Ethical and Transparency Standards (e.g., GPP2022)
This domain tests whether you can apply ethical and transparency standards to real publication decisions. GPP2022, ICMJE, COPE, and EQUATOR are the key reference points, but exam questions usually test judgment rather than definitions.
Core standards
- Publish all company-sponsored research, including negative and inconclusive results, completely, accurately, and in a timely way. Selective publication is a central ethical failure.
- Require authors to meet all ICMJE criteria. Prevent ghost, guest, and gift authorship. Disclose professional medical-writing support and its funding.
- Disclose sponsor role, funding, conflicts of interest, and any writing assistance. "Data on file" is not a substitute for a publishable report.
- Register trials prospectively and post results as required by registries, funders, and journals. Include data-sharing statements and protect patient privacy.
- Avoid duplicate or redundant publication. Label secondary analyses clearly and cite the primary report.
- Follow COPE guidance for plagiarism, image manipulation, corrections, expressions of concern, and retractions.
Worked example
A sponsor wants to publish only the per-protocol analysis showing benefit and omit the negative intention-to-treat result. Reasoning: this would violate complete and balanced reporting and GPP2022 principles. The manuscript should report both analyses, explain the discrepancy, and follow CONSORT. The abstract and plain-language summary must reflect the same data. If the sponsor refuses, the publication professional should escalate through the publication steering committee and compliance channels.
Transparency in practice
- Make the protocol and statistical analysis plan available where policy requires.
- Use reporting guidelines appropriate to the design.
- Avoid spin in titles, abstracts, and conclusions; conclusions should not exceed the data.
- Screen journals for legitimate peer review and transparency policies.
Traps that cost marks
- Treating GPP2022 as optional guidance rather than an expected standard.
- Confusing acknowledgment with authorship.
- Omitting negative results or presenting them only in supplementary files.
- Failing to disclose writing support or sponsor control.
- Duplicate publication or undisclosed secondary analysis.
- Ignoring prospective trial registration.
- Listing a department head as a guest author.