Ethical Considerations Dr. Richard Adanu Editor-in-Chief International Journal of Gynecology and Obstetrics (IJGO)

Trial registration Institutional Board approval Consent Authorship Conflict of interest Plagiarism

Trial registration What is a clinical trial? “any research project that prospectively assigns people or a group of people to an intervention, with or without concurrent comparison or control groups, to study the cause-and-effect relationship between a health- related intervention and a health outcome.” WHO definition, endorsed by International Committee of Medical Journal Editors (ICMJE)

Why is it important to register a clinical trial? Fulfills ethical obligations to participants and the research community Who benefits: Patients, general public, research community Provides information to potential participants and referring clinicians Who benefits: Patients, clinicians Reduces publication bias Who benefits: Users of medical literature

Helps editors and others understand the context of study results Who benefits: Editors, users of medical literature Promotes more efficient allocation of research funds Who benefits: Grant agencies, research community Helps institutional review boards (IRBs) determine the appropriateness of a research study Who benefits: IRBs, ethicists Zarin DA, Keselman A. Registering a clinical trial in ClinicalTrials.gov. Chest. 2007;131(3):

In addition: It is law or federal policy (e.g. US Federal law, WHO policy, ICMJE policy, World Medical Association policy) It is required for Journal publication if a Journal follows ICMJE recommendations

How to register a clinical trial When? At or before onset of patient enrollment (prospective registration) Where? ICMJE approved registries registration/ Registries that participate in the WHO clinical trials portal

Institutional approval Original research studies must be reviewed and approved by an institutional body, e.g. - Institutional Review Board (IRB) - Independent Ethics Committee (IEC) - Ethical Review Board (ERB) - Research Ethics Board (REB)

Document this information in the cover letter and Methods section (it will be queried at submission if missing) Provide an explanation if the study was exempt or there is no locally available IRB This documentation must be available for review if requested

Consent Methods section: informed consent provided by study participants Cover letter: signed consent obtained from a patient described in a Case Report (Patient Permission Form) Obtain consent for any identifiable photos or videos

Authorship ICMJE criteria Substantial contributions to the conception or design of the work; or the acquisition, analysis, or interpretation of data for the work; and Drafting the work or revising it critically for important intellectual content; and Final approval of the version to be published; and Agreement to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.

Include anyone not meeting the criteria in an Acknowledgment section Include a Contributions section listing who did what Each author should sign the journal’s Author Guarantee Form Changes to authorship require explanation and signed agreement from ALL authors

Conflict of interest Disclose any potential conflict of interest at submission, financial or other, e.g. -Financial support (supplies, services, salary from a commercial organization) -Expert testimony, consulting, honoraria, stock holdings, equity interest, ownership, patent-licensing situations, sponsor involvement -Relationships or activities potentially influencing the submitted work

What is plagiarism? Intentional: “an act or instance of using or closely imitating the language and thoughts of another author without authorization and the representation of that author's work as one's own”( Unintentional: inclusion of the source citation but direct use of the original wording without quotation marks, or poor paraphrasing Self-plagiarism: Failure to paraphrase, even your own work, may have implications for infringement of a publisher’s copyright (common in Methods and “salami publishing”)

TIPS Be aware of what it is and do not do it Plagiarism check software is used so instances will be identified Seek language editing services if English is not your first language Thank you