Thursday, August 30, 2012

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.”

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