The UTMB Institutional Biosafety Committee and its Noncompliance with NIH Biosafety Guidelines

Documents and Information

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For nearly one year (since 16 September 2002), the Sunshine Project and non-profit partners* have sought information on the Institutional Biosafety Committee (IBC) of the University of Texas Medical Branch at Galveston (UTMB), including its membership, policies, meeting minutes and decisional documents.

The purpose of the effort is to ensure that biodefense projects do not threaten arms control treaties nor endanger communities that surround biocontainment facilities conducting biodefense research. For more information on the collaborative effort, which includes research on institutions other than UTMB, please see the following URLs:

http://www.sunshine-project.org/publications/pr/pr141002.html
http://www.sunshine-project.org/biodefense/openletters.html
http://www.sunshine-project.org/publications/pr/pr260203.html

From September 2002 through February 2003, UTMB simply ignored requests for information about its Institutional Biosafety Committee. Because UTMB refused to substantively reply, at the end of February 2003, the Sunshine Project began requesting information under the Texas Public Information Act . UTMB responded with legal briefs sent to the Texas Attorney General in which it has resisted release of any and all information about or from its IBC, with the exception of a one page document listing the committee members.

The letters below document UTMB's refusal to follow the NIH Guidelines and its effort to entrench policies that do not follow NIH's Guidelines through decisions of the Texas Attorney General.

UTMB's failure to respond to requests for information on its IBC and the non-compliant policies stated in its legal briefs may cost the University its elegibility to recieve NIH funding for recombinant DNA research (i.e. genetic engineering and related procedures), including UTMB's proposals for a National Biocontainment Laboratory and a Regional Center of Biodefense Excellence.

Two days prior to releasing this information and initiating this public action to end UTMB's funding eligibility, the Sunshine Project contacted UTMB (specifically, its Biodefense Director, Dean of Medicine, and Vice President for Business Affairs) and made a final request that UTMB resolve this dispute amicably (in a "mutually acceptable manner that creates an adequate public window on the activities of the UTMB IBC").

* These are: Citizens Education Project (Salt Lake City, UT), Coalition for a Safe Lab (Hamilton, MT), Council for Responsible Genetics (Cambridge, MA), Los Alamos Study Group (Santa Fe, NM), Nuclear Watch of New Mexico (Santa Fe, NM), Physicians for Social Responsibility (Washington, DC), Tri-Valley CAREs (Livermore, CA), and Western States Legal Foundation (Oakland, CA).

UTMB's Institutional Biosafety Committee

The current procedures and requirements for recombinant DNA are specified in the current "NIH Guidelines for Research Involving DNA Molecules." UTMB must comply with these guidelines if NIH funding is to be maintained. The Biological Safety Committee shall act as the Institutional Biosafety Committee as defined in those guidelines.

Internally the university maintains oversight through the Institutional Biosafety Committee. This committee is mandated by the National Institutes of Health to review and approve the use of biological agents on campus. The committee's focus is the adherence to biological safety practices that protect the researcher and the community the institution serves. The Institutional Biosafety Committee has the authority to approve the use of a biological agent, deny approval or take action to stop work.

Section IV-B-2-a-(6). When possible and consistent with protection of privacy and proprietary interests, the institution is encouraged to open its Institutional Biosafety Committee meetings to the public.

Section IV-B-2-a-(7). Upon request, the institution shall make available to the public all Institutional Biosafety Committee meeting minutes and any documents submitted to or received from funding agencies which the latter are required to make available to the public. If public comments are made on Institutional Biosafety Committee actions, the institution shall forward both the public comments and the Institutional Biosafety Committee's response to the Office of Biotechnology Activities, National Institutes of Health, 6705 Rockledge Drive, Suite 750, MSC 7985, Bethesda, MD Ê20892-7985 (20817 for non-USPS mail), 301-496-9838, 301-496-9839 (fax).

Section IV-B-2-a-(3). The institution shall file an annual report with NIH/OBA which includes: (i) a roster of all Institutional Biosafety Committee members clearly indicating the Chair, contact person, Biological Safety Officer (if applicable), plant expert (if applicable), animal expert (if applicable), human gene therapy expertise or ad hoc consultant(if applicable); and (ii) biographical sketches of all Institutional Biosafety Committee members (including community members).

