The Sunshine Project
Biosafety Bites (v.2) #13 (1 June 2006)

Complaint Filed Against "Sham" University of South Carolina Institutional Biosafety Committee

Biosafety Bites begins in 2006 with a complaint, filed today, against the University of South Carolina, whose Institutional Biosafety Committee (IBC), the Sunshine Project has concluded, is a sham. The complaint seeks termination of US National Institutes of Health funding for genetic engineering projects at the University. The Committee can produce no minutes that reflect it ever conducting any serious biosafety business and exercising its responsibilities. In fact, the first University of South Carolina IBC meeting ever held appears to have come about only as a result of persistent requests for minutes from the Sunshine Project.

In addition, the complaint raises questions about the National Science Advisory Board on Biosecurity (NSABB), which is advising the US government on the safety and security of dual-use research involving biological weapons agents and technologies. The NSABB includes the President of the University of South Carolina as a voting member. The complaint asks a question: "How can the NSABB develop effective guidance for dual-use research, and recommendations in which the public can have confidence, if it is tainted by affiliations with institutions that receive federal biotechnology grants yet do not heed current, allegedly obligatory, guidelines?"

The Sunshine Project anticipates that this will be the first of many complaints filed in 2006, as initial indications are that little has improved with the IBC system since we last examined it in detail in 2004. Future 2006 editions of Biosafety Bites will include reports from the front lines of biodefense facilities and the failing Asilomar-inspired IBC system.

1 June 2006

Dr. Amy Patterson
Office of Biotechnology Activities
National Institutes of Health

COMPLAINT PURSUANT TO THE NIH GUIDELINES CONCERNING NONCOMPLIANCE BY THE UNIVERSITY OF SOUTH CAROLINA

The Sunshine Project brings to your attention noncompliance with the NIH Guidelines by the University of South Carolina. The Sunshine Project requests that NIH OBA immediately terminate all NIH funding for biodefense and recombinant DNA projects at the University of South Carolina.

We especially urge prompt action in this matter because of the presence of the President of the University of South Carolina on the National Science Advisory Board for Biosecurity (NSABB)(1), as it is entirely inappropriate for leaders of institutions that are noncompliant with the existing NIH Guidelines to advise on development of new federal recommendations to ensure the safety and security of dual-use research.

In late January 2004, the Sunshine Project first requested IBC minutes from the University of South Carolina (USC). The University did not reply to our request. On 24 May 2004, the Sunshine Project again requested the minutes of the USC IBC. The University did not reply to the second request. On 7 July 2004, the USC IBC minutes were requested for a third time, with a copy of the request sent to NIH OBA.

In reply to our third request for USC IBC minutes for a period spanning more than two and a half years, USC provided two sheets of paper with a total content of two thirds of a page of text written on them. The "minutes" reflected that the only IBC meeting that had been held was on 7 July 2004, when the USC IBC had an emergency get together in response to the Sunshine Project's requests for its minutes. This IBC meeting appears to have been the first ever held by the University of South Carolina. It was not prompted by NIH OBA or by other biosafety business, rather, it came about as a result of a public inquiry.

The "minutes" of the 7 July 2004 meeting, comprising less than a half a page, primarily reflect discussion of the Sunshine Project's request, and the noncompliance of the USC IBC membership with the NIH Guidelines. No review of protocols or substantive activity is recorded. The second page of paper, purportedly IBC minutes, contains a single paragraph stating that "a portion" of the USC IBC held a discussion to find committee members, elect a chair, and to adopt a biosafety manual on 21 May 2004. This discussion by part of the IBC allegedly occurred on a Friday, three days before the Sunshine Project's second request for the USC IBC minutes was made.

The Sunshine Project drew public attention to USC's problems in October 2004 in our report Mandate for Failure (2), wherein the USC IBC was given the lowest rating of "failing". This report was transmitted to your office and was prominently discussed in the science and academic press.

