Single IRB

CTTI to Support NIH Workgroup in Developing Evaluation Plan for Single IRB Policy

Posted on by Lorri Bingham

The NIH has selected CTTI to support a workgroup that will develop a comprehensive plan for assessing the NIH’s new single institutional review board (sIRB) policy. The policy, which became effective in January, requires U.S. sites participating in nonexempt multicenter human subjects research funded by the NIH to use a sIRB for ethical review, with the goal of improving the quality and efficiency of clinical research.

 

“For nearly a decade, CTTI has championed the adoption of sIRBs for multicenter clinical trials,” said Pamela Tenaerts, executive director at CTTI. “We are excited to use our expertise to craft an evaluation plan for the NIH policy, and to design standard evaluation methods that can be used by academic organizations, research sponsors, and others who are interested in implementing sIRBs.”

 

Sites in multicenter clinical trials have typically relied on their own IRBs to conduct required ethical reviews, often leading to needless repetition across sites. The goal of the NIH’s new sIRB policy is to enhance and streamline the review process for multicenter studies so that research can proceed as quickly as possible and research oversight may be improved.

 

CTTI has developed a number of recommendations and resources to support sIRB adoption, and the NIH referenced CTTI’s work in a 2014 draft policy recommending the use of sIRBs. Currently, CTTI is gathering information from sponsors, investigators, IRB members, and research and regulatory coordinators to determine actions that the NIH, the FDA, and the Office for Human Research Protections can take to help the research community adopt sIRB review.

CTTI Hosts Free Webinar to Highlight Key Initiatives of MDIC to Advance Medical Device Regulatory Science

Posted on by Lorri Bingham

CTTI will host a free, public webinar on Thurs., May 17, at 12:00 p.m. EDT to highlight key initiatives of the Medical Device Innovation Consortium (MDIC), a public-private partnership working to advance medical device regulatory science. Attendees will learn how MDIC’s and CTTI’s efforts—particularly around engaging patients as equal partners and driving single IRB adoption—complement each other to improve clinical trials.

 

Add to Calendar

 

Stephanie Christopher and Dan Schwartz of MDIC will present on topics including:

 

  • The Science of Patient Input initiative to develop a framework for patient input in clinical trials.
  • A preview of results from the project to integrate patient preferences into the design of clinical trials.
  • Early Feasibility initiative to highlight Early Feasibility Study (EFS) Metrics and Contract projects.

CTTI has long recognized that overcoming the complex challenges facing the clinical trials enterprise requires strong coordination across initiatives. By ensuring our enterprise-wide efforts are complementary and not duplicative, we can more efficiently and successfully improve the R&D process and increase the quality and efficiency of clinical trials.

 

Topic: MDIC and CTTI: Synergies in Clinical Trials Efforts

Date: Thurs., May 17, 2018, 12:00-1:00 p.m. EDT (GMT -04:00)

Presenters: Stephanie Christopher and Dan Schwartz (MDIC)

CTTI Continues to Address Barriers to Single IRB Adoption: Latest Expert Meeting Summary Now Available

Posted on by Lorri Bingham

Using a single institutional review board (sIRB) for multisite trials can improve the quality and efficiency of multicenter clinical trials—and beginning Jan. 25, 2018, the National Institutes of Health (NIH) is requiring use of an sIRB for NIH-funded multicenter clinical research.

To help drive adoption of sIRB review, CTTI has developed several recommendations, resources, and tools for use by the research community, and recently convened an expert meeting to discuss further actions that CTTI, the U.S. Food and Drug Administration (FDA), Office for Human Research Protections (OHRP), and NIH can take to ease the transition. The expert meeting included representatives from academia, government agencies, IRBs, pharmaceutical, and device companies, contract research organizations, and patient groups, with the goal of identifying remaining gaps in knowledge and potential solutions to implementing a sIRB model.

Meeting participants highlighted the need for clarity around language and procedures, and emphasized that early collaboration among parties can mitigate the challenges. Participants felt that the time is right to learn from each other by sharing successful models of sIRB review among the private sector, academia, and government research organizations. Next steps from CTTI will involve new projects and committees to develop additional supportive tools and strategies for implementing sIRB review.