DATE	RECIPIENT(S)	RESULT	MODE	NOTE
16 Sep 2002	Dr. C.J. Peters, Director, UTMB Center for Biodefense	No response	e-mail	See this request below.
16 Oct 2002	Dr. C.J. Peters Dr. John Stobo, UTMB President	No response	e-mail and fax	Requested reply to 16 September e-mail.
19 Nov 2002	Dr. C.J. Peters Dr. John Stobo Dr. James Guckian, Vice Chancellor for Health Affairs, Univ. of Texas System Dr. Mark Yudof, Chancellor, Univ. of Texas System	No germane response.	e-mail and fax	Following this communication, the Sunshine Project received a short letter from Dr. Peters which responded (ambiguously) to the question about classified research raised in the e-mail of 16 September. The letter did not answer questions concerning UTMB IBC composition and policies.
23 Jan 2003	Mr. Tom Curtis, UTMB Public Affairs Dr. C.J. Peters	No reponse	e-mail	In a set of questions concerning other aspects of UTMB biodefense research, UTMB is again asked for the names and affiliations of its IBC members. There is no reply.
18 Feb 2003	Dr. C.J. Peters Dr. John Stobo Dr. James Guckian Dr. Mark Yudof	No reponse	e-mail and fax	Open letter requested pledge "That the UTMB Center for Biodefense will maintain a fully transparent Biosafety Committee that will review and (dis)approve all projects to be conducted in the BL3 and BL4 facilities, and that all Biosafety Committee documentation will be made concurrently available to the entire public, and that any member of the public will have the right to attend all portions of all committee meetings" (full text here)
27 Feb 2003	Mr. Tom Curtis, UTMB Public Affairs Dr. C.J Peters	• Refused release of its IBC minutes • Denies the existence of a "record containing a summary of the institutional affiliations and qualifications of IBC members"	e-mail	Request filed under Texas Public Information Act was forwarded by UTMB to Richard Moore, UTMB Vice President for Business and Administration. Moore's job duties include appointing members of the UTMB IBC. See this request and UTMB's response below.
3 Jul 2003	Mr. Richard Moore, UTMB Vice President for Business and Administration	• Refused release of IBC decisional documents • Seeks legal clearance to refuse all requests for all IBC documents.	e-mail	Request filed under Texas Public Information Act. The final disposition of this request awaits a ruling by the Texas Attorney General scheduled to be made on or before 22 September 2003. See this request and UTMB's response below.
15 Jul 2003	Dr. C.J. Peters Dr. Stanley Lemon, UTMB Dean of Medicine, Principal Investigator in UTMB Application for a National Biocontainment Laboratory	No response	telephone	Non-profits from across the US telephone Peters and Lemon to request a response to the letter of 18 February. Ten days later, UTMB files its legal brief of 25 July (see below) requesting that the Attorney General's permission for UTMB to deny all requests for all IBC documents.
28 Jul 2003 and 29 Jul 2003	Dr. C.J. Peters Dr. Stanley Lemon Mr. Richard Moore	• Lemon replies that UTMB is "fully compliant with all applicable disclosure laws and NIH Guidelines".	e-mail and telephone	Click here.

The initial Sunshine Project request for information on the UTMB IBC and its policies was made on 16 September 2002.

UTMB never replied to the request. When no response from UTMB came after one month, follow-up letters, copied to John Stobo (UTMB President) and James Guckian (University of Texas System Vice Chancellor for Health Affairs) were sent by fax and e-mail on 16 October 2002. When UTMB still refused to respond, another set of letters was sent on 19 November 2002.

On 27 February 2003, the Sunshine Project filed its first Texas Public Information Act request for UTMB IBC documents:

To: "Curtis, Tom" <tcurtis@utmb.edu>
From: Edward Hammond <hammond@sunshine-project.org>
Subject: TX FOI request
Cc: "Peters, Clarence J." <cjpeters@utmb.edu>
X-Attachments:

Dear Tom,

Pusuant to the Texas Public Information Act, Chapter 552, Texas Government Code, I hereby request:

1) The roster of members of the Institutional Biosafety Committee mentioned in Section 6 of UTMB's NBL application (on page 25 of my "redacted" version), in its entirety.

2) If a responsive record containing a summary of the institutional affiliations and qualifications of IBC members exists, please provide that document as well.

3) Minutes of all IBC meetings from November 2002 through the date of your response.

You may send your reply to:

Edward Hammond
The Sunshine Project
101 W 6th St, Suite 607
Austin TX 78701

Plese do not hesitate to contact me if you have any questions about this request.

As I anticipate filing further FOI requests, will you please advise me of how your recordkeeping system functions? Does UTMB has an FOI case log which assigns requests a unique identifier? It will ease our correspondence. If you do not have such a system, I suggest that we agree on a identifiers that will enable us to correspond using that "shorthand" rather than restating the description of the subject records in each case.

Sincerely,
Edward Hammond

UTMB legal brief of 20 March 2003 to Greg Abbott, Attorney General of Texas (3 pages)

The yellow highlighting has been added by the Sunshine Project. The bold phrases are part of the UTMB original.

