On October 20, 2014 the Office for Human Research Protections (OHRP) released a draft guidance on how to apply the Department of Health and Human Services (HHS) regulations on protecting human subjects (45 CFR Part 46) who participate in research studies intended to evaluate risks of treatments or procedures commonly used by healthcare professionals and recognized as “standard of care.” In standard-of-care research (or comparative effectiveness research), participants are randomized to receive one of two (or more) treatments that are accepted by medical experts as appropriate treatments for a given disease or condition.
Because treatments assigned to some participants might be different than the treatments they would have been assigned if they were not participating in the study, and the risks associated with one treatment might be different from the risks associated with another treatment, the OHRP recommends that these risks be fully described to potential participants as a part of the informed consent process.
Click here for the full draft guidance: Draft Guidance on Disclosing Reasonably Foreseeable Risks in Research Evaluating Standards of Care
The Institute of Medicine is planning a two-day public workshop in December to discuss human subjects protections in standard-of-care research. Click here for more information.
The Institute of Medicine (IOM) has released a new report, Integrating Research and Practice: Health System Leaders Working Toward High-Value Care: Workshop Summary. The report summarizes the presentations and discussions from two meetings held in April and June 2014 by the IOM’s Roundtable on Value & Science-Driven Health Care, with sponsorship from the Patient-Centered Outcomes Research Institute (PCORI).
The workshops brought together health system leaders and researchers to discuss partnerships for progress toward a learning healthcare system in which the continuous generation of knowledge informs better care. Attendees identified challenges and established priorities in integrating clinical research into healthcare delivery systems. There was a particular focus on the recently established National Patient-Centered Clinical Research Network (PCORnet).
View the Workshop Summary
(Note: The workshop summary contains the opinions of the workshop presenters and does not reflect conclusions of the IOM.)
Slides and a workshop summary are now available from the Institute of Medicine website.
On April 23-24, 2014, the Institute of Medicine held a Roundtable on Value & Science-Driven Health Care workshop titled “Health System Leaders Working Towards High Value Care Through Integration of Care and Research” in Washington, DC. The workshop, sponsored by the Patient-Centered Outcomes Research Institute (PCORI), brought together stakeholders from across research networks, health systems, industry, and the patient community to engage on barriers and opportunities in building a continuously learning health system, where routinely collected health data informs improvements in evidence-based care. Eric Larson, MD, MPH, of the Group Health Research Institute chaired the workshop Planning Committee.
Workshop goals included:
- Fostering the development of a shared commitment, vision, and strategy among health system leaders building a national clinical research network
- Broadening and deepening health systems’ leadership awareness of the prospects for and from a continuously learning health system
- Learning from models and examples of productive integration of research with care delivery programs
- Identifying common issues compelling to health systems leaders related to science, technology, ethics, regulatory oversight, business, and governance
- Exploring strategic opportunities for executive, clinical, and research leaders to forge working partnerships for progress
- Considering the approach and desirable outcomes of a meeting of CEO leaders vital to building and sustaining a functional, real-time national clinical research network
One particular focus of the meeting was the recently launched National Patient-Centered Clinical Research Network (PCORnet). Workshop participants included representatives from PCORnet’s Clinical Data Research Networks and Patient-Powered Research Networks. Speakers provided real-world examples of learning health systems and urged leaders to make a business case for the learning health system model. Speed and dissemination of research were discussed as important considerations for patients.
The meeting was open to the public via webcast. Archived meeting presentations will be made available; a link will be provided in an update to this post. Workshop-related tweets can be found with the hashtag #IOMPCORI.
View the workshop agenda and briefing materials.