Research Compliance: Staying Out of the Spotlight

Over the last ten years, research compliance has become a major focus of government regulators and enforcers. We have seen some of the biggest settlements in Department of Justice history related to FDA “non-compliance” in areas such as illegal off-label uses of drugs/devices, concerns over the Average Wholesale Price of drugs and biologicals, violations of federal conflicts of interest rules, erroneous research billing, incorrect time and effort certifications for federal grants and trials, and serious instances of research misconduct—all of which destroy the trust we have in our scientists and the research organizations who sponsor or employ them. Here are some of the noteworthy settlements from the last year:

October 30, 2014: Former Northwestern Physician to Pay $475,000 to Settle Cancer Research Grant Fraud Claims

October 28, 2014: Columbia University to Pay $9 million to Resolve False Claims Case on AIDS Research Grants

January 7, 2015: Drug Company to Pay $2.1 million to Resolve NIH Contract Allegations

January 16, 2015: Federal Court Allows Claims Against Gilead to Proceed

In the midst of these cases, the federal government and industry sponsors alike have decreased available funding for research studies making it more and more difficult to find support for research studies. As a result of these enforcement efforts and the decreases in funding, research sponsors and research sites have dramatically increased their oversight efforts and have developed and implemented comprehensive research compliance programs to detect and prevent violations in the law/regulation. As we know, there is considerable risk in the conduct of research, but the best defense any organization has against the government’s wrath, is a research compliance program.

Here are some helpful research misconduct resources:

ORI website: http://ori.hhs.gov/

ORI Sample Policy and Procedures for Responding to Research Misconduct Allegations

ORI Guidelines for Institutions and Whistleblowers: Responding to Possible Retaliation Against Whistleblowers in Extramural Research

ORI Handbook for Institutional Research Integrity Officers

PBI has developed a program, The Research Law and Compliance Forum, to help attorneys, compliance professionals, researchers, administrators and others to understand and address the high risk areas of any research enterprise. The program is scheduled for Tuesday, August 18 (from 8:30 am – 3:50 pm) at The CLE Conference Center in the Wanamaker Building in Philadelphia.

The PBI has convened an outstanding faculty—all of whom are industry experts in research law and compliance. The faculty will cover topics such as “FMV and Anti-kickback Risks in Research”, “Dealing with Non-Compliance in Human Research Protections”, “Privacy Issues in Clinical Research”, “FDA Law for Beginners”, and much more. This all-day Forum also includes an Ethics module “Bioethics and Legal Ethics” which will outline the ethical dilemmas inherent in the conduct of research. This program outlines the top risk areas to be addressed as part of research compliance programs and will help attorneys and compliance professionals design a research assessment, research training, a work-plan for research and the framework for policies and procedures for the conduct of research. We hope you will join us for this Forum. If you have any questions regarding the program, please feel free to contact Lisa Murtha (lisa.murtha@fticonsulting.com) or Emily Barnes at ebarnes@pbi.org. We look forward to seeing you next week.

By | 2015-08-12T10:04:06+00:00 August 12th, 2015|Categories: Health Law|Tags: , , , , , |Comments Off on Research Compliance: Staying Out of the Spotlight

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