biology, clinical medicine, nursing, psychology, and all other social sciences. There are various codes for the proper and responsible conduct of human experimentation in medical research, the best known of these codes are the Nuremberg Code of 1947, Anchor and the World Medical Organization’s Helsinki Declaration of 1964 (revised in 1975).
In the U.S.A., the Nuremberg Code and the related Declaration of Helsinki delineates what is considered ethical conduct for human subjects’ research and forms the basis for the US Code of Federal Regulations – Title 45 Volume 46 (The Common Rule). The Nuremberg Code’s influence on global human-rights law and medical ethics has been profound. Its basic requirement of informed consent, for example, has been universally accepted and is articulated in international law in Article 7 of the United Nations International Covenant on Civil and Political Rights (1966). ICCPR Article 7 states “No one shall be subjected to torture or to cruel, inhuman or degrading treatment or punishment. In particular, no one shall be subjected without his free consent to medical or scientific experimentation.”
The US Federal Policy for the Protection of Human Subjects or the “Common Rule” was codified in separate regulations by 15 Federal departments and agencies. The United States Department of Health and Human Services (HHS) regulations 45 CFR part 46 governs all federally-funded research in the United States. The Right to Informed Consent is delineated in the federal regulation Protection of Human Subjects, 45 CFR 46 also known as the Common Rule under the authority granted by the U.S. Department of Health and Human Services. There are also Welfare Codes for the conduct of social and behavioral research such as that published by the American Psychological Association in 1973.
These rights have been delineated in multiple international human rights documents and in the relevant case law, but unfortunately color of law, and color of official right violations of these rights routinely happen within mental health institutions, prison and correctional institutions, long term care facilities and in the provision of health care to financially disadvantaged populations.
The doctor-patient and doctor-human subject relationship is a relationship in which the doctor has great power and authority. In this imbalance of power, ethical violations of human rights can and do occur. The persons most vulnerable to exploitation as human subjects of medical research are those who are already marginalized and disadvantaged. Groups such as migrants, prisoners, children, people with disabilities, racial and ethnic minorities are more likely to be targeted by researchers.
There are many more cases of torture and ill-treatment in health-care settings than are officially reported to US authorities. Victim/survivors of this kind of abuse often are unable or unwilling to report what has happened to them. Thus, official reports represent only a small fraction of this problem. Ill treatment is not justified by health care system inadequacies or lack of medical resources. Individuals have the right to an adequate standard of health care (“right to health”). The right to be protected from torture and ill treatment also provides objective restrictions on certain kinds of therapies.
Inter-American Convention on the Elimination of All Forms of Discrimination against Persons with Disabilities, supra note 35, Preamble and Article III (1).
Article 12 of the Convention affirms the equal recognition before the law and legal capacity of the persons with disabilities. States Parties should: 1) Reaffirm that persons with disabilities have the right to recognition everywhere as a person before the law. 2) Recognize that persons with disabilities enjoy legal capacity on an equal basis with others in all aspects of life. 3) Take appropriate measures to provide access by persons with disabilities to the support they may require in exercising their legal capacity. 4) Ensure that all measures that relate to the exercise of legal capacity provide for appropriate and effective safeguards to prevent abuse in accordance with international human rights law. Such safeguards shall ensure that measures relating to the exercise of legal capacity respect the rights, will and preferences of the person, are free of conflict of interest and undue influence, are proportional and tailored to the person’s circumstance, apply for the shortest time possible and are subject to regular review by a competent, independent and impartial authority or judicial body. The safeguards shall be proportional to the degree to which such measures affect the person’s rights and interests.