AAHRPP Launches New Website

We invite you to visit our redesigned website, which takes off this week!

You can check out the most recent edition of the Advance newsletter, learn about newly accredited organizations, see upcoming webinars, and read revised tip sheets. Also find out about our 2013 Conference in Miami!

Just go to the website to see our standards, procedures, and fee schedule.

New to our site are the logos and some case studies of accredited organizations.

Please check it out and let us know what you think.

AAHRPP Offers Educational Webinar

IRB Review of Research Involving Adults With Diminished Capacity to Consent

Almost every IRB deals with research involving participants with diminished capacity to consent, in projects that either directly study such populations or affect them incidentally. This webinar will describe the AAHRPP requirements for research involving participants with diminished capacity to consent, what researchers should know and plan for, and how IRBs should review and approve such research. (Elements II.4.A. and II.4.B)

The Presenters:

Leslie Katzel, M.D., Ph.D., University of Maryland School of Medicine and the Baltimore Veterans Affairs Medical Center

Susan Stayn, J.D., Stanford University

Dates and Times:
October 23, 2012, 8:00 a.m.  Register for October 23 webinar
October 25, 2012, 3:30 p.m.  Register for October 25 webinar

The cost for each connection is $90 for AAHRPP clients
and $130 for non-clients (including as many colleagues as you wish) 

Two More Earn AAHRPP Accreditation: Major Clinical Research Center in India and CRO in U.S.

AAHRPP has accredited two more organizations, including a third institution in India and a second contract research organization (CRO).

Please join us in congratulating the newly accredited organizations:

• Jehangir Clinical Development Centre Pvt. Ltd., Pune, India
• Celerion, Lincoln, Nebraska

More information is available in this news release.

Strengthening Researchers’ Role in the HRPP

One of the most significant improvements in the research enterprise is the now widespread acceptance that responsibility for protecting participants rests not just with the institutional review board (IRB) but with the organization as a whole—including its researchers.

This shift in perspective is often attributed to AAHRPP’s emphasis on comprehensive human research protection programs (HRPPs). Even organizations highly respected for their research have educated researchers and underscored their role in strengthening protections while preparing for AAHRPP accreditation.

For example, at Connecticut Children’s Medical Center (AAHRPP accredited since 2009), the accreditation process included education on research ethics, federal regulations, hospital policies and procedures, the role of investigators and the HRPP, and interacting with the IRB.

As a result, “the level of awareness and responsibility for subject protection is always in the forefront,” says Francis J. DiMario Jr., M.D., HRPP Medical Director and IRB chair at Connecticut Children’s. “Researchers feel they have a role to play and a stake in the entire process.”

Organizations cite the following benefits of increased researcher involvement:

• Better understanding of researchers’ responsibilities.
• Improved communication.
• Increased collaboration.
• Greater likelihood that research proposals will meet federal and organizational requirements and, therefore, will face fewer hurdles for approval.
• Fewer protocol deviations and incidents of noncompliance.
• Higher-quality research.
• Stronger research protections.

James Hagadorn, M.D., M.S., has seen the value of AAHRPP accreditation firsthand, both at Connecticut Children’s Medical Center and at other organizations that pursue AAHRPP accreditation. In addition to serving as a member of the Medical Center’s IRB and as Director of its Fellowship Program in Neonatal-Perinatal Medicine, Dr. Hagadorn is an AAHRPP site visitor.

“We see the teamwork that develops as a natural part of going through the accreditation process,” he says. “Ten years ago, investigators often viewed the IRB as an obstacle. Today that’s unusual―and definitely considered obsolete.”

Instead, the AAHRPP team members are “consistently impressed that all the different components of the HRPP are working toward the same goal,” Dr. Hagadorn says. “They consider it a partnership, and that’s much better for the researchers, the organization, and research participants.”

SAVE THE DATE: April 3-5, 2013, in Miami!

2013 AAHRPP Conference – Quality Human Research Protection Programs
Evidence-Based Practice in a Global Environment

This conference will highlight evidence-based bioethics research and its practical application in human research protection programs. We will examine successful strategies and address the increasingly global nature of research.

The pre-conference day will focus on the nuts and bolts of the accreditation process.

STAY TUNED FOR MORE!

