ISPOR CODE OF ETHICS FOR RESEARCHERS

Task Force Chair:
Francis Palumbo PhD, JD, Director, University of Maryland Center on Drugs & Public Policy, Baltimore, Maryland, USA

Task Force Group:
Rod Barnes, MBA, Director, Health Economics, Alcon Laboratories, Fort Worth, Texas, USA
Patricia Deverka, MD, MS, Vice President, Scientific Affairs, Merck-Medco Managed Care LLC, Franklin Lakes, New Jersey, USA
William McGhan, PharmD, PhD, Professor, University of the Sciences in Philadelphia, Pennsylvania, USA
Lawrence Mullany, MD, MBA, Regional and Pharmacy Medical Director, AvMed Health Plan, Gainesville, Florida, USA
Albert Wertheimer, MBA, PhD, Temple University School of Pharmacy, Philadelphia, Pennsylvania, USA

ISPOR CODE OF ETHICS FOR RESEARCHERS

Prepared by the ISPOR Code of Ethics Task Force
Approved by the ISPOR Board of Directors January 13, 2003
 

PREAMBLE
ISPOR, as an organization, expects itself and its members to adhere to the highest ethical standards. In doing so, ISPOR recognizes that its activities and that of its members affect a number of constituencies and these include but are not limited to:

• Patients who are ultimately going to experience the greatest impact of the research.
• Decision-makers and Administrators who need results that are both practical and useful.
• Practitioners who will be treating or not treating patients with therapies, medications and procedures made available or not made available because of the research.
• Government Groups who require the results of research to set policy.
• The profession of outcomes researchers
• Payers who must decide what is covered without compromising the health of the patient.
• Colleagues, where relationships in conducting research and its related activities are particularly critical.
• Research employees and how they are regarded, compensated and treated by the researchers for whom they work
• Students who work for researchers, where respect and lack of exploitation are important. They are the future of the profession.
• Employers where the research affects their decisions on providing health benefits
• Clients for whom the research is conducted and the researchers ’ relationships with them.

The following code of ethics for members of the International Society for Pharmacoeconomics and Outcomes Research includes ethical considerations for ISPOR members on research practices, research sponsorship, research publication and dissemination, and relationships with others. This code of ethics also includes ethical considerations for the Society.
The code is something to which we believe all ISPOR members should aspire. However, we recognize that members' own organizations may also have ethical codes that should be followed. We also recognize legal considerations may sometimes be important, for example in relation to employment law. Therefore the code is advisory rather than mandatory and ISPOR welcomes an ongoing debate about ethical standards in the field of pharmacoeconomics and outcomes research.

DESIGN AND RESEARCH PRACTICES

• Members should maintain a current knowledge of research practices.
• Members should adhere to the standards of practice for their respective fields of research and identify any official guidelines/standards used
• Members’ research designs should be defined a priori, reported transparently, defended relative to alternatives, and planned to minimize all types of bias
• Members should respect the rights of research subjects in designing and conducting studies.
• Members should respect the reputations and rights of colleagues when engaged in collaborative projects.
• Members should maintain and protect the integrity of the data used in their studies.
• Members should not draw conclusions beyond those, which their data would support.

• Members should fully disclose the identity of sponsors of their research.
• Members should strive to avoid bias and the appearance of bias in conducting research.
• Members should avoid conflicts of interest and the appearance of conflicts of interest. As a point of reference, members should look to the rules on disclosure of interest laid down by major peer reviewed journals.
• Members should maintain their professional autonomy and objectivity in conducting and reporting research.

• Members should endeavor to publicly disseminate all their work, and to publish it in peer reviewed journals when possible.
• Members should discourage, where possible, listing of an author on any publication where the individual has not performed substantial work. As a point of reference, members should look to the checklists provided by major peer reviewed journals to assist them in deciding inclusion of authors.
• Members should respect contractual rights when they agree to perform work for hire and should refrain from disseminating information, which it was agreed, in advance and at the time the contract was signed, would remain proprietary.
• Methods sections of papers should give thorough, transparent attention to all measures taken to minimize bias
• Methods sections of papers should identify and defend all departures from the a priori analysis plan
• Members should discourage the exclusion of an author from any publication where the individual has performed substantial work.
• Members should work with editors of journals and other publications to encourage an appropriate peer review process that examines the quality of the methodological rigor independently of the institution for which the individual works. Nonetheless any contributor should disclose relationships with a company or competitor of any product discussed in the work.

• Members should treat their research employees with respect and should compensate them fairly for their work.
• Members should protect and promote the interests of their employers, provide competent work, adhering to these broader guidelines, and protect proprietary information.
• Members should treat students with respect and refrain from exploiting them under any circumstances.
• Members should provide competent, honest and objective work for clients, adhering at all times to relevant standards of conduct for conducting and reporting research.

• ISPOR should publicize this code of ethics to members and non-members.
• ISPOR should strive for a balance in sponsorship of its conferences and other activities, thereby avoiding the appearance of bias or conflict of interest.
• Because, as a practical matter, most funding will come from commercial interests, ISPOR should issue its own statement of objectivity and autonomy from sponsors.
• ISPOR should strive to assure that its journal, Value in Health, only publishes papers that have gone through a rigorous peer- review process.
• ISPOR should have a Board of Directors that is representative of the various constituencies the society serves.
• ISPOR program, planning and selection committees should have membership representative of all of its major constituencies.
  
  
  For ISPOR Code of Ethics for Researchers background information, see:
  http://www.ispor.org/workpaper/healthscience/TFCodeEthics.pdf.
  Background information for the ISPOR Code of Ethics for Researchers is also published in Value in Health. The Value in Health citation for this report is:
  Palumbo F, Barnes R, Deverka, M, McGhan W, Mullany L, Wertheimer A.
  ISPOR Code of Ethics for Researchers Background Article - Report of the ISPOR Task Force on Code of Ethics for Researchers. Value Health 2004;7:111-117. See http://www.ispor.org/workpaper/CodeBackground.pdf.