|FDA says will not object to waiver of informed consent for minimal risk studies in new guidance|
July 28, 2017: In a new guidance, the FDA explains that it does not intend to object to the conduct of a minimal risk clinical study if the IRB has waived or altered the requirement for informed consent.
|New article compares different approaches for notification and authorization in pragmatic clinical research|
July 6, 2017:Dr. Kevin Weinfurt and colleagues in the Regulatory/Ethics Core compare how acceptable different approaches to notification and authorization are to potential participants in pragmatic research.
|May 2017 Steering Committee Meeting||6/20/2017|
|New article from the Collaboratory’s PRO Core published in eGEMs|
June 12, 2017: The NIH Health Care Systems Research Collaboratory’s Patient-Reported Outcomes (PRO) Core publishes an article in eGEMs on the incorporation of PROs for both care and research.
|New Foundation Established to Advance the Sustainability of PCORnet|
April 18, 2017: The People-Centered Research Foundation is a new nonprofit supporting the vision and successes of PCORnet, the National Patient-Centered Clinical Research Network.
|New Users’ Guide for Integrating Patient-Reported Outcomes in Electronic Health Records|
March 14, 2017: A draft users’ guide that focuses on best practices for integrating (PROs) in electronic health records (EHRs) is available for public comment through April 7, 2017.
|Collaboratory phenotypes paper published in eGEMs special issue|
August 17, 2016: A recently published special issue of eGEMs explores strategic uses of evidence to transform healthcare delivery systems.
|May 2016 Steering Committee Meeting||6/8/2017|
|Perspective on Clinician Engagement for Continuous Learning|
March 7, 2017: The National Academy of Medicine (NAM) has published a new discussion paper that advances the vision of a continuously learning health system, focusing on actions to foster more active engagement of front-line clinicians.
|Collaboratory Authors Publish a Perspective on Pragmatic Trial Informatics in JAMIA|
March 14, 2017: The Collaboratory’s Phenotypes, Data Standards, and Data Quality Core group have published a new article describing the informatics challenges of conducting pragmatic clinical trials.
|New NIH Funding Opportunity Announcement to Support NIH Collaboratory Demonstration Projects|
December 15, 2016: This FOA solicits applications to support Demonstration Projects that include an efficient, large-scale pragmatic clinical trial. Applications are due June 2, 2017.
|NIH Collaboratory Invites Requests to Query the Distributed Research Network |
January 25, 2017: Have a question about the rates of medical conditions or the frequency of use of medical and surgical treatments? The NIH Collaboratory invites you to query its DRN.
|DHHS and 15 other agencies announce changes to Common Rule |
January 18, 2017: The Department of Health and Human Services and 15 other agencies have announced revisions to the Federal Policy for the Protection of Human Subjects, known as the Common Rule.
|New Online NIH Course on Pragmatic and Group-Randomized Trials|
January 24, 2017: The National Institutes of Health’s Office of Disease Prevention (ODP) has released a free, self-paced online course on designing and analyzing pragmatic and group-randomized trials.
|Use of Data from Electronic Health Records to Customize Medical Treatments|
January 10, 2017: In a recent segment on NPR’s Morning Edition, commentators discuss the potential of using electronic health records to customize medical treatments.
|NIH Technical Assistance Videocast for Researchers January 24|
January 11, 2017: The NIH's Office of Strategic Coordination is holding a live information session regarding its FOA "NIH Healthcare Systems Research Collaboratory - Demonstration Projects for Pragmatic Clinical Trials (UG3/UH3)."
|Understanding the Potential of Real-World Evidence|
December 20, 2016: In a recent article in the New England Journal of Medicine, authors propose how the term “real-world evidence” should be understood in order for this type of research to fulfill its potential to inform and improve healthcare.
|NIH Issues RFI for Opportunities in Suicide Research Using Existing Datasets|
November 18, 2016: NIMH hass issued a request for information to solicit input on opportunities for using existing datasets in suicide prevention research. Responses are due December 2, 2016.
|HHS Releases Final Rule for Trials Data Reporting|
September 19, 2016: The Department of Health and Human Services has released the final rule for registering and reporting results from clinical trials as specified under Section 801 of the Food and Drug Administration Amendments Act (FDAAA).
|Recent Collaboratory ethics articles among the most downloaded from AJOB Empirical Bioethics|
October 27, 2016: Five Collaboratory ethics articles were among the most downloaded since 2014 from AJOB: Empirical Bioethics.
|American Journal of Bioethics publishes special issue on ethics of research in usual care settings |
April 29, 2016: The American Journal of Bioethics has published a special issue on ethics of research in usual care settings. The publications were supported by a bioethics supplement awarded to the NIH Collaboratory’s Regulatory/Ethics Core.
|Collaboratory Writing Team Presents at American Medical Writers Association|
October 7, 2016: At the 2016 American Medical Writers Association conference, the NIH Collaboratory’s writing team led a session for scientific communicators engaged in disseminating findings from pragmatic clinical trials.
|LIRE Trial Completes Enrollment|
October 3, 2016: The Lumbar Imaging with Reporting of Epidemiology (LIRE) trial has completed enrollment. Congratulations to the LIRE study team on this important milestone!
|NIH Collaboratory ABATE Infection Trial Highlighted in Wall Street Journal|
September 15, 2016: The ABATE Infection trial, an NIH Collaboratory project led by Dr. Susan Huang, is featured in the September 12 Health section of the Wall Street Journal.
|New NIH Collaboratory resource for the transparent reporting of PCTs|
September 1, 2016: The NIH Collaboratory has developed a tool to assist authors in the complete and transparent reporting of their pragmatic clinical trials (PCTs).
|New video highlights the importance of stakeholder advisory boards|
August 9, 2016: The PATIENTS program at the University of Maryland has produced a brief video on the role of Stakeholder Advisory Boards.
|New article on physicians’ perspectives regarding pragmatic clinical trials|
July 19, 2016: The Journal of Comparative Effectiveness Research has published an article examining clinicians’ views on participating in pragmatic clinical research.
|ICD-Pieces trial begins enrollment|
July 18, 2016: The Improving Chronic Disease Management with Pieces (ICD-Pieces) pragmatic trial has begun enrollment. Congratulations to the ICD-Pieces team!
|NIH issues final policy on use of single IRB|
June 21, 2016: The NIH has issued a final policy requiring the use of a single institutional review board for multi-site non-exempt human subjects research funded by the NIH. The policy will take effect May 25, 2017.