In March 2006, the Sunshine Project again requested minutes of the USC IBC. In response, it provided one additional sparsely-filled sheet of paper, indicating that it has met once since 7 July 2004. At this most recent meeting - held in September 2005 - the IBC was still discussing the Sunshine Project's request for its minutes made more than a year previously. It was also still resolving problems with its membership. And, yet again, its minutes reflect no protocol review and no serious biosafety business. In fact, the IBC is so weak that one of its most substantive acts of 2005 was to have the biosafety officer e-mail the URL for the NIH Guidelines to the committee members.

In May 2004, NIH OBA issued guidance to IBCs on the requirements of the Guidelines for meeting minutes including, among other obligations, that they record "the committee's rationale for particular decisions, documenting that the IBC has fulfilled its review and oversight responsibilities..."(3)

The USC IBC does not meet regularly, does not review protocols, does not have a compliant membership, and does not even seem to care about its noncompliance. When the Sunshine Project requested its minutes in 2006, the USC biosafety officer complained to her colleagues about the "burden" of responding - in this case, providing about a page of text in an e-mail to a public requester.(4)

It is obvious that the University of South Carolina's Institutional Biosafety Committee is a sham. Its list of members and "minutes" are nothing more than a façade, and not even a very elaborate one, designed to lend the appearance that the University of South Carolina cares about the NIH Guidelines, to which it is supposedly required to comply. NIH OBA, to date, seems eager to believe this fiction.

The University of South Carolina cannot claim ignorance of the NIH Guidelines nor that it is unaware of the problem. The Sunshine Project has requested its minutes four times and publicly criticized its response. The requests have, at various times, been handled by IBC members, safety staff, medical school professors, and its General Counsel's office.

The institution is aware of the problem, which makes the presence of the President of the University of South Carolina on the National Science Advisory Board for Biosecurity (NSABB) all the more perplexing and problematic. One might have expected that the President would have ensured that his own house was in order before seeking to advise the nation on dual-use research compliance, but that assumption would obviously be incorrect. Similarly, it might have been expected that NIH OBA would seek NSABB members from institutions that are compliant with existing relevant federal research recommendations, but this too seems not to be the case.

Rather, USC is unequivocally in violation of the NIH Guidelines. This situation requires your action should you wish the IBC system to be effective and to enjoy a level of credibility among the public.(5) We request that relevant funding to the University of South Carolina be terminated immediately and that the government seek reimbursement of all relevant federal funds disbursed to the University for all research conducted during the entire period of the institution's noncompliance. (In this case, this appears to be all such projects ever funded by NIH at USC.)

Finally, we reiterate our desire that NIH OBA address the problematic issues, not unique to this member, raised by the presence of USC leadership on the NSABB given ongoing noncompliance by USC with the NIH Guidelines. How can the NSABB develop effective guidance for dual-use research, and recommendations in which the public can have confidence, if it is tainted by affiliations with institutions that receive federal biotechnology grants yet do not heed current, allegedly obligatory, guidelines?

NOTES AND SOURCES

(1) NIH OBA. NSABB 2005-2006 Voting Members. URL: http://www.biosecurityboard.gov/members_05_06_voting.asp

(2) The Sunshine Project. Mandate for Failure, p. 30. URL: http://www.sunshine-project.org/biodefense/tspibc.pdf

(3) NIH OBA. Questions and Answers Concerning Institutional Biosafety Committee (IBC) Meeting Minutes, 14 May 2004. URL: http://www4.od.nih.gov/oba/IBC/IBC_Minute_Q_A.pdf

(4) E-mail from Patty Gillies Hamilton (USC Biosafety Officer) to the ABSA Biosafety Forum listserver, 16 March 2006.

(5) "Asilomar proved to be the wrong approach...". An Open Letter from Social Movements and other Civil Society Organizations to the Synthetic Biology 2.0 Conference May 20-22, 2006 Berkeley, California. 19 May 2006. URL: http://www.etcgroup.org/article.asp?newsid=562

Records provided by USC and said to be IBC Meeting Minutes of 21 May 2004, 7 July 2004 and 21 September 2005.