found at “Fear and Loathing in Bioethics”
In Conversation with…John Banja, PhD
Editor’s Note: John Banja, PhD, is Assistant Director for Health Sciences and Clinical Ethics and Associate Professor of Clinical Ethics at Emory University School of Medicine. Dr. Banja, whose doctorate is in philosophy, is currently participating in AHRQ-funded studies designed to help clinicians communicate more effectively in emotionally charged situations after errors or unforeseen outcomes. His book, Medical Errors and Medical Narcissism, covers issues around the appropriate, ethical disclosure of medical errors by health care professionals.
Dr. Robert Wachter, Editor, AHRQ WebM&M: Tell us what you mean by medical narcissism.
Nope,no room for ethical lapses or traumatization here.:
“Guidance on Engagement of Institutions in Human Subjects Research”
“Research is defined in 45 CFR 46.102(d) as follows:
Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities.
Human subject is defined in 45 CFR 46.102(f) as follows:
Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains
1. (1) data through intervention or interaction with the individual, or
2. identifiable private information.
Intervention includes 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. Interaction includes communication or interpersonal contact between investigator and subject. Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects.
Institution is defined in 45 CFR 46.102(b) as any public or private entity or agency (including federal, state, and other agencies).
For purposes of this document, an institution’s employees or agents refers to individuals who: (1) act on behalf of the institution; (2) exercise institutional authority or responsibility; or (3) perform institutionally designated activities. “Employees and agents” can include staff, students, contractors, and volunteers, among others, regardless of whether the individual is receiving compensation.”
“An audience member at a lecture by Georgi Morozov on forensic psychiatry in the Serbsky Institute asked, “Tell us, Georgi Vasilevich, what is actually the diagnosis of sluggish schizophrenia?” Since the question was asked ironically Morozov replied ironically: “You know, dear colleagues, this is a very peculiar disease. There are not delusional disorders, there are not hallucinations, but there is schizophrenia!”“