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Current Trends in Institutional Biosafety Committee Practices Raymond W. Hackney, Jr.1*, Theodore A. Myatt2, Kathleen M. Gilbert3, Rebecca R. Caruso4, and Susanne L. Simon5 1Duke

University, Durham, North Carolina, 2Brigham and Women’s Hospital, Boston, Massachusetts, 3Harvard University, Boston, Massachusetts, 4Harvard Medical School, Boston, Massachusetts, and 5Environmental Health & Engineering, Inc., Needham, Massachusetts

Abstract The NIH Guidelines for Research Involving Recombinant DNA Molecules (Guidelines) require institutions that receive NIH funding for recombinant DNA (rDNA) research to establish an institutional biosafety committee (IBC) to review and approve rDNA experiments, and to ensure that rDNA research is conducted according to the Guidelines. Three national surveys of IBCs registered with the NIH were conducted in 2002, 2007, and 2010 to assess IBC practices and identify trends over time. The surveys showed that over time IBCs increased compliance with the Guidelines and improved IBC management and staffing levels. The NIH site visit program resulted in enhanced oversight of rDNA research by IBCs that participated in the site visit. The data from the surveys suggest that many IBCs do a good job of compliance with the intent of the Guidelines while others struggle to meet their obligations in terms of research review, training, and other aspects of Guidelines compliance.

Introduction The National Institutes of Health (NIH) first published the NIH Guidelines for Research Involving Recombinant DNA Molecules (Guidelines) in 1976 which established institutional biosafety committees (IBCs) as the foundation for institutional review and oversight of recombinant DNA (rDNA) research (National Institutes of Health, 2011; Shipp & Patterson, 2003). The Guidelines are cited as a term and condition of NIH funding in the NIH Grant Policy Statement and, consequently, institutions receiving funds for rDNA research must fully conform to the Guidelines for all rDNA research conducted at or sponsored by that institution. The Guidelines encourage institutions not receiving NIH rDNA to voluntarily comply with the Guidelines as a standard of practice. Institutions are required to establish an IBC to ensure compliance with the NIH Guidelines including assessing containment levels, facilities, procedures, and training. As the amount of funding for research involving rDNA has grown, the number of IBCs registered with the NIH has risen steadily from 57 IBCs in 1976 to 798 IBCs in 2011 (NIH OBA, 2011). From 1976 to 2001, very few efforts were organized to provide training for IBCs or opportunities for IBCs to come together to learn from each other. Beginning in 2001, the NIH Office of Biotechnology Activities (OBA) reached out to IBC members with training programs, sponsored conferences, and a site visit program to review IBC practices www.absa.org

(NIH OBA, 2011). These site visits helped IBCs and their institutions’ upper administration to focus on compliance issues with the Guidelines. In 2004, the National Research Council published a report proposing that IBCs consider whether the results of proposed research, although intended for public good, could also be used by bioterrorists as a public health threat (NRC, 2004). This proposal sparked debate as to whether IBCs were equipped and ready to take on this additional responsibility of “dual-use” concerns. Criticism of IBCs included their lack of expertise relevant to dual-use research (NSABB, 2007), lack of staffing and funding resources (Cook-Deegan et al., 2005), and failure to fully comply with the current Guidelines (Enserink, 2004; Field, 2005). In addition, a watchdog group, known as The Sunshine Project, criticized IBCs for a lack of transparency, such as not sharing IBC minutes upon request, as is required by the Guidelines (The Sunshine Project, 2004). In 2007, a report of Texas A&M University’s failure to inform the Centers for Disease Control and Prevention (CDC) Select Agent Program of four laboratory-acquired infections (LAIs) drew attention to both the CDC and the NIH requirements for reporting laboratory incidents and exposures (Brainard & Fischer, 2007). This paper describes the analysis of data from three independent surveys conducted over the course of 8 years of IBCs registered with the NIH, focusing on IBC practices and institutional support (Hackney, 2003; Hackney, 2007; Myatt, 2010; Myatt, 2011). The purpose of the surveys was to shed light on how IBC practices have changed over this time period and to identify ways that IBCs could be strengthened.