Tapping the Expertise of Legal Counsel

In an increasingly complex research enterprise, it’s not unusual for human research protection programs (HRPPs) to look to legal counsel to help strengthen standard operating procedures (SOPs), interpret state law, and educate institutional review board (IRB) members and researchers about federal and state laws and regulations that pertain to research.

Larger organizations can often turn to in-house attorneys, but even they sometimes lack the necessary background in research compliance. The challenge is greater for smaller HRPPs, which typically have fewer resources and must look outside the organization for legal support.

How do you choose an attorney? And when should you seek legal counsel? The following tips provide some guidance.

Choosing an attorney

• Start by limiting your selection to lawyers or firms with expertise in research compliance. “There’s a big difference between a lawyer who is familiar with HIPAA for general hospital purposes and one who understands how HIPAA applies to IRBs in their capacity as privacy boards,” says Robyn Shapiro, J.D. A partner in the Health Care Practice Group of DrinkerBiddle & Reath, Ms. Shapiro has served as an adviser to HRPPs for major health systems, including AAHRPP-accredited Aurora Health Care in Milwaukee, Wisconsin.
• Consider the legal landscape in your state. If your state has its own laws regulating research, your best bet is to choose a local attorney who specializes in research compliance. More likely, however, your state relies on federal regulations to govern research. In that case, a local attorney must be able to interpret the federal regulations in the context of state and local laws that affect research, such as privacy laws or age of majority.
• Ask your colleagues at AAHRPP-accredited organizations for recommendations. 
• Seek out potential candidates during conferences and seminars. Whenever possible, make connections by attending presentations that focus on research compliance.
• Be alert for potential conflicts of interest. Your legal counsel’s first obligation is to protect the organization. At times that might be at odds with the primary obligation of the HRPP director or members of the IRB. Therefore, even if your HRPP director or an IRB volunteer is trained as an attorney, it might be unwise and unfair to turn to that person for legal advice.

When to seek legal counsel

• For guidance on sensitive issues, such as participation and consent of research participants who are decisionally impaired.
• For help with drafting SOPs.
• For advice on interpreting and preparing for new regulations, such as the recently revised National Institutes of Health regulations on individual financial conflict of interest.

If possible, try to anticipate situations that might require legal assistance—and reach out to an attorney in advance. “For SOPs and the new laws that are coming down the pike, you’ll absolutely need a lawyer,” Ms. Shapiro says, “and it will be easier and more comfortable if you’ve established a relationship ahead of time.”

Conference in Bangalore, India: November 3-4, 2012

AAHRPP is co-organizing with Manipal Hospitals and Pfizer a conference entitled Practical Solutions to Challenges in Research Ethics.

The Manipal Hospitals are the first in India to achieve AAHRPP accreditation, and the focus of the conference is on strengthening human research protection programs, sharing solutions, and thinking about the challenges ahead. It is intended for hospitals, investigators, human subject protection professionals, and sponsors of research.

The two-day conference begins on November 3 at the Hotel Matthan in Bangalore. Please check with AAHRPP for registration information, including discounted rates for researchers and academia. For further details, please contact Sarah Kiskaddon. 

New draft guidance being distributed by the FDA for comment purposes:

Suicidal Ideation and Behavior: Prospective Assessment of Occurrence in Clinical Trials (Revision 1)

This guidance revises the draft guidance issued in September 2010 regarding the prospective assessment of suicidality in clinical trials.

Comments and suggestions pertaining to this document should be submitted within 60 days of the notice announcing the availability of the draft guidance in the Federal Register.

Copies are available for download here.

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.

Registration Has Begun for the 2012 Advancing Ethical Research Conference in San Diego

Don’t forget to register for the AER Conference on December 4, 5, and 6, 2012, in San Diego.

Those of you considering AAHRPP accreditation or already in the application process have an opportunity to take advantage of the “Accreditation of HRPPs Track.” Five highly practical workshops and didactic sessions will focus on various aspects of the accreditation process. For organizations that are already AAHRPP accredited, there is also a session dedicated to collecting and analyzing metrics for quality improvement.

Please note that these and other conference program descriptions are available on the PRIM&R website:

•     Collecting and Analyzing Metrics for HRPP Quality Improvement
•     Making Accreditation Happen in Smaller Programs
•     Preparing for a Successful Site Visit
•     AAHRPP’s Top Ten Findings in Reviews of Application Materials and Draft Site Visit Reports
•     Breaking Down the “Rumors” about the Accreditation Standards