Optimizing the Nation's Investment in Academic Research A New Regulatory Framework for the 21st Century (2016) / Chapter Skim
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5 Regulations and Policies Related to the Conduct of Research
5 Regulations and Policies Related to the Conduct of Research
Pages 85-116
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From page 85... ...
The specific areas of consideration are conflict of interest (COI) , human subjects research, and animal subjects research.
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From page 86... ...
In the late 1990s, reports from the HHS OIG and the Government Accountability Office, among others, raised questions about the effectiveness of institutional review boards (IRBs) and how well the safety of human research subjects was being protected.
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From page 87... ...
It defined FCOIs in research, and required research institutions to implement and enforce their own COI policies. It also required institutions, whenever they discovered that a grant recipient had a conflicting financial interest, to address the problem by eliminating, mitigating, or managing the conflict.
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From page 88... ...
NSF, which had essentially adopted the 1995 PHS regulation soon after it was issued, did not adopt the new 2011 PHS regulation or revise its existing policy. NSF requires that investigators disclose all significant financial interests that "would reasonably appear to be affected by the research or educational activities funded or proposed for funding by NSF." 9 This contrasts with the PHS policy that expands disclosures to any significant financial interests that "would reasonably appear to be related to the investigator's institutional responsibilities which include: research and other scholarly activities; clinical care activities; teaching or educational activities; and administrative activities." 10 The Uniform Guidance directs all federal agencies to create COI policies and requires award recipients to disclose any potential conflicts of interest.
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From page 89... ...
. Added travel reimbursement to the calculation of the threshold for financial conflicts of interest (FCOIs)
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From page 90... ...
Task Force on Administrative Burden in 2013–2014 conducted a large qualitative survey of federally funded researchers at colleges, universities, and nonprofit institutions. 16 AAMC invited all of its member medical schools and teaching hospitals to participate in the study and collected data on institutional COI policies, the number of full-time equivalent employees who oversaw the administration of COI policies, the number of significant financial interests (SFIs)
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From page 91... ...
The NSB survey also concluded that the new regulations resulted in substantial increases in administrative burden and financial costs, but limited perceived benefit in terms of increased protections against FCOIs. 21 Together, the results of the AAMC, COGR, and NSB surveys indicate that implementation of the new 2011 PHS FCOI regulation resulted in an increase in the number of SFIs that had to be reviewed by institutions, but without a proportional increase in the number of FCOIs that warranted reporting to PHS funding 17 Lisa Nichols, NIH Request for 3-year Extension of Reporting Requirements Associated with Revised FCOI Requirements (Washington, DC: Council on Governmental Relations, An Association of Research Universities, 2015)
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From page 92... ...
The 2011 revision of the PHS FCOI regulation has resulted in increased time and cost burdens to investigators and institutions that are disproportionate to any resulting benefit to the scientific enterprise and research subjects. The 2013 Uniform Guidance, which directs all federal agencies to create COI policies, includes troublesome provisions and nonspecific language that may result in multiple COI policies across the federal government.
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From page 93... ...
can subscribe to the system to access disclosure information for specif ic investigators, in an effort to comply with the PHS COI policy. a FDP Institutional Clearinghouse, Federal Demonstration Partnership, accessed August 24, 2015, http://sites.nationalacademies.org/PGA/fdp/PGA_070596.
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From page 94... ...
Institutional policies should state that this responsibility lies with individual investigators and failure to comply is subject to sanc tions. HUMAN SUBJECTS RESEARCH Research involving human subjects that is conducted using federal funding, or that falls under the jurisdiction of the U.S.
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From page 95... ...
The Common Rule creates two layers of procedural protections for human subjects. Applicable human subjects research must be approved by an IRB before investigators are permitted to initiate research.
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From page 96... ...
29 More recent revelations of unethical federally sponsored research conducted during earlier eras, including the radiation experiments that took place during the Cold War and PHS-sponsored studies in the 1940s that deliberately exposed people in Guatemala to sexually transmitted infections without their consent, reinforce the need for oversight of human subjects research. 30,31 Over the past half century, the research enterprise has undergone dramatic changes that raise questions about whether the Common Rule and other applicable human research regulations are the most appropriate regulatory framework.
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From page 97... ...
Furthermore, HIPAA protections may be inappropriate for human subjects research, as HIPAA policies fail to align with those of the OHRP that enforces the Common Rule. 35,36,37,38 In addition, proposed changes to the Common Rule would require researchers to obtain written consent to use biospecimens, even those that have been de-identified, creating additional administrative burden without adding to the protections of human research subjects.
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From page 98... ...
Research that falls within specified categories (e.g., select research involving educational tests, surveys or interviews or research that involves preexisting data or specimens so long as researchers do not retain identifiers) is exempt from Common Rule requirements.
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From page 99... ...
45, 46 As contemplated in the Common Rule ANPRM and as recommended by the Presidential Commission for the Study of Bioethical Issues, a regulatory mandate or presumption that a single IRB serve as the IRB of record for all domestic sites, with narrow exceptions for sites with community sovereignty concerns such as those within Native American reservations, would reduce redundancy and inconsistency while enhancing efficiency of review. 47,48,49 42 "Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators," Federal Register 76, no.
