October 15, 2004

New service aims to help investigators navigate maze of research regulations

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Gordon Bernard, M.D.

New service aims to help investigators
navigate maze of research regulations

As scientists go about their research they bump into all manner of non-scientific considerations, from conflict of interest to protection of intellectual property to the myriad approvals required for research with human subjects.

Researchers can certainly be pardoned for not always fully grasping the complex nuances of what they're up against, said Gordon R. Bernard, M.D., assistant vice chancellor for Research. “For example, if you're not careful, research on a device or drug you've created sets you up for conflict of interest. And though the motivation may be altruistic, failure by an investigator to apply for patent protection will greatly lower the chances of a drug's discovery ever being developed.”

To help investigators and study personnel sort through the complexities, Bernard has set up Research Support Services (www.mc.vanderbilt.edu/rss) as a new arm of the VUMC Office of Research.

“Especially in the context of clinical research, it's apparent that the number of groups that the researcher must interact with within our institution is increasing,” Bernard said. “To the investigator, the way forward can become hidden. Our hope is that, by sitting down with one of our research services consultants, investigators can avoid missteps and discover the best path to achieving their research goals.”

While consultation may be helpful at any time, it may be especially so in the conceptual stages of research, leading to research proposals that meet funding criteria and stand up best to safety review, Bernard said.

Research Support Services has three research services consultants and they're recruiting a fourth. Free services include: information hotline for quick answers to basic questions: 322-7343; guidance regarding human subject safety evaluation (Internal Review Board) and navigation of the IRB process; support for protocol development; help in negotiating contractual agreements with funding sources; assessment of human subjects research programs; help with study organization; preparation of study documents; training and education; referral to Vanderbilt subject experts for assistance regarding conflict of interest, technology transfer, intellectual property, contractual issues, etc.

For more information call Research Support Services, 322-7343.