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:5/26/2016)... ... May 26, 2016 , ... There are nearly 14.5 million ... million cancer survivors worldwide. On Sunday, June 5, 2016, communities around the world will ... Survivors Day®. , National Cancer Survivors Day® is an annual worldwide Celebration of ...
(Date:5/26/2016)... , ... May 26, 2016 , ... In an effort to provide hair restoration information ... both Snapchat users and those who do not use the app. Dr. Mohebi, the founder ... page, Dr. Mohebi Live . , Dr. Mohebi says, “The positive response to ...
(Date:5/26/2016)... ... May 26, 2016 , ... North Cypress Medical ... at Blackhorse Golf Club in Cypress. With the help of community partners, the event ... empowers, and renews hope for wounded service members and their families through health, wellness, ...
(Date:5/26/2016)... ... May 26, 2016 , ... Power Systems, a leading developer ... Instructor Certification Course in Stoughton, Massachusetts. The course was led by Power Systems’ ... 8 hour interactive course to qualify participants as certified PowerWave trainers. , ...
(Date:5/26/2016)... ... ... The introduction of our professional athletes coincides with the company’s new campaign: “LOOK ... are proud to introduce Meghan Klingenberg, defender and World Champion with the US Women’s ... Los Angeles who was a second round selection in the 2012 NFL draft. We ...
Breaking Medicine News(10 mins):
(Date:5/24/2016)... -- Open Access Journal Focusing on ... Elsevier , a world-leading provider of scientific, technical ... launch of Clinical Neurophysiology Practice ... clinical practice issues in clinical neurophysiology. The journal will ... and didactic reviews. It is an official journal of ...
(Date:5/23/2016)... , May 23, 2016 ... Handling Equipment Market by Product (Wheelchair, Scooters, Medical ... (Bariatric Care, Critical Care, Wound), Accessories (Lifting, Transfer) ... to 2021", published by MarketsandMarkets, the patient handling ... Billion by 2021 at a CAGR of 10.5% ...
(Date:5/23/2016)... ALBANY, New York , May 23, 2016 /PRNewswire/ ... new market report titled, " Exocrine Pancreatic Insufficiency Market ... Forecast 2013 - 2023 ." According to the report, ... at a CAGR of 8.3% from 2015 to 2023 ... pancreatic insufficiency (EPI) is a condition characterized by the ...
Breaking Medicine Technology: