Senate Clears First Minibus Appropriations Bill: Expiration of CR and Report of Deficit Reduction Committee Looming

On November 1, the Senate voted 69-30 to pass S. 2112, a Minibus Appropriations bill, which included the FY 2012 Commerce, Justice, Science (CJS), Agriculture/Rural Development, and Transportation/ HUD spending bills.  

The House and Senate are now conferring in a conference committee to reconcile spending differences in the Senate Minibus legislation and the three separate bills that emerged from various stages of the House appropriations process.   Although the Agriculture/Rural Development bill had passed the House in June, CJS only made it through Committee, and the Transportation/HUD bill never got past the Subcommittee level.

(In the October 21^st issue of COSSA Washington Update, we stated that the House had not enacted any of the FY 2012 appropriations bills. That was a mistake for which we apologize. The House has passed six of the twelve spending bills.)

In passing the Minibus, the Senate rejected a whole host of amendments, none of which dealt with the National Science Foundation or the Census, two targets of past attempts to shift funding among the agencies in the CJS bill.

The House is on recess the week of November 7.  However, upon its return both Houses of Congress will need to deal with the November 18 expiration of the Continuing Resolution (CR) that has funded the government's agencies and programs since the start of FY 2012 on October 1, 2011. The expectation is that the new CR, lasting until mid-December, will become attached to the Minibus, thus leading to the likely enactment of those three spending bills and possibly more.

The House and Senate leadership are contemplating adding some other FY 2012 spending bills to this Minibus. Homeland Security and Legislative Branch are considered the two possible additions.

Furthermore, the Senate has announced a second Minibus that would include the Energy and Water, Financial Services, and State and Foreign Operations FY 2012 spending bills.

SBE Releases "Rebuilding the Mosaic" Report

After soliciting the community in August 2010 for input and suggestions and receiving over 250 papers, the National Science Foundation's Social, Behavioral and Economic Sciences (SBE) directorate has released Rebuilding the Mosaic: Fostering Research in the Social, Behavioral, and Economic Sciences at the National Science Foundation in the Next Decade. The report is available on the COSSA Web page at www.cossa.org. The 252 papers are available at: http://www.nsf.gov/sbe/sbe_2020.

Written by Myron Gutmann, Assistant Director for SBE, and Amy Friedlander, Senior Advisor in the Office of the Assistant Director of SBE, the report, according to the Executive Summary, notes:

• Interest in the social, behavioral and economic (SBE) sciences is broad, deep, and varied, reflected both in the characteristics of the researchers and in the range of the science that they pursue and believe will be possible.

• Future research will be interdisciplinary, data-intensive, and collaborative. That vision rests on thorough grounding in the core SBE sciences that continue to present important, discipline-based research and methodological challenges.

• The research community looks to NSF/SBE to provide leadership and direction in building capacity and infrastructure, most notably in interdisciplinary training (capacity-building) and infrastructure (data and facilities to support analysis, simulation, tools, and training in new research methods, including integration and synthesis across data, methods, and disciplines).

• Four major topic areas have been identified within the wealth of ideas received: population change; sources of disparities; communication, language, and linguistics; and technology, new media, and social networks.

• NSF/SBE's existing programs serve their communities well. New topics, especially multidisciplinary ones, may invite a more flexible structure within the directorate.

• NSF/SBE will continue to explore new ideas in the future, concentrating over the next five years on more focused planning activities that will: 1) strengthen the ability of the directorate to support interdisciplinary research, develop human capacities, and build out the data and organizational infrastructure; and 2) consider approaches required to shift resources to relevant priorities.

1. Investing In Basic Research - According to Collins, 52 percent of the NIH's budget goes to basic research that will not get done if it is not supported by the agency. Basic research, he reported, is flourishing, and the agency wants to motivate investigators to seek funding for this research.  
2. Accelerating Discovery Through Technology - The NIH is playing an increasing role in this area.
3. Advancing Translational Science - He noted that the translational agenda has been a part of the NIH portfolio which the agency is looking at in new ways. He pointed out that he had accepted the SMRB's recommendation to create the National Center for Advancing Translational Science (NCATS). The NIH is "energized by NCATS' potential and grateful to the SMRB for helpful and important recommendations." Responding to a question regarding the fair amount opposition to NCATS, Collins responded that as the concept and the goals have been made clear embracement of the plan has grown and there is a lot of receptivity. He recognized that there was a lot of misunderstanding initially.
4. Encouraging New Investigators And New Ideas - This theme is most important. According to Collins, supporting new investigators and new ideas is a constant source of struggle and anxiety for him.

COSSA Responds to Office of Human Research Protection Proposal to Revise the Common Rule

In July, the Office of Human Research Protection (OHRP) in the Department of Health and Human Services (HHS) issued an Advanced Notice of Proposed Rulemaking (ANPRM) to begin the process of revising the Common Rule that governs the protection of subjects in human research (see Update, July 25, 2011).   The Office sought comments from the affected research and patient communities.

On October 26, COSSA joined many other organizations in responding to the ANPRM.   A White Paper drafted by Felice Levine of the American Educational Research Association, former University of Michigan Law Professor Richard Lempert, and Paula Skedsvold of the Federation of Associations on Behavioral and Brain Research (FABBS), covered a myriad of issues raised by the notice and attempted to answer the 70 questions it posed.   The White Paper was signed by 22 organizations. Many others, including some who signed the COSSA response, sent their own documents to OHRP.

The 72 page response also includes an appendix prepared by Connie Citro, Director of the Committee on National Statistics (CNSTAT), which focuses on the recommendations from a host of reports produced by CNSTAT and the National Academies on the issue of data access, privacy, and confidentiality.

While noting that COSSA and its co-signees "strongly support the aims and ambition of this project to revise the Common Rule," there are a number of criticisms on the proposal embodied in the White Paper. At the same time, the groups expressed their pleasure "to see specific attention to SBS [Social and Behavioral Science] research and ways that it differs from biomedical research whose potential for physical harm led to the development of the Common Rule."

First, COSSA supports the recommendation to "separate informational risks from physical and psychological risk and the proposed plan to remove the evaluation of information risk from the purview of Institutional Review Boards (IRBs)."

The response calls for clarification of the definitional language in the Common Rule "to meaningfully distinguish for IRBs the difference between and the implications of the probability or likelihood that a harm of a certain type might occur and the magnitude of the harm." The White Paper cites the Social and Behavioral Sciences Working Group on Human Research Protections (which Levine chaired) of the National Human Research Protections Advisory Committee, "which called attention to the need to separately evaluate the probability of a harm and its likely severity." Since the current regulations conflate the implications of likelihood or probability of harm and the magnitude of harm, theWhite Paper argues for revision of the Common Rule's language to avert this confusion.

COSSA also supports the recommendation to separate informational risks from physical and psychological risk and the proposed plan to remove evaluation of information risk from the purview of Institutional Review Boards (IRBs).

With regard to data protection and confidentiality, the ANPRM suggested using rules set up by the Health Insurance Portability and Accountability Act (HIPAA). COSSA strongly opposes the use of HIPAA for these purposes. The White Paper argues that HIPPA's standards are unsuitable for several reasons: "HIPPA is designed to provide privacy protection for administrative health records related to specific categories of Personal Identifiable Information (PII) and has failings even as a mechanism for permitting health research consonant with privacy protection; HIPAA was not intended to identify data security and data protection mechanisms that would reduce risks of advertent or inadvertent data disclosure while allowing appropriate research use, nor is it well suited to this end; and, because HIPAA was drafted with an eye to protecting patient medical records, it is particularly ill-suited to the kinds of data security and subject protection issues that SBS researchers encounter in wide-ranging research beyond health and beyond the use of administrative records (e.g., census data)."

