Hello- Let me add my 2 cents here. Yes, if an institution is receiving federal funding, it needs an IRB (and is it is good idea to have one anyway for a myriad of reasons). However, a huge dilemma is brewing, especially among social scientists. Based on a few cases of GROSS failure to properly manage research programs that result in harm to participants, some schools have been heavily sanctioned by the feds, whose policies now do have some sharp teeth. However, the prevailing portrait of the ORI as a predator, looking for any deviation of federal policy so that it can yank the institutions' research program is way, way, way overblown. The fallout from the prevailing image is that IRBs are becoming paranoid, afraid to approve any study that has an ounce of potential controversy. This hits the social scientists especially hard because much of what we do is controversial in someone's eyes. The cycle continues. Social scientists are increasingly resentful of IRBs and their members (quite a literature on this already), charging, among other things, arrogance, incompetence, anti-science bias, and the like. And the truth is that many IRB members are neither truly "up" on federal policy and/or they have never, themselves, done any empirical research. (At my last university one IRB chair was a history professor.) So, now you often hear of a real antagonism between IRBs and investigators--not a healthy situation for science. I have an ORI grant to study this problem. Data are still raw, but I will post a summary when available. I think you will find it interesting.
Patricia Keith-Spiegel, PhD on 10/15/02 10:11 PM, [EMAIL PROTECTED] at [EMAIL PROTECTED] wrote: > > > Marie makes a very good point about the issue of federal funding. Of course, > it > can be a wide issue because while a particular study which is not funded might > be found in violation, if there is any federal funding AT ALL coming into an > institution, it can all be frozen--that is a violation in a nonfunded study > can > result in suspension of funds to a funded study within an institution. > > In addition, while it's probably true that you only have to follow the CFR to > maintain federal funding, I think that in our litiginous society it is not a > bad idea, anyway, to follow the federal codes. It certainly provides one with > a > good cushion in case of legal problems! The problem, generally, is that many > universities ARE being sued over what may seem like relatively innocuous > studies--even survey studies. > > The whole brou ha ha, as I understand it, that nearly shut down Virginia > Commonwealth University, started with an objection by a relative of a subject, > to a couple of survey items, from a questionnaire that was part of a larger > study, and from there snowballed into an avalanche. > > So, I'd still say that to follow the federal codes is probably a smart > idea.... > > Annette > > Quoting Marie Helweg-Larsen <[EMAIL PROTECTED]>: > >> The original note from David Daniel does not indicate whether his >> university is receiving federal funding for human subjects research. The >> federal guidelines (that Annette provides a link to) only have to be >> followed IF the university is required to follow federal IRB guidelines >> which (as I understand it) they only have to do if they receive federal >> funding for research with human subjects. Perhaps David can expand here: >> are you asking what the federal guidelines require or are you asking >> what would be good for a voluntary IRB? >> Marie >> >> Annette Taylor wrote: >> >>> I think that federal codes ALWAYS supercede any "local" guidelines, >>> including APA guidelines. Note the difference between a "code" >>> and a "guideline". >>> >>> You should go to >>> http://ohrp.osophs.dhhs.gov/humansubjects/guidance/45cfr46.htm >>> where all of the details are spelled out precisely, including the >>> composition of the committee. And yes, you do need a community member... >>> >>> annette >>> >>> >>> >>> On Tue, 15 Oct 2002, David B. Daniel, Ph.D. wrote: >>> >>> >>> >>>> I think this has been discussed before but: What is the optimal >> membership >>>> make-up of a human subjects review board? We have a proposal to include a >>>> community member, an administrator and several faculty. Just wondering. >>>> >>>> David >>>> >>>> >>>> \\|// >>>> (o o) >>>> --------oOOo-(_)-oOOo---------------- >>>> >>>> David B. Daniel, Ph.D. >>>> Department of Psychology Associate Research Scientist >>>> University of Maine at Farmington New England Research Institutes >>>> 234 Main Street >>>> Farmington, ME 04938 >>>> 207-778-7411 >>>> [EMAIL PROTECTED] >>>> >>>> >>>> >>>> --- >>>> You are currently subscribed to tips as: [EMAIL PROTECTED] >>>> To unsubscribe send a blank email to [EMAIL PROTECTED] >>>> >>>> >>>> >>> >>> Annette Taylor, Ph. D. >>> Department of Psychology E-mail: [EMAIL PROTECTED] >>> University of San Diego Voice: (619) 260-4006 >>> 5998 Alcala Park >>> San Diego, CA 92110 >>> >>> "Education is one of the few things a person >>> is willing to pay for and not get." >>> -- W. L. Bryan >>> >>> >>> >>> --- >>> You are currently subscribed to tips as: [EMAIL PROTECTED] >>> To unsubscribe send a blank email to [EMAIL PROTECTED] >>> >>> >> >> >> >> --- >> You are currently subscribed to tips as: [EMAIL PROTECTED] >> To unsubscribe send a blank email to [EMAIL PROTECTED] >> > > > > --- > You are currently subscribed to tips as: [EMAIL PROTECTED] > To unsubscribe send a blank email to [EMAIL PROTECTED] --- You are currently subscribed to tips as: [EMAIL PROTECTED] To unsubscribe send a blank email to [EMAIL PROTECTED]
