In The Spotlight

On March 28, 2003, Tommy G. Thompson, Secretary of the United States Department of Health and Human Services (HHS), announced the publication of a proposed draft guidance to protect human-research subjects from the risks of harm possibly arising from researchers' financial conflicts of interests. See “Financial Relationships and Interests in Research Involving Human Subjects: Guidance for Human Subject Protection,” which is posted at www.fda.gov/ohrms/dockets/GUIDANCES/DGUIDES.htm. Because of shrinking revenues, more and more physicians during the past decade have become involved with privately sponsored research as a way of augmenting their incomes, even though they have not necessarily understood the fraud and abuse risks involved, nor are they fully appreciative of the reasons for fully disclosing to patients they enroll in such studies these financial conflicts of interest.

As I noted in Fraud and Abuse Issues in Private Clinical Pharmaceutical Research, 3; Health Care Fraud & Abuse Newsl (Dec. 2000), “The Office of the Inspector General (OIG) issued a 'Fraud Alert' in August 1994 concerning payments by pharmaceutical manufacturers. [This Fraud Alert] … demonstrat[ed] the agency's continued concerns about certain pharmaceutical manufacturers improperly characterizing the payment of substantial funds to physicians as 'research grants' under circumstances where the grant recipients performed minimal services.”

The proposed draft guidance last month will notably apply to all HHS-agencies, including the Food and Drug Administration (FDA), the Centers for Disease Control (CDC), and the National Institutes of Health (NIH). This is an improvement, since the current patchwork of human research-subject protections vary between the “Common Rule” of several federal agencies with the FDA's related policies. As explained in the press release, the draft guidance proposes different means through which researchers, Investigational Review Boards (IRBs), and sponsoring institutions can manage the risks posed by such financial conflicts of interest:

• Institutions could separate responsibility for financial decisions and research decisions, or could establish conflict-of-interest committees to verify the absence of financial interests in the research;
• IRBs could verify that all members have no conflicts of interest regarding proposals they consider;
• [Clinical] Investigators could directly provide subjects with information on the source of funding and the funding arrangements for reviewing and carrying out the research; and
• Investigators and IRBs could ensure that an independent third party is used to explain the research study to subjects and obtain subjects' consent.

Press Release available at http://hhs.gov/news/press/2003/pres/20030328.html.

Michael E. Clark, Editor-in-Chief of this publication, represents clients in a variety of business and white collar matters. Clark can be reached at 713-896-0557.

On March 28, 2003, Tommy G. Thompson, Secretary of the United States Department of Health and Human Services (HHS), announced the publication of a proposed draft guidance to protect human-research subjects from the risks of harm possibly arising from researchers' financial conflicts of interests. See “Financial Relationships and Interests in Research Involving Human Subjects: Guidance for Human Subject Protection,” which is posted at www.fda.gov/ohrms/dockets/GUIDANCES/DGUIDES.htm. Because of shrinking revenues, more and more physicians during the past decade have become involved with privately sponsored research as a way of augmenting their incomes, even though they have not necessarily understood the fraud and abuse risks involved, nor are they fully appreciative of the reasons for fully disclosing to patients they enroll in such studies these financial conflicts of interest.

As I noted in Fraud and Abuse Issues in Private Clinical Pharmaceutical Research, 3; Health Care Fraud & Abuse Newsl (Dec. 2000), “The Office of the Inspector General (OIG) issued a 'Fraud Alert' in August 1994 concerning payments by pharmaceutical manufacturers. [This Fraud Alert] … demonstrat[ed] the agency's continued concerns about certain pharmaceutical manufacturers improperly characterizing the payment of substantial funds to physicians as 'research grants' under circumstances where the grant recipients performed minimal services.”

The proposed draft guidance last month will notably apply to all HHS-agencies, including the Food and Drug Administration (FDA), the Centers for Disease Control (CDC), and the National Institutes of Health (NIH). This is an improvement, since the current patchwork of human research-subject protections vary between the “Common Rule” of several federal agencies with the FDA's related policies. As explained in the press release, the draft guidance proposes different means through which researchers, Investigational Review Boards (IRBs), and sponsoring institutions can manage the risks posed by such financial conflicts of interest:

• Institutions could separate responsibility for financial decisions and research decisions, or could establish conflict-of-interest committees to verify the absence of financial interests in the research;
• IRBs could verify that all members have no conflicts of interest regarding proposals they consider;
• [Clinical] Investigators could directly provide subjects with information on the source of funding and the funding arrangements for reviewing and carrying out the research; and
• Investigators and IRBs could ensure that an independent third party is used to explain the research study to subjects and obtain subjects' consent.

Press Release available at http://hhs.gov/news/press/2003/pres/20030328.html.

Michael E. Clark, Editor-in-Chief of this publication, represents clients in a variety of business and white collar matters. Clark can be reached at 713-896-0557.