Meeting minutes and supplementary materials are available that summarize discussions related to the ethics and regulatory issues associated with each of the new UG3 NIH Collaboratory Trials. These discussions, which took place by teleconference, 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 as well as some IRBs responsible for oversight of the projects.
informed consent
February 5, 2018: Clinical Effectiveness Research Innovation Collaborative (CERIC) Aims to Streamline Oversight for Learning Activities
One of the Clinical Effectiveness Research Innovation Collaborative (CERIC) group’s priority actions is to create a supportive regulatory environment for learning activities that aim to provide evidence for healthcare improvement. In support of this goal, the National Academy of Medicine hosted a day-long meeting on January 25, 2018, to propose and communicate streamlined approaches for oversight of learning activities, informed consent, and privacy protection. The meeting attendees included key representatives from health systems, institutional review boards, patient groups, the Office for Human Research Protections (OHRP), and privacy experts. Dr. Richard Platt is a co-chair of the collaborative, and Dr. Jeremy Sugarman was part of a panel on the revisions to the Common Rule. Background materials for the meeting included articles from the Collaboratory Regulatory/Ethics Core’s special series in Clinical Trials. Meeting attendees sought to clarify regulatory barriers to embedding continuous learning activities in health systems, practices, and health plans and also to suggest possible solutions that would help streamline approaches in support of an enduring learning health system.
Participants discussed the grey area between quality improvement and research, and the differences in regulations for each. One critical issue that was identified is that the foundations of the current regulatory environment are built on the Belmont Report, a forty-year old document originally intended to prevent incidents like the Tuskegee Syphilis Study from ever happening again. While the ethical principles in the Belmont Report—respect for persons, beneficence, and justice—are still relevant today, much has changed since the original writing of the document. Healthcare is increasingly complex and conducted in a digital world, and bold ideas may be needed to create an alternate system for the betterment of all. Next steps for the group include the creation of a document that describes a framework for learning activities and includes a series of case examples for OHRP to review in order to provide clarification and answers to frequently asked questions (FAQs).
January 18, 2018: Implementation of Revised Common Rule Delayed
On January 17, 2018, the Department of Health and Human Services and 15 other federal departments and agencies announced a delay to both the effective and compliance dates for the revisions to the “Federal Policy for the Protection of Human Subjects” (also known as the Common Rule). Most provisions in the revised Common Rule were scheduled to go into effect on January 19, 2018. The Interim Final Rule announced a delay until July 19, 2018, with the option for further delay, to give institutions additional time to prepare to implement the revisions. Before July 19, 2018, institutions may only begin implementing provisions of the revised Common Rule that do not conflict with the pre-2018 Common Rule.
A notice of proposed rulemaking (NPRM) is also in development to seek public comment on a proposal for further delay in the required implementation of the revised Common Rule (for example, until January 21, 2019). A decision will be made after considering public comments.
November 20, 2017: NIH Collaboratory Core Working Group Interviews: Reflections from the Ethics and Regulatory Core
We recently asked Drs. Jeremy Sugarman and Kevin Weinfurt, Co-chairs of the Ethics and Regulatory Core, to reflect on the first 5 years of the Core as well as on the challenges ahead. The regulatory and ethical landscape for pragmatic clinical trials was not well defined when the Core began 5 years ago, and the Core helped to map and navigate the emerging landscape to enable the implementation of NIH Collaboratory Trials in ways that satisfied ethical and regulatory criteria.
“The Core’s work has led to the creation of a substantial body of scholarship contributing to the ongoing policy and ethics debates about pragmatic clinical trials.” – Drs. Sugarman and Weinfurt
Upcoming CTTI Webinar on Informed Consent Recommendations
The Clinical Trials Transformation Initiative’s Informed Consent Project will unveil recommendations and associated resources for informed consent on Thursday, November 19.
Presenters include Jennifer Lentz, Global Informed Consent Process Owner in Global Clinical Operations at Eli Lilly and Company, and Michele Kennett, Assistant Vice Chancellor for Research and Director of the Institutional Review Board at the University of Missouri.
• Topic: Informed Consent Project Recommendations
• Date: Thursday, November 19, 2015
• Time: 12 – 1 pm EST
To join the public webinar: Meeting Number: 732 884 847 Meeting Password: ctti After you connect to the website, please follow step-by-step instructions for connecting to the audio. If you prefer to connect to audio only, you can join by phone at: 1-855-244-8681 Call-in toll-free number (US/Canada) 1-650-479-3207 Call-in toll number (US/Canada)
FDA Issues Draft Guidance on Use of Electronic Informed Consent (eIC)
On March 9, 2015, the U.S. Food and Drug Administration (FDA) issued draft guidance on the Use of Electronic Informed Consent in Clinical Investigations (document opens as a PDF). In a question-and-answer format, the guidance provides recommendations for investigators, sponsors, and institutional review boards (IRBs) on the use of electronic media and processes to obtain informed consent for FDA-regulated clinical investigations of medical products, including human drug and biological products, and medical devices, and combinations thereof.
Electronic informed consent, or eIC, refers to the use of electronic systems and processes to convey information related to the study and to obtain and document informed consent. Electronic media formats may include text, graphics, audio, video, podcasts, and interactive websites, biological recognition devices, and card readers. Use of electronic systems may allow for rapid notification to study participants of any amendments pertaining to the informed consent, promote timely entry of eIC data into the study database, and allow for timely collection of the informed consent data from remote locations.
The guidance provides answers to these questions:
- How should the information in the eIC be presented to the subject?
- How and where may the eIC process be conducted?
- How and when should questions from subjects be answered?
- What steps may be taken to facilitate the subject’s understanding of the information being presented?
- What steps may be taken to ensure that new or additional information is conveyed to the subject during the course of the clinical investigation?
- Does FDA allow the use of electronic signatures to document eIC?
- What special considerations should be given to the use of eIC for pediatric studies?
- Should subjects receive a copy of their eIC and have easy access to the material and information presented to them in their eIC?
- What steps can be taken to help ensure confidentiality of the information once eIC is obtained?
- Can HIPAA authorizations for research, which are frequently combined with informed consent documents, be obtained electronically?
- What are the IRB’s responsibilities in the eIC process?
- What eIC documentation does FDA require for submission with applications?
- What steps can be taken to ensure the system archives the documents appropriately?
- What materials or documents will FDA require during an inspection?
The comment period ends May 7, 2015. Users can submit electronic comments using the docket number HHS-OPHS-2015-0002 at the Federal eRulemaking Portal: http://www.regulations.gov.
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.