Informed Consent

CTTI Presents Innovations in Informed Consent at the AAHRPP Conference

Posted on by Lorri Bingham

In November 2015, CTTI released official recommendations for a new model of informed consent that places the focus back where it should be: the participant. This innovative approach to informed consent emphasizes the process, which should be an interactive, ongoing conversation between the participant and the research investigator or staff. Several tools are included within the recommendations, which were developed to assist researchers (at the site and sponsor) in implementing this strategy.

Today, two colleagues involved in CTTI’s Informed Consent Project, Michele Kennett and Ross McKinney, will present these recommendations at the 2016 Annual AAHRPP Conference. If you are attending this event, we invite you to attend this session and learn more about the project:

2016 Annual AAHRPP Conference
Conference Location: Longbeach, CA
Presentation Topic: Innovations in Informed Consent: the CTTI Project
Presentation Date & Time: Wednesday, April 20, 2016, from 10:30 AM – 11:45 AM
Speakers:

  • Ross McKinney, MD, MBA, Professor of Pediatrics, Duke University
  • Michele Kennett, JD, MSN, LLM, Director, Human Research Protections, University of Missouri

 

CTTI’s Recommendations on Informed Consent to be Featured in Upcoming NIH Collaboratory Grand Rounds

Posted on by Lorri Bingham

NEW recommendations on Informed Consent

On Friday, January 8, Jennifer Lentz of Eli Lilly and patient advocate Jane Perlmutter will present CTTI’s actionable, evidence-based recommendations on informed consent at the NIH Collaboratory Grand Rounds webinar.

The proposed new model for the informed consent process places the focus back where it should be: the participant. Furthermore, the consent process should be an interactive, ongoing conversation between the participant and the research investigator or staff. We encourage anyone interested in improving clinical trial quality and efficiency to attend.

Webinar Topic: The Clinical Trials Transformation Initiative’s Informed Consent Project: Recommendations and Resources

Speakers:

  • Jennifer Lentz, Global Informed Consent Process Owner, Global Clinical Operations, Eli Lilly and Company
  • Jane Perlmutter, PhD, Patient Advocate

Date & Time: Friday, January 8, 2016 from 1:00 – 2:00 p.m. EST

Meeting Info: CLICK HERE to view webinar login details

Recording Now Available: Webinar Unveiling of CTTI’s Informed Consent Project Recommendations

Posted on by Lorri Bingham

On November 19, 2015, CTTI hosted a webinar to present a new model of the informed consent process that places the focus back where it should be: the participant. This webinar was the official unveiling of CTTI’s recommendations resulting from the Informed Consent Project. We are pleased to now share the recording of this webinar:

We encourage you to share this recording with your colleagues in the clinical trials enterprise.

To view recordings of other CTTI webinars, CLICK HERE.

Focus on the Process: CTTI Recommendations for Improved Informed Consent

Posted on by Lorri Bingham

NEW recommendations on Informed Consent

CTTI recommends a new model for the informed consent process that places the focus back where it should be: on the participant. The consent process should be an interactive, ongoing conversation between the participant and the research investigator or staff. “Patients who really understand what they are agreeing to when they sign an informed consent document are much more likely to adhere to trial requirements and be retained for the entire timeframe of the trial,” notes patient advocate, Jane Perlmutter. “Thus, not only is excellent consenting better for patients, it will also lead to more efficient and less costly trials.”

At a CTTI-hosted webinar on November 19, 2015, sponsors will hear suggestions and learn about tools to help them restructure the informed consent process and document to be more participant-friendly while retaining key information. The webinar will also explore the benefits of e-consent and how appropriate and thorough research staff training can improve the overall process for everyone involved.

The need for this new direction is recognized. “The Association of Clinical Research Professionals (ACRP) supports the recommendations put forth by our partners in the Clinical Trials Transformation Initiative,” says Jim Kremidas, ACRP Executive Director. “We are confident these recommendations will result in a more efficient and higher quality informed consent process conducted by clinical research professionals. A clear understanding of the risks and expectations clinical trial participants face will enhance their experience and drive better quality research.”

You’re Invited! CTTI Recommendations for an Improved Informed Consent Process to be Unveiled in November 19 Webinar

Posted on by Lorri Bingham

Join CTTI on November 19, 2015, as they host a webinar to present a new model of the informed consent process that places the focus back where it should be: the participant. This webinar will be the official unveiling of CTTI’s recommendations resulting from the Informed Consent Project and it is open to the public. We encourage you to share this invitation with your colleagues in the clinical trials enterprise.

Webinar Title: Public Unveiling of CTTI’s Informed Consent Project Recommendations

Date & Time: Thursday, November 19, 2015 from 12:00 – 1:00 p.m. EST

Speakers:

  • Jennifer Lentz, Global Informed Consent Process Owner, US CMS Coordinator, Global Clinical Operations, Eli Lilly and Company
  • Michele Kennett, Assistant Vice Chancellor for Research, Director of Human Research Protections, Director of MU Institutional Review Board, University of Missouri

Webinar Login:

  • CLICK HERE to enter meeting.
  • 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)

Expert Meeting Summary Available: Multi-stakeholder Perspectives on Improving Informed Consent

Posted on by Lorri Bingham

Key stakeholders in the clinical trials enterprise acknowledge that informed consent documents are too lengthy and difficult for research participants to understand, and the informed consent process is not meeting the needs of the participants; however, there is currently little consensus around what a more effective informed consent model should look like. Actionable recommendations are needed, and CTTI is working to address this unmet need.

In March CTTI convened a multi-stakeholder group of experts and thought leaders from across the clinical trials enterprise to explore more effective informed consent processes. Specifically, the meeting attendees set out to:

  • Discuss previous and current efforts to improve informed consent documents and the informed consent process, including alternatives to the traditional paper informed consent document
  • Identify potential remedies for concisely communicating the required elements of informed consent, including how consenter training affects the informed consent process
  • Propose a more effective process, including informed consent documentation, for ensuring research participants’ understanding of critical informed consent elements
  • Suggest potential strategies and opportunities for pilot testing the informed consent process improvement recommendations

We are pleased to share the summary, as well the presentation materials from this expert meeting. These materials describe the current challenges involved with the consent process and provide an evidence-based foundation for moving forward.

Click here to view all meeting materials.