The Ethics of Research on Human Subjects

Research Activity on Human Subjects: Any systematic attempt to gain generalizable knowledge about humans A systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge A human subject is a living individual, about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information

Nuremburg Code (1946) “The voluntary consent of the human subject is absolutely essential” - research subjects should have legal capacity to consent, and the mentally disabled and children are not suitable subjects Research subjects “should be so situated as to be able to exercise free power of choice” – which means the American practice of using prisoners is at least questionable Human subjects “should have sufficient knowledge and comprehension of the elements of the subject matter involved as to make an understanding and enlightened decision” – ruling out the American practice of using the mentally disabled as subjects

UNETHICAL RESEARCH Nazi Doctors in WW II –Types of experiments: Hypothermia experiments – subfreezing water immersion Oxygen deprivation to learn about endurance Deliberate injection by lethal organisms Efficient sexual sterilization Efficient death –Research for the ends of war –Third Reich’s program for ‘racial hygiene’, purifying the German people by extermination and sterilization of groups –Nuremberg War Crime Trials

Tuskegee Syphilis Study African-American men from Tuskegee, Macon County, Alabama Observing the natural progression of secondary syphilis, for 40 years What was wrong? Ethical issues: –Not conscripted for World War II in case they might get treatment –Not treated with penicillin after 1943 –Not informed about the availability of penicillin Nuremberg Code not seen as applicable to the USA, even 25 years later President Clinton’s apology in 1996

The Belmont Report (1979) First US bioethics commission established – National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, created in terms of the National Research Act (1974) Commission charged with identifying the basic ethical principles that should underlie the conduct of human subjects research Summarizes the basic ethical principles identified by the Commission in the course of its deliberations

Research on Human Subjects Three basic ethical principles relevant to ethics of research involving human subjects: The expression “basic ethical principles” refers to those general judgments that serve as a basic justification for the many particular ethical prescriptions and evaluations of human actions. 1.Respect for persons 2.Beneficence 3.Justice

Respect for Persons Informed Consent Information –Clear and Cogent –Can be Understood by the Subject Consent –Voluntary –Free of Coercion and Undue Influence

Informed Consent & Surveys Clear information on the study: what, why, what risk, where will the info be reported, anonymity, voluntary participation Anonymous surveys and obtained consent forms will likely need to be separate documents Implied consent may be used in studies where there is less than minimal risk & surety that subjects do not fall in one of the protected categories Contact & sponsor information needs to be provided. Beneficence, if applicable, needs to be stated

Respect for Persons Protection of Persons with less Autonomy –Minors –Employees –Infirmed/Elderly –Prisoners –Mentally ill –Pregnant mothers Implied Consent: –Risk Free –Minimal Risk –Marginally above minimum Risk –Above minimal risk

Beneficence: An effort to secure people's well-being A decision about when it is justifiable to seek certain benefits despite the risks involved Secure the Well-Being of Patients –Do No Harm –Maximize Possible Benefits –Minimize Possible Harms

Justice Fair distribution of the benefits of research and the burdens of being a research subject The selection process as well as the outcome of the process must be fair Social, racial, sexual, and cultural biases must be avoided Selection of participants because of convenience or because they can be manipulated must be avoided