Materials and Methods Survey The 2002 survey consisted of 54 questions about administration of committee responsibilities, committee membership, and review and oversight of recombinant DNA research. The 2007 survey consisted of 68 questions, 40 of which were the same as the 2002 survey. New questions were asked about the type of rDNA research being conducted, whether the IBC addressed “dual-use” concerns, training of IBC members and principal investigators (PIs), information included in the IBC meeting minutes, and review of exempt experiments. The 2010 survey con-

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sisted of 77 questions, 29 of which were from the 2007 survey, including 17 questions from the 2002 survey. New topics in 2010 included questions on the NIH OBA site visit program, laboratory staff training on rDNA, incident reporting, and containment policies for animals inoculated with viral vectors. Each survey asked demographic questions such as the general professional title (e.g., Faculty) of the person completing the survey, his or her role on the IBC, and his or her type of institution (i.e., university, hospital/clinic, research institute, government laboratory, medical school, biotechnology company, or pharmaceutical company).

Survey Administration For each survey, contact information for IBCs registered with the NIH OBA was obtained through a Freedom of Information Act (FOIA) request to NIH OBA (NIH OBA, 2002, 2006, 2010). Each survey was administered differently. In 2002, a notification letter and the survey were mailed to the IBC contacts. A postcard was sent as a reminder to non-responders. In 2007, a notification letter was mailed and an invitation to participate in the survey was e-mailed to the IBC contacts and the biological safety officers (BSOs). The e-mail included a link to a web-based survey (Qualtrics, Provo, UT). E-mail reminders were sent to non-responders. In 2010, an e-mail notification and invitation were sent to IBC contacts and BSOs. The e-mail invitation included a link to the web-based software (Zoomerang®, MarketTools, Inc., Mill Valley, CA). In the invitation, participants were asked that only one survey be completed per IBC. Reminders were sent via e-mail to increase the response to the IBC survey. For each survey, responses were kept confidential, and the survey results were reported only in aggregate, as the population of institutions that responded to the survey. The 2002 and 2007 surveys were reviewed and approved by the Institutional Review Board at the University of North Carolina at Chapel Hill. The 2010 survey was reviewed by the Harvard University Faculty of Medicine Committee on Human Studies

and the Institutional Review Board (IRB) for Harvard Medical School and Harvard School of Dental Medicine.

Data Analysis Statistical analyses and data manipulation were performed using SAS® Statistical Software (SAS® 9.1.3 Service Pack 4; SAS Institute, Cary, NC).

Results The survey response rates were 43.6% (168/397) in 2002, 45.1% (302/669) in 2007, and 29.2% (233/799) in 2010. The percentages of survey respondents by institution type were very different when compared to the percentage of IBCs registered with the NIH by institution type, as shown in Table 1. Academic institutions were the majority participants in all survey years (61% in 2002, 62% in 2007, and 71% in 2010) while representing only 41% of IBCs registered with the NIH. Hospitals and clinics had low participation rates in all survey years (10% in 2002, 11% in 2007, and 5% in 2010) although they comprise 38% of IBCs registered with the NIH.

IBC Management and Staffing IBC management resided most frequently in the Environmental Health and Safety Department (45% in 2002, 33% in 2007 and 2010) and the Research Compliance Department (23% in 2002, 33% in 2007, and 32% in 2010), as shown in Table 2. The majority of respondents (61% in 2010) indicated that the same department manages the IBC as well as other committees (e.g., IACUC and IRB. Individuals responsible for IBC management include IBC chairs (29%), biological safety officers (25%), IBC coordinators (11%), research compliance officers (7%), environmental health and safety directors (5%), or others (22%) as indicated in the 2010 survey. The number of respondents with one or more full-time equivalent employees (FTE) devoted to the management and support of the IBC increased from 36% in 2002 to 43%

Table 1 Comparison of the types of institutions registered with NIH versus institutions that participated in the three surveys (NIH Office of Biotechnology Activities, 2011).

