University of Rochester Clinical and Translational Science Institute Reaches Out to Community, Region

Now in its third year of operation, the University of Rochester CTSI has made significant inroads in improving community awareness about scientific research and is fostering more collaboration among investigators in Upstate New York. It continues to work locally—to increase community engagement and participation—and regionally—to bring researchers together to share resources. At the same time, the CTSI is constructing a new facility to house clinical and translational science efforts on campus.

Getting the Community Involved
The CTSI’s Community Engagement Key Function is building on a foundation of successful efforts to improve community awareness of clinical research, particularly among minority populations (in 2004, the medical school received the Association of American Medical Colleges Outstanding Community Service Award). Members of the Community Engagement group spent 18 months conducting focus groups, surveys and interviews to better understand community perceptions of health research and the issues that may prevent individuals from participating. They found that while education, race, socioeconomic factors and fear all play a role in the inclination and ability to volunteer for medical research, people can and do change their beliefs and intentions when they have good information and when researchers reduce logistical barriers to participation. The CTSI used this information to develop a new clinical trials website and a public information campaign.

Promoting Regional Partnerships
To harness the collective talents and resources of the region’s biomedical research community and promote collaboration, the University of Rochester CTSI organized the Upstate New York Translational Research Network, a consortium of 13 major institutions from Albany to Buffalo. It has given rise to the Emergency Research Network of the Empire State, which brings together the emergency medicine departments of six institutions to facilitate research on emergency medical outcomes across the region. Another network initiative streamlines the process of conducting clinical studies across multiple institutions by enabling participating institutions to “defer” to the decision of the sponsoring organization’s institutional review board.

CTSA Consortium Child Health Oversight Committee Furthers Pediatric Research

The CTSA Consortium Child Health Oversight Committee (CC-CHOC, formerly the Pediatric Oversight Committee) changed its name to more accurately represent the diversity of disciplines and specialties within the CTSA consortium. The committee has made progress on a number of fronts to further pediatric translational research.

Workshops Address Need for Collaboration, Education
In February, the committee sponsored the CTSA Consortium Pediatric Drug & Medical Device Development Conference at NIH. The workshop aimed to leverage the clinical research infrastructure of the CTSAs to enhance the development of medical therapeutics that meet the needs of children. The participants determined that the infrastructure for pediatric clinical trials for drug and device development is insufficient, fragmented and burdened with complex, redundant regulatory and legal requirements. They agreed on the need for training to improve investigator understanding of the additional regulatory requirements for data monitoring, data integrity and quality assurance necessary to support submission of a marketing application for a new drug or medical device. In response, the CC-CHOC will sponsor investigator training with a focus on data managment for regulatory submissions (August 27, 2009, at the Natcher Conference Center). Members of the CC-CHOC will participate in a prioritization process meeting for pediatric pharmaceuticals and medical devices (in November 2009). More Information About the February Meeting

In April, the CC-CHOC’s Pediatric Research Ethics group and the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) held a workshop that compared institutional review board (IRB) models for multisite pediatric studies. Workshop participants discussed ways to enhance the speed, efficiency and quality of IRB review through process improvement. The workshop included both an on-site and online component, allowing more than 250 speakers, panelists and attendees from across the country to participate. More Information

Committee Moves Forward on Biobank, Metrics
In September 2008, the CC-CHOC’s Pediatric Rare Diseases group received an administrative supplement to develop a pilot distributed biobank for possible CTSA-consortium-wide use. Investigators are currently developing operational principals, federated architecture and tool sets. The Metrics of Success group has developed eight outcome measures or “starter metrics” intended to track child health research at individual CTSA sites over time, which were piloted by some group member CTSAs and are being further evaluated by the CC-CHOC now.

Face-to-Face Meeting Sets Priorities, Showcases Talent in Concurrent Pediatric Academic Society (PAS) Meeting
At its annual meeting in May, the CC-CHOC elected new leadership and discussed plans for the upcoming year. Priorities include aligning with the CTSA consortium’s five strategic goals, enhancing interdisciplinary participation in CC-CHOC activities and initiating a survey of the membership at large to elicit clear goals for the group.

Dr. Anthony Hayward, DCRR Director, provided the keynote address, Status of Child Health Translational Research: Opportunities and Challenges in the CTSAs.

This meeting marked the first time that the annual meeting was held in conjunction with the PAS meeting, enabling many committee members to attend both. As PAS partners, the CC-CHOC showcased CTSA pediatric research at a symposium and two platform sessions. The CC-CHOC members agreed that the concurrent meeting arrangement was effective and plan to continue it next year, when the PAS meets in Vancouver. More Information

News from the CTSA Consortium Steering Committee: Clinical Research Key Function Committee Established to Streamline Reporting

The CTSA Consortium Steering Committee is examining the responsibilities and relationships of the key function committees (KFCs) to the strategic goal committees (SGCs). The KFCs are the principal knowledge resource from which SGCs may directly draw expertise. Achieving the strategic goals set by the Steering Committee is the primary focus of the CTSA consortium; therefore, KFCs are expected to contribute their expertise and serve in a vertically integrated structure as a resource for the SGCs.

Three CTSA KFCs and their subgroups are closely intertwined: Clinical Research Management, Participant and Clinical Interactions Resources and Regulatory Knowledge. The missions of these three KFCs include the following shared topics:

• Clinical protocol review and processing
• Educational materials in human subject studies
• Best practices in human subject studies
• Informed consent
• Contracting and intellectual property processes
• Compliance with regulations
• Clinical protocol budget monitoring
• Human subject recruitment
• Protection of human subjects in research
• Regulatory process documentation

To streamline the interaction of these three committees with the SGC to which they map most closely—National Clinical and Translational Research Capacity (SGC number one)— these three committees will report their activities through one integrated KFC, the Clinical Research Innovation KFC.

The three committees—Clinical Research Management, Participant and Clinical Interactions Resources and Regulatory Knowledge—and their subgroups will continue to function within the Clinical Research Innovation KFC with their current membership and leadership. No immediate change is proposed for their current priorities, goals or milestones.

CTSA Federated Access Now Underway

NCRR began providing federated access to the CTSA wiki on February 18. At that time only seven CTSA institutions were federated with the NIH. Now, 15 CTSA institutions and their partners are federated with the NIH through InCommon, a network supporting shared management of access to online resources in support of U.S. education and research.

Additionally, NCRR’s Scientific Information System (SIS) for submitting data for grant progress reports, is now available using federated access. Individuals from institutions federated with NIH who currently have access to these systems can now log in by entering their home institution usernames and passwords using a simple drop-down menu.

“The new method of accessing the CTSA wiki is a great improvement,” said Daniel Ford, M.D., M.P.H., CTSA principal investigator for the Johns Hopkins Institute for Clinical and Translational Research. “While keeping track of passwords seems like a small barrier, the federated approach means I am much more likely to access the CTSA wiki from anywhere.”

Principal investigators submitting annual grant progress reports to the NCRR SIS must now use federated access to log into the system (by entering their home institution username and password). Each principal investigator may designate up to two other people to help submit progress reports and manage the SIS account.

Federating with CTSA and partner organizations through the InCommon network facilitates sharing resources across institutions, said Bill Barnett, Ph.D., director of information infrastructures at Indiana University’s Clinical and Translational Sciences Institute.

“By deploying federated identity support, we can create a trusted online environment in which people can come together, easily access state-of-the-art technologies and services and use them to work collaboratively to improve health care practice and outcomes while protecting patient privacy.”

For more information about how you can start using federated access, see the CTSA federation fact sheet.