Conflicts of Interest Hopkins Study: Researchers Don’t Want to Disclose $$

 Disgruntled NIH scientists who want to suspend conflict of interest rules that prevent them from legally getting outside income from pharmaceutical and biotech companies hired polsters to poll affected scientits.

Half of NIH 8,000 employees responded to the poll which shows (a) that "nearly 40 percent" of scientists say they're looking fo other jobs; (b) "Among all NIH scientists, only 18 percent said they were trying to leave or considering it"–so which is it, 40% or 18%?
 
  According to the agency's principal deputy directors, "nearly nine in 10 scientists reported they still intend to work at NIH a year from now." Despite rumblings of low morale–" the scientists' job satisfaction rate of 81 percent reflects one of the government's most positive work forces."

Arthur Caplan, medical ethics chairman at the Center for Bioethics, University of Pennsylvania, said  "we still haven't figured out exactly how to manage conflict of interest." 
"To have a large number of the senior scientists unhappy spells trouble. You don't want them to retire or leave," he said. 

Of note, the U of Penn Center for Bioethics and its faculty have been criticized for legion financial conflicts of interest.  [1]

The findings of a  $3 million study by Johns Hopkins faculty confirm that researchers don't disclose the magnitude of their financial stake in the commercial aspect of their research. They don't want patients whom they recruit as test subjects to know how much of a financial investment they have in the testing of an experimental medical intervention.

Researchers' non-compliance with disclosure requirements renders the meaning of Informed Consent in medical research into a farce.

1.  "The pharmaceutical sponsors of the University of Pennsylvania Center for Bioethics and its faculty's projects are now facing multimillion dollar fraud sanctions (AstraZeneca), a Nigerian lawsuit for research abuse (Pfizer), massive class-action payouts (Wyeth-Ayerst), a criminal probe into obstruction of justice (Schering Plough), an ongoing fraud lawsuit (Merck and Medco), and allegations of suppressing research data on suicide in children (GlaxoSmithKline)." See: Dr. Carl Elliott, Not-So-Public Relations How the drug industry is branding itself with bioethics. SLATE
Dec. 15, 2003 at:  http://www.slate.com/id/2092442/ and  www.ahrp.org/cms/content/view/378/27