Type of Institution Academic Clinic/Hospital Commercial Research Institute Government Other

2002 Survey Registered Participants IBCs (168) (397) 61% 53% 10% 14% 10% 10% 14% 12% 7% 5% — —

2007 Survey Registered Participants IBCs (293*) (669) 61% 42% 11% 31% 8% 12% 12% 10% 7% 4% 1% 1%

2010 Survey 2011 Participants Registered (232) IBCs (798) 71% 40% 5% 38% 5% 9% 13% 6% 5% 6% 1% 1%

*Note: 302 institutions completed 90% of the 2007 survey, but only 293 answered the question for type of institution. 12

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in 2007. The 2010 survey included questions about both technical and administrative support for the IBC. Fifty-two percent provide more than one technical support FTE, and 29% provided more than one administrative support FTE. When these questions were matched by institution and then combined, 58% of the participants stated they provide more than one FTE for support of the IBC, whether technical or administrative support. Figure 1 shows the percent of participants providing more than one FTE by survey year. Independent of IBC management, 70% of respondents in 2010 employed more than one FTE to support the biosafety program. As expected, the institutions with more than one FTE of biosafety support were much more likely to have more than one FTE for support of their IBCs. To control for the size of the institution, we evaluated the number of BSOs per the number of PIs per institution and determined that there was approximately one BSO per 110 PIs per institution. In the 2010 survey, 42% of IBCs report meeting on a monthly basis, 19% quarterly, 14% as needed, 10% semiannually, and 7% annually. The number of IBCs that meet monthly increased from 18% in 2002, to 28% in 2007, and

42% in 2010. The 2010 survey showed that at each meeting the majority of IBCs (81%) review less than 10 registrations. Seven percent of the IBCs reported heavier workloads, typically reviewing more than 20 protocols per meeting. Most institutions conduct official committee business, such as review and approval of protocols, primarily in faceto-face meetings (94% in 2010). Some committees also conduct official business by telephone conference call (25% in 2010), e-mail (34% in 2010), and video conference (4% in 2010). Most institutions (58% in 2010) do not use a software system to manage the review process and electronic storage of protocols. However, many (21% in 2010) have developed their own in-house IBC software, 8% use commercially available protocol management software, and 7% use a database software program, such as Microsoft Access.

Review and Approval Process In the 2010 survey, most IBCs (67%) reported reviewing research involving rDNA as well as other biological hazards, 16% review only rDNA research, and 17% include review of other laboratory hazards, such as hazardous chemicals. When asked whether members of the public

Table 2 What institutional office or department has responsibility for management or support of the IBC?

Answer Academic department

2002 2%

2007 5%

2010 2%

45%

33%

33%

—

4%

5%

Research compliance office

23%

33%

32%

Vice chancellor for research

13%

14%

7%

Other (Please specify.)

15%

15%

22%

Environmental/occupational health and safety Office of research subjects protection/IRB

Figure 1 Percent of IBCs reporting one or more FTE employees by survey year.

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(excluding unaffiliated community members) would be permitted to attend an IBC meeting, the number answering affirmatively increased from 52% to 77% from 2002 to 2007; however, the percentage of IBCs that indicated that a member of the public had ever attended a meeting decreased from 22% to 12% from 2002 to 2007. The percent of respondents having the IBC committee meeting minutes available upon request increased from 49% to 93% from 2002 to 2007. To ensure that rDNA experiments requiring IBC review and approval actually come to the committee for review, all three survey years showed similar results indicating that the majority of participants hold the PI responsible for submitting registrations, withhold IACUC approval, conduct lab audits, and stop grant processing, as shown in Table 3. In the 2010 survey, when asked under what conditions respondents would allow an individual or subset group to make an expedited review and approval in lieu of full committee review, 41% stated for work exempt from the Guidelines, 31% for BSL-1 experiments, 13% for BSL2 experiments, and 36% indicated they do not conduct expedited reviews, as shown in Table 4. While the majority of participants (75%) registered experiments exempt from the Guidelines, most indicated that they do not require full IBC