Now Available: CTTI Symposium Presentations

Posted on by Lorri Bingham

For those unable to attend the CTTI 10-year Symposium on Feb. 6, we are pleased to share slides from each of the exciting, informative sessions:

Meeting Presentations

  1. Welcome and Introduction to CTTI by Pamela Tenaerts, CTTI
  2. Welcome from the Executive Committee by Jacqueline Corrigan-Curay, FDA, CDER
  3. Keynote Address by Robert Califf, Duke University / Verily
  4. Reflection on Quality by Design by Robert Temple, FDA, CDER
  5. Quality by Design Project Overview and Recommendations by Ann Meeker-O’Connell, Johnson & Johnson
  6. Quality by Design Case Study by Julie Dietrich, Amgen, Inc
  7. PGCT Project Overview and Recommendations by Bray Patrick-Lake, Duke Clinical Research Institute
  8. PGCT Case Study by Ron Bartek, Friedreich’s Ataxia Research Alliance
  9. PGCT Case Study by Jeff Sherman, Horizon Pharma
  10. Single IRB of Record Project Overview and Recommendations by Soo Bang, Celegene
  11. Single IRB of Record Case Study by Hallie Kassan, Feinstein Institute for Medical Research, Northwell Health

Thank you again to all of our esteemed presenters who made the CTTI Symposium a great success! Keep an eye on this blog for a complete recap of the event later this week.

Navigating the Updated Common Rule

Posted on by Lorri Bingham

CTTI TOOLS AND RECOMMENDATIONS CAN HELP RESEARCHERS MEET NEW REQUIREMENTS FOR INFORMED CONSENT DOCUMENTS AND CENTRAL IRBS

This year the US Department of Health and Human Services released long-awaited updates to the Federal Policy for the Protection of Human Subjects, better known as the Common Rule. Originally issued in 1991, the Common Rule governs a large proportion of U.S. research involving human participants. CTTI offers resources and tools that can help investigators seeking to understand and implement some of these new requirements, including recommendations that closely parallel key Common Rule standards for informed consent documents and the use of central institutional review boards (central IRBs).

Informed Consent Documents

The revised Common Rule states that informed consent documents (ICDs) “…must begin with a concise and focused presentation of the key information” that is most likely to help prospective study participants understand the reasons for or against participating in a trial.  CTTI’s recommendations for using shorter, simpler informed consent documents that utilize a “tiered approach” to presenting information and incorporate health literacy and reading level assessments provide a structured path that can help in creating ICDs that satisfy Common Rule requirements:

SIMILARITIES BETWEEN COMMON RULE REQUIREMENTS & CTTI RECOMMENDATIONS FOR INFORMED CONSENT DOCUMENTS

New Common Rule Requirements for Informed Consent Documents (2017)CTTI Recommendations for Informed Consent Documents (2013)Concise and focused presentation of key information most likely to assist a prospective subject or legally authorized representative in understanding the reasons why one might or might not want to participate in the research.

Information in this part of the ICD must be organized and presented in a way that facilitates comprehension. Use of tiered approach, including:

  • Section that includes only elements required by federal regulations
  • Additional information in chapter format
  • 1-2 page summary of the study

Draft ICDs should be evaluated with:

  • Standardized health literacy/plain language assessments
  • Reading level assessments
  • Usability testing with comparable patients

Source: Federal Policy for the Protection of Human Subjects https://www.federalregister.gov/documents/2017/01/19/2017-01058/federal-policy-for-the-protection-of-human-subjects Source: CTTI Recommendations: https://ctti-clinicaltrials.org/files/ctti-informedconsent-recs.pdf

Use of a Single or Central IRB

Another facet of the revised Common Rule that harmonizes with CTTI recommendations relates to the use of single IRBs for oversight of research activities in multicenter trials. In 2013, CTTI recommended the use of a central IRB (in other words, a single IRB of record for all research sites participating in a clinical study) in order to improve quality and efficiency. Although the Common Rule does not require all multisite trials to use a central IRB, it does mandate that U.S. institutions involved in cooperative research in the United States (with certain exceptions) use a single IRB and notes that

When working optimally, we expect the central IRB model will work more efficiently and require less personnel time and fewer resources for tracking and implementing IRB changes and approvals, thereby eliminating the potential for unnecessarily duplicative reviews.

CTTI offers several tools that can assist research sites, sponsors, and IRBs in successfully navigating the challenges of using a central IRB model, including a template IRB authorization agreement; an evaluation checklist that helps sites assess readiness, helps sites or sponsors select a central IRB, and helps central IRBs to assess research sites; and a considerations document that delineates the central IRB’s responsibilities versus the site’s institutional obligations.

