What is transparency anyway?

A premise of science is that research is meticulous and objective therefore the results are valid and credible. Published articles should provide clearly written, transparent descriptions of how the research was conducted, results obtained, and conclusions reached based on appropriate uses of analytical tools. Reporting of research should be truthful, free of bias, and provide enough information about how the work was performed to allow others to replicate the work and to be useful for further analyses. In the case of medical research, this is especially important as the information (especially from clinical trials) influences decisions regarding patient care and health policy.

However, factors such as individual biases, competition among research groups for funding, interest in career advancement, and profitability often discourage openness and transparency. This lack of transparency is often evident not only in lack of clarity or completeness in the writing of a report, but also in incomplete reporting of data, analytic tools, and materials, hindering replication efforts.

The responsibility for promoting greater openness in research falls not only to the individuals performing the work, but to the funders of the work (including government, foundation, and industry sponsors), institutions where the work is being done, and to journal editors and peer reviewers, who do the final check on the quality of the research before it is released to readers. Many journals have encouraged higher quality research by creating more useful, specific information for authors, requiring registration of clinical trials, and requiring adherence to published guidelines for reporting specific types of medical studies. Most journals enforce consequences for scientific misconduct or ethical breeches, however, transparency is often lacking. Fortunately, there are guidelines to help move scientific reporting toward greater openness.

TOP Initiative

The Transparency and Openness Promotion (TOP) Committee, sponsored by the Center for Open Science (COS), created a set of guidelines using several categories of openness as requirements for publication in order to promote transparency, openness, reproducibility of scientific research, and, in the process, public credibility.¹ These guidelines stipulate varying levels of openness based on the mission of a specific journal, leading to increased credibility and, at the highest levels, reproducibility. The guidelines cover eight standards of transparency in the research process, with three levels of transparency for each standard, so journals can adopt standards with a level of stringency most appropriate for their own mission.

The TOP guidelines transparency standards:

1. Citation Standards for citing articles and data, thus recognizing original contributions
2. Data Transparency, stating the level of availability of data
3. Analytic Methods, stating the statistical methods and software used
4. Research Materials, stating the level of sharing
5. Design and Analysis Transparency, reporting research design and analysis about the research process and completeness of reporting of the methodology
6. Preregistration of Studies to make research more discoverable even if it is not ultimately published
7. Preregistration of Analysis Plans to verify whether the research is hypothesis-testing or hypothesis-generating
8. Replication, which addresses whether or at what level the journal requires independent replications of a study before publication

The TOP Committee suggests that journals select the standards they wish to adopt and at which level. Some editors may believe that this type of reform should come from the research community itself rather than editors, especially because editors cannot easily enforce compliance. However, the adoption of such standards is an important effort that provides publishers with tools to communicate with researchers about expectations.

The EQUATOR Network

The EQUATOR (Enhancing the QUAlity and Transparency Of health Research) Network, launched in 2008, is a source for scientists, editors, and institutions wanting to define best practices in the reporting of medical research. The goal of this international organization is “to improve the reliability and value of published health research literature by promoting transparent and accurate reporting and wider use of robust reporting guidelines.”² EQUATOR has developed design-specific guidelines for scientific reporting and offers resources for editors, authors, and educators.

The practices the EQUATOR guidelines developers were most concerned about included non-reporting of negative studies, selective reporting of outcomes in studies, omission of information in describing research methods and interventions, inadequate reporting of adverse events, and misleading presentations of results and data—all potentially leading to “spin” in the medical literature.^3,4 The reporting guidelines aim to alleviate these shortcomings by providing specific advice and educational tools for authors, editors, and educators.

The reporting guidelines for the main study types include:

• CONSORT for randomized clinical trials, requiring a checklist and prospective trial registration, which also has a number of more specific extensions pertaining to such areas as trial designs that differ from the standard trial or on reporting harms
• STROBE for observational studies
• PRIMSA for systematic reviews
• STARD for diagnostic/prognostic studies
• CARE for case reports

The EQUATOR Network also curates toolkits for:

• Writing research
• Selecting the appropriate reporting guidelines
• Peer reviewing research
• How to develop a reporting guideline
• Using guidelines in your journal

Author transparency

An article on transparency in research or the publishing of research would not be complete without a discussion on transparency as applied to authorship. Multiple influences affect the credibility of the authors themselves; everyone has biases. Many clinical trials are sponsored by drug companies, while other studies are funded by governmental agencies or foundations, and authors are eager to renew grants or secure tenure. It often is not clear who did what in the writing of subsequent reports: Who wrote the paper? Who actually performed the research? Who provided materials or performed statistical analyses? Who might have contributed intellectually but is not named in the byline (a “ghost author”) and conversely, who might have been placed in the byline as a courtesy by being associated with other members of an author group, e.g., a department chair, who is really a “guest author”? Who paid for the research? All this information needs to be available so readers can decide for themselves if bias exists in the research or the reporting of a study. Thus, it’s important that authors are accurately identified according to criteria prescribed by a journal and that journals publish the contributions and full disclosures of all identified authors.

