ISMPP Code of Ethics
Revised; Nov.1, 2016

CODE of ETHICS for MEDICAL RESEARCH PUBLICATION

PRINCIPLES for PUBLICATION PROFESSIONALS

PREAMBLE

The 2016 ISMPP Code of Ethics updates the shared values and ethical benchmarks for all medical publication professionals globally, regardless of whether they are ISMPP members.

Since the release of the previous ISMPP Code of Ethics in 2011, the medical publication environment has evolved to promote increased transparency and greater integrity. This 2016 ISMPP Code of Ethics advances ethical best practices, engages a broader community, and incorporates pivotal professional guidelines that have been published since 2011 and changes in legal and regulatory requirements. The 2016 ISMPP Code of Ethics also provides fundamental resources addressing good publication practice, recommendations regarding data sharing and increased transparency, and recognized guidelines for the ethical reporting of scientific and medical research.

The ISMPP Code of Ethics is a living document that will be updated periodically to maintain its relevance and remain harmonious with the ethical values of ISMPP and the medical publication profession.

ETHICAL PRINCIPLES

I. Principles for Publication Practices

  1. Ensuring medical publications are scientifically and ethically sound, and comply with laws, regulations, policies, and ethical principles governing professional practice and related activities;

  2. Ensuring that scientific and clinical integrity is an indispensable attribute of the publication development process and of the resulting publication;

  3. Opposing behavior that violates accepted ethical or legal standards;

  4. Providing precise and accurate information in all representations of qualifications, experience, competency, and performance of services; and

  5. Neither offering nor accepting inappropriate payments, gifts, or other benefits that could influence professional actions and judgment.

II. Applying Principles to Good Publication Practice

A. Publication Planning and Execution

  1. Adhering to the highest standards of applicable laws, accepted publication guidelines, and ethical guidelines on role-associated responsibilities, authorship, and content [see Appendix for generally accepted guidelines];

  2. Ensuring the timely reporting and publication of all study results regardless of outcome;

  3. Ensuring accuracy, completeness, and a lack of bias in publications;

  4. Providing clinical trial registry numbers for studies involving human subjects; and

  5. Strictly avoiding plagiarism, duplication, and any other unethical practices.

  6. Adhering to high standards for scientific rigor and excellence;

  7. Unbiased submission and review of manuscripts, regardless of source and content, including negative or inconclusive results;

  8. Submission and publication of manuscripts in a timely and appropriate manner;

  9. Implementation of robust procedures that detect, discourage, and rebuke ghostwriting, plagiarism, publication bias, and other unethical publication practices;

  10. Adoption of standard practices that require full disclosure of author contributions, financial and editorial support, and actual and potential conflicts of interest to their readership;

  11. Establishment of clear policies and guidelines governing the conduct of publication professionals including, but not limited to, requiring full disclosure of potential conflicts of interest; and

  12. Ensuring that the commercial needs and interests do not influence the scientific rigor of the publication review process.

  13. Accurate disclosure of all information regarding actual and potential conflicts of interest, including, but not limited to, compensation, stock ownership, intellectual property considerations, or other financial benefits or in-kind value provided;

  14. Providing appropriate information about financial contributions or other support relating to publication development, including, but not limited to, support for medical writing and sources of funding for studies being reported;

  15. Acknowledgment and accurate disclosure of the role of contributors who do not satisfy accepted authorship criteria;

  16. Opposition of guest authorship (authors who do not meet authorship criteria), ghost authorship (individuals who meet authorship criteria and are not identified or acknowledged), and ghost writing (the contributions of professional medical writers or other contributors who are not identified or acknowledged); and

  17. Ensuring that a conflict of interest does not compromise the legitimate interests of an employee, employer, client, customer, or contractor, nor influence or interfere with professional judgments.

B. Publication

  1. Adhering to high standards for scientific rigor and excellence;

  2. Unbiased submission and review of manuscripts, regardless of source and content, including negative or inconclusive results;

  3. Submission and publication of manuscripts in a timely and appropriate manner;

  4. Implementation of robust procedures that detect, discourage, and rebuke ghostwriting, plagiarism, publication bias, and other unethical publication practices;

  5. Adoption of standard practices that require full disclosure of author contributions, financial and editorial support, and actual and potential conflicts of interest to their readership;

  6. Establishment of clear policies and guidelines governing the conduct of publication professionals including, but not limited to, requiring full disclosure of potential conflicts of interest; and

  7. Ensuring that the commercial needs and interests do not influence the scientific rigor of the publication review process.

