The Research and Science Policy Update is a monthly digest of news items related to important developments that impact biomedical researchers on a variety of issues including research funding, government oversight, and regulatory burden. In addition, reports related to research endeavors around the world and from research advisory groups are presented. The information contained in the Research and Science Policy Update is assembled by the ASIP Research and Science Policy Committee, and products of this Committee’s work (position statements, letters, white papers) will be highlighted
For more information contact:
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Common Rule for Human Research Subjects Protections
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Implementation of the
Common Rule
has been postponed for an additional 6 months; the revised rule (first announced in 2017 to go into effect January 2018 and subsequently postponed until July 2018) will now go into effect January 21, 2019. In the interim 6 months (July 19, 2018 to January 20, 2019), institutions may, but are not required to, take advantage of the following three burden-reducing rules:
- The revised definition of “research,” which deems certain activities not to be research. The revised definition will generally not be applicable to pathology research.
- The allowance for no annual continuing review of certain categories of research. This provision may be beneficial to pathology investigators.
- The elimination of the requirement that institutional review boards review grant applications or other funding proposals related to the research. This provision may be beneficial to pathology investigators.
There are potential ramifications for adopting these burden-reducing options, some of which are outlined in a recent
NIH Notice
.
The ASIP suggests that members speak with their institutional officials about potential adoption.
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The Environmental Protection Agency issued a Notice of Proposed Rulemaking (NPRM) entitled
Strengthening Transparency in Regulatory Science
with a comment deadline of August 16, 2018. The ASIP has joined 69 organizations endorsing a July 16
press release objecting to the proposed regulations.
Among the other endorsers are the
American Association for the Advancement of Science
(AAAS);
American Association for Cancer Research
(AACR);
American Medical Association
(AMA); and the
American Association of Medical Colleges
(AAMC). In addition, the
Federation of American Societies for Experimental Biology
(FASEB) - of which the ASIP is a member - released its
statement
on the Notice of Proposed Rulemaking, joining many others concerned about the proposed new rules. The ASIP Research and Science Policy Committee is currently drafting additional, in-depth comments on this NPRM.
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Return of Individual Research Results: Evans Rebuttal by Dreyfus and Sobel Now Available
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In January 2018, the
American Journal of Human Genetics
(AJHG) published a
Commentary by Evans
entitled
HIPAA’s Individual Right of Access to Genomic Data: Reconciling Safety and Civil Rights
. After discussion with the ASIP Research and Science Policy Committee, ASIP’s Science Policy Consultant Jennifer Dreyfus and Executive Officer Emeritus Mark Sobel were tasked with writing a response to the Commentary, designed to open a community-wide discussion on the merits of returning the subset of genetic results where researchers are unsure of the meaning or significance of the finding. Their
Letter to the Editor
of AJHG was published online on July 5. Also published in the same issue of AJHG was the
Evans response
to ASIP’s statement of concern. Several days later, the National Academies of Sciences, Engineering, and Medicine (NASEM) published a report from the Committee on the Return of Individual-Specific Research Results Generated in Research Laboratories (see below). The latter did not specifically address the legal interpretation of Evans’ premise, but did not endorse access to all genomic data as a civil right. We look forward to others in the biomedical research community weighing in on this discussion.
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National Academies Address Return of Individual Research Results
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The National Academies of Sciences, Engineering, and Medicine (NASEM) Committee on the Return of Individual-Specific Research Results Generated in Research Laboratories issued its recommendations entitled
Returning Individual Research Results to Participants: Guidance for a New Research Paradigm
. The document contains twelve recommendations and can be found
HERE
. Briefly, the Committee supports the return of individual research results to participants even if they are not generated in a CLIA-certified laboratory. It recommends, for non-CLIA laboratories, an intermediate quality control system (“Quality Management System” [QMS]), which would need to be developed. The Committee recommends that the National Institutes of Health be responsible for developing the QMS. According to the Report, support for releasing individual results from a non-CLIA certified laboratory increase with increasing value to the research participant and increasing feasibility of results return. Please note that the NASEM Report does not constitute regulations, but provides several recommended guidelines, including those listed below.
- All results generated by CLIA laboratory must be available to research participants except in the following situations: (a) research is currently underway and a determination has been made that research results should not be released until after completion of the research study (whereby upon completion, results will be released to research participants); or (b) as allowed under HIPAA, the research/research institution has determined that disclosure under HIPAA would disclose trade secrets or confidential commercial information by the covered entities.
- Results generated by a non-CLIA certified laboratory may be released if generated by a research laboratory with an externally accountable QMS (such an external quality management system has yet to be developed). As with the two recommendations listed below, the results may include a description of limits on test validity and interpretation.
- Results may be released with IRB approval if generated by a non-CLIA certified laboratory where that laboratory has used an alternative quality process not falling under the (yet to be developed) externally accountable QMS.