 

For complete listings of publicly available CTTI implementation tools and recommendations, visit the CTTI website.

New NIH Policy Aligns With CTTI’s Work to Increase Adoption of Central IRBs

Posted on by Lorri Bingham

The NIH has issued a final policy requiring the use of a single institutional review board (IRB) for multi-center NIH-funded clinical trials. The policy will take effect May 25, 2017.

Since 2010, CTTI has been working to address barriers to the adoption of central IRBs for multi-center clinical trials through its Central IRB and subsequent Central IRB Advancement projects. The draft NIH policy released in 2014 referenced CTTI’s recommendations, and the final policy reflects CTTI’s shared goal to increase the efficiency of clinical trials through the use of central IRBs.

With the NIH mandate now finalized, CTTI’s tools are available to help with implementation. These include the following:

  • a template IRB authorization agreement
  • an evaluation checklist with considerations for 1) assessing an institution’s readiness for central IRB adoption, 2) selecting a central IRB, and 3) deciding when a central IRB should work with a specific institution
  • a considerations document to address the often blurred distinctions between responsibilities for ethics review and other institutional obligations

According to the new policy, “while the NIH anticipates that there will be challenges associated with implementation, we expect these to be short-lived. Once the transition to the new way of operating is made, the benefits of widespread use of [single IRBs] will outweigh any costs and, ultimately, reduce burdens to the research process.”

CTTI applauds this important progress for the clinical trials enterprise.

 

CTTI’s Recommendations & Implementation Tools for Advancing the Use of Central IRBs to be Featured in Upcoming MDICx Webinar

Posted on by Lorri Bingham

CTTI’s recommendations and implementation tools for advancing the use of central IRBs for multi-center clinical trials will be presented at the next webinar in the MDICx series. The featured speakers include Cynthia Hahn, Chief Operating Officer, The Feinstein Institute for Medical Research, and Soo Bang, Sr. Director, Global Alliances & Business Development, Celgene Corporation.

Webinar Details:

  • Date: Wednesday, August 12th
  • Time: 12:00 p.m. – 1:00 p.m. ET
  • REGISTER HERE

We look forward to this event and encourage the sharing of this invitation with colleagues involved in the clinical trial enterprise.

Recording Now Available: NIH Collaboratory Grand Rounds Features CTTI’s Central IRB Recommendations

Posted on by Lorri Bingham

On July 10, 2015, the NIH Collaboratory’s Grand Rounds Webinar Series featured the work of CTTI’s Central IRB Advancement Project. Co-team leader Cynthia Hahn reviewed the recently released recommendations for advancing the use of central IRBs for multicenter clinical trials.

We are now pleased to share the recording of this webinar:

CTTI Releases New Tools to Help Organizations Implement Central IRBs in Multi-Center Clinical Trials

Posted on by Lorri Bingham

Today the Clinical Trials Transformation Initiative (CTTI) announced new recommendations that support the use of a single institutional review board (IRB) of record for multi-center clinical trials.  Included within the recommendations are tools, such as evaluation checklists, to help sponsors, research institutions and central IRBs implement this model.

In a multi-center clinical trial, full review by each site’s IRB can lead to significant delays in study start-up and may not enhance the protection of research participants.  Since 2010 CTTI has been working to understand and address barriers to using a single IRB of record for multi-center clinical trials in the United States. The project was initiated because some research sites were hesitant to use a central IRB, despite encouragement from the U.S. Food and Drug Administration (FDA) and the U.S. Office of Human Research Protections (OHRP).

“Using a single IRB for multi-site clinical research is an important step in accelerating the translation from discoveries to health benefits. The Clinical and Translational Science Awards (CTSA) program is working toward using a single IRB for multi-site studies. The CTTI Central IRB recommendations will be very helpful in advancing towards this goal,” said Petra Kaufmann, M.D., M.Sc., director of the Division of Clinical Innovation at the National Center for Advancing Translational Sciences (NCATS) of the National Institutes of Health (NIH).

In addition to the evaluation checklists, CTTI has released a Considerations Document and an IRB authorization agreement template, to support communication and contractual relationships between institutions and a central IRB. CTTI has also hosted webinars during which individuals from sponsor and research organizations have presented their experience of adopting a central IRB model as examples that others can follow.

A complete list of recommendations can be found here.