IRBs and the Practice of Research Ethics. November 7, 2012. Objectives. Abbreviated historical context What is an IRB? Review criteria Informed Consent Confidentiality Conflicts of Interest Vulnerable Populations Challenges for faith-based care. The technological imperative.
November 7, 2012
---J. Robert Oppenheimer
“The Commission believes that the rights of subjects should be protected by local review committees operating pursuant to federal regulations located in institutions where research involving human subjects is conducted. Compared to the possible alternatives of a regional or national review process, local committees have the advantage of greater familiarity with the
IRB ultimately determines level of risk.
Retrospective review is forbidden by law.
Note: Specific review criteria are provided by law (FDA and DHHS) with exceptions and/or additional rules for particular categories of research
Note: “Each IRB needs to articulate its own financial reasonableness standards for research-related costs in order to evaluate whether subjects are adequately protected” (KM Hunt in Amdur & Bankert).
Note: This includes negative results and “gag orders” Sponsors may want in contracts
OHRP lists these:
OHRP list continued:
“[I]n a scientific age, it is too easy to raise ethical questions with a frivolous conscience and to no serious purpose. A man of frivolous conscience announces that there are ethical quandaries ahead that we must urgently consider before the future catches up with us. By this he often means that we need to devise a ‘new ethics’ that will provide the rationalization for doing in the future what men are bound to do because of the novel interventions and procedures that science will soon make possible. . . Such a person is of
“Let us all remember that a slower progress in the conquest of disease would not threaten society, grievous as it is to those who deplore that particular disease be not yet conquered, but that society would indeed be threatened by the erosion of those moral values whose loss, possibly caused by too ruthless a pursuit of scientific progress, would make its most dazzling triumphs not worth having.” ---Hans Jonas