Re: RESADM-L Digest - 24 Jan 2000 to 25 Jan 2000 Nancy Peterson 28 Jan 2000 09:03 EST
Right off the bat, my first question is: How does this person "manage" the IRB? Is s/he the Chair? Does s/he make the IRB appointments? How is s/he "pursuing clinical trial business?' As a PI? Rounding up volunteers? Is his/her success in "pursuing business" directly dependent upon IRB approvals? Some times the easiest response to a "conflict of interest" and/or "ethical" question is" "Would you be absolutely comfortable responding to any questions raised?" ************************************************************************** Nancy Kay Peterson Director of Grants & Sponsored Projects Somsen Hall Room 202-C Winona State University Winona, MN 55987 Phone: 507.457.5519 Fax: 507.457.2415 xxxxxx@winona.msus.edu http://www.winona.msus.edu/grants/ Deborah Everds To: xxxxxx@HRINET.ORG <xxxxxx@NWU cc: .EDU> Subject: Re: RESADM-L Digest - 24 Jan 2000 to 25 Sent by: Jan 2000 Research Administratio n List <xxxxxx@hri net.org> 01/27/00 04:35 PM Please respond to Research Administratio n Discussion List
> >Topics of the day: > > 1. IRB and Clinical Trials (2) > >My question is related to the conduct and business of clinical trials and the management of IRB's. I had an investigator ask an intriguing question and want to hear from you all. This investigator has made reference to conflict of interest and ethics. I would appreciate any and all responses whether to this listserv or directly to me. > >Question: In a centralized research administration office, do you think there is a conflict of interest or any ethical problems if the person responsible for the management of the IRB also be involved in the pursuit of clinical trial business? > >Thank you. > > >Thane J. Peterson >Director of Research >Iowa Health System >1215 Pleasant, Suite 305 >Des Moines, Iowa 50309 > >515-241-5725 >515-241-4185 FAX Dear Thane: Here are some different articles and quotes I have put together regarding Conflicts of Interests. I have included some cites on this as well if you want to read further Institutions need to minimize the impact of conflicts of interests on their institutions, and be aware that regulatory oversight will probably become more stringent in this area. A conflict of interest is a set of conditions in which professional judgment concerning a primary interest (such as a patient's welfare or the validity of research) tends to be unduly influenced by a secondary interest (such as financial gain). In general, the primary interest of a physician, scholar, or other worker is determined by his or her professional duties, such as the health of patients or the integrity of research. "The secondary interest is usually not illegitimate in itself, and indeed it may even be a necessary and desirable part of professional practice. Only its relative weight in professional decisions is problematic. A conflict of interest differs from scientific misconduct, fraud, or plagiarism. For instance there is great potential for conflicts of interests for IRB members because many are researchers themselves and may be more interested in new scientific discoveries than protecting human research subjects. In addition, many institutions rely on the results of their clinical research for revenue, and a successful clinical trial is often critical to achieving large profits. An institution may exert pressure on IRB members so they can reap these rewards. (See David S. Shimm & Roy G. Spence, Jr., Conflict of Interest and Informed Consent in Industry-Sponsored Clinical Trials, 12 J. LEGAL MED. 477, 507 (1991); see, e.g., William Booth, Conflict of Interest Eyed at Harvard, 242 SCIENCE 1497, 1497.) Prudent stewardship of public funds that support research programs requires that appropriate steps be taken to ensure high quality results. Therefore, recipient organizations must establish safeguards to prevent employees, consultants, or members of governing bodies from using their positions for purposes that are, or give the appearance of being, motivated by a desire for private financial gain for themselves or others such as those with whom they have family, business, or other ties. Therefore, each institution receiving PHS funds must have written policy guidelines on conflict of interest and avoidance thereof. These guidelines should reflect state and local laws and must cover financial interests, gifts, gratuities and favors, nepotism, and other areas such as political participation and bribery. These rules must also indicate how outside activities, relationships, and financial interests are reviewed by the responsible and objective institution official(s). In addition, the institution has the responsibility for maintaining objectivity in research by ensuring that the design, conduct, or reporting of research will not be biased by any conflicting financial interest of investigators responsible for the research in accord with the provisions of PHS regulations 42 CFR Part 50, Subpart F, and 45 CFR Part 94. If this cannot be handled at the institutional level, the funding agency should be notified. (PHS Grants Policy Statement, Revised April 1, 1994, p. 8-18). Conflict of interest problems are further exacerbated by the reduced amount of governmental funding available for research. Since the 1970s, the NIH has been forced to dramatically reduce the amount of money available for research, even though the cost of scientific study has continued to increase. The shortage of government funding has caused many medical school faculty members to turn to industry to fund their research. To receive NIH or NSF funding all key personnel on NIH or NSF grant proposals must sign a Conflict of Interest form declaring they have no conflict of interest regarding the research they are proposing, or if they do they must fully disclose it. Institutions need to be aware of, and balance, the market pressures being born by the FDA and pharmaceutical companies to bring new drugs expeditiously to market, as well as, the institutions desire to obtain revenue for conducting these trials against the best interests of their patients, and their interest in limiting liability that could stem from conducting and or/participation in clinical trials. Regards, Deborah Research Administrator Cell & Molecular Biology Northwestern University Medical School 303 East Chicago Avenue Chicago, IL 60611 Phone: 312-503-4334 =================================== 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") ===================================