Succeeding at Community Engagement

Two organizations share their innovative approaches

Organizations often tell us they’re unsure how best to meet AAHRPP requirements for community involvement. Two institutions—Rush University Medical Center and the University of New Mexico Health Sciences Center (UNM HSC)—achieve this standard by tapping into community networks, drawing on researchers’ connections, and reaching out to surrounding community members at home and in their neighborhoods.

“An important feature of most of our community studies is that we don’t expect the participants to come to us,” says Martha Clare Morris, Sc.D., Assistant Provost for Community Research at Rush. “Instead, we train people to meet and work with participants in their own communities.”

Both Rush and UNM HSC emphasize that communication is key. “We listen first. That’s how meaningful community engagement begins,” says Corey Ford, M.D., Ph.D., Senior Associate Dean for Research at UNM HSC.

Rush: A Distinctive Record
Rush was awarded AAHRPP accreditation in June and met Standard I-4 with distinction because of the medical center’s community programs. This accomplishment reflects Rush’s long-standing commitment to community research, education, and intervention.

According to Mary Jane Welch, D.N.P., A.P.R.N., B.C., C.I.P., Director, Human Subjects’ Protection at Rush, one of the easiest, most effective ways to increase community awareness of research is to take advantage of existing outreach efforts. The Human Subjects’ Protection office partnered with the Rush Generations Program for Health and Aging and now participates in Generations events, providing information and answering questions about research. The Human Subjects’ Protection office also staffs a table at Rush’s semiannual community health fairs.

“At first, we didn’t get much interest,” Dr. Welch says. “But now, people look forward to it and call us ahead of time to make sure we’ll be there.”

Rush also partners with other educational institutions. Along with the University of Chicago, Northwestern University, and the University of Illinois at Chicago, Rush is a member of the Chicago Consortium for Community Engagement. The consortium’s accomplishments include the development of a human subjects training curriculum for community partners and the establishment of an inter-institutional committee to increase the diversity of participants in clinical trials.

UNM HSC: Collaborating With HEROs, Pueblos
UNM HSC engages the community at patient care, education, and research sites across New Mexico. In 2011, the university took part in 576 activities in 179 communities.

Among UNM HSC’s most successful outreach efforts is its statewide network of Health Extension Rural Offices (HEROs). HERO agents live and work within the community and connect the community with university resources in education, clinical service, and research. Agents bring the latest research and health care practices to the community and act as the community’s advocate with UNM HSC. They voice community concerns, serve on the institutional review board (IRB), and offer input on research and health issues.

UNM HSC also partners with tribal communities to make sure research studies respect the values of New Mexico’s Native American population. UNM HSC provides IRB services for 16 of the state’s 19 pueblos. Researcher training includes extended modules on cultural sensitivity and other issues unique to community research.

Adaptive Clinical Trials: Scientific and Ethical Issues to Consider

Article of Note: Journal of the American Medical Association

JAMA, June 13, 2012 – Vol. 307, No. 22

A recent issue of JAMA features two articles expressing viewpoints about adaptive trials in clinical research that may be of interest.

An adaptive clinical trial is one in which key characteristics, such as randomization ratio, number of treatment arms, and number of interim analyses conducted, are adjusted while enrollment in the trial is ongoing. The adjustments use prospectively defined decision rules, and they respond to the data accumulating in the trial. For example, using accumulating information can increase the probability that future trial participants are assigned to the study group with a better expected outcome, or the least effective drug doses may be eliminated earlier than in a fixed trial.

Broadly speaking, adaptive trials may minimize the harms to study participants and increase the likelihood that participants will directly benefit. However, understanding the performance characteristics of an adaptive trial may be challenging for both IRBs and trial participants.

In addition, scientific concerns about maintaining blinding (as researchers see trial design changes), as well as questions about whether adaptive trials can be replicated, remain challenges that may limit scientific validity.

For the full articles see http://jama.jamanetwork.com/journal.aspx

IRB Innovation: Streamlining Approvals Through Collaboration, Regionalization

AAHRPP Advance is an ideal forum for sharing innovative practices that have proved successful and can serve as a model for other research organizations. The following Advance post highlights the University of New Mexico Health Science Center’s (UNM HSC) institutional review board and its statewide and regional collaborations.

UNM HSC has turned to collaboration—with community-based organizations and fellow AAHRPP-accredited institutions—to develop an effective approval process that respects community values and facilitates clinical translational research.

Through its Clinical and Translational Science Center, UNM HSC serves all of New Mexico—more than 121,000 square miles. To cover such an extensive geographic region, UNM HSC has successfully partnered with organizations both within and beyond the state to provide more effective, efficient reviews for multisite studies. UNM HSC also has taken significant steps to engage the community in research and ensure that studies reflect the cultural sensitivities and priorities of New Mexico’s diverse population.

Within New Mexico: Community Engagement Efforts

• UNM HSC serves as the IRB for more than 40 organizations statewide, including 16 of the state’s 19 Native American pueblos. As a result, researchers can move forward after receiving approval from a single IRB.
• As part of its community outreach, UNM HSC has forged relationships with Health Extension Rural Offices across the state. HEROs act as liaisons between the IRB and their home communities, provide input on a broad range of research issues, and even serve on the IRB.
• Human protection training for researchers now includes additional modules designed specifically for those conducting research in the pueblos. The training, which was developed in collaboration with the community, is a requirement for researchers interested in recruiting in the pueblos.

Beyond New Mexico: Facilitating CTSA Research

• UNM HSC received National Institutes of Health funding under the Clinical and Translational Science Awards (CTSA) program in 2010. Since then, UNM HSC has partnered with two other CTSA organizations—the University of Colorado Denver and the University of Utah—to form a regional CTSA-driven IRB to streamline the review process for multisite trials.
• All three organizations have agreed that multisite trials will be reviewed by a single IRB, an agreement made possible, in part, because all three are AAHRPP accredited and are comfortable relying on one another to uphold the highest research standards.

For more information on UNM HSC’s statewide and regional IRB efforts, contact Michael Briggs.