Barbara We have had this happen in a couple of instances, each time the IRB did not review it until it has a proper signature. Once we found it before the review began and called the Dept Chair. The other time we didn't realize it until after the review was started and we held it and notified the Dept. Chair. In once instance the chair withdrew the IRB application. In the other instance the Chair allowed it to go forward after his review and a written warning was placed in the faculty members personnel file, in both instances the Dean was notified. One of the faculty members is no longer at the school. We felt that this was an extremely serious matter and the IRB was prepared to act, if the School Chair or Dean did not. If you can't trust an investigator to get the appropriate signatures prior to the study being started, how can you trust them not to falsify the data once the study begins? I hope this helps. Barbara J. LoDico, B.S., CIP Executive Director, Human Subject Protections University of Medicine & Dentistry of New Jersey Human Subjects Protection Program Office 65 Bergen Street, Suite 507 Newark, NJ 07107-2000 P.O. Box 1709 xxxxxx@umdnj.edu Phone: 973-972-1149 Fax: 973-972-1598 Beeper: 973-421-0670 voice message: 866-208-6365 -----Original Message----- From: Research Administration List [mailto:xxxxxx@hrinet.org]On Behalf Of Mike McCallister Sent: Thursday, November 13, 2003 10:06 AM To: xxxxxx@hrinet.org Subject: Re: [RESADM-L] Forged Signature on IRB Application Off with their heads! Off with their heads! Spanky At 08:37 AM 11/13/2003, you wrote: >Hi Barbara, >If this in in fact a forgery, that PI has done a dreadful thing in signing her >own permission slip! Regardless of the innocuos nature of the procedure she is >planning, it is still a major breach of the highest magnitude, and it should >never, ever happen. >How do you know it is a forgery? >If it is, she should under no circumstances be allowed to proceed, and if you >all overlook it, you are tacitly giving approval by failure to act. >In this case I don't think the students' short term needs come first; a model >of ethical behavior is absolutely required, and the ends do not justify the >means. Whatever follows from that is what the institution has to face up to >and deal with, even if it is major unpleasantness. >I don't think your office should even have to determine what to do; it should >come from the President's office. >Roberta > >Barbara Gray wrote: > > > Compliance/IRB staffers out there, how would you deal with this situation? > > > > We require department chairs to sign off on human subject applications. > > A faculty member is in a rush to have an human subject protocol approved > > (under expedited criteria) for a very innocuous procedure--virtually no > > risk at all except it is a phyical measurement that does not fit within > > exemption criteria. (Note that the project involves students who will > > be collecting the data as part of a class assignment.) She indicates > > she'll just sign for her chair, we indicate that she can't do that, and, > > lo and behold, the signature page comes in a couple of days later with > > the chair's signature forged. > > > > Would you take this to her chair? Her dean? The provost? Would you > > prohibit her from implementing the protocol (which will impact the > > students in her class)? Would you bar her from doing human subject > > research for a period of time? Is this "misconduct" that should be > > referred for handling through ORI regs? (note that we've made our > > misconduct policy applicable to all research and scholarship, not just > > that funded externally or by the Feds.) Personally, I find the faculty > > member's action offensive and unethical (if not downright illegal)--if > > she will do this on an application, might she do the same someday on a > > consent form?? But, in the big scheme of things, is this worth going to > > the mat on? After all, it's only falsification of an internal > > signature, not scientific data.... > > > > Thanks. > > > > -- > > ================================================================== > > Barbara H. Gray, Director > > Office of Research & Grants Administration > > College of Charleston > > 66 George Street > > Charleston, SC 29424 > > Campus Location: 407-G Bell Bldg. > > Office: 843.953.5673 Desk: 843.953.5885 Fax: 843.953.6577 > > e-mail: xxxxxx@cofc.edu URL: http://www.orga.cofc.edu/ > > ================================================================== > > > > ====================================================================== > > Instructions on how to use the RESADM-L Mailing List, including > > subscription information and a web-searchable archive, are available > > via our web site at http://www.hrinet.org (click on "Listserv Lists") > > ====================================================================== > > >====================================================================== > Instructions on how to use the RESADM-L Mailing List, including > subscription information and a web-searchable archive, are available > via our web site at http://www.hrinet.org (click on "Listserv Lists") >====================================================================== Mike McCallister, Ph.D. Office of Research and Sponsored Programs University of Arkansas at Little Rock 2801 South University Little Rock, AR 72204-1099 (o) 501-569-8474 (c) 501-590-5609 (f) 501-371-7614 http://www.ualr.edu/orsp/ Better blatant than latent. ====================================================================== Instructions on how to use the RESADM-L Mailing List, including subscription information and a web-searchable archive, are available via our web site at http://www.hrinet.org (click on "Listserv Lists") ====================================================================== ====================================================================== Instructions on how to use the RESADM-L Mailing List, including subscription information and a web-searchable archive, are available via our web site at http://www.hrinet.org (click on "Listserv Lists") ======================================================================
