Ethics and Regulatory Documentation
This page contains links to summaries of discussions about the NIH Collaboratory Trials from ethical and regulatory perspectives. These discussions, which took place as teleconferences, included representation from the trials’ principal investigators and study teams, members of the Ethics and Regulatory Core, NIH staff, and Coordinating Center personnel, with additional input provided in some instances by representatives from the Office for Human Research Protections (OHRP). For more information:
- Visit the NIH Collaboratory Trials page for detailed descriptions of the trials.
- Visit the Ethics and Regulatory Core page for information about ethical and regulatory considerations in pragmatic trials, including a comprehensive list of tools, publications, and resources.
See the OHRP statement of participation in NIH Collaboratory Trials discussions.
Meeting Minutes and Updates for NIH Collaboratory Trials
Principal Investigator: Susan Huang, MD, MPH
Principal Investigators: James Tulsky, MD; Angelo Volandes, MD, MPH
Principal Investigators: Sebastian Tong, MD, MPH; Kushang Patel, PhD, MPH
Principal Investigators: Jennifer Kawi, PhD, MSN, FNP-BC, CNE; Jane Bolin, PhD, JD, RN; Hulin Wu, PhD, MS
Principal Investigators: Richard L. Skolasky, Jr, ScD, MA; Kevin McLaughlin, DPT
Principal Investigators: Karen Sherman, PhD, MPH; Lynn DeBar, PhD, MPH
Principal Investigator: Julie Fritz, PhD, PT
Principal Investigators: Michele Balas, PhD; Eduard Vasilevskis, MD, MPH
Principal Investigator: Gary Rosenthal, MD
Principal Investigators: Lynn DeBar, PhD, MPH; Rachel Gold, PhD, MPH; Nicole Cook, PhD, MPA
Principal Investigators: Michael Ho, MD, PhD; Sheana Bull, PhD, MPH
Principal Investigators: Edward Melnick, MD, MHS; Gail D'Onofrio, MD, MS
Principal Investigators: Kari Stephens, PhD; Rodger Kessler, PhD
Principal Investigators: Kathleen Sluka, PT, PhD; Leslie Crofford, MD
Principal Investigators: Margaret Kuklinski, PhD; Stacy Sterling, DrPH, MSW
Principal Investigators: Ardith Z. Doorenbos, PhD, RN; Judith M. Schlaeger, PhD; Robert Molokie, MD; Miriam O. Ezenwa, PhD, RN; Nirmish Shah, MD
Principal Investigator: Myles Wolf, MD, MMSc
Principal Investigators: Elizabeth Wick, MD; Genevieve Melton-Meaux, MD, PhD; Rebecca Sudore, MD
Principal Investigator: Miguel Vazquez, MD
Principal Investigators: Christine Goertz, DC, PhD; Adam Goode, PT, DPT, PhD; Jon Lurie, MD, MS; Hrishikesh Chakraborty, DrPH
Principal Investigators: Susan S. Huang, MD, MPH; Richard Platt, MD; Lead Investigator: Shruti Gohil, MD, MPH
Principal Investigator: Sara Singer, PhD, MBA
Principal Investigator: Jeffrey Jarvik, MD, MPH
Principal Investigators: David Wetter, PhD, MS; Guilherme Del Fiol, MD, PhD; Kensaku (Ken) Kawamoto, MD, PhD
Principal Investigator: Stephanie Fitzpatrick, PhD
Principal Investigators: Andrea Cheville, MD; Jon Tilburt, MD
Principal Investigators: Michael Ho, MD, PhD; Sheana Bull, PhD, MPH
Principal Investigator: Natalia Morone, MD
Principal Investigator: Lynn DeBar, PhD
Principal Investigator: Corita Grudzen, MD, MSHS; Keith Goldfeld, DrPH
Principal Investigators: Susan Mitchell, MD, MPH; Vincent Mor, PhD; Angelo Volandes, MD, MPH
Principal Investigators: Diana Burgess, PhD; Roni L. Evans, DC, MS, PhD; Katherine E. Hadlandsmyth, PhD
Principal Investigator: Greg Simon, MD, MPH
Principal Investigators: Rachel Winer, PhD, MPH; Amanda Petrik, PhD; Jasmin Tiro, PhD
Principal Investigator: Gloria D. Coronado, PhD; Beverly B. Green, MD, MPH
Principal Investigators: Chenchen Wang, MD, MSc; Helen Lavretsky, MD, MS; Eric Roseen, DC, MSc; Robert Saper, MD
Principal Investigator: Laura Dember, MD
Principal Investigator: Douglas Zatzick, MD
OHRP Statement of Participation in NIH Collaboratory Trials Discussions
OHRP participated in a number of the ethics and regulatory discussions regarding trials conducted through the NIH Pragmatic Trials Collaboratory to provide technical advice as needed on the requirements of the Department of Health and Human Services Human Subjects Protection Regulations (45 CFR 46 Subpart A - the "Common Rule"). In these discussions, OHRP was able to state whether or not it would be reasonable for an IRB to approve such a study. However, it was carefully noted that these were not comprehensive formal reviews of the protocols and hence any statements generated from these discussions should not be construed as affirmative determinations of regulatory compliance.
We understand that one of the purposes for making these discussion minutes publicly available is to inform IRBs, institutions, and investigators of how the human subjects protection regulations might apply to studies similar to those being conducted through the NIH Collaboratory. OHRP notes that determining how the human subjects protection regulations apply must take into consideration study-specific information. If IRBs, institutions, or investigators have questions about how the regulations apply to a specific study, they may contact OHRP by phone at 866-447-4777 (toll-free within the United States) or 240-453-6900, or by email at ohrp@hhs.gov.