Click here to download the above brief
(without highlighting) in PDF format

On 15 May 2003, the Texas Attorney General ruled in favor of UTMB's claim that the IBC meeting minutes that the Sunshine Project requested are exempt from disclosure; but limited the decision "to the facts as presented to us". The yellow highlighting has been added by the Sunshine Project.

Click here to download the above ruling
(without highlighting) in PDF format

On 3 July 2003, the Sunshine Project filed its second Texas Public Information Act request for UTMB IBC documents:

To: rmoore@utmb.edu
From: Edward Hammond <hammond@sunshine-project.org>
Subject: TX FOI Request
Cc:
X-Attachments:

Dear Mr. Moore,

Pursuant to the Texas Public Information Act, Chapter 552, Texas Government Code, the Sunshine Project hereby requests the following documents in the possession of the University of Texas Medical Branch (UTMB):

1. All Notifications for Use of Biological Agents received by the UTMB Institutional Biosafety Committee (IBC) from 1 September 2001 through 3 July 2003, in their entirety;

2. All approvals, denials, and stop work actions issued by the UTMB IBC from 1 September 2001 through 3 July 2003, in their entirety.

You may send your reply to:

Edward Hammond
The Sunshine Project
101 West 6th St, Suite 607
Austin TX 78701

Please do not hesitate to contact me at this e-mail address if you have any questions about this request.

Sincerely,

Edward Hammond

UTMB legal brief of 25 July 2003 to Greg Abbott, Attorney General of Texas (4 pages)

Asserts confidentiality of all IBC documents, seeks Attorney General's "previous determination" that it may refuse public requests for all IBC documents, etc. The yellow highlighting has been added by the Sunshine Project. The bold and bold underlined phrases are part of the UTMB original.

Click here to download the above brief
(without highlighting) in PDF format

4 August 2003

Dr. Anthony S. Fauci, Director
National Institute of Allergy and Infectious Diseases
National Institutes of Health
Building 31, Room 7A03
31 Center Drive MSC 2520
Bethesda MD 20892-2520

by electronic mail, fax, and courier

Dear Dr. Fauci,

This urgent letter is sent to you in relation to the Sunshine Project’s complaint against the University of Texas Medical Branch at Galveston (UTMB). Our complaint, which is before the National Institutes of Health (NIH) Office of Biotechnology Activities (OBA), is based on the fact that the UTMB Institutional Biosafety Committee (IBC) does not comply with the NIH Guidelines for Research Involving Recombinant DNA Molecules (NIH Guidelines).

This letter is sent to you because NIAID has indicated that awards for National Biocontainment Laboratories (NBL) and Regional Centers of (Biodefense) Excellence (RCE) are imminent. UTMB has applied for both of those grants. As stated in Section I-D-1 of the NIH Guidelines, all projects involving recombinant DNA at NIH-funded institutions must comply with the Guidelines. Because UTMB’s Institutional Biosafety Committee is not in compliance, NIAID would not act in accordance with federal regulations should it award UTMB an NBL or RCE grant (Note 1) at this time.

On 29 July, the Sunshine Project contacted OBA (Note 2) to alert that office of its complaint and to request details of NIH’s procedures for certifying compliance with its Guidelines. Upon OBA’s reply, we will file a lengthier document containing all of the elements of our complaint, related documentation, and specific remedies that we request.

Because of the possibility that NIAID may plan to decide on NBL and RCE awards before OBA is able to address our complaint, this letter brings to NIAID’s knowledge important elements that will form part of our final OBA filing. The attachments to this letter include items authored by UTMB that plainly demonstrate noncompliance and, in and of themselves, disqualify UTMB from NBL and RCE awards.

The elements of our complaint include:

1. That UTMB does not comply with NIH Guidelines at Section IV-B-2-a-(7) (Note 3) because it refuses public access to the minutes of its IBC meetings; (Note 4)

2. That UTMB does not comply with NIH Guidelines at Section IV-B-2-a-(7) (Note 5) because it maintains that all information concerning the actions of its IBC is confidential, thereby precluding the possibility of public comments on its actions and evading NIH oversight; (Note 6)

3. That UTMB does not comply with the NIH Guidelines at Section IV-B-2-a-(6) (Note 7) because it makes no effort to distinguish between those IBC activities that may involve justifiable “privacy and proprietary interests” and those that it is encouraged to make public, rather, it conducts activities in secret;

4. That UTMB has misled the Attorney General of Texas with respect to the responsibilities of an Institutional Biosafety Committee by stating that the UTMB IBC is constituted under 45 C.F.R. §46.103, (Notes 8 and 9) rather than 32 C.F.R. §627.7, (Note 10) and that this erroneous information was provided (Note 11) for the purpose of furthering UTMB’s noncompliance with the NIH Guidelines;

5. That UTMB, responding to a Texas Public Information Act request, has falsely asserted that it has no record (Note 12) "containing a summary of the institutional affiliations and qualifications of IBC members"  (Note 13) when NIH Guidelines at Section IV-B-2-a-(3) require UTMB to produce a yearly report containing "biographical sketches of all Institutional Biosafety Committee members".

