Human Research Ethics. Roger L. Bertholf, Ph.D. Associate Professor of Pathology Chief of Clinical Chemistry & Toxicology University of Florida Health Science Center/Jacksonville. The Nuremberg Trials. The International Military Tribunal (1945) The Doctors Trial (1946)
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Roger L. Bertholf, Ph.D.
Associate Professor of Pathology
Chief of Clinical Chemistry & Toxicology
University of Florida Health Science Center/Jacksonville
15 of 23 guilty, 7 hanged, 5 life sentences
“Before IRBs, the only consent required was that of a researcher's department head. The Nuremberg Code was ignored in practice. As I look back on it, the interpretation of these codes was that they were necessary for barbarians, but not for fine upstanding people . . .”
Dr. William Silverman, Columbia pediatrician, on the postwar mentality
“ . . . the judgment of the investigator is not sufficient as a basis for reaching a conclusion concerning the ethical . . . set of questions.”
NIH panel that investigated studies at Jewish Chronic Disease Hospital
“The investigator’s judgment must be subject to prior peer review to ensure an independent determination of risks and benefits and . . .voluntary informed consent.”
NIH Director James Shannon, endorsed by Surgeon General William Steward, Feb 1966
Philadelphia Enquirer, 1972 as a basis for reaching a conclusion concerning the ethical . . . set of questions.”
“Ethical lapses are almost never cases of bad people, doing bad things, for no good reason. Rather, they are good people, doing bad things, for good reasons.”
Loosely quoting Marcia Angell, MD
former Editor-in-Chief, NEJM
GAO, OIG, OHRP, DHHS, NIH, FDA, AAMC, AAU, NBAC, Congress, media…
Univ of Minnesota doing bad things, for no good reason. Rather, they are good people, doing bad things, for good reasons.”
Univ of Rochester
West LA, VA Hosp
Univ of Ill - Chicago
Univ of Pennsylvania
Univ of Oklahoma
Johns HopkinsINSTITUTIONS SANCTIONED BY FEDERAL AGENCIES
A pathologist submits a protocol that would involve saving surgical specimens submitted from prostate surgeries for future studies using a new immunohistochemical method that may help predict the long term survival of prostate cancer patients. She believes her research is exempt from IRB review, since it does not put subjects at any risk, and involves tissues that would be discarded anyway.
A local biotechnology company is developing a test for genetic markers of asthma. As part of their validation protocol, the company needs to correlate the presence of the markers with asthma. They have offered your lab $150 for each blood specimen from a patient with the diagnosis of asthma. To protect themselves in case their records are audited, the company will require you to maintain a “key” that can be used to identify the source of each specimen, if necessary.
The manufacturer of a new birth control device wants to determine whether use of the device causes any side effects in women. Previous studies have demonstrated that the device is about 85% effective. Subjects must be fertile, discontinue any other form of birth control, and be involved in a monogamous sexual relationship. The purpose of the study and potential risks are adequately explained in the consent form, which the subject must sign to enroll. The device is free to participants, but no other payment is offered.
“. . .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.”
“. . .both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes.”
An ED physician wants to determine whether massive doses of TPA can help revive patients who have not responded to conventional resuscitative measures. He will only use this therapy in patients who otherwise would be pronounced dead. He submits a protocol that defines explicitly the circumstances under which a patient will become a candidate for the protocol, and requests a waiver of informed consent.