regulatory issues

Upcoming CTTI Webinar on Informed Consent Recommendations

Posted on by Gina Uhlenbrauck

CTTI-logo-127x100The 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FDA Issues Draft Guidance on Use of Electronic Informed Consent (eIC)

Posted on by Gina Uhlenbrauck

On March 9, 2015, the U.S. Food and Drug Administration (FDA) issued draft guidance on the Use of Electronic Informed Consent in Clinical Investigations (document opens as a PDF).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.

New Search Feature for FDA Guidance Documents

Posted on by Gina Uhlenbrauck

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.

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

Posted on by Gina Uhlenbrauck

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. 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

Posted on by Gina Uhlenbrauck

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.