6. That UTMB is seeking to embed its noncompliant policies in rulings of the Attorney General of Texas by requesting a decision that would exempt from release all "documents created by, for, or as a result of UTMB’s BSC meetings." (Notes 14 and 15)

 

In view of the above, the Sunshine Project requests that NIAID suspend any consideration of UTMB’s NBL and RCE grant applications until such time as OBA completes an investigation and UTMB’s IBC is brought into compliance.

 

NIAID may wish to periodically visit the web page where the Sunshine Project is making information available about the UTMB IBC and our complaint to OBA. This page located at:

http://www.sunshine-project.org/biodefense/utmb.html

The Sunshine Project’s complaint against UTMB stems from a collaborative effort with other non-profit organizations who are cooperating to work to ensure that biodefense projects do not weaken the Biological and Toxin Weapons Convention nor endanger communities that surround biocontainment facilities conducting biodefense research. Partners in that effort include the Citizens Education Project (Salt Lake City, UT), Coalition for a Safe Lab (Hamilton, MT), Council for Responsible Genetics (Cambridge, MA), Los Alamos Study Group (Santa Fe, NM), Nuclear Watch of New Mexico (Santa Fe, NM), Physicians for Social Responsibility (Washington, DC), Tri-Valley CAREs (Livermore, CA), and Western States Legal Foundation (Oakland, CA). You will find links to information about the collaboration at the URL indicated above.

Please do not hesitate to contact me should you have any questions concerning this request.

Sincerely,

 

Edward Hammond
Director

Enclosures (by courier)

cc: Mr. Alan Shipp, NIH OBA

---

(1) The same holds true for all other applications for work involving rDNA from UTMB researchers as well as applications from researchers at other institutions who intend to perform the NIH-funded work in UTMB biocontainment facilities.

(2) With a copy to Barbara Shadrick of NIAID.

(3) "Upon request, the institution shall make available to the public all Institutional Biosafety Committee meeting minutes".

(4) "It is the position of UTMB that all records generated by the BSC are confidential by statute." (emphasis in original), in brief from Ms. Carol Longoria, Office of General Counsel, University of Texas System, to the Honorable Greg Abbott, Attorney General of Texas, 20 March 2003 (“UTMB Brief of 20 March 2003”), seeking to deny Sunshine Project Texas Open Records Act request of 27 February 2003 for minutes of UTMB IBC meetings.

(5) "If public comments are made on Institutional Biosafety Committee actions, the institution shall forward both the public comments and the Institutional Biosafety Committee's response to the Office of Biotechnology Activities, National Institutes of Health..."

(6) "It is the position of UTMB that all records generated by the BSC are confidential by statute." (emphasis in original) and "This is the second time Mr. Hammond has sought access to BSC documents... In both instances Mr. Hammond seeks access to documents either generated for, as part of, or as a result of BSC Committee meetings", in brief from Ms. Longoria to Attorney General Abbott, 25 July 2003 ("UTMB Brief of 25 July 2003"), seeking to deny Sunshine Project Texas Open Records Act request of 3 July 2003 for Notifications of Use, approvals, denials, and stop work orders received or issued by the UTMB IBC.

(7) "When possible and consistent with protection of privacy and proprietary interests, the institution is encouraged to open its Institutional Biosafety Committee meetings to the public."

(8) Which mandates an Institutional Review Board.

(9) UTMB Safety Manual, Chapter 9, "Biological Safety", page 40, states: "The current procedures and requirements for recombinant DNA are specified in the current "NIH Guidelines for Research Involving DNA Molecules." UTMB must comply with these guidelines if NIH funding is to be maintained. The Biological Safety Committee shall act as the Institutional Biosafety Committee as defined in those guidelines" URL: http://www.utmb.edu/policy/ihop/search/08-01-12.pdf. And with specific respect to UTMB’s NBL application, "Internally the university maintains oversight through the Institutional Biosafety Committee. This committee is mandated by the National Institutes of Health to review and approve the use of biological agents on campus. The committee's focus is the adherence to biological safety practices that protect the researcher and the community the institution serves. The Institutional Biosafety Committee has the authority to approve the use of a biological agent, deny approval or take action to stop work." UTMB National Biocontainment Laboratory Frequently Asked Questions - http://www.utmb.edu/nbl/faq.htm

(10) i.e., the Federal Laboratory Safety Program.

