Navigation Links
Policies regarding IRB members' industry relationships often lacking
Date:3/24/2009

At a time of heightened concern about conflicts of interest posed by relationships between academic medical researchers and commercial firms, a new study finds that a significant number of academic institutions do not have clear policies covering the industrial relationships of members of Institutional Review Boards (IRBs), committees charged with ensuring that clinical studies uphold patient rights and follow ethical guidelines. In the April issue of Academic Medicine, researchers from the Massachusetts General Hospital (MGH) Institute for Health Policy report that many IRBs do not require members to disclose industrial relationships and that procedures for defining, reporting and handling conflicts vary widely among institutions.

"This study points to an obvious need for more consistent policies and accountability in regards to industry relationships within IRBs," says lead author Christine Vogeli, PhD. "IRBs and medical schools can't manage what they don't know, so consistent reporting among IRB members is vital to ensuring the integrity and safety of medical research."

Every institution in the U.S. that conducts research involving human participants must have an IRB, which is responsible for reviewing proposed studies to make sure the rights and safety of participants are protected and that study protocols are scientifically valid and follow ethical and regulatory guidelines. IRBs also monitor the conduct of studies to make sure that appropriate practices are maintained. In 2006 MGH Institute of Health Policy researchers, including the authors of the current study, published a survey of IRB members regarding their personal industrial relationships, whether their IRBs had policies or processes regarding such relationships, and their own actions regarding protocols related to companies with which they had relationships.

The current study surveyed the chairs of IRBs at 107 U.S. medical schools and research hospitals regarding how their committees managed members' industrial relationships, whether members were required to disclose such relationships, how and to whom conflicts were disclosed, and where responsibility for overseeing such conflicts should reside. While nearly 75 percent of chairs reported their IRBs had a defined process for disclosure of industry relationships, of the 25 percent without such processes, only one had any requirement that voting members disclose relationships.

Written policies defining conflicts of interest were reported by 68 percent of chairs, the others indicating they did not have or were not aware of such policies. Chairs of IRBs without written conflict definitions indicated that responsibility for determining whether a conflict existed was left to the chair, the whole IRB, another group or individual, or that members would assess their own relationships. Policies describing how conflicts should be handled were reported by 74 percent of chairs.

Among chairs who reported dealing with a member conflict of interest in the past year, 68 percent indicated that conflicted members had never participated in discussions about the protocols in question or left the room when votes were taken. Although all of the chairs that had dealt with a recent conflict reported no conflicted members ever voted on protocols in which they had an interest, in the 2006 survey of IRB members, one third of respondents reported that they had voted on such a protocol at least once.

"It is shocking that, after more than 20 years of talking about industry relationships and conflicts of interest, there are still IRBs out there that haven't dealt with this issue," says Eric G. Campbell, PhD, of the MGH Institute for Health Policy, the study's senior author. "It also is clear that many IRB chairs have no clue about the behavior of their members who have industry relationships. The IRB is the primary mechanism medical schools and hospitals have to ensure the appropriate conduct of clinical research, and IRBs without clear, well-defined and enforced policies about conflicts of interest cannot accomplish their fundamental mission,"


'/>"/>

Contact: Sue McGreevey
smcgreevey@partners.org
617-724-2764
Massachusetts General Hospital
Source:Eurekalert

Related medicine news :

1. MaxLife Fund Corp. purchases a portfolio of Life Settlement Policies with a face value of $4,000,000
2. Statement from Employment Policies Institute on Senator Hillary Clintons Health Care Plan
3. New Survey Reveals Kidney Patients Concern About Medicare Policies
4. TV Documentary Examines Three Decades of Tobacco Politics, Policies and People in Minnesota
5. Draft Rules Wont Stop Insurers Illegal Cancellations of Health Policies
6. U of M study: Medicare lacks tools, incentives to enforce evidence-based coverage policies
7. New Academic Analysis Identifies Three Barriers to Achieving Healthy and Achievable Policies to Combat Obesity in America
8. Statement From Mens Health Network: U.S. Presidential Candidates Overlook Real Problem in U.K. & U.S. Health Policies Towards Men
9. APHA Adopts New Policies on Food Safety, Global Climate Change, Multidrug-Resistant Organisms, Breastfeeding and Feminine Hygiene
10. Health Net Hit With Class Action Alleging Unfair Business Practices Over Retroactive Cancellations of Health Insurance Policies
11. Space sentinels: New tools in space to improve European environment and security policies
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/26/2016)... ... 2016 , ... Quality metrics are proliferating in cancer care, and are derived ... eye of the beholder, according to experts who offered insights and commentary in the ... Care. For the full issue, click here . , For the American Society ...
(Date:6/26/2016)... ... June 26, 2016 , ... Many ... been diagnosed with endometriosis. These women need a treatment plan to not only ... approach that can help for preservation of fertility and ultimately achieving a pregnancy. ...
(Date:6/25/2016)... ... June 25, 2016 , ... First Choice Emergency ... named Dr. Sesan Ogunleye, as the Medical Director of its new Mesquite-Samuell Farm facility. ... Director of our new Mesquite location,” said Dr. James M. Muzzarelli, Executive Medical Director ...
(Date:6/24/2016)... ... June 24, 2016 , ... A recent article published June ... with. The article goes on to state that individuals are now more comfortable seeking ... common operations such as calf and cheek reduction. The Los Angeles area medical group, ...
(Date:6/24/2016)... ... June 24, 2016 , ... Global law firm Greenberg Traurig, P.A. announced ... attorneys chosen by their peers for this recognition are considered among the top 2 ... received special honors as members of this year’s Legal Elite Hall of Fame: ...
Breaking Medicine News(10 mins):
(Date:6/26/2016)... June 26, 2016 One of Australia,s ... the formation of a new biotechnology company, Noxopharm Limited [ABN 50 ... an IPO and to list on the ASX. Noxopharm ... ready to enter a Phase 1 clinical study later this year. ... address one of the biggest problems facing cancer patients - the ...
(Date:6/26/2016)... Jazz Pharmaceuticals plc (Nasdaq: JAZZ ) announced ... Act of 1976, as amended ("HSR"), with respect to ... CPXX ) expired effective June 24, 2016, ... previously announced on May 31, 2016, Jazz Pharmaceuticals and ... Jazz Pharmaceuticals has commenced a tender offer for all ...
(Date:6/26/2016)... , June 27, 2016  VMS Rehab Systems, Inc. ... will take whatever measures required to build a strong ... which is currently listed on the OTC Markets-pink current ... Chairman and CEO, "We are seeing an anomaly in ... understand, not only by the Company, but shareholders and ...
Breaking Medicine Technology: