The NIH Collaboratory’s Health Care Systems Interactions Core has published a document entitled Lessons Learned from the NIH Health Care Systems Research Collaboratory Demonstration Projects. The Principal Investigators of each of the Demonstration Projects shared their trial-specific experience with the Core to develop the document, which presents problems and solutions for initiation and implementation of pragmatic clinical trials (PCTs). Lessons learned are divided into the following categories: build partnerships, define clinically important questions, assess feasibility, involve stakeholders in study design, consider institutional review board and regulatory issues, and assess potential issues with biostatistics and the analytic plan.
Other tools available from the Health Care Systems Interactions Core include a guidance document entitled Considerations for Training Front-Line Staff and Clinicians on Pragmatic Clinical Trial Procedures and an introduction to PCTs slide set.
The New England Journal of Medicine today published a perspective by NIH Deputy Directory Kathy L. Hudson, PhD, and NIH Director Francis S. Collins, MD, PhD, in which they outline the major reforms proposed for regulations governing the ethical conduct of research involving humans, known as the Common Rule (45 CFR 46, Subpart A).
The proposed changes are meant to enhance respect for research participants, calibrate oversight to level of risk, simplify consent documents, streamline IRB review, increase privacy and security safeguards, and facilitate broad participation in research.
“These long-overdue reforms will bring the Common Rule into the 21st century. They should help the scientific community take a giant leap forward in showing respect for research participants, without whom the biomedical research enterprise would cease to exist.”
The NIH is encouraging all stakeholders—the public, researchers, and patients—to closely review the proposed changes and participate in the comment process by the December 7, 2015, deadline.
For more information on the proposed revisions:
Grand Rounds Presentation, Kathy Hudson (video)
Department of Health and Human Services' website on the NPRM
OHRP Webinars on the NPRM
Living Textbook Chapter: Informed Consent: Emerging Issues and Controversies
On March 9, 2015, the U.S. Food and Drug Administration (FDA) issued draft guidance on the Use of Electronic Informed Consent in Clinical Investigations (document opens as a PDF).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.
A new feature on the FDA.gov website allows you to search for FDA guidance documents on all topics from one convenient location:
FDA Guidance Document Search Feature
Guidance documents represent the FDA’s current thinking on particular topics and are used by stakeholders to understand the agency’s interpretation of regulations and policies.
There are approximately 3,000 guidance documents available on the site, which can be searched by keyword or filtered by date issued, FDA organizational unit, subject, draft or final status, and comment period.
The search feature was implemented in January 2015 in response to site visitor feedback.
The NIH Collaboratory’s Biostatistics and Study Design Core has released the first in a series of guidance documents focusing on statistical design issues for pragmatic clinical trials. Each of the four guidance documents are intended to help researchers by providing a synthesis of current developments in the field, discuss possible future directions, and, where appropriate, make recommendations for application to pragmatic clinical research.
The guidance documents are available through the Living Textbook and can be accessed on the “Tools for Research” tab or directly here.