approval and review for III-F exempt experiments. The majority of respondents (66%) indicated that individuals are assigned to review registrations and make recommendations before full committee review. Eight percent of participants indicated that they have been officially charged to review experiments for dual-use issues, 44% consider dualuse issues, 33% do not address them, and 15% are considering whether or not to address them. Although 46% reported that the PI is responsible for initially determining the section of the Guidelines under which their experiments fall, the majority (89%) have the BSO or other official verify the determination. The majority of participants (64%) will grant approvals within a month after submission, and 29% will take between 1 and 3 months. Participants grant IBC approvals for 1 year (31%), 3 years (35%), and 5 years (22%), with 22% indicating “other” for length of approval period.

Training Compliance with the requirements for IBC member training increased from 21% in 2002 to 40% in 2007 and 74% in 2010, as shown in Figure 2. In the 2010 survey, less than half of the participants require PI (49%) and lab staff training (46%) on the NIH Guidelines. In the 2010 survey,

Table 3 What measures (if any) does your institution/organization have to ensure that rDNA experiments requiring IBC review and approval actually come to the committee for review? (Please select all that apply.)

Answer For all or some experiments, it is the Principal Investigators’ responsibility to submit registration documents to the IBC for approval

2002

2007

2010

70%

75%

79%

67%

63%

68%

—

40%

58%

57%

53%

51%

—

33%

45%

Other

14%

17%

13%

No formal mechanism is in place to ensure that those experiments are reviewed by the IBC

7%

5%

12%

Animal experiments involving rDNA are not approved by Institutional Animal Care and Use Committee (IACUC) without IBC approval Lab audits/inspections No grant involving rDNA is processed without IBC approval Human gene transfer experiments are not approved by Institutional Review Board (IRB) without IBC approval

Table 4 Under which conditions is expedited review and approval done? (Please select all that apply.)

Answer Only for experiments exempt from the NIH Guidelines

2002 —

2007 20%

2010 41%

—

—

36%

Experiments conducted at biosafety level 1

41%

24%

31%

Other (please specify)

16%

31%

22%

Experiments conducted at biosafety level 2

13%

11%

13%

—

—

9%

Not applicable (e.g., don’t have expedited review)

Experiments that fall under Section III-E of the NIH Guidelines 14

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Figure 2 Percent of IBCs reporting that IBC member training is required.

the majority of respondents (59%) train IBC members during regularly scheduled IBC meetings, while 33% use online training. Online training was the most frequently used method to train PIs (42%) and lab staff (47%). The reported frequency of training PIs on the NIH Guidelines ranged from one time only (29%) to annually (25%) to every 3 years (18%). Participants were more likely to document NIH Guidelines training for IBC members (76%) compared to PIs (67%) and laboratory staff (47%). The most common training content for IBC members (91%) and PIs (83%) was their responsibilities as described in the Guidelines, while dual-use research was the least likely topic to be covered among the three groups (37% IBC, 19% PIs, 14% lab staff). IBC members (73%) and PIs (61%) were more likely to be trained in the IBC approval process than lab staff (42%). The majority of respondents who required training covered the following topics for PIs, lab staff, and IBC members: categories of experiments in Section III of the Guidelines, the Biosafety in Microbiological and Biomedical Laboratories (BMBL) biosafety levels, NIH risk groups, PI responsibilities, and incident reporting.

OBA. Of these, 80% stated they believed that the site visit enhanced rDNA research oversight. These enhancements included improvements to the IBC review process (61%), more thorough reporting (42%), increased training (82%), inspections (33%), coordination with other committees (48%), and funding and staffing (22%). Among those that had site visits, 46% reported incidents to NIH, while 20% of institutions that did not have a site visit reported incidents to NIH (Figure 3). Of academic institutions, with or without an affiliated hospital, that had a site visit, 85% reported incidents, while 25% of those without site visits had reported incidents. Of the non-academic institutions, only 11% of those without site visits have reported incidents to NIH. Seventy percent of institutions that had site visits reported that they train their PIs in the NIH Guidelines, whereas only 45% of institutions that did not have a site visit reported they train their PIs. Fifty-one percent of institutions that had a site visit reported that they train their lab staff in the NIH Guidelines, and only 44% of institutions that did not have a site visit reported they train their lab staff in the Guidelines, as shown in Figure 3.

