Featured Research

from universities, journals, and other organizations

Model Language Unveiled To Help Clinical Researchers Disclose Financial Conflicts

Date:
January 21, 2007
Source:
Johns Hopkins University
Summary:
There is near-universal agreement about the need for clinical researchers to disclose financial interests to research participants, but until now there has been little guidance available on exactly how to do it. Using an empirically-based approach, team creates new tool to do the right thing.

Facing a wide range of practices on how financial conflicts of interest are disclosed to potential clinical research participants, experts at Johns Hopkins University, Duke University, and Wake Forest University have published new language designed to help clinical researchers better disclose their financial interests in research. Featured in the January 2007 issue of IRB: Ethics and Human Research, the new language is designed to provide guidance for researchers seeking to properly disclose the types of financial interests most commonly found in clinical research.

"There is near-universal agreement about the need for clinical researchers to disclose financial interests to research participants, but until now there has been little guidance available on exactly how to do it," said principal investigator Jeremy Sugarman, M.D., the Harvey M. Meyerhoff Professor of Bioethics and Medicine at the Johns Hopkins Berman Institute of Bioethics. "Our team looked beyond the need for disclosure. We researched how it should be done. Using an empirically-based approach, we have helped create the right tools to do the right thing. The new language is a model for others to use, test, and improve upon."

Developed as part of an ongoing, $3 million-dollar project called the Conflict of Interest Notification Study (COINS), the new disclosure statements are designed to be used in written materials provided to potential research participants before giving their informed consent.

"If you are thinking about participating in a clinical research trial, you should understand what you are getting yourself into, and that includes any financial interests involved," said Kevin Weinfurt, Ph.D., deputy director of the Center for Clinical and Genetic Economics at the Duke Clinical Research Institute. "We also recognized that people vary in their informational needs. So to provide adequate disclosure to all people, we included a core statement in the new disclosure language that's to be made available to everyone. We then added an explicit invitation for potential research participants to ask for more detail."

After extensive focus group testing and multiple rounds of review by representatives of Institutional Review Boards, the COINS project team has unveiled the following generic disclosure for situations in which a financial interest exists but does not present a measurable risk to a research participant.

***The person leading this medical research study might benefit financially from this study. The Institutional Review Board and a committee at ABC University have reviewed the possibility of a financial benefit. They believe that the possible financial benefit to the person leading the research is not likely to affect your safety and/or the scientific quality of the study. If you would like more information, please ask the researchers or the study coordinator.***

The new model language also includes specific language for situations in which there may be risks to participants. The team categorized this additional language by the nine types of financial interests most commonly encountered in clinical research, including:

  • Salary support
  • Money received outside of the study
  • Per capita payments
  • Finders' fees restricted to research uses
  • Unrestricted finders' fees
  • Researchers holding a patent
  • Universities holding a patent
  • Researchers owning equity
  • University owning equity

"The determination of risk to potential research participants can be complex, and varies by research institution. Individual institutions using the new language may want to modify key phrases to suit their purposes," said Jeremy Sugarman. "This is language that can help these institutions craft better written materials. It can also help serve as a model for how to accurately phrase disclosure in discussions with potential research participants. It could even be expanded and presented in other formats, such as stand-alone pamphlets or videos about clinical research."

"The COINS project is about providing a framework for establishing sound policy and practices for the disclosure of conflicts of interest in clinical research," said Kevin Weinfurt. "Toward that end, we have developed something practical: working disclosure language. We hope that others will want to use the new language as a template to further refine the options for appropriate disclosure, and ultimately, minimize potential risks to research subjects."

The Conflict of Interest Notification Study (COINS) was initiated to establish a framework for developing policy and practices for disclosing conflicts 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. The new disclosure language for researchers' use was developed through the use of focus group testing, cognitive pre-testing to evaluate participants' understanding, and numerous, subsequent expert panel reviews and revisions.