It’s worth noting an important distinction at this point: Disclosures offer insights into readily measurable conflicts of interest (usually financial), but no disclosure adequately measures bias. Bias is the problem, of course, for which disclosures of conflicts of interest are merely surrogate measures.^5,6

ICMJE Authorship Criteria

The International Committee of Medical Journal Editors (ICMJE) has established widely endorsed criteria for authorship:

1. Substantial contributions to the conception or design of the work, or acquisition, analysis, or interpretation of data for the work; AND
2. drafting the work or revising it critically for important intellectual content; AND
3. final approval of the version to be published; AND
4. 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.

CRediT

The National Information Standards Organization (NISO) developed CRediT (Contributor Roles Taxonomy), a high-level authorship taxonomy that can be used to describe each contributor’s specific contribution. They also provide recommendations on how to implement CRediT.

The 14 Contributor Roles outlined by CRediT

• Conceptualization
• Data curation
• Formal analysis
• Funding acquisition
• Investigation
• Methodology
• Project administration
• Resources
• Software
• Supervision
• Validation
• Visualization
• Writing – original draft
• Writing – review & editing

COPE guidance

The Committee on Publication Ethics (COPE) also provides guidance on authorship, primarily focusing on how to handle concerns surrounding authorship and contributorship. There are cases that outline precedence, an ethics toolkit for editorial offices, guidelines on handling disputes, and flowcharts on how to deal with concerns of authorship.

The pharmaceutical industry

The pharmaceutical industry is also making attempts to create more transparency and credibility in publications generated by their research divisions. The Medical Publishing Insights and Practices Initiative (MPIP) is a collaboration among pharmaceutical companies aimed at elevating trust, transparency, and integrity in publishing industry-sponsored studies. One of MPIP’s initiatives is Transparency Matters, a “global education platform and call to action to improve the transparency and credibility of industry-sponsored research publications.”⁷ The hub provides resources from articles and videos to tools and ways to take action.

Conflict of interest transparency

For maximum transparency in a research article, all authors should provide a full disclosure of potential for conflicts of interest, and these disclosures should be published with the article. ICMJE explains that the “potential for conflict of interest and bias exists when professional judgment concerning a primary interest (such as patients’ welfare or the validity of research) may be influenced by a secondary interest (such as financial gain).”⁸ To help alleviate the potentially daunting and confusing task of listing conflicts of interest, ICMJE has put together a comprehensive form journals can use in the collection of author disclosures. Not all editorial offices may collect this form, but it can be useful for authors to determine what they should disclose. As with other guidelines, COPE offers several resources to help authors, reviewers, editors, and publishers navigate the disclosing of conflicts of interest.

Summary

The efforts made by all these initiatives are to be applauded by authors as they help in some measure to increase the transparency and validity of their work. The further hope is that expectation of transparency and rigor in reporting will foster better research design and thus more credibility in the eyes of the reader. Editors are always looking for well-written papers containing innovative and paradigm-changing research that colleagues can build upon and replicate.

References

1. Nosek BA, Alter G, Banks GC, Borsboom D, Bowman SD, Breckler SJ, et al. Promoting an open research culture. Science2015; 348(6242):1422-1425. doi: 10.1126/science.aab2374
2. About us. EQUATOR Network. Accessed September 21, 2023. https://www.equator-network.org/about-us/
3. Simera I, Moher D, Hirst A, Hoey J, Schulz KF, Altman DG. Transparent and accurate reporting increases reliability, utility, and impact of our research: reporting guidelines and the EQUATOR network. BMC Med 2010;8:24. doi: 10.1186/1741-7015-8-24
4. Gross RA. Style, spin, and science. Neurology 2015;85:10–11. doi: 10.1212/WNL.0000000000001753
5. Schwid SR, Gross RA. Bias, not conflict of interest, is the enemy. Neurology 2005;64:1830-1831.
6. Knopman DS, Baskin PK, Pieper KM, Quimby SL, Gross RA. Reporting potential bias: Neurology’s evolving policies. Neurology 2011;76:110-112. doi 10.1212/WNL.0b013e318206f646
7. Medical Publishing Insights & Practices Transparency Matters. Accessed September 21, 2023. https://mpip-initiative.org/transparencymatters/index.html
8. Disclosure of Financial and Non-Financial Relationships and Activities, and Conflicts of Interest. ICMJE. Accessed September 21, 2023. https://www.icmje.org/recommendations/browse/roles-and-responsibilities/author-responsibilities--conflicts-of-interest.html

Adapted from Transparency in research and reporting by Patricia K. Baskin and Robert A. Gross, https://www.wolterskluwer.com/en/expert-insights/authors-transparency-in-research-reporting

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