Monday, September 10, 2012

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.”

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