IBC Accountability and Incident Reporting Fifty-nine percent of respondents in 2002 and 54% in 2007 indicated that their IBC makes a formal report to an institutional official to whom it is accountable. The number of respondents reporting an incident to NIH rose from 15% in 2002 and 2007 to 31% in 2010.

Discussion

NIH Site Visits Eighteen percent of the respondents in the 2010 survey reported that their institution had a site visit from NIH www.absa.org

The three surveys of IBCs, conducted over 8 years, showed improvements in IBC management and increased compliance with the NIH Guidelines. There was a dramatic increase in the IBCs’ openness to the public from 2002 to 2007 based on the willingness of respondents to allow public attendance at IBC meetings and public access to IBC meeting minutes. Compliance with training IBC members and reporting rDNA incidents to the NIH increased signifi-

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Figure 3 Comparison of training and incident reporting compliance for IBCs that had NIH site visits versus IBCs without site visits.

cantly from 2002 to 2010. Over the survey time period, the meeting frequency of IBCs increased, which may indicate that IBCs are devoting more attention to their responsibilities under the Guidelines. Increased IBC staffing levels from 2002 to 2010 may have contributed to these increased compliance trends. There are several likely explanations for the improvements in IBC management, staffing, and compliance observed over the course of the surveys. First, the NIH OBA has, since 2001, increased efforts to offer educational conferences and courses for IBC members and those responsible for IBC oversight. Therefore, the workforce is likely to be more educated on the Guidelines than in the past. Second, the NIH OBA established the site visit program, which allows for an in-depth review of the rDNA research oversight structure and practice for an institution. The program review can also reveal a need for additional staff in order to fulfill the IBC responsibilities. Of those respondents to the 2010 survey, 22% of those who reported that they had a site visit at their institution indicated that they had increased funding or staffing as a result of the site visit. Finally, incidents in the news and public scrutiny drew attention to weaknesses in IBC compliance with the Guidelines (Brainard & Fischer, 2007; Enserink, 2004; Field, 2005; Cook-Deegan et al., 2005; National Research Council, 2004; The Sunshine Project, 2004). While compliance has increased, there are a number of issues with which many IBCs are still struggling, including training and incident reporting. The NIH Guidelines (section IV-B-1-h) require institutions to ensure that IBC members, PIs, and laboratory staff are trained in laboratory safety and implementation of the NIH Guidelines. IBCs have made significant progress in their compliance with the 16

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training requirements in the Guidelines since 2002. However, among institutions participating in the survey, less than 50% required training on the NIH Guidelines for PIs and laboratory staff. Similarly, while incident reporting increased to 31% in the 2010 survey, this may still represent a significant under-reporting, as evidenced by the comparison of incident reporting compliance among institutions with site visits versus those without site visits. Our results suggest that the NIH site visit program raised awareness of and compliance with the training and reporting requirements of the Guidelines since respondents that had an NIH site visit were far more likely to require training for their PIs and incident reporting than institutions that have not had a site visit. It should be noted that increased reporting among respondents that had a site visit may be due to the NIH requesting that institutions send them any incidents involving rDNA before the site visit. Lack of training may be the result of limited staff for the IBC and biosafety programs. While the upward trend in IBC staffing is encouraging, IBCs are still likely to have less staff and resources than their sister committees that oversee the care and use of research animals (Institutional Animal Care and Use Committee or IACUC) and research involving human trial participants (Institutional Review Board or IRB) (NAS, 2000). IBCs are mandated, not by law but by the NIH Guidelines for institutions that receive NIH funding for rDNA research. In contrast, IACUCs and IRBs are regulated by federal law (Animal Welfare Act and National Research Act, respectively, and non-compliance may result in significant fines for the institution. Additionally, IACUCs and IRBs also have accrediting organizations (Association for Assessment and Accreditation of Laboratory Animal Care and Association for the Accreditation of

