TY - JOUR
T1 - ISPOR Code of Ethics 2017 (4th Edition)
AU - Santos, Jessica
AU - Palumbo, Francis
AU - Molsen-David, Elizabeth
AU - Willke, Richard J.
AU - Binder, Louise
AU - Drummond, Michael
AU - Ho, Anita
AU - Marder, William D.
AU - Parmenter, Louise
AU - Sandhu, Gurmit
AU - Shafie, Asrul A.
AU - Thompson, David
N1 - This is an author-produced version of the published paper. Uploaded in accordance with the publisher’s self-archiving policy.
PY - 2017/12/1
Y1 - 2017/12/1
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=85035349993&partnerID=8YFLogxK
U2 - 10.1016/j.jval.2017.10.018
DO - 10.1016/j.jval.2017.10.018
M3 - Article
C2 - 29241881
AN - SCOPUS:85035349993
SN - 1098-3015
VL - 20
SP - 1227
EP - 1242
JO - Value in Health
JF - Value in Health
IS - 10
ER -