ABSTRACT
Authorship and dissemination policies vary across NIH research consortia. We aimed to describe elements of real-life policies in use by eligible U01 clinical research consortia. Principal investigators of eligible, active U01 clinical research projects identified in the NIH Research Portfolio Online Reporting Tools database shared relevant policies. The characteristics of key policy elements, determined a priori, were reviewed and quantified, when appropriate. Twenty one of 81 research projects met search criteria and provided policies. K elements (e.g., in quotations): “manuscript proposals reviewed and approved by committee” (90%); “guidelines for acknowledgements” (86%); “writing team formation” (71%); “process for final manuscript review and approval” (71%), “responsibilities for lead author” (67%), “guidelines for other types of publications” (67%); “draft manuscript review and approval” (62%); “recommendation for number of members per consortium site” (57%); and “requirement to identify individual contributions in the manuscript” (19%). Authorship/dissemination policies for large team science research projects are highly variable. Creation of an NIH policies repository and accompanying toolkit with model language and recommended key elements could improve comprehensiveness, ethical integrity, and efficiency in team science work while reducing burden and cost on newly funded consortia and directing time and resources to scientific endeavors.
Acknowledgments
Prevention of Lower Urinary Tract Symptoms (PLUS) Research Consortium
Research Centers and Investigators
Loyola University Chicago - Maywood, IL (U01DK106898) Multi-Principal Investigators: Linda Brubaker, MD; Elizabeth R. Mueller, MD, MSME
Investigators: Marian Acevedo-Alvarez, MD; Colleen M. Fitzgerald, MD, MS; Cecilia T. Hardacker, MSN, RN, CNL; Jeni Hebert-Beirne, PhD, MPH; Missy Lavender, MBA.
University of Alabama at Birmingham - Birmingham, AL (U01DK106858) Principal Investigator: Alayne D. Markland, DO, MSc
Investigators: Tamera Coyne-Beasley, MD, MPH, FAAP, FSAHM; Kathryn L. Burgio, PhD; Cora E. Lewis, MD, MSPH; Gerald McGwin, Jr., MS, PhD; Camille P. Vaughan, MD, MS; Beverly Rosa Williams, PhD.
University of California San Diego - La Jolla, CA (U01DK106827) Principal Investigator: Emily S. Lukacz, MD
Investigators: Sheila Gahagan, MD, MPH; D. Yvette LaCoursiere, MD, MPH; Jesse Nodora, DrPH.
University of Michigan - Ann Arbor, MI (U01DK106893) Principal Investigator: Janis M. Miller, PhD, APRN, FAAN
Investigators: Lisa Kane Low, PhD, CNM, FACNM, FAAN.
University of Minnesota (Scientific and Data Coordinating Center) - Minneapolis MN (U24DK106786) Multi-Principal Investigators: Bernard L. Harlow, PhD; Kyle D. Rudser, PhD
Investigators: Sonya S. Brady, PhD; Cynthia S. Fok, MD, MPH; Peter Scal, PhD; Todd Rockwood, PhD.
University of Pennsylvania – Philadelphia, PA (U01DK106892) Multi-Principal
Investigators: Diane K. Newman, DNP; Ariana L. Smith, MD; Investigators: Amanda Berry, MSN, CRNP; Terri H. Lipman, PhD; Heather Klusaritz, PhD, MSW; Ann E. Stapleton, MD; Jean F. Wyman, PhD
Washington University in St. Louis - Saint Louis, MO (U01DK106853) Principal Investigator: Siobhan Sutcliffe, PhD, ScM, MHS
Investigators: Aimee S. James, PhD, MPH; Jerry L. Lowder, MD, MSc; Melanie R. Meister, MD, MSCI.
Yale University - New Haven, CT (U01DK106908) Principal Investigator: Leslie M. Rickey, MD, MPH
Investigators: Marie A. Brault, PhD; Deepa R. Camenga, MD, MHS; Shayna D. Cunningham, PhD.
Steering Committee Chair: Linda Brubaker, MD. UCSD, San Diego. (January 2021-)
NIH Program Office: National Institute of Diabetes and Digestive and Kidney Diseases, Division of Kidney, Urologic, and Hematologic Diseases, Bethesda, MD.
NIH Project Scientist: Julia Barthold, M.D.
The authors would also like to thank all of the research groups who provided their authorship and publication policies for this review, including the ChiLDReN, the Childhood Liver Disease Research Network.
Disclosure statement
No potential conflict of interest was reported by the author(s).
Supplementary material
Supplemental data for this article can be accessed online at https://doi.org/10.1080/08989621.2022.2116318