Rather than using HIPAA, COSSA recommends "an examination of options available for researchers, establishing data protection plans, and for oversight of those plans that are efficient, flexible, and in accord with the data being collected, and an independent study of these options drawing upon expert sources," such as the National Research Council (NRC) of the National Academies. In addition, the Rule should "exempt from further specification, review, or registration of data protection plans, research using only data derived from public use files that have been already vetted through a disclosure review board, data archives, survey/data centers, or federally approved data archives or other federally approved system of access."   At same time, the OHRP should hold researchers who seek excused status for restricted data use accountable in accord with their data security and protection plans.

 Changes to Expedited Review

COSSA supports all three areas of change (revising the criteria for expedited review, eliminating continuing routine review of expedited studies, and streamlining submission requirements) contemplated in the ANPRM.The plan to expand the research activities appropriate for expedited review and to increase the clarity of what qualifies as minimal risk is long overdue, according to the response. Specifically, COSSA: supports updating the list of research activities that qualify a study for expedited review and for periodically considering further expansion based on empirical assessment of the levels of risk; supports the default assumption that research that falls under one of the listed activities is by definition minimal risk and thus qualifies for expedited review; and appreciates that there may be a need for reviewers to be able to determine that listed research should receive full IRB review. COSSA strongly recommends that such decision should be documented and subject to auditing to avert the migration from expedited to full review.

COSSA also agrees that annual or continual review of expedited studies is not a good use of an IRB's (or a researcher's) time and strongly supports eliminating continuing review of expedited studies and a streamlined documentation for expedited studies.

In one of its strongest criticisms of current practice, COSSA emphasized that the language inviting IRBs to determine whether research procedures are "consistent with sound research design" should be stricken or modified, since they are not directly germane to human subjects' protections and are beyond the expertise of IRBs.

The ANPRM offered a new category of "excused" research that would significantly streamline the research review process. However, it was coupled with the imposition of additional regulations relating to data protection and consent policies.   COSSA expresses concern about the coupling of these two concepts.

The White Paper notes: "The introducing of an excused category for research that, apart from possible information risks involves no more than minimal risk, is attractive because it largely removes from IRBs the burden and distractions of review tasks that do little if anything to protect human subjects."

Once again, COSSA recommends an independent study by the NRC to determine: 1) what exemption should mean and means in practice; 2) the appropriateness of exempting studies of various sorts from IRB review; 3) whether or not oversight under the Common Rule is appropriate when research is exempt; and 4) what principles and procedures should be used in determining what research should be exempt.

With regard to the proposed consent rules for "excused" research, COSSA strongly advises that "any revisions to the consent rules with respect to use of preexisting data focus on the objectives of the consent process and confidentiality protections put in place and on whether researchers using existing data do so consonant with consent agreements, rather than seeking to assess on a project-by-project basis the extent to which consent sufficiently anticipates the scope of scientific uses by the initial researcher or subsequent researchers."

Informed Consent Issues

COSSA strongly recommends that a revised Common Rule should set forth what needs to be accomplished through the consent process and the alternative approaches to obtaining meaningful consent, rather than emphasizing the default of written forms as the requirement.

Specifically, the White Paper argues, consent forms should have straightforward language that satisfies the requirements for a general consent that allows for future data use. The focus should be on informational risk in the consideration of subsequent use of non-research as well as research data, COSSA declared, and "in the SBS sciences, de-identified, data even if collected for non-research reasons, are public-use data and research should proceed without further consent."

COSSA opposes the proposed extension of the federal regulations to all research in the belief that there are too many complexities involved to use the Common Rule as "the best way to achieve the protections that are desired."

For the full White Paper, including the appendix, go to:

http://www.cossa.org/advocacy/2011/SBS-White-Paper-ANPRM-10-26-11.pdf.

Ladson-Billings Delivers AERA's 2011 Brown Lecture