Category Archives: Regulatory issues

Office for Human Research Protections Releases Draft Guidance on Disclosing Risks in Standard-of-Care Research


On October 20, 2014 the Office for Human Research Protections (OHRP) released a draft guidance on how to apply the Department of Health and Human Services (HHS) regulations on protecting human subjects (45 CFR Part 46) who participate in research studies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Click here for the full draft guidance: Draft Guidance on Disclosing Reasonably Foreseeable Risks in Research Evaluating Standards of Care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.​


 

PCORI Executive Director Dr. Joe Selby to Speak on Regulatory Issues Concerning Big Data


The meeting of the Secretary’s Advisory Committee for Human Research Protections (SACHRP) scheduled for July 21-22, 2014, will include a session on “Regulatory Issues Concerning Big Data.” Joe Selby, MD, MPH, executive director of the Patient-Centered Outcomes Research Institute (PCORI), will speak, along with leaders from the NIH and FDA. The session is scheduled for 1:30-3:45 pm on Monday, July 21.

SACHRP provides recommendations on human subjects protection to the Secretary of the U.S. Department of Health and Human Services and reviews activities of the Office for Human Research Protections (OHRP). Other topics to be covered during the two-day meeting include informed consent comprehension, the return of research results to human subjects, and ethical/regulatory issues in interventional social media research.

The meeting is available to the public and will be videocast live.

View the meeting agenda
View the live webcast (available July 21-22, 2014)

A link to materials from the meeting will be provided in an update to this post when available.


Collaboratory Investigators Publish Article on Ethical and Regulatory Complexities for Pragmatic Clinical Trials in JAMA


“Ethics and Regulatory Complexities for Pragmatic Clinical Trials,” a Viewpoint article by Jeremy Sugarman, MD, MPH, MA, and Robert Califf, MD, was published online in JAMA today. In the article, the authors draw on early experiences from two large networks conducting pragmatic clinical trials, the NIH Collaboratory and the National Patient-Centered Clinical Research Network (PCORnet), to describe 10 ethical and regulatory complexities facing this new field of research. Topics covered include informed consent, risk determination, the role of gatekeepers, and institutional review board review and oversight, among others, as well as the ongoing need for further discussion and research as a key part of efforts aimed at creating a learning healthcare system.

Dr. Sugarman is chair of the Regulatory/Ethics Core of the NIH Collaboratory and deputy director for medicine of the Johns Hopkins Berman Institute of Bioethics. Dr. Califf is the principal investigator of the NIH Collaboratory Coordinating Center and director of the Duke Translational Medicine Institute.


Grand Rounds (4-25-2014): CTTI’s Central IRB Advancement Project

Update:

Archived video and slides from the April 25 Grand Rounds are now available on the NIH Collaboratory Grand Rounds webpage.


This Friday’s NIH Collaboratory and PCORnet Grand Rounds (“CTTI Advancing the Use of Central IRBs Project: Academic Institution and Government Sponsor Perspectives”) will be presented by Cynthia Hahn and Petra Kaufmann, MD, MSc, team leaders for the Clinical Trials Transformation Initiative’s Central IRB Advancement Project. Ms. Hahn is vice president of Clinical Research & Regulatory Affairs for the Feinstein Institute for Medical Research. Dr. Kaufmann is director of the Office of Clinical Research for the National Institute of Neurological Disorders and Stroke.

CTTI’s Central IRB Advancement Project is a follow-up to its previous Central IRB Project that conducted expert and stakeholder interviews to produce considerations and recommendations for central IRB adoption. The current project will take additional steps in encouraging the implementation of these recommendations and addressing remaining barriers to further advance the use of central IRBs for multicenter clinical trials. Expected deliverables include tools and best practices for researchers, sponsors, sites, and IRBs.

The Grand Rounds presentation will take place from 1:00-2:00 PM Eastern time on Friday, April 25. Details are available here. Archived video and slides from the presentation will be available early the following week; links to archived material will be provided in an update to this post.


SACHRP Meeting to Discuss Research Consent Issues


The Department of Health & Human Services’ Secretary’s Advisory Committee on Human Research Protections (SACHRP) has announced that it will be holding a 2-day public meeting centering on consent issues in clinical research.

Part of the meeting will be devoted to discussion of consent issues in the context of cluster randomized trials. Unlike “typical” clinical trials that randomly assign an individual research volunteer to receive one of two treatment options, or a treatment vs. a placebo, a cluster randomized trial (or CRT) randomly assigns groups of people to an intervention. These groups can include clinics, hospitals, city blocks, or whole healthcare systems. Because CRTs randomize groups rather than individuals, obtaining consent from the people involved in such research can present a number of challenging issues.

Meeting participants will also discuss a variety of other topics related to the application of regulations governing research conduct in the current era, as well as potential changes to such regulations.

The meeting, which will include programmed presentations as well as a period for public comment, will be held in Washington, DC, on March 12-13, 2014, at the U.S. Department of Health and Human Services, 200 Independence Avenue SW., Hubert H. Humphrey Building, Room 800. A full program of the meeting’s events is available here, and additional description and context are available from the Federal Register.