(11) UTMB Brief of 20 March 2003 and UTMB Brief of 25 July 2003

(12) UTMB Brief of 20 March 2003.

(13) Sunshine Project Texas Public Information Act request of 27 February 2003.

(14) Again, "It is the position of UTMB that all records generated by the BSC are confidential by statute", followed by "UTMB requests that the attorney general allow us to use this decision as a guideline for withholding BSC documents that are protected from release by statute," (i.e., all IBC records), and "Any previous determination that arises from this request will apply specifically in instances where a requestor seeks access to documents created by, for, or as a result of UTMB’s BSC meetings." (emphasis in original), UTMB Brief of 25 July 2003.

(15) The UTMB IBC is one of many IBCs constituted by institutions subject to the Texas Public Information Act, thus, UTMB's attempts to entrench its policies with the Texas Attorney General may endanger compliance with the NIH Guidelines by other institutions, such as Texas A&M University, Texas Technological University, and all components of the University of Texas System that conduct NIH-funded rDNA research.

 

OGDEN, GIBSON, WHITE & BROOCKS, L.L.P.
ATTORNEYS
2100 PENNZOIL SOUTH TOWER
711 LOUISIANA
HOUSTON, TEXAS 77002
TEL. (713) 844-3000
FAX (713) 844-3030
URL: www.ogwb.com

August 4, 2003

Via Facsimile and Certified Mail

Honorable Greg Abbott
Attorney General of Texas
Open Records Division
209 West 14th Street
Austin, Texas 78711

 

Re: Texas Public Information Act Request of Edward Hammond of the Sunshine Project requesting documents in the possession of the University of Texas Medical Branch relating to the Institutional Biosafety Committee; ID # 188021.

Dear General Abbott:

We represent the Freedom of Information Foundation of Texas (FOIFT). FOIFT is submitting these comments on behalf of and in support of Mr. Hammond and the Sunshine Project in support of the above referenced Public Information Act request. On July 3, 2003, Mr. Hammond requested the following information from UTMB:

1. All notifications for use of biological agents received by the UTMB Institutional Biosafety Committee (IBC) from 1 September 2001 through 3 July 2003, in their entirety;

2. All approvals, denials, and stop work actions issued by the UTMB IBC from 1 September 2001 through 3 July 2003, in their entirety.

In its request for opinion and its briefs, UTMB is taking the position that the requested information is confidential by law. UTMB relies on two statutes outside the Public Information Act in support of its position. The first of these is §161.032 of the Texas Health & Safety Code regarding medical committees, and the second is §51914(1) of the Texas Education Code providing protection to scientific and technical information developed by Texas institutions of higher education.

UTMB is taking the position that all requested records are confidential and absolutely none are excepted.

Texas Health & Safety Code § 161.032

UTMB has previously, as has Texas Tech University Health Sciences Center, argued that an institutional biosafety committee falls within the definition of a “medical committee” set forth in §161.031.

In its briefing to the Attorney General’s Office, UTMB states that it “refers to its institutional biosafety committee as the "biological safety committee" or "BSC," not as "IBC." This semantic quibbling has more to it than meets the eye. UTMB goes on to state that: "The BSC is a university medical center or health science center committee established to oversee biological research activities pursuant to 45 C.F.R. §46.103." However, this is incorrect. 45 C.F.R. §46.103 mandates creation of an IRB or an institutional review board, not an institutional biosafety committee. (1)

Like other institutions that conduct medical research on human subjects, UTMB maintains an IRB whose purpose is to "review, to approve the initiation of, and to conduct periodic review of, biomedical [and behavioral] research on human subjects." (2) Some of the records of the UTMB IRB might arguably be exempt under Health and Safety Code §161.032 because they might contain exemptible data pertaining to administration of experimental drugs to human subjects.  However, no records of the UTMB IRB are a subject of this request.