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Human Research Protection Programs, respectively) that involve rigorous site visits and review of their programs by peers from similar institutions. Consequently, institutions are more likely to distribute more resources to the IACUC and IRBs than IBCs even though the NIH Guidelines give the NIH the authority to withhold funding (or require NIH approval for all rDNA experiments at an institution) for non-compliance. The establishment of a similar accreditation program for IBCs might result in increased institutional funding and, consequently, increased compliance. Although IBCs’ willingness to be open to the public has improved, some IBC administrative practices may be contrary to the principle of openness. While most IBCs conduct face-to-face meetings, many said they also conduct official business, such as protocol review and approval, by e-mail which does not allow for public attendance. Another practice that is not consistent with the Guidelines is an expedited review, a delegated review and approval by an individual or subset of the committee on behalf of the committee (NIH Office of Biotechnology Activities, 2005). In contrast, IACUC and IRBs are allowed to utilize expedited reviews by the committee chair or designated member (Office for Human Research Protection, 2003; Office of Laboratory Animal Welfare, 2002). The use of expedited reviews by IRBs and IACUCs may contribute to confusion over its use by IBCs. Coordination among IBCs, IACUCs, and IRBs is important to ensure that each committee is reviewing all research proposals that are under their purview. However, it appears that not all IBCs are coordinating with the other committees. For instance, only two-thirds of respondents withhold IACUC approval until IBC approval has been granted, and only one-half stated that committee representatives attend each other’s meetings. To be effective, it is generally recognized that IBCs need the support and involvement of high-level leadership within the institution. However, nearly one-half reported in 2007 that they are not required to make formal reports to an institutional official to whom it is accountable. The involvement of senior leadership in the appointment of IBC members or having senior leadership serve on the IBC promotes the committee’s authority and demonstrates its significance to the PIs and research staff (NIH Office of Biotechnology Activities, 2010). Senior leadership can also ensure that needed resources are provided, enabling the committee to fulfill all of its responsibilities. The study has several limitations. First, there was a very low response rate (5% in the 2010 survey) to the surveys from hospitals and clinics, an institution type that has increased dramatically in the NIH IBC database population over the course of the surveys. Fifty-five hospitals and clinics were registered IBCs in 2002 as compared with 303 in 2010. One of the reasons that may have contributed to the lack of response from these organizations was that a handful of commercial organizations that manage IBCs for the vast majority of registered clinics and hospitals did not respond to the surveys. Many of these hospitals and clinics www.absa.org

that are registered with NIH may have a very small number of clinical trials being conducted at their sites that require IBC review. The lack of response from clinics and hospitals and the high response rate from academic institutions (71% of the IBCs that participated in the 2010 survey were from academic institutions compared with 42% in the actual IBC population registered with NIH) suggests that the survey results are more representative of academic IBCs than the IBCs from other types of institutions. A second limitation is that institutional responses were not matched from survey to survey which would have allowed evaluation of trends in institution-specific compliance over time.

Conclusions The surveys of IBCs show that the population of IBCs, as an aggregate group, has made significant strides since 2002 in providing staffing, training, frequent meetings, openness to the public, and compliance with the Guidelines. Our results suggest that many IBCs are doing an excellent job and are following many of the practices required by the NIH OBA. Much of the improvements can be attributed to the leadership and support provided by NIH OBA through their educational programs, site visit programs, and guidance communications. However, the results indicate that there may be many IBCs that lack adequate staffing and oversight, and that do not provide the required training. The guidance and leadership of OBA will need to continue and grow in order to reach and strengthen the many IBCs that still struggle to comply with the requirements described in the NIH Guidelines.

Acknowledgment The authors wish to thank all of the IBC professionals who participated in the surveys. *Correspondence should be addressed to Raymond W. Hackney, Jr. at raymond. [email protected].

