Informed Consent

CTTI Informed Consent Project Expert Meeting

MARCH 10, 2015 TO MARCH 11, 2015

CTTI Project: Informed Consent

Meeting Objectives

  • Present findings and conclusions from the project literature review and expert interview series
  • Solicit feedback and develop consensus on proposed recommendations to enhance the informed consent process

Meeting Location:

DoubleTree by Hilton Hotel Washington DC, Silver Spring, MD

Meeting Materials:

Meeting Summary

Meeting Agenda

List of meeting attendees

Meeting Presentations:

The views and opinions expressed in this presentation are those of the individual presenter and should not be attributed to the Clinical Trials Transformation Initiative, or any organization with which the presenter is employed or affiliated.

Presenting CTTI Recommendations: Informed Consent

CTTI Project: Informed Conent

Webinar Presenters:

  • 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

*The views and opinions expressed in this video are those of the speaker and do not necessarily reflect the official policy or position of CTTI.

Webinar Objective:

Team members from CTTI’s Informed Consent Project unveiled the official recommendations resulting from this project. These recommendations propose a new model for the informed consent process that places the focus back where it should be: on the participant.

New CTTI Publication Highlights Stakeholder Preferences for Informed Consent Language in HABP/VABP Studies

Posted on by Hannah Faulkner

A peer-reviewed article recently published in JAMA Network Open details CTTI work to get stakeholder feedback on informed consent language for hospital-acquired and/or ventilator-associated bacterial pneumonia (HABP/VABP) studies. The article describes the process of gathering feedback from 52 stakeholders to identify the most important elements to include in the informed consent process.

Previous CTTI research suggested that an early enrollment strategy using advance consent in pneumonia antibiotic trials is acceptable to key stakeholders. As part of that research, CTTI also engaged these stakeholders to identify, describe, and reach consensus on essential concepts that should be included in an advance consent form for a HABP/VABP clinical trial. Concepts were:

  • Reassurances on patient health and treatment
  • Reasons for advance consent and enrolling early
  • Explanation of non-inferiority

The proposed consent language developed in this process, in combination with a strategy for enrolling patients at highest risk for pneumonia before infection onset, may help potential participants make informed decisions about their involvement in clinical research. It may also improve enrollment rates in trials from which data are urgently needed to evaluate new treatments and improve patient care.

Learn more about past CTTI work on HABP/VABP.

Happy Holidays from CTTI – Gifts you can use

Posted on by Lorri Bingham

Happy Holidays

If quality, efficient trials are on your wish list, we’ve got you covered.

CTTI’s latest recommendations and tools:

In 2016, there were over 30,000 downloads from the CTTI website. Popular favorites include our evidence-based recommendations on trial quality, informed consent, and patient group engagement.

By engaging all stakeholders to develop actionable solutions, we are creating a better system for clinical trials. Thank you to all of our members and contributors for their efforts this past year, and best wishes for a successful 2017!