Value in Health
December 2017 Volume 20, Issue 10, p1227-1440
ISPOR Code of Ethics 2017 (4th Edition)
Jessica Santos, Francis Palumbo, Elizabeth Molsen-David, Richard J. Willke, Louise Binder, Michael Drummond, Anita Ho, William D. Marder, Louise Parmenter, Gurmit Sandhu, Asrul A. Shafie, David Thompson
Published online: December 1, 2017
As the leading health economics and outcomes research (HEOR) professional society, ISPOR has a responsibility to establish a uniform, harmonized international code for ethical conduct. ISPOR has updated its 2008 Code of Ethics to reflect the current research environment. This code addresses what is acceptable and unacceptable in research, from inception to the dissemination of its results.
There are nine chapters: 1 – Introduction; 2 – Ethical Principles respect, beneficence and justice with reference to a non-exhaustive compilation of international, regional, and country-specific guidelines and standards; 3 – Scope HEOR definitions and how HEOR and the Code relate to other research fields; 4 – Research Design Considerations primary and secondary data related issues, e.g., participant recruitment, population and research setting, sample size/site selection, incentive/honorarium, administration databases, registration of retrospective observational studies and modeling studies; 5 – Data Considerations privacy and data protection, combining, verification and transparency of research data, scientific misconduct, etc.; 6 – Sponsorship and Relationships with Others (roles of researchers, sponsors, key opinion leaders and advisory board members, research participants and institutional review boards (IRBs) / independent ethics committees (IECs) approval and responsibilities); 7 – Patient Centricity and Patient Engagement new addition, with explanation and guidance; 8 – Publication and Dissemination; and 9 – Conclusion and Limitations.