Distinct from the medical functions of the IRB in overseeing research on human subjects, the UTMB Institutional Biosafety Committee (IBC) is established to fulfill the National Institute of Health (“NIH”) Guidelines for Research Involving Recombinant DNA Molecules:

The current procedures and requirements for recombinant DNA are specified in the current "NIH Guidelines for Research Involving DNA Molecules." UTMB must comply with these guidelines if NIH funding is to be maintained. The Biological Safety Committee shall act as the Institutional Biosafety Committee as defined in those guidelines. (3)

The purpose of the UTMB IBC does not relate to providing medical care, nor to obtaining and verifying informed consent, nor to approving, denying, or reviewing any ethical or legal aspect of experiments on humans. The IBC’s primary purpose is biosafety – that is to insure that experiments involving the creation and laboratory use of genetically modified organisms are appropriate for the biological containment level where they will be conducted and that these experiments do not pose unacceptable risks to researchers and the health (due to accidental release of genetically modified organisms) and environment of the surrounding community. (4)

IBC’s are mandated pursuant to 32 C.F.R. §627.7 -- Laboratory Safety Program, not 45 C.F.R. §46.103, as asserted by UTMB. Section 627.7(c) regards safety meetings and safety committees. Section 627.7(c)(3) states:

When work with recombinant DNA molecules is undertaken, an Institutional Biosafety Committee (IBC) for review of such work will be established and will function as stated in the NIH guidelines for Research Involving Recombinant DNA Molecules (see Appendix A to this part).

UTMB’s IBC is not a medical committee, it is a safety committee. Further, we must note that the NIH guidelines that 32 C.F.R. §627.7(c)(3) mandate be followed by the IBC include the following:

Section 4-B-2-a-(6). When possible and consistent with protection of privacy and proprietary interests, the institution is encouraged to open its institutional biosafety committee meetings to the public.

Section 4-B-2-a-(7). Upon request, the institution shall make available to the public all institutional biosafety committee meeting minutes and any documents submitted to or received from funding agencies which the later are required to make available to the public.

Accordingly, the very federal statute which requires UTMB to have an IBC also requires UTMB to make its IBC minutes public. As regards the Texas Public Information Act, it is well settled that “information specifically made public by law outside the Public Information Act may not be withheld pursuant to any of the Act’s exceptions to required public disclosure.” (quoting OR 97-0154. See also Tex. Att’y Gen. 544 (1990); Tex. Att’y Gen. 525 (1989).

Accordingly, UTMB’s efforts to claim protection from disclosing this information by framing the IBC as a “medical committee” is frivolous on its face and runs counter to the very enabling legislation and mandating its creation.

Because IBC is not a medical committee, further discussion of the treatment of confidentiality of medical committee records is unnecessary. However, even if the IBC at times functions as a medical committee, only the documents that reflect committee proceedings and deliberations relating to standards and quality of care are confidential under §161.032 of the Health and Safety Code and therefore required to be withheld under §552.101 of the Government Code. OR2003-2813; OR2003-4793; Jordan v. Court of Appeals, 701 S.W.2d 644 (Tex. 1985).

However, IBC is a safety committee, not a medical committee and does not review standards or quality of care. The NIH guidelines which mandate public release of the information in question, however, also provide for the protection of proprietary interests. Therefore, it is also necessary to address UTMB’s claim that the information at issue is protected under the Education Code. 

Texas Education Code § 31.914

Initially, a governmental body’s general claim that an exception applies to an entire file or report, when the exception clearly is not applicable to all the information in the file or report, does not comport with the requirements of the Public Information Act, which requires the governmental body to determine which exception, if any, applies to which specific information, and then to present the applicability of that claim to the Attorney General within a reasonable time. Tex. Att’y Gen. ORD 150 (1977). For example, in the facts examined by the Attorney General in Tex. Att’y Gen. ORD 363 (1983), the Sabine River Authority had received a request under the Open Records Act for certain personnel records. The letter from the Sabine River Authority accompanying the records contended that the material was excepted from disclosure by statutory exception. However, none of the claimed exceptions were clearly applicable. Because the Sabine River Authority had failed to make any showing as to (how or why a particular exception applied) to the requested material, the Attorney General concluded all of the records were available to the public.

Indeed, the Public Information Act specifically requires UTMB and all other public entities to “label that copy of the specific information, or of the representative’s sample, to indicate which exceptions apply to which parts of the copy.” Tex. Gov’t Code §552.301(e)(2). This statutory provision should be read together with §552.301(f) which prohibits a governmental body from requesting a determination when “the Attorney General or a court determine that the information is public information under this chapter that is not excepted by subchapter C.” The governmental entity is to provide that information that is public information promptly, to specifically identify that information to which it believes an exception applies in its submission to the Attorney General.

There is simply no question that much of the material sent by UTMB to the Attorney General is not excepted under the Texas Education Code and should therefore be turned over immediately.

Section 51.914 of the Education Code provides in pertinent part:

In order to protect the actual or potential value, the following information shall be confidential and shall not be subject to disclosure under Chapter 552, Government Code, or otherwise:

(1) All information relating to a product, device, or process, the application or use of such a product, device, or process, in all technological and scientific information (including computer programs) developed in whole or in part at a state institution of higher education, regardless of whether patentable or capable of being registered under copyright or trademark laws, that have a potential for being sold, traded, or licensed for a fee.