Contact: Vera Hassner Sharav
veracare@ahrp.org
 
~~~~~~~~~~~~~~~~~~~~~~~
Associated Press
Ethics rules send NIH scientists packing
By RITA BEAMISH,
Sat Oct 28, 2:27 PM ET

Nearly 40 percent of the scientists conducting hands-on research at the National Institutes of Health say they are looking for other jobs or are considering doing so to escape new ethics rules that have curtailed their opportunity to earn outside income.

Most scientists say the ethics crackdown is too severe, and nearly three-quarters of them believe it will hinder the government's ability to attract and keep medical researchers, according to a survey commissioned by the government's premier medical research agency.

The tightened rules were put in place last year after NIH found dozens of scientists had ran afoul of existing restrictions on private consulting deals that had enriched them with money from drug and biotechnology companies.

Outside income from such companies is now banned. NIH also is placing greater restrictions and disclosure requirements on employees' financial holdings.
"Of course we are concerned when any employees are saying they might consider leaving as a result of a change of policy," said Dr. Raynard Kington, the agency's principal deputy director. But he said in a telephone interview Friday that the survey results are muddy because they combine both those actively seeking to leave and those thinking about it.

NIH Director Elias Zerhouni, in a letter Thursday to the staff, said the survey "does suggest concerns about the impact of the regulations on recruitment and retention." But he added, "At this time we do not anticipate revisions in the regulations."

About 8,000 NIH employees, or about half the work force, responded to the Internet-based survey.
Employee job satisfaction was high overall, the survey found. But 39 percent of the scientists researching disease and cures — known as tenure and tenure-track scientists — said they actively were seeking new work or considering leaving NIH because of the rules.

Overall, 3,336 NIH scientists responded to the survey, including 512 tenure and tenure-track researchers.
Among all NIH scientists, only 18 percent said they were trying to leave or considering it. Those who are not in the tenure group typically do not conduct research themselves and instead manage outside research conducted with NIH money by universities and other nonfederal entities. They are less likely to have private consulting opportunities.

One-third of all NIH scientists said they believed the new rules will hurt NIH's ability to fulfill its mission, and most said the old rules could have been enforced better rather than tightened.
NIH officials said they now want to question former and potential employees to see how the changes influenced their decisions.

Kington highlighted a finding that nearly nine in 10 scientists reported they still intend to work at NIH a year from now. Despite rumblings of low morale, he said the scientists' job satisfaction rate of
81 percent reflects one of the government's most positive work forces.

Officials also emphasized employees' belief that the new rules will boost the agency's credibility with the public. Seventy-three percent of the employees who responded agreed with that, the survey found.
"We have to monitor closely and we'll continue do that, and if we show through our evaluations objective evidence of an impact on our ability to recruit and retain the smartest staff, scientific and nonscientific, that we can, then we will be the first ones to make the case for modifying the rules, but we're not there yet," Kington said.

One NIH administrator who left over the ethics rules said the agency's changes were handled poorly.
"Dedicated public servants were harassed right out of NIH. That's a disservice to us all," said Edward Maibach, the former associate director of the biggest NIH component, the National Cancer Institute. He is now director of Public Health Communication at the George Washington University. Maibach said he left the NCI nearly two years ago because new financial disclosure requirements invaded his privacy.

The changes are "a dramatic backlash," to earlier policies encouraging outside work by NIH scientists to speed practical application of scientific advances, he said.
Arthur Caplan, medical ethics chairman at the University of Pennsylvania, said tighter rules were needed but "we still haven't figured out exactly how to manage conflict of interest."
"To have a large number of the senior scientists unhappy spells trouble. You don't want them to retire or leave," he said.

"The leaders of the NIH and in Congress have to think a bit harder about giving a tiny bit of breathing room so that NIH scientists are not sent into a monastery from which they can't ever come out in the name of scientific integrity."
___
On the Web:
NIH survey: http://www.nih.gov/about/ethics/evaluationslides.pdf
Memo on survey results: http://www.nih.gov/about/ethics/10262006COImemo.htm

FAIR USE NOTICE: This may contain copyrighted (© ) material the use of which has not always been specifically authorized by the copyright owner. Such material is made available for educational purposes, to advance understanding of human rights, democracy, scientific, moral, ethical, and social justice issues, etc. It is believed that this constitutes a 'fair use' of any such copyrighted material as provided for in Title 17 U.S.C. section 107 of the US Copyright Law. This material is distributed without profit.

FOR IMMEDIATE RELEASE
Berman Bioethics Institute
at Johns Hopkins University
Office of Communications
Media Contact: Ed Bodensiek
410-516-8523;
ebodensiek@jhu.edu 

September 8, 2006
U.S. Clinical Researchers Resist Full Financial Disclosure, According to Conflicts-of-Interest Study
Too Much Disclosure Can Burden Informed Consent Process, Study Participants Say

Researchers and officials charged with the ethical oversight of research are often reluctant to fully disclose financial interests to potential clinical research participants, according to the latest Conflict-of-Interest Notification Study (COINS), just published in the Fall 2006 issue of the Journal of Law, Medicine and Ethics.

