ISMPP Code of Ethics
Revised; Jan. 29, 2019

CODE of ETHICS for MEDICAL RESEARCH PUBLICATION

PRINCIPLES for PUBLICATION PROFESSIONALS

PREAMBLE

The 2019 ISMPP Code of Ethics details the shared global values and ethical benchmarks for all medical publication professionals, regardless of ISMPP membership.

The ISMPP Code of Ethics is periodically revised to reflect contemporary best practices in the work of medical publication professionals. This 2019 version incorporates recent updates to pivotal professional guidelines, along with changes in legal and regulatory requirements, which have occurred since the 2016 iteration. The 2019 ISMPP Code of Ethics also recognizes the broadening community involved in medical research, including patients and patient organizations and the important role of ISMPP in creating and updating Good Publication Practice guidelines for industry. Furthermore, the 2019 code further emphasizes best practice in transparency at all stages of the publication process, including appropriate data sharing. The 2019 ISMPP Code of Ethics continues to draw and build on fundamental resources of relevance to publication professionals, with the ultimate goal of furthering medicine for the benefit of patients.

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. Ensure medical publications are scientifically and ethically sound, and comply with laws, regulations, policies, and best publication practices (including collaboration with patient organizations, when appropriate);

  2. Support publication best practices through the periodic update and independent publication of Good Publication Practice (GPP) guidelines for industry;

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

  4. Oppose behavior that violates accepted ethical or legal standards;

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

  6. Neither offer nor accept inappropriate or undisclosed 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. Adhere 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. Ensure authors and those responsible for the integrity of the data have timely access to all relevant original data sources;

  3. Ensure the timely reporting and publication of all study results regardless of outcome and in accordance with local laws and regulations;

  4. Ensure accuracy, completeness, availability, and a lack of bias in publications;

  5. Provide clinical trial registry numbers for clinical trials involving human subjects; and

  6. Avoid plagiarism, duplication, and any other unethical practice.

B. Publication

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

  2. Disclose commercial interests of the publication medium and those involved for transparency;

  3. Provide unbiased submission and review of manuscripts, regardless of their source and content, including data or study design limitations, negative or inconclusive results;

  4. Ensure submission and publication of manuscripts in a timely and appropriate manner;

  5. Advocate for transparent review procedures for submitted manuscripts according to published guidelines and take steps to vet publisher credentials to avoid data publishing with deceptive/predatory congresses or journals;

  6. Implement robust procedures that detect, discourage, and rebuke ghostwriting, plagiarism, publication bias, and other unethical publication practices;

  7. Adopt accountable data reporting policies that ensure data are accurate, complete, and can be traced to original data sources;

  8. Disclose conflicts of interest for all parties (within the website or the publication itself) (see C. Disclosure);

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

  10. Establish clear policies and guidelines governing the conduct of publication professionals including, but not limited to, requiring full disclosure of potential conflicts of interest (either in accordance with journal policy or in compliance with International Committee of Medical Journal Editors recommendations); and

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

C. Disclosure

  1. Disclose 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 by all involved in the publication;

  2. Provide 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. Acknowledge and accurately disclose the role of contributors who do not satisfy accepted authorship criteria;

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

  5. Ensure that a potential 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.     Consider including a statement from publishers, editors, and authors that intellectual property rights associated with a publication will not be used to infringe the further scientific development of medicines or medical interventions that may benefit patients;

2.     Advocate sharing of data used in the generation of publications within intellectual property protection limits, technical limitations, and while maintaining patient privacy;

3.     Recognize, respect, and protect the intellectual property rights and contributions of all, including copyright laws governing the use and distribution of published materials; and

4.     Prohibit 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 at: https://www.fda.gov/regulatoryinformation/lawsenforcedbyfda/significantamendmentstothefdcact/foodanddrugadministrationamendmentsactof2007/default.htm; accessed Jan 25, 2019

2.     Foreign Corrupt Practices Act (FCPA) of 1977. Available at: http://www.justice.gov/criminal/fraud/fcpa/; accessed Jan 25, 2019

3.     European Medicines Agency (EMA). Available at: http://www.ema.europa.eu/; accessed Jan 25, 2019

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 Jan 25, 2019

5.     United Kingdom Bribery Act (UKBA) of 2010. Available at: http://www.legislation.gov.uk/ukpga/2010/23/contents; accessed Jan 25, 2019

6.     The EU General Data Protection Regulation (GDPR), which overhauled data privacy regulations is described at: https://eugdpr.org/ accessed Jan 25, 2019 

B. Conduct and Reporting of Studies

1.     World Medical Association Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Subjects. Available at: https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/; accessed Jan 25, 2019

2.     Principles on Conduct of Clinical Trials and Communication of Clinical Trial Results (Pharmaceutical Research and Manufacturers of America [PhRMA]). Available at: https://www.phrma.org/codes-and-guidelines/phrma-principles-on-conduct-of-clinical-trials; accessed Jan 25, 2019

3.     Joint Position on the Publication of Clinical Trial Results in the Scientific Literature. (IFPMA/EFPIA/JPMA/PhRMA). Available at: https://www.ifpma.org/wp-content/uploads/2010/11/Joint-Position-on-Publication-of-CT-Results-in-Literature-Revised-Oct2017vF.pdf; accessed Jan 25, 2019

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 Jan 25, 2019

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 Jan 25, 2019

6.     Principles on Interactions with Patient Organizations (Pharmaceutical Research and Manufacturers of America [PhRMA]). Available at: http://www.phrma.org/codes-and-guidelines/phrma-principles-on-interactions-with-patient-organizations-2012; accessed Jan 25, 2019

7.     Good Practices for Outcomes Research (International Society for Pharmacoeconomics and Outcomes Research [ISPOR]) (Pharmaceutical Research and Manufacturers of America [PhRMA]). Available at: https://www.ispor.org/heor-resources/good-practices-for-outcomes-research; accessed Jan 25, 2019 

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 Jan 25, 2019

  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 Jan 25, 2019

  3. Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals (International Committee of Medical Journal Editors [ICMJE]). Updated Dec 2018. Available at: http://www.icmje.org/icmje-recommendations.pdf; accessed Jan 25, 2019

  4. Committee on Publication Ethics (COPE): Promoting Integrity in Research Publication. Available at: http://publicationethics.org/; accessed Jan 25, 2019

  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 Jan 25, 2019

  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 Jan 25, 2019

  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 Jan 25, 2019

  8. Husereau D, Drummond M, Petrou S, Carswell C, Moher D, Greenberg D, et al. Consolidated Health Economic Evaluation Reporting Standards (CHEERS) Statement. Value in Health. 2013;16:e1-e5. Available at: http://www.valueinhealthjournal.com/article/S1098-3015(13)00065-X/pdf; accessed Jan 25, 2019