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From page 100... ...
54 Currently, the Common Rule 49 Moral Science: Protecting Participants in Human Subjects Research (Washington, DC: Presidential Commission for the Study of Bioethical Issues, 2012) , http://bioethics.
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From page 101... ...
60 Respondents to the FASEB survey noted that regulations are not calibrated to the level of risk posed by a given research study and that multisite research protocols are associ 55 "Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators," Federal Register 76, no.
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From page 102... ...
Findings Federally sponsored research involving human subjects encompasses a wide range of risk to participants. The review and approval procedures specified by the Common Rule are risk stratified only to a limited extent.
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From page 103... ...
Examples might include certain categories of research involving vulnerable populations such as prisoners, re search involving sensitive information, or research involving col lection of information that might place participants at legal risk. 64 This is consistent with the 2014 NAS Committee on Revisions to the Common Rule for the Protection of Human Subjects in Research in the Behavioral and Social Sciences and the proposed changes in the 2011 Common Rule ANPRM.
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From page 104... ...
The committee's recommendation differs from the ANPRM's proposal in exempting Native American and Alaska Native sites from this requirement, given sovereignty concerns. The committee's proposal aligns with that in the 2011 report of the Presidential Commission for the Study of Bioethical Issues, (see Moral Science: Protecting Participants in Human Subjects Research (Washington, DC: Presidential Commission for the Study of Bioethical Issues, 2012, http://bioethics.gov/sites/default/ files/Moral%20Science%20June%202012.pdf)
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From page 105... ...
5.6. The committee recommends that Congress instruct HHS to work with other agencies to ensure that research involving biospecimens is eligible for a waiver or modification of informed consent, so long as the proposed research meets the conditions for waiver or modification of informed consent as specified in the Common Rule.
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From page 106... ...
Laboratory animal medicine and an understanding of husbandry needs of animals have evolved as well. There also has been an increase in the efforts by animal rights groups wishing to stop all research involving animals.
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From page 107... ...
Statutes Public Law 89-544; Animal Welfare Act; 7USC Sect 21312156; 9CFR,Ch1, Subch A, Pt 2 Public Law 99-158; Health Research Extension Act; 42USC 6A, Subch II, Pt A Section 283e and Pt H Section 289d Public Law 92-522; Marine Mammal Protection Act; 16 USC Ch 31 Public Law 102-40; VA Authorization; 38USC Pt V, Ch73, SubchI,Sect 7303 (Continued)
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From page 108... ...
Guidelines and Documentation Requirements for Research Involving Human and Animal Subjects
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From page 109... ...
Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (National Institutes of Health) Guidelines for the Care and Use of Mammals in Neuroscience and Behavior Research (National Research Council)
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From page 110... ...
Because there are so many different regulations and policies applied to animal research, there is redundancy, omission, confusion, and sometimes contradiction in the regulations of the present oversight system. Nature of Concern The research community takes its responsibility to protect the health and well-being of research animals seriously.
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From page 111... ...
In addition, the institution must report any noncompliance events as they occur, regardless of the level of significance or the impact on the health and/or safety of the research animals. NIH also requires an institutional assurance that is renewed every 4 years that describes specific aspects of the program, including IACUC functions, protocol review, occupational health, and congruency between the animal care procedures specified in grant proposals and those carried out in the laboratory setting.
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From page 112... ...
The Task Force also held a series of roundtable discussions with more than 200 faculty and administrators. Research involving animal subjects and IACUC requirements were among those that respondents associated with the greatest administrative workload.
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From page 113... ...
Government Principles and the AWA (Table 5-1) ; however, the submission of documents to the agencies assuring and reporting the status of animal oversight and 73 See Sandra Schneider, Kristen Ness, Sara Rockwell, Kelly Shaver, and Randy Brutkiewicz, 2012 Faculty Workload Survey: Research Report, (Washington, DC: Federal Demonstration Partnership, 2014)
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From page 114... ...
Additionally, as a research plan evolves, approval for modifica 75 In 2015, NSF entered into a Memorandum of Understanding with OLAW requiring grantee institutions to have an approved PHS assurance. See Office of Laboratory Animal Welfare - MOU Between NIH and NSF, available at: http://grants.nih.gov/grants/ol aw/references/mou_nsf.htm)
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From page 115... ...
RECOMMENDATIONS The committee recommends that: 5.7. Congress direct the White House Office of Science and Technology Policy to convene within one fiscal year representatives from federal agencies that fund animal research and representatives from the research community to assess and report back to Congress on the feasibility and utility of developing a unified federal approach for the development, promulgation, and management of policies and regulations pertaining to the care and use of research animals.
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From page 116... ...
6. Performing unnecessary training on topics that do not directly ben efit research animals (e.g., training on procedures irrelevant to their day-to-day activities or regulatory background that does not pertain to active protocols)
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