Regulations
IRB Review
Researchers
Research Ethics
History
100
The probability of harm or injury (physical, psychological, social, or economic) occurring as a result of participation in a research study
What is a risk as defined in regulation?
100
Purpose, background, resources available to conduct and monitor the research, study design (inclusion, exclusion criteria, procedures involved in the research, risks from the research
What information is reviewed by IRB members to make required determinations about risks?
100
Providing a CV, documenting that a medical license is valid, and providing evidence of research ethics training
What are ways of ensuring the researcher has adequate qualifications and expertise?
100
The moral obligation to act for the benefit of others, helping them to further their important and legitimate interests, often by preventing or removing possible harms and making efforts to secure their well-being.
What is beneficence?
100
A classic experiment in social psychology, conducted for 6 days in 1971. Undergraduate students at a prestigious private university were divided into "guards" and "prisoners" and sent to a mock "prison". Some guards became sadistic, and engaged in increasingly pornographic and violent activities to control "prisoners"; some prisoners suffered mental breakdowns. One prisoner developed a psychosomatic rash over his entire body when he learned that his parole request had been turned down. The study demonstrated how social environments can create situations that transform ordinary individuals into willing perpetrators or victims of evil, and serves as an example of how social and behavioral research can present real risks to participants.
What is the Stanford Prison Experiment?
200
The probability and magnitude of harm or discomfort anticipated in the proposed research are not greater, in and of themselves, than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests
What is minimal risk as defined in regulation?
200
Requiring that researchers demonstrate their qualifications, and that they have adequate resources to monitor participants; changing selection criteria to exclude persons at highest risk; substituting non-invasive procedures, when possible, or using procedures already being performed for treatment or diagnostic purposes; and when indicated requiring pregnancy testing are examples of points IRB members can consider when making this determination.
What is minimizing risks by using procedures which are consistent with sound research design and do not unnecessarily expose subjects to risk?
200
Research subject's belief that enrolling in a research trial will provide direct therapeutic benefit, despite what appears to be an adequate informed consent process.
What is therapeutic misconception?
200
Many highly secretive and classified studies were conducted on US citizens and residents between 1944-1994 funded by Central Intelligence Agency and the United States military. These studies offered no benefit, and involved substantial risks; research continued after federal regulations governing research were approved. The studies involved some of the most prestigious research institutions and universities in the US, including the University of California, Los Angeles; University of Chicago; Vanderbilt University; and federal research laboratories including Brookhaven National Laboratory, Hanford Sites, Lawrence Berkeley Laboratory, Lawrence Livermore National Laboratory, Los Alamos National Laboratory, and Oak Ridge Sites. President Clinton offered an official apology in 1995. As of 2010, no U.S. government researchers have been prosecuted.
What are the human radiation experiments?
300
A description of any reasonably foreseeable risks or discomforts to the subject
What is a required consent disclosure about risks?
300
Research on cancer clusters was reported in the press and property values declined.
What are economic risks?
300
Clinicians are expected to recognize patients' wishes, including a right to refuse treatment even if the physician (rightly) thinks the patient is mistaken. Physicians should not deceive or withhold information from patients. But if risks are not reasonable, or if risks are not minimized, then IRBs--not patients or physicians--may deny research. In short: autonomy rules in clinical practice, and another principle rules in research.
What is paternalism?
300
The National Research Act of 1974 established the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, and mandated that the Public Health Service to come up with regulations that would protect the rights of human research subjects. This report, published in 1979, identified the basic ethical principles that should underlie the conduct of biomedical and behavioral research involving human subjects.
What is the Belmont Report?
400
The long-range effects of applying knowledge gained in the research (for example, the possible effects of the research on public policy)
What is a type of risk that does not fall under the purview of the IRB?
400
Research on migrant laborers resulted in participants being arrested on drug charges and being deported.
What are legal risks?
400
An ethical test for clinical studies, requiring that at the outset of a trial there exists a state of honest, professional disagreement in the community of expert practitioners as to the preferred treatment. To justify exposing participants to risk, the IRB must conclude that the evidence supporting the various therapeutic procedures is sufficient that, were it widely known, expert clinicians would disagree as to the preferred treatment.
What is clinical equipoise?
400
A clinical research study, conducted between 1932-1972 sponsored and continuously supervised by the U.S. Department of Health. Studied the effects of untreated syphilis in 400 African American men. Researchers withheld treatment even when penicillin became widely available.
What is the US Public Health Service Tuskegee Study of Untreated Syphilis in the Negro Male (the Tuskegee study)?
500
The probability and magnitude of physical or psychological harm that is normally encountered in the daily lives, or in the routine medical, dental, or psychological examination of healthy persons.
What is the regulatory definition of minimal risk for studies involving prisoners?
500
Scheduling research procedures (such as blood draws) so they coincide with medical visits, or scheduling surveys and interviews at times when a participant will already be at the research facility are examples.
What are examples of using procedures already being performed on subjects for diagnostic or treatment purposes?
500
This ethical theory was developed by Mill and Bentham, who sought a single, coherent, scientific, and objective moral principle for individuals and governments. Here is the principle: Actions are right in proportion to their promotion of happiness, and wrong as they produce the reverse.
What is Utilitarianism?
500
Problems caused by this drug resulted in the Kefauver-Harris Drug Amendments Act in 1962, which gave the FDA the authority to require that manufacturers demonstrate safety and effectiveness of drugs prior to marketing and sale, and prevented research on unapproved drugs without FDA's approval. The drug was attractive as a non-barbiturate tranquilizer; it was even marketed over the counter in some European countries in the 1950s. But problems such as phocomelia highlighted the need for a rigorous drug approval process and improved surveillance.
What is thalidomide?
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