Ethics and Regulatory Documentation

Ethics and Regulatory Documentation

This page contains links to minutes and supplementary materials summarizing a series of discussions about NIH Collaboratory pragmatic clinical trial Demonstration Projects from regulatory and ethical perspectives. These discussions, which took place as teleconferences, included representation from study principal investigators and study teams, members of the NIH Collaboratory Ethics and Regulatory Core, NIH staff, and NIH Collaboratory Coordinating Center personnel, with additional input provided by representatives from the Office for Human Research Protections.

For more information:

  • Visit the Demonstration Projects page for detailed descriptions of the NIH Collaboratory Demonstration Projects.
  • Visit the Ethics and Regulatory Core page for additional information on ethical and regulatory considerations in pragmatic trials, including a comprehensive list of tools, publications, and resources.

OHRP Statement of Participation in Health Care Systems Research Collaboratory Demonstration Project Discussions

The Office for Human Research Protections (OHRP) participated in the regulatory and ethics discussions regarding demonstration project studies being conducted through the NIH Health Care Systems (HCS) Research Collaboratory to provide technical advice as needed on the requirements of the Department of Health and Human Services (DHHS) Human Subjects Protection Regulations (45 CFR 46 Subpart A - the "Common Rule"). OHRP has not affirmatively determined that the HSC Research Collaboratory demonstration projects, as they were described during the discussions, would meet all of the regulatory requirements. Any OHRP statement that it would be reasonable for an IRB to approve one of the studies discussed was based on the information presented during the discussion.

We understand that one of the purposes for making these discussion minutes publicly available is to inform institutional review boards (IRBs), institutions, and investigators of how the human subjects protection regulations might apply to studies similar to those being conducted through the HCS Research 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 U.S.) or (240) 453-6900, or by e-mail at


Meeting Minutes and Updates for NIH Collaboratory Demonstration Projects

Fibromyalgia TENS in Physical Therapy Study (FM TIPS) - Principal Investigators: Kathleen Sluka, PT, PhD, Leslie Crofford, MD

Group-based Mindfulness for Patients with Chronic Low Back Pain in the Primary Care Setting (OPTIMUM) - Principal Investigator: Natalia Morone, MD

Non-pharmacological Options in Postoperative Hospital-based and Rehabilitation Pain Management (NOHARM) - Principal Investigators: Andrea Cheville, MD, Jon Tilburt, MD

Pragmatic Trial of Acupuncture for Chronic Low Back Pain in Older Adults (AcuOA) - Principal Investigators: Karen Sherman, PhD, MPH, Lynn DeBar, PhD, MPH

Advance Care Planning: Promoting Effective and Aligned Communication in the Elderly (ACP PEACE) - Principal Investigators: James Tulsky, MD, Angelo Volandes, MD, MPH

Guiding Good Choices for Health (GGC4H): Testing Feasibility and Effectiveness of Universal Parent-Focused Prevention in Three Healthcare Systems - Principal Investigators: Margaret Kuklinski, PhD, Stacy Sterling, DrPH, MSW

Pragmatic Trial of User-Centered Clinical Decision Support to Implement EMergency Department-Initiated BuprenorphinE for Opioid Use Disorder (EMBED) - Principal Investigators: Edward Melnick, MD, MHS, Gail D'Onofrio, MD, MS

Personalized Patient Data and Behavioral Nudges to Improve Adherence to Chronic Cardiovascular Medications (Nudge) - Principal Investigators: Michael Ho, MD, PhD, Sheana Bull, PhD, MPH

Primary Palliative Care for Emergency Medicine (PRIM-ER) - Principal Investigator: Corita Grudzen, MD, MSHS

Pragmatic Trial of Higher vs. Lower Serum Phosphate Targets in Patients Undergoing Hemodialysis (HiLo) - Principal Investigator: Myles Wolf, MD, MMSc

Lumbar Image Reporting with Epidemiology (LIRE) - Principal Investigator: Jeffrey Jarvik, MD, MPH 

Collaborative Care for Chronic Pain in Primary Care/Pain Program for Active Coping and Training (PPACT) - Principal Investigator: Lynn DeBar, PhD

Active Bathing to Eliminate Infections (ABATE) - Principal Investigator: Susan Huang, MD, MPH

Blood Pressure Medication Timing Study (BPMedTime) - Principal Investigator: Gary Rosenthal, MD

Suicide Prevention Outreach Trial (SPOT) - Principal Investigator: Greg Simon, MD, MPH

Strategies and Opportunities to Stop Colorectal Cancer (STOP CRC) - Principal Investigator: Gloria Coronado, PhD

Time to Reduce Mortality in End-Stage Renal Disease (TiME) - Principal Investigator: Laura Dember, MD

A Policy-Relevant U.S. Trauma Care System Pragmatic Trial for PTSD and Comorbidity (Trauma Survivors Outcomes and Support [TSOS]) - Principal Investigator: Douglas Zatzick, MD

Improving Chronic Disease Management with Pieces (ICD-Pieces) - Principal Investigator: Miguel Vazquez, MD

Pragmatic Trial of Video Education in Nursing Homes (PROVEN) - Principal Investigators: Susan Mitchell, MD, MPH; Vincent Mor, PhD; Angelo Volandes, MD, MPH


Ethics and Regulatory Documentation: Ethics and Regulatory Documentation. In: Rethinking Clinical Trials: A Living Textbook of Pragmatic Clinical Trials. Bethesda, MD: NIH Health Care Systems Research Collaboratory. Available at: Updated February 28, 2020.