Accordingly, UTMB must demonstrate both that the information in question is technological and scientific information developed at UTMB, and that it also has a potential for being sold, traded, or licensed for fee.

One must note, at the beginning, that there is a striking discontinuity between UTMB’s claim that the information is confidential under the Health and Safety Code and could not even be obtained through subpoena and at the same time to argue that the information is capable of being sold. However, given that the IBC is not a medical committee, there is some potential that particular items could possibly be sold and that some of the scientific and technological information was in fact developed at UTMB.

The NIH guidelines which require release of as much material as possible in connection with an IBC, require this release only be "consistent" with proprietary interests. Accordingly, not all information may be withheld, but only that specific information which could reveal the scientific or technological information that could be sold. Of course, this would require UTMB designating those sections which they have failed to do. Accordingly, the entire information should be released through UTMB’s failure to so designate.

However, at a minimum, the Attorney General’s office should redact only those portions of the requested information that are provably within §51.914.

In making that determination, the following letter rulings are instructive on how previous requests have been handled by your office: 

OR 2001-1554 ("However, you have not explained, nor can we determine how release of the report itself would reveal details of the proposed research.);

OR 2003-3219 (Also request of UTMB by Ms. Carol Longoria) (Attorney General’s Office marked information which did not fall into the language of the statute despite UTMB’s claim the entire application was confidential.);

Tex. Att’y Gen. ORD-497 (1988) (Information about licensing, contracting, equity deals, and federal governmental financing, does not reveal details about the research itself.);

Tex. Att’y Gen. ORD-557 (1990) (Failed to demonstrate how minutes of a committee meeting or its proceedings constitute scientific or technological information that had a potential for being sold a license or traded for a fee. The information did not on its face reveal details of the research itself or allow a person to appropriate the research efforts of the university or its scientists.);

OR 2001-2107 (Cover letter is not excepted.);

OR 2001-2327 (Failed to demonstrate that any of the information in question was confidential under §51.914.);

OR 2002-0417 (Again a request from Ms. Longoria at UTMB) (“However, you have not demonstrated that the release of some of this information would reveal information directly relating to the substance of various research protocols or experiments which could be appropriated by other interested parties.”);

OR 2002-1496 ("Licensing contracts between the university and [third party] do not directly reveal details about the technology and therefore are not confidential under §51.914. See ORD-497 at 6. Likewise, we find that you have not adequately demonstrated that attachment number 1 directly reveals details about the technology that could be sold, traded, or licensed.");

OR 1999-3193 ("On the other hand, the document submitted as tab 3 consists solely of the titles of various scientific experiments and how the IRB voted on these experiments. You have not explained, nor can we determine from the face of these documents, how the release of this information would reveal the details of the proposed research.").

Accordingly, the foregoing makes it clear that UTMB's burden is more than a mere assertion that the information falls within the language of the statute. UTMB must also affirmatively demonstrate that it is so and specifically identify the information it claims meets the statutory language.

Summary

In sum, the IBC not a medical committee as defined in the Texas Health and Safety Code, it was set up under a different CFR than that represented to the Attorney General’s Office by UTMB, it is a safety committee. Further, the enabling legislation and regulations setting up the IBC mandate the very information requested by Mr. Hammond be released. Accordingly, no exception of the Public Information Act can serve to prevent its release.

It is extremely unlikely that any of the submitted information actually does reveal any of the details of the research and scientific and technological information developed by UTMB. UTMB has not stated who developed it, when it was developed, in connection with which researcher or which project it was developed or any details that would allow the Attorney General to conclude how or why this research, if any, falls within the statutory language. To the extent all the information is not released, the Attorney General should, consistent with the NIH guidelines, redact only that information UTMB has clearly demonstrated falls within the proprietary category set out in the Texas Education Code.

We appreciate the opportunity to submit these comments on behalf of Mr. Edward Hammond and the Sunshine Project. We are also attaching to this letter Mr. Hammond’s recent correspondence to the National Institute of Health regarding UTMB’s refusal to turn over the information in question which, in addition to setting forth some of the issues raised in the above brief, also provides some background with regard to the Sunshine Project.

Very truly yours,

 

Joseph R. Larsen

JRL/q

Enclosure

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(1) (See also 42 U.S.C. §289(a)) (providing that secretary of health and human services shall by regulation require that each entity which applies for grant, contract, or cooperative agreement for any project or program which involves conduct of biomedical or behavioral research involving human subjects submit in or with its application for such grant, contract, or cooperative agreement assurances satisfactory to the secretary that it has established "institutional review board" to review biomedical and behavioral research involving human subjects conducted at or supported by such entity).

