Appendix B

Background Discussion Document: Selected Guidelines for Transparent Reporting

SELECTED GUIDELINES FOR TRANSPARENT REPORTING

The purpose of this document is to help inform workshop discussions on improving the harmonization of guidelines for transparent reporting across journals and funding agencies so that biomedical researchers propose and report data in a consistent manner. This discussion document was compiled based on criteria described in the Transparency and Openness Promotion (TOP) guidelines;¹ the National Academies of Sciences, Engineering, and Medicine report on Reproducibility and Replicability in Science;² and the National Institutes of Health (NIH) policy on Enhancing Reproducibility through Rigor and Transparency.³ Each of the guidelines summarized below has a different scope and purpose.

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¹ Available at https://cos.io/top (accessed January 12, 2020).

² Available at https://www.nap.edu/catalog/25303/reproducibility-and-replicability-in-science (accessed January 12, 2020).

³ Available at https://grants.nih.gov/policy/reproducibility/index.htm (accessed January 12, 2020).

BRIEF DESCRIPTIONS OF GUIDELINES SUMMARIZED

• The Animal Research: Reporting In Vivo Experiments (ARRIVE) guidelines recommend criteria for the reporting of primary research using animals. The guidelines were based on the Consolidated Standards of Reporting Trials (CONSORT) guidelines, but cover diverse study types. They were developed by the National Centre for the Replacement, Refinement and Reduction of Animals in Research (NC3Rs), and were first published in PLOS Biology in 2010. The ARRIVE guidelines are currently being revised; a preprint of the revised ARRIVE guidelines and the accompanying Explanation and Elaboration document are available on BioRxiv, respectively at https://www.biorxiv.org/content/10.1101/703181v1 and at https://www.biorxiv.org/content/10.1101/703355v1.
• The CONSORT statement recommends information to include when reporting a randomized trial; was developed by an international group of trialists, methodologists, and medical journal editors; and was first published in JAMA in 1996 and last revised in 2010 and published in multiple journals. For more information, see http://www.consort-statement.org.
• The DRAFT materials, design, analysis, and reporting (MDAR) checklist for authors represents a generic set of minimum requirements applicable to all reporting studies in the life sciences for the explicit purpose of increasing transparent reporting and reproducibility, developed by the MDAR working group specifically seeking common reporting points from across multiple journals. The checklist is being pilot tested by volunteer journals, and therefore has not been published at the time of this writing. The statement of task is available at https://osf.io/preprints/metaarxiv/9sm4x.
• NIH policies:
  • “Data Sharing” policy, developed by NIH, to encourage data generated with NIH funding to be “made as widely and freely available as possible while safeguarding the privacy of participants, and protecting confidential and proprietary data.” The policy requires a data sharing plan for final research data generated on grants of $500,000 or more, and was implemented in 2003. For more information, see https://grants.nih.gov/grants/policy/data_sharing.
  • “Dissemination of NIH-Funded Clinical Trial Information” policy, developed by NIH and implemented in 2017, mandates that all clinical trials funded in part or in whole by NIH must be registered at ClinicalTrials.gov. The policy also requires that summary results be posted to ClinicalTrials.gov. For more infor

• • mation, see https://grants.nih.gov/grants/guide/notice-files/not-od-16-149.html.

  • “Enhancing Reproducibility through Rigor and Transparency” policy, developed by NIH, to clarify expectations for grantees and reviewers in describing or assessing proposed studies in applications and progress reports, announced in 2015 and implemented in 2016. For more information, see https://grants.nih.gov/policy/reproducibility/index.htm.
• The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement recommends an evidence-based minimum set of reporting elements for systematic reviews and meta-analyses; was developed by an international group; and was first published in 2009 in multiple journals (PLOS Medicine, Annals of Internal Medicine, BMJ, Journal of Clinical Epidemiology, and Open Medicine). For more information, see http://www.prismastatement.org.
• The Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) statement, developed by an international collaboration of trialists, methodologists, journal editors, and ethicists, recommends minimum content to include in clinical trial protocols, from study enrollment through closeout, first published in the Annals of Internal Medicine and BMJ in 2013. For more information, see https://www.spirit-statement.org.
• The TOP guidelines describe eight modular standards of transparency that journals can select from to introduce policy and best practices at their publication; was developed by the Center for Open Science with input from journals, funders, and professional societies; and was first published in Science in 2015. See https://cos.io/top for information about TOP, including a summary table and links to complete policy language.

1. NIH policies represented include Data Sharing Policy, Dissemination of NIH-Funded Clinical Trial Information, and Rigor and Transparency.

2. Based on criteria described in the Transparency and Openness Promotion (TOP) guidelines, https://cos.io/top.

3. Based on criteria described in the National Academies report Reproducibility and Replicability in Science.

4. Based on criteria described in the NIH policy on Enhancing Reproducibility through Rigor and Transparency.

5. Covered by multiple NIH policies and offices, including Human Subjects Research policies and the NIH Office of Laboratory Animal Welfare.

* Covered by U.S. government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern.

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