About the Johns Hopkins Berman Institute of Bioethics

One of the largest centers of its kind in the world, the Johns Hopkins Berman Institute of Bioethics is the home for collaborative scholarship and teaching on the ethics of clinical practice, public health, and biomedical science at Johns Hopkins University. Since 1995, the Institute has worked with governmental agencies, non-governmental organizations, and private sector organizations to address and resolve ethical issues. Institute faculty represent such disciplines as medicine, nursing, law, philosophy, public health, and the social sciences. Their works helps anticipate and inform debates on complex moral challenges; discerns ethically acceptable alternatives in medical, scientific, and public health policy; and helps to prepare the next generation of bioethicists. More information is available at http://www.bioethicsinstitute.org.


Story Source:

The above story is based on materials provided by Johns Hopkins University. Note: Materials may be edited for content and length.


Cite This Page:

Johns Hopkins University. "Model Language Unveiled To Help Clinical Researchers Disclose Financial Conflicts." ScienceDaily. ScienceDaily, 21 January 2007. <www.sciencedaily.com/releases/2007/01/070119144454.htm>.
Johns Hopkins University. (2007, January 21). Model Language Unveiled To Help Clinical Researchers Disclose Financial Conflicts. ScienceDaily. Retrieved July 25, 2014 from www.sciencedaily.com/releases/2007/01/070119144454.htm
Johns Hopkins University. "Model Language Unveiled To Help Clinical Researchers Disclose Financial Conflicts." ScienceDaily. www.sciencedaily.com/releases/2007/01/070119144454.htm (accessed July 25, 2014).

Share This




More Health & Medicine News

Friday, July 25, 2014

Featured Research

from universities, journals, and other organizations


Featured Videos

from AP, Reuters, AFP, and other news services

Beatings and Addiction: Pakistan Drug 'clinic' Tortures Patients

Beatings and Addiction: Pakistan Drug 'clinic' Tortures Patients

AFP (July 24, 2014) A so-called drugs rehab 'clinic' is closed down in Pakistan after police find scores of ‘patients’ chained up alleging serial abuse. Duration 03:05 Video provided by AFP
Powered by NewsLook.com
Too Few Teens Receiving HPV Vaccination, CDC Says

Too Few Teens Receiving HPV Vaccination, CDC Says

Newsy (July 24, 2014) The Centers for Disease Control and Prevention is blaming doctors for the low number of children being vaccinated for HPV. Video provided by Newsy
Powered by NewsLook.com
New Painkiller Designed To Discourage Abuse: Will It Work?

New Painkiller Designed To Discourage Abuse: Will It Work?

Newsy (July 24, 2014) The FDA approved Targiniq ER on Wednesday, a painkiller designed to keep users from abusing it. Like any new medication, however, it has doubters. Video provided by Newsy
Powered by NewsLook.com
Doctor At Forefront Of Fighting Ebola Outbreak Gets Ebola

Doctor At Forefront Of Fighting Ebola Outbreak Gets Ebola

Newsy (July 24, 2014) Sheik Umar Khan has treated many of the people infected in the Ebola outbreak, and now he's become one of them. Video provided by Newsy
Powered by NewsLook.com

Search ScienceDaily

Number of stories in archives: 140,361

Find with keyword(s):
Enter a keyword or phrase to search ScienceDaily for related topics and research stories.

Save/Print:
Share:

Breaking News:
from the past week

In Other News

... from NewsDaily.com

Science News

    Health News

      Environment News

        Technology News



          Save/Print:
          Share:

          Free Subscriptions


          Get the latest science news with ScienceDaily's free email newsletters, updated daily and weekly. Or view hourly updated newsfeeds in your RSS reader:

          Get Social & Mobile


          Keep up to date with the latest news from ScienceDaily via social networks and mobile apps:

          Have Feedback?


          Tell us what you think of ScienceDaily -- we welcome both positive and negative comments. Have any problems using the site? Questions?
          Mobile: iPhone Android Web
          Follow: Facebook Twitter Google+
          Subscribe: RSS Feeds Email Newsletters
          Latest Headlines Health & Medicine Mind & Brain Space & Time Matter & Energy Computers & Math Plants & Animals Earth & Climate Fossils & Ruins