(2) UTMB Institutional Review Board, "IRB Structure and Function and Informed Consent Requirements," Powerpoint presentation available at url:http:\\research.utmb.edu\irb\.

(3) See UTMB Safety Manual, Chapter 9, "Biological Safety," Page 40.

(4) NIH Guidelines, Section IV-B-2-a-(6): “At least two members shall not be affiliated with the institution (apart from their membership on the Institutional Biosafety Committee) and who represent the interest of the surrounding community with respect to health and protection of the environment (e.g., officials of state or local public health or environmental protection agencies, members of other local governmental bodies, or persons active in medical, occupational health or environmental concerns on the community.

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Letter from NIH Office of Biotechnology Activities (6 August, PDF only)

Download here

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Letter to NIH OBA from Bioweapons Experts

 

16 September 2003

Dr. Amy P. Patterson, M.D.
Director
Office of Biotechnology Activities
National Institutes of Health
6705 Rockledge Dr
Suite 750, MSC 7985
Bethesda MD 20892-7985

Dear Dr. Patterson,

This letter concerns the importance of transparency in biological defense research with respect to the public access practices of the University of Texas Medical Branch at Galveston (UTMB).

In early August, the Office of Biotechnology Activities began an investigation of UTMB's Institutional Biosafety Committee (IBC) and its compliance with the NIH Guidelines for Research Involving Recombinant DNA Molecules. The investigation was prompted by a complaint from the Sunshine Project, a non-profit watchdog organization which has been denied access to the minutes and other records of the UTMB IBC. The University asserts that all IBC records are confidential by statute. UTMB's policy does not comply with the NIH Guidelines, which require public access to the minutes of IBC meetings, require a mechanism for public commentary on IBC decisions, and which encourage UTMB to open its IBC meetings to the public.

We write as organizations and individuals expert in arms control and the Biological Weapons Convention (BWC). Since the rejection by the present US administration of the nearly-completed, legally-binding Protocol to strengthen the BWC in 2001, the US biodefense program has been expanding rapidly. Secret US biodefense activities that have recently been revealed include construction and testing of a biological agent production facility, weaponization of a biological agent, and construction of a biological munition. These projects, and others documented through FOIA, may be only the tip of the iceberg and suggest that the US may be embarking on an exploration of the military applications of biotechnology.

The situation has led to a deterioration of international confidence in the intent of US biodefense research. In this context, under NIH programs, UTMB seeks to become a national center of biodefense research. On September 4th, NIAID awarded UTMB a $48 million grant for a Regional Center of Excellence in Biodefense. Also under the NIAID biodefense program, UTMB is seeking $110 million to construct a biosafety level four National Biocontainment Laboratory. That proposed lab would complement another UTMB BSL-4 facility scheduled to begin operation within weeks. UTMB researchers have received federal funding for biodefense research from other sources inluding the Defense Threat Reduction Agency (DTRA), Defense Advanced Research Projects Agency (DARPA), the US Army, and the US Navy.

We believe that your office must respond vigorously to UTMB's failure to comply with the NIH Guidelines. Overlooking violations at UTMB would encourage noncompliance elsewhere and remove an important incentive for safe research on the most dangerous pathogens. The loss of public accountability would blur the distinction between NIH's mission and that of the Department of Defense.

Our concerns with the policies of UTMB IBC also relate to laboratory biosafety. The record of UTMB biodefense researchers is not reassuring. In 1994, inadequate safeguards at a Yale University laboratory operated by two scientists now at UTMB resulted in a major biosafety accident. That incident resulted in the infection of a scientist with a BSL-4 agent (sabia virus) and the endangerment of scores of individuals exposed to the infected scientist, who circulated for several days in Connecticut and Massachusetts. The accident prompted an investigation by the Centers for Disease Control and calls for more stringent laboratory biosafety practices.

In the interest of security and biosafety, we urge your office to suspend HHS funding for biological defense research at UTMB until it effectively implements transparency policies that comply with the NIH Guidelines. By upholding the public access requirements of the NIH Guidelines in this case, the Office of Biotechnology Activities will help ensure biosafety at UTMB and other biodefense facilities. That will reassure the public as to the safety of HHS-sponsored biotechnology research and will help ensure that research at NIH-funded facilities is compliant with letter and spirit of the Biological Weapons Convention.

Sincerely,

Jan van Aken, Director
Sunshine Project Germany

Ian Davis, Director
British American Security Information Council (BASIC)

John Isaacs, President
Council for a Livable World

Lynn Klotz
Consultant

Brian Rappert
University of Exeter

Barbara Hatch Rosenberg
State University of New York at Purchase

Mark Wheelis
University of California at Davis