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Hackney, R. W. (2007). Survey of Institutional Biosafety Committees—2007. Presented at the 50th Biological Safety Conference. Nashville, TN. Available at: www. absa50.org/pdf/177Hackney.pdf. Accessed online 2011. Myatt, T., Bosselman, J., Simon, S., Hackney, R., Gilbert, K., & Caruso, R. (2010). Current trends in institutional biosafety committees (IBC)—National survey of IBCs. Poster presentation at the 53rd Biological Safety Conference, Denver, CO. Myatt, T., Bosselman, J., Simon, S., Hackney, R., Gilbert, K., & Caruso, R. (2011). Current trends in Institutional Biosafety Committees (IBC)—National survey of IBCs. Paper presented at the NIH Conference: IBCs in an Evolving Research Landscape. San Diego, CA. National Academies of Science (NAS). (2000). Strategies that influence cost containment in animal research facilities. Washington, DC: National Academies Press. National Institutes of Health (NIH). (2011). NIH guidelines for research involving recombinant DNA molecules (May 2011). Available at: http://oba.od.nih.gov/oba/rac/ Guidelines/NIH_Guidelines.pdf. Accessed online 2011. National Institutes of Health (NIH), Office of Biotechnology Activities. (2002). Freedom of Information Act (FOIA) Available at: www.foia.gov/. Accessed online 2002. National Institutes of Health (NIH), Office of Biotechnology Activities. (2004). Minutes of Institutional Biosafety Committee meetings. Available at: http://oba.od.nih.gov/ rdna_ibc/ibc_training.html. Accessed online 2011. National Institutes of Health (NIH), Office of Biotechnology Activities. (2005). Requirements of IBCs in the NIH Guidelines. IBC basics: An introduction to the NIH Guidelines and the oversight of recombinant DNA research. Paper presented at the NIH OBA Conference, San Diego, CA. Available at: http://oba.od.nih.gov/rdna_ibc/ ibc_training.html. Accessed online 2011. National Institutes of Health (NIH), Office of Biotechnology Activities. (2006). Freedom of Information Act (FOIA) request. Information received December 4, 2006. National Institutes of Health (NIH), Office of Biotechnology Activities. (2010). Freedom of Information Act (FOIA) request. Information received July 2010.

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National Institutes of Health (NIH), Office of Biotechnology Activities. (2010). The NIH OBA IBC Site Visit Program. Paper presented at the 53rd Biological Safety Conference, Denver, CO. National Institutes of Health (NIH), Office of Biotechnology Activities. (2011). Freedom of Information Act (FOIA) request. Information received May 6, 2011. National Institutes of Health (NIH), Office of Biotechnology Activities. Reporting of incidents involving recombinant DNA to the NIH Office of Biotechnology Activities (OBA). Available at: http://oba.od.nih.gov/oba/ibc/ FAQs/FAQS%20about%20Incident%20Reporting.pdf. Accessed online 2011. National Institutes of Health (NIH), Office of Biotechnology Activities. Training and educational materials. Available at: http://oba.od.nih.gov/rdna_ibc/ibc_training.html. Accessed online 2011. National Institutes of Health (NIH), Office of Laboratory Animal Welfare (OLAW). (2002). Institutional Animal Care and Use Committee Guidebook (pp. 92-93). Bethesda: OLAW. National Research Council (NRC). (2004). Biotechnology research in an age of terrorism. Washington, DC: National Academies Press. National Science Advisory Board for Biosecurity (NSABB). (2007). Proposed framework for the oversight of dual use life sciences research: Strategies for minimizing the potential misuse of research information. Bethesda: National Institutes of Health. Shipp, A. C., & Patterson, A. P. (2003). The National Institutes of Health system for enhancing the science, safety, and ethics of recombinant DNA research. Comparative Medicine, 53(2), 159-164. The Sunshine Project. (2004). Mandate for failure: The state of institutional biosafety committees in an age of biological weapons research. Available at: www. sunshine-project.org/. Accessed online 2011. U.S. Department of Health and Human Services, Office for Human Research Protection (OHRP). (2003). Guidance on expedited review procedures. Available at: www.hhs. gov/ohrp/policy/exprev.html. Accessed online 2011.

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