 Instead, those interviewed suggest a better approach for such disclosures would be to offer potential research participants a range of dollars or even use adjectives such as a “substantial investment” to describe the extent of a researcher’s financial interest.

The study, a survey of attitudes, beliefs and practices among members of institutional review boards, conflict-of-interest committees and researchers, reveals a key reason for the reluctance among researchers to share the full dollar amount: the belief that because potential research subjects may lack the sophistication to put conflicts of interest in context, they may overestimate the influence of money on the researcher’s behavior and possibly refuse to participate.

“The findings raise important questions about the informed consent process,” said principal investigator Jeremy Sugarman, M.D., the Harvey M. Meyerhoff Professor of Bioethics and Medicine at The Berman Bioethics Institute at Johns Hopkins University. “Some researchers appear to believe that because disclosing any dollar amount could influence a person’s decision of whether or not to participate in a clinical trial, the dollar amount shouldn’t be revealed at all. Instead, the person should only be told that a financial interest exists, but there’s widespread disagreement on how to do it.

Should researchers name the source of their funds? Should the disclosure highlight potential consequences of the financial relationship? When and how should all of that be disclosed?”
The ongoing Conflict of Interest Notification Study (COINS) was initiated to establish a framework for developing policy and practices for disclosing conflict of interest in research. The $3 million dollar, five-year study is funded by the National Heart, Lung, and Blood Institute of the National Institutes of Health. Respondents in the study’s latest results were solicited from 40 academic medical centers, independent hospitals, independent institutional review boards, and unaffiliated research entities. The study is conducted by Duke University Medical Center, Wake Forest University and Johns Hopkins University.

All 40 of the researchers, conflict-of-interest committee chairs, and institutional review board chairs interviewed for the study say that when a financial interest does exist, that interest should be disclosed, albeit in limited ways short of full disclosure. For example, some participants in the COINS study believed that the sheer complexity required by full disclosures could detract attention away from the actual decision of whether or not to participate in the trial itself. Such financial interests often range from intellectual property interests to consulting fees to other special arrangements.

Others believe that full disclosure should be made to include the dollar amount and source of funding, but in a straightforward, simple manner to minimize confusion among potential clinical trial participants.
“The ultimate goal of the project is to provide a framework for establishing sound policy and practices for disclosing conflict of interest in clinical research,” said Kevin Weinfurt, Ph.D , deputy director of the Center for Clinical and Genetic Economics at the Duke Clinical Research Institute. “We are hoping that the data we’re collecting will benefit officials who are struggling with the best ways of minimizing potential risks to study subjects and advancing the cause of clinical science.”

Many of the study’s respondents suggest that disclosure of financial interests take place at the beginning of the informed consent process, when information about the risks and benefits of participation are initially presented. While there are concerns about disclosing the full dollar amounts of financial interests, respondents said that the disclosure of the existence of such financial interests should occur because it:
– enables informed decision-making,
– promotes trust in researchers and research institutions, and
– reduces the risk of legal liability.

“The previous COINS study demonstrated a variety of conflict-of-interest policies at medical institutions across the United States, but no real settled opinion on how to move forward. Now the latest results tell us that researchers and their officials charged with oversight want to disclose financial conflicts of interest, and almost always for the right reasons, they just disagree on how to do it,” said Jeremy Sugarman.

“There is a clear need to next gather data on exactly how potential research participants would use different forms of disclosure in their decision-making. That way, we might better respect the integrity of the research enterprise while better protecting the rights and interests of research participants.”

Institutional review boards are panels of experts at research institutions that evaluate and approve studies involving humans, while conflict of interest committees ensure that individual researchers and institutions do not have financial conflicts.

About the Berman Bioethics Institute at Johns Hopkins University
One of the largest centers of its kind in the world, the Berman Bioethics Institute is the home for collaborative scholarship and teaching on medical and public health ethics at the Johns Hopkins University. Since 1995, the institute has applied a deep, multidisciplinary pool of bioethics expertise to help government agencies, non-governmental organizations, and private sector organizations all over the world. Using various methods of inquiry drawn from the biological, behavioral, and social sciences, the institute’s faculty members help reveal complex moral challenges on the horizon, develop new frameworks for decision-making and ethical analysis, and work toward ethically acceptable alternatives in medical, scientific, and public health policy. The institute also runs numerous academic training programs and fellowships to prepare the next generation of bioethics experts, and hosts various educational events throughout the year to help elevate the public discourse on bioethics. The institute is funded by individual donors, foundations, and public research grants. More information is available at www.bioethicsinstitute.org.
~~~~~~~~~~~~~~~~~~~~~~~~~~~