@inbook{1a920b5620e845288ec529a005b3cef5,
title = "Strengthening the Role of the IBC in the 21st Century",
abstract = "The US government (USG) has not fully implemented a robust system to evaluate dual-use research (DUR). In particular, the USG has failed to effectively fund, support, and expand the role of the local Institutional Biosafety Committee in the oversight of DUR and in the changing scientific landscape; a comprehensive education program for all in life sciences research with regard to the dual-use dilemma has not been forthcoming; and finally, there has been no systematic evaluation of the impact of USG policy, regulations, and guidance on an institution's cost structure and on scientific discovery. We detail our judgments on current USG DUR policy and provide recommendations for future oversight of DUR from our perspective as senior administrators and laboratory scientists charged with the responsibility of conducting life-sciences research in an era of increasing regulatory requirements and decreasing federal support.",
keywords = "2011 influenza A/H5N1 controversy, Dual-use research, Institutional Biosafety Committee, National Institutes of Health Guidelines, Oversight of dual-use research of concern (DURC), Protocol review",
author = "Buller, {R. Mark} and Connell, {Nancy D.} and Morse, {Steven S.} and Mark Campbell and Tait, {Raymond C.}",
note = "Funding Information: 1991 was a significant year for federal oversight of research, as it not only was the year in which formulas were set for F&A rates, but also was the year when the Common Rule was adopted to provide for human subject protection across federal agencies. While the cap on administrative cost rates is unchanged since 1991, the same cannot be said of the regulatory landscape that contributes to those costs. Recently, the Council on Government Relations (COGR) compiled a list of regulations that have been implemented or amended between 1991 and 2013, as well as interpretations/implementations that have impacted business practices [60] . That document lists 52 regulations/amendments, 20 interpretations/implementations, and nine further regulatory changes that were proposed at the time that the document was published. A partial list of regulatory requirements follows with which most investigators will be familiar, as many impact the management of federally funded awards: ● 1994: NIH Guidelines for Research Involving Recombinant DNA Molecules ● 1994: Deemed Exports (EAR & ITAR) ● 1995: Conflicts of Interest (Amendments August 2012) ● 1996: Health Insurance Portability & Accountability Act of 1996 (HIPAA) Privacy Rule (Amendments January 2013) ● 2000: Misconduct in Science (Federal-wide Policy) ● 2002: BSAT (under CDC and USDA/APHIS) Public Health Security & Bioterrorism Preparedness & Response Act of 2002; companion to the USA PATRIOT Act (2001); revised October 2012 ● 2002: FISMA: Federal Information Security Management Act (Title III, E Government Act of 2002) OMB Circular A-130, Management of Federal Information Resources, Appendix III, Security of Federal Automated Information Systems ● 2008: Homeland Security Chemical Facilities Anti-Terrorism Standards (CFATS) ● 2009: National Institutes of Health Guidelines for Human Stem Cell Research ● 2006: National Science Foundation Responsible Conduct of Research Training (America COMPETES Act; implemented 2010) ● 2012: US Government Policy for the Oversight of Life Sciences Dual Use Research of Concern ● 2013: NIH, Mitigating Risks of Life Science Dual Use Research of Concern. Faced with the ongoing need to comply with these and other regulatory and/or financial reporting requirements, research institutions have developed multiple structures to manage these recurrent functions. This is reflected to some degree in compliance committees, many involving faculty representation, that include IRB, IACUC, IBC, IRE, Conflict of Interest (COI) committees, etc. While those committees largely depend on the willingness of research faculty to volunteer time in support of committee functions, the infrastructure behind these (and other) committees cannot be supported on a voluntary basis. Indeed, that infrastructure requires expert personnel, information systems, office space, and other institutional resources. Because of the multiplicity of these operations and the varying organizational structures that support them, it is very difficult to obtain an exact accounting of the institutional costs exacted by these compliance-related operations. That said, several recent studies provide estimates of costs associated with the array of research-related regulatory requirements associated with federal funding. The previously referenced HERD study estimated that indirect costs incurred by research institutions in FY2010 exceeded federal F&A support by $4.6 billion dollars. Another survey, undertaken by the Association of American Medical Colleges (AAMC), examined indirect costs of medical schools with research programs that received federal funding that ranged from moderate ($26 million) to very high ($751 million) levels in FY2013 [56] . That study showed that institutional expenditures for unreimbursed indirect costs of external awards averaged . That study showed that institutional expenditures for unreimbursed indirect costs of external awards averaged $0.15 per dollar of direct costs. As noted previously, other internal expenditures also were incurred (e.g., startup packages, additional salary support for research effort, bridge funding), so that the combined institutional costs amounted to $0.53 per dollar of direct costs..15 per dollar of direct costs. As noted previously, other internal expenditures also were incurred (e.g., startup packages, additional salary support for research effort, bridge funding), so that the combined institutional costs amounted to . That study showed that institutional expenditures for unreimbursed indirect costs of external awards averaged $0.15 per dollar of direct costs. As noted previously, other internal expenditures also were incurred (e.g., startup packages, additional salary support for research effort, bridge funding), so that the combined institutional costs amounted to $0.53 per dollar of direct costs..53 per dollar of direct costs. Of course, the costs of compliance are not only measured in dollars nor are they visited only on research institutions. Those costs are visited on investigators, as well, often in the form of reduced research productivity. Data regarding reduced productivity have been collected by the Federal Demonstration Partnership (FDP), a collaboration among 10 federal agencies and 119 federally funded institutional partners that is sponsored by the National Academies ), greatly reducing (to 57.7%) the estimated proportion of funded effort actually spent on active research. [51] . The FDP survey was completed by 13,453 Principal Investigators with active federal grants in FY2010 (a 26% response rate). Respondents identified many administrative functions that consumed their effort (see Table 13.3 Publisher Copyright: {\textcopyright} 2016 Elsevier Inc. All rights reserved.",
year = "2016",
month = feb,
day = "8",
doi = "10.1016/B978-0-12-801885-9.00013-5",
language = "English (US)",
isbn = "9780128018859",
pages = "217--246",
booktitle = "Ensuring National Biosecurity",
publisher = "Elsevier Inc.",
}