Psych IRB Lecture notes & Inhumane Experiments PDF

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IRB: Institutional review board
Informed Consent
Nurenburg Code
Protected Populations, Animals
Declaration of Helsinksi ...

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PSYCH 203 Montclair State University Spring 2017 Notes #3 ___________________________________________________________________ INSTITUTONAL REVIEW BOARDS (IRBs): An institutional review board (IRB), also known as an independent ethics committee (IEC), ethical review board (ERB), or research ethics board (REB), is a type of committee used in research in the United States that has been formally designated to approve, monitor, and review biomedical and behavioral research involving humans. They often conduct some form of risk-benefit analysis in an attempt to determine whether or not research should be done. The purpose of the IRB is to assure that appropriate steps are taken to protect the rights and welfare of humans participating as subjects in a research study. Exempt Research: when there is no risk or minimal risk. Risks:

Physical Harm, Psychological Harm, Loss of Privacy, Confidentiality.

Benefits:

Effective Treatment, Money, Prize, Information, Satisfaction, Attention.

___________________________________________________________________ INFORMED CONSENT: Informed consent is a process for getting permission before conducting a healthcare intervention on a person. A health care provider may ask a patient to consent to receive therapy before providing it, or a clinical researcher may ask a research participant before enrolling that person into a clinical trial. Informed consent is collected according to guidelines from the fields of medical ethics and research ethics. An informed consent can be said to have been given based upon a clear appreciation and understanding of the facts, implications, and consequences of an action. To give informed consent, the individual concerned must have adequate reasoning faculties and be in possession of all relevant facts. Impairments to reasoning and judgment that may prevent informed consent include basic intellectual or emotional immaturity, high levels of stress such as PTSD or a severe intellectual disability , severe mental illness, intoxication, severe sleep deprivation, Alzheimer's disease, or being in a coma. Some acts can take place because of a lack of informed consent. In cases where an individual is considered unable to give informed consent, another person is generally authorized to give consent on his behalf, e.g., parents or legal guardians of a child (though in this circumstance the child may be required to provide informed assent) and conservators for the mentally ill. In cases where an individual is provided insufficient information to form a reasoned decision, serious ethical issues arise. Such cases in a clinical trial in medical research are anticipated and prevented by an ethics committee or Institutional Review Board.

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___________________________________________________________________ OTHER: Protected Populations: pregnant women, prisoners, minors, minorities, intellectually disabled. Deception, Debriefing: Ethics and Animal Research:

~7% of published psychological research Institutional Animal Care and Use Committee (IACUC)

Fraud vs Plagiarism:

___________________________________________________________________ NURENBURG CODE (1947): On August 20, 1947, the judges delivered their verdict in the "Doctors' Trial" against Karl Brandt and 22 others. These trials focused on doctors involved in the human experiments in concentration camps. The suspects were involved in over 3,500,000 sterilizations of German citizens. The trials began on December 9, 1946 in Nuremberg, Germany and were led exclusively by the United States. Harry Truman approved these trials in January 1946. Several of the accused argued that their experiments differed little from pre-war ones and that there was no law that differentiated between legal and illegal experiments. In May of the same year, Dr. Leo Alexander had submitted to the Counsel for War Crimes six points defining legitimate medical research. The trial verdict adopted these points and added four. The ten points constituted the "Nuremberg Code". Although the legal force of the document was not established and it was not incorporated directly into either the American or German law, the Nuremberg Code and the related Declaration of Helsinki are the basis for the Code of Federal Regulations Title 45 Part 46, which are the regulations issued by the United States Department of Health and Human Services governing federally funded human subjects research in the United States. The Nuremberg code includes such principles as informed consent and absence of coercion; properly formulated scientific experimentation; and beneficence towards experiment participants. 1. Required is the voluntary, well-informed, understanding consent of the human subject in a full legal capacity. 2. The experiment should aim at positive results for society that cannot be procured in some other way. 3. It should be based on previous knowledge (like, an expectation derived from animal experiments) that justifies the experiment. 4. The experiment should be set up in a way that avoids unnecessary physical and mental suffering and injuries. 5. It should not be conducted when there is any reason to believe that it implies a risk of death or disabling injury. 6. The risks of the experiment should be in proportion to (that is, not exceed) the expected humanitarian benefits.

7. Preparations and facilities must be provided that adequately protect the subjects against the experiment’s risks. 8. The staff who conduct or take part in the experiment must be fully trained and scientifically qualified. 9. The human subjects must be free to immediately quit the experiment at any point when they feel physically or mentally unable to go on. 10. Likewise, the medical staff must stop the experiment at any point when they observe that continuation would be dangerous.

___________________________________________________________________ DECLARATION OF HELSINKI (1964): The Declaration of Helsinki is a set of ethical principles regarding human experimentation developed for the medical community by the World Medical Association. It is widely regarded as the cornerstone document on human research ethics. It is not a legally binding instrument under the international law, but instead draws its authority from the degree to which it has been codified in, or influenced, national or regional legislation and regulations. Its role was described by a Brazilian forum in 2000 in these words "Even though the Declaration of Helsinki is the responsibility of the World Medical Association, the document should be considered the property of all humanity.” The Declaration was originally adopted in June 1964 in Helsinki, Finland, and has since undergone seven revisions (the most recent at the General Assembly in October 2013) and two clarifications, growing considerably in length from 11 paragraphs in 1964 to 37 in the 2013 version. The Declaration is an important document in the history of research ethics as it is the first significant effort of the medical community to regulate research itself, and forms the basis of most subsequent documents. Prior to the 1947 Nuremberg Code there was no generally accepted code of conduct governing the ethical aspects of human research, although some countries, notably Germany and Russia, had national policies. The Declaration developed the ten principles first stated in the Nuremberg Code, and tied them to the Declaration of Geneva (1948), a statement of physicians' ethical duties. The Declaration more specifically addressed clinical research, reflecting changes in medical practice from the term 'Human Experimentation' used in the Nuremberg Code. A notable change from the Nuremberg Code was a relaxation of the conditions of consent, which was 'absolutely essential' under Nuremberg. Now doctors were asked to obtain consent 'if at all possible' and research was allowed without consent where proxy consent, such as a legal guardian, was available. The 1975 revision was almost twice the length of the original. It clearly stated that "concern for the interests of the subject must always prevail over the interests of science and society." It also introduced the concept of oversight by an 'independent committee' which became a system of Institutional Review Boards (IRB) in the US, and research ethics committees or ethical review boards in other countries. In the United States regulations governing IRBs came into effect in 1981. 'Legal guardian' was replaced with 'responsible relative'. The duty to the individual was given primacy over that to society, and concepts of publication ethics were introduced.

__________________________________________________________________ BELMONT REPORT (1978): The Belmont Report is a report created by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. Its full title is the Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research, Report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Report was issued on 30 September 1978 and published in the Federal Register on 18 April 1979. The Report took its name from the Belmont Conference Center where the document was drafted in part. The Belmont Report summarizes ethical principles and guidelines for research involving human subjects. Three core principles are identified: respect for persons, beneficence, and justice. Three primary areas of application are also stated. They are informed consent, assessment of risks and benefits, and selection of subjects.

___________________________________________________________________ TUSKEGEE SYPHILIS EXPERIMENT (1932 – 1972): A clinical study conducted between 1932 and 1972 in Tuskegee, Alabama, by the U.S. Public Health Service. In the experiment, 400 impoverished black males who had syphilis were offered "treatment" by the researchers, who did not tell the test subjects that they had syphilis and did not give them treatment for the disease, but rather just studied them to chart the progress of the disease. By 1947, penicillin became available as treatment, but those running the study prevented study participants from receiving treatment elsewhere, lying to them about their true condition, so that they could observe the effects of syphilis on the human body. By the end of the study in 1972, only 74 of the test subjects were alive. 28 of the original 399 men had died of syphilis, 100 were dead of related complications, 40 of their wives had been infected, and 19 of their children were born with congenital syphilis. The study was not shut down until 1972, when its existence was leaked to the press, forcing the researchers to stop in the face of a public outcry.

___________________________________________________________________ GUATEMALA SYPHILIS EXPERIMENT (1946 -1948): A United States-led human experiment conducted in Guatemala from 1946 to 1948. It was done during the administration of American President Harry S. Truman and Guatemalan President Juan José Arévalo with the cooperation of some Guatemalan health ministries and officials. Doctors infected soldiers, prostitutes, prisoners and mental patients with syphilis and other sexually transmitted diseases, without the informed consent of the subjects, and treated most subjects with antibiotics. This resulted in at least 83 deaths. In October 2010, the U.S. formally apologized to Guatemala for conducting these experiments.

___________________________________________________________________ MILGRAM EXPERIMENT ON OBEDIENCE TO AUTHORITY FIGURES (1961): A series of social psychology experiments conducted by Yale University psychologist Stanley Milgram. They measured the willingness of study participants, men from a diverse range of occupations with varying levels of education, to obey an authority figure who instructed them to perform acts conflicting with their personal conscience; the experiment found, unexpectedly, that a very high proportion of people were prepared to obey, albeit unwillingly, even if apparently causing serious injury and distress. Milgram first described his research in 1963 in an article published in the Journal of Abnormal and Social Psychology and later discussed his findings in greater depth in his 1974 book, Obedience to Authority: An Experimental View. The experiments began in July 1961, in the basement of Linsly-Chittenden Hall at Yale University, three months after the start of the trial of German Nazi war criminal Adolf Eichmann in Jerusalem. Milgram devised his psychological study to answer the popular question at that particular time: "Could it be that Eichmann and his million accomplices in the Holocaust were just following orders? Could we call them all accomplices?" The experiments have been repeated many times in the following years with consistent results within differing societies, although not with the same percentages around the globe.

___________________________________________________________________ STANFORD PRISON EXPERIMENT (1971): A study on the psychological effects of becoming a prisoner or prison guard. The experiment was conducted at Stanford University on August 14–20, 1971, by a team of researchers led by psychology professor Philip Zimbardo using college students. It was funded by the U.S. Office of Naval Research and was of interest to both the U.S. Navy and Marine Corps as an investigation into the causes of conflict between military guards and prisoners. The experiment is a classic study on the psychology of imprisonment and is a topic covered in most introductory psychology textbooks. The participants adapted to their roles well beyond Zimbardo's expectations, as the guards enforced authoritarian measures and ultimately subjected some of the prisoners to psychological torture. Many of the prisoners passively accepted psychological abuse and, at the request of the guards, readily harassed other prisoners who attempted to prevent it. The experiment even affected Zimbardo himself, who, in his role as the superintendent, permitted the abuse to continue. Two of the prisoners quit the experiment early, and the entire experiment was abruptly stopped after only six days, to an extent because of the objections of graduate student Christina Maslach, whom Zimbardo was dating (and later married). Certain portions of the experiment were filmed, and excerpts of footage are publicly available.

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