C. Disclosure

  1. Accurate disclosure of all information regarding actual and potential conflicts of interest, including, but not limited to, compensation, stock ownership, intellectual property considerations, or other financial benefits or in-kind value provided;

  2. Providing appropriate information about financial contributions or other support relating to publication development, including, but not limited to, support for medical writing and sources of funding for studies being reported;

  3. Acknowledgment and accurate disclosure of the role of contributors who do not satisfy accepted authorship criteria;

  4. Opposition of guest authorship (authors who do not meet authorship criteria), ghost authorship (individuals who meet authorship criteria and are not identified or acknowledged), and ghost writing (the contributions of professional medical writers or other contributors who are not identified or acknowledged); and

  5. Ensuring that a conflict of interest does not compromise the legitimate interests of an employee, employer, client, customer, or contractor, nor influence or interfere with professional judgments.

D. Intellectual Property Protection Principles

  1. Recognizing, respecting, and protecting the intellectual property rights and contributions of all, including copyright laws governing the use and distribution of published materials; and

  2. Prohibiting plagiarism, copying, or using in substantially similar form, materials prepared by others without proper acknowledgment or citation.

Appendix

A. Laws and Regulatory Agencies

  1. Food and Drug Administration Amendments Act (FDAAA) of 2007. Available here; accessed August 9, 2016

  2. Foreign Corrupt Practices Act (FCPA) of 1977. Available at: http://www.justice.gov/criminal/fraud/fcpa/; accessed August 9, 2016

  3. European Medicines Agency (EMA). Available at: http://www.ema.europa.eu/; accessed August 9, 2016

  4. Physician Payment Sunshine Act (part of Patient Protection and Affordable Care Act of 2010); information pertaining to disclosures available at: https://www.cms.gov/openpayments/; accessed August 9, 2016

  5. United Kingdom Bribery Act (UKBA) of 2010. Available at: http://www.legislation.gov.uk/ukpga/2010/23/contents; accessed August 9, 2016

B. Conduct and Reporting of Studies

  1. World Medical Association Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Subjects. Available at: http://www.wma.net/en/30publications/10policies/b3/index.html; accessed August 9, 2016

  2. Principles on Conduct of Clinical Trials and Communication of Clinical Trial Results (Pharmaceutical Research and Manufacturers of America [PhRMA]). Available at: http://www.phrma.org/principles-and-guidelines-clinical-trials; accessed August 9, 2016

  3. Joint Position on the Publication of Clinical Trial Results in the Scientific Literature. (IFPMA/EFPIA/JPMA/PhRMA). Available at: http://www.efpia.eu/uploads/Modules/Documents/20100610_joint_position_publication_10jun2010.pdf; accessed August 9, 2016

  4. The EQUATOR (Enhancing the QUAlity and Transparency Of health Research) Network. The EQUATOR Network provides access to more than 280 accepted guidelines. Available at: www.equator-network.org; accessed August 9, 2016

  5. Institute of Medicine. Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk. Available at: http://iom.nationalacademies.org/Reports/2015/Sharing-Clinical-Trial-Data.aspx; accessed August 9, 2016

C. Publication Guidelines

  1. Battisti WP, Wager E, Baltzer L, Bridges D, Cairns A, Carswell CI, et al. Good Publication Practice for Communicating Company-Sponsored Medical Research: GPP3. Ann Intern Med. 2015;163(6):461-464. Available at: http://annals.org/article.aspx?articleid=2424869; accessed August 9, 2016

  2. Norris R, Bowman A, Fagan JM, Gallagher ER, Geraci AB, Gertel A, et al. International Society for Medical Publication Professionals (ISMPP) position statement: the role of the professional medical writer. Curr Med Res Opin. 2007;23(8):1837-1840. Available at: http://www.ismpp.org/assets/docs/Certification/StudyMaterials/norris%202007.pdf; accessed August 9, 2016

  3. Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals (International Committee of Medical Journal Editors [ICMJE]). Updated December 2015. Available at: http://www.icmje.org/icmje-recommendations.pdf; accessed August 9, 2016

  4. Committee on Publication Ethics (COPE): Promoting Integrity in Research Publication. Available at: http://publicationethics.org/; accessed August 9, 2016

  5. Council of Science Editors’ White Paper on Promoting Integrity in Scientific Journal Publications 2012. Available at: www.councilscienceeditors.org/wp-content/uploads/entire_whitepaper.pdf; accessed August 9, 2016

  6. Mansi BA, Clark J, David FS, Gesell TM, Glasser S, Gonzalez J, et al. Ten recommendations for closing the credibility gap in reporting industry-sponsored clinical research: a joint journal and pharmaceutical industry perspective. Mayo Clin Proc. 2012;87(5):424-9. Available at: http://www.mayoclinicproceedings.org/article/S0025-6196(12)00298-4/fulltext; accessed August 9, 2016

  7. Marušić A, Hren D, Mansi B, Lineberry N, Bhattacharya A, Garrity M, Clark J, et al. Five-step authorship framework to improve transparency in disclosing contributors to industry-sponsored clinical trial publications. BMC Med. 2014;12:197. Available at: http://bmcmedicine.biomedcentral.com/articles/10.1186/s12916-014-0197-z; accessed August 9, 2016 

ISMPP Code of Ethics
Revised; Nov. 1., 2016