- Results generated by a non-CLIA certified laboratory that does not use a QMS or an alternative quality process, should not be released to research participants.
The above is a summary of the NASEM Report, which will be discussed in further detail at the upcoming meeting of the ASIP Research and Science Policy Committee. This summary should not be viewed as institutional policy suggestions, legal advice, or recommendations to address any specific research situation. Responsibility for addressing issues related to HIPAA, CLIA, and return of results remain within the purview of each research institution. We look forward to providing the ASIP community with updates on this important topic.
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The Scientific Research Community Addresses Sexual Harassment
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This past month has seen significant commentary on the issue of sexual harassment in the scientific research community. The National Science Foundation (NSF
)
received praise
from members of Congress on their updated sexual harassment policy. For information about the updated policy and other resources, see
NSF’s webpage
on sexual harassment.
NASEM released its report on sexual harassment in academia, entitled “
Sexual Harassment of Women: Climate, Culture, and Consequences in Academic Sciences, Engineering, and Medicine
.” The consensus study outlined the need to expand the definition of sexual harassment, proposing a variety of recommendations. Conclusions included the need for organizations to establish a diverse, inclusive and respectful environment with strong, diverse leaders promoting values of respect and civility. NASEM identified the need to expand efforts past legal compliance with Titles VII and IX and towards evidence-based, effective interventions to prevent harassment. Other recommendations included increased transparency and accountability for compliance with sexual harassment policies and behavior standards, as well as disciplinary actions related to policy infractions. Social, healthcare, legal, and career support services should be available for those targeted by sexual harassment.
NIH’s Advisory Committee to the Director discussed sexual harassment at its June meeting. The
presentation by Lawrence Tabak
, Principal Deputy Director of the NIH, cited many of the findings of the NASEM report. He notes specifically that grants are awarded to institutions, not their employees, and that awardees are responsible for their employees. Should the NIH hear of concerns with specific extramural programs, the NIH may contact institutional leadership as well as potentially renegotiate terms and conditions of awards. The NIH expects institutions to inform them of problems with a researcher, noting specifically the institutional obligation to inform the NIH of a change in the status of a program director or principal investigator. The NIH is also focused on sexual harassment concerns within the intramural program. In August 2018, NIH will be updating policies and will launch a web platform and hotline for reporting allegations.
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Update on the FY 2019 Federal Budget
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The House and Senate Appropriations Committees have each passed an FY 2019 Labor, Health, and Human Services (LHHS) bill. The Senate bill called for an increase of $2 billion for the NIH, or 5.4 percent, above FY 2018. The House bill proposed a smaller increase of $1.25 billion or 3.4%. As federal budgeting efforts continue, we will keep you apprised of reconciliation efforts. For now, we are cautiously optimistic that there will be additional funding for every institute and center, as well as increases for specific projects (e.g., BRAIN initiative, Alzheimer’s research).
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OMB Rolls Out Government Realignment Program
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The Office of Management and Budget (OMB) has issued a
Government Reform & Reorganization Plan
outlining plans to reorganize the federal government by combining several agencies and privatizing select activities. There are smaller items in the proposal that could be accomplished directly by the Executive Branch, but the vast majority will require a 60-vote congressional approval. Proposals include moving the authority over federal nutrition programs from the Department of Agriculture to the Department of Health and Human Services, which would be renamed the Department of Health and Public Welfare. The first proposal related to the NIH would modify some of NIH’s administrative functions to align “…
management with best practices and break down administrative silos through standardization of structures and processes agency-wide
.” Little detail was provided to further explain this effort. The other NIH-related proposal would integrate the following three programs under the NIH umbrella with each forming a new NIH Institute: the Agency for Healthcare Research and Quality, the National Institute for Occupational Safety and Health, and the National Institute on Disability, Independent Living, and Rehabilitation Research. Should this proposal gain traction in Congress, further updates will be provided.
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The Supreme Court issued its
ruling upholding the Trump Administration-proposed travel ban on June 26, 2018. The ASIP and FASEB continue to oppose this initiative given the detrimental impact of the travel ban on international education and conferences, as well as collaborative research.
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Next Steps on Clinical Trial Definition
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The ASIP recently shared concerns with the NIH about the
redefinition of clinical trials
.
The new definition classifies a broad set of basic research studies as clinical trials. This change was made without sufficient notification and research community consultation. In May, the ASIP joined a small group of professional societies to discuss the new definition of clinical trials and the impact on our members who are basic science researchers with Dr. Lawrence Tabak,
NIH Principal Deputy Director. Following that meeting, the NIH proposed several steps, including
delaying enforcement
of the policy for basic science studies. The NIH will issue a Request for Information about this policy, allowing a formal mechanism for groups such as the ASIP to convey concerns on behalf of our membership. In addition, late this Fall, the NIH intends to issue a basic science parent funding opportunity announcement (FOA) that may allow for additional opportunities for funding of basic scientific research that did not easily fit under an existing FOA.
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