4

Regulations and Policies Related to the Acquisition and Use of Federal Research Grants

In the next three chapters, beginning with the development of a grant proposal and proceeding to the conduct of research and the accounting for research expenditures, the committee provides an assessment of several areas where regulatory requirements and research funding processes are viewed as particularly and needlessly burdensome to the research enterprise. These include proposal preparation, progress reporting, subrecipient monitoring, conflicts of interest, human subjects research, animal research, auditing practices, reporting of compensation for personnel expenses, and aspects of the Uniform Guidance. The committee then analyzes the consequences of these requirements and offers specific findings. The focus of the current chapter is regulatory requirements related to the development and management of a federally funded research project. The specific areas of consideration are proposal preparation, progress reporting, and subrecipient monitoring.

PROPOSAL PREPARATION¹

At its core, proposal preparation is an act of scholarship, as the creation of a research proposal is fundamentally an intellectual process that provides the investigator with an occasion to articulate the importance of a particular scientific question and to offer a strategy for addressing that question. Ideally, the process provides the investigator with an opportunity to summarize relevant

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¹The discussion in this section applies primarily to grants made in support of discrete, delineated projects to be performed by the named investigator(s) in an area representing the investigator’s specific interest and competencies [“NIH Research Project Grant Program (R01),” National Institutes of Health, Office of Extramural Research, accessed August 12, 2015, http://grants.nih.gov/grants/funding/r01.htm]. These grants represent a primary source of funding for new and established investigators and form a large percentage of grants awarded by nondefense funding agencies. In agencies where there is an interest in particular deliverables (e.g., defense agencies), competitive contract proposals are commonly employed.

literature, evaluate hypotheses, and describe the scientific merits of the proposed research activity. A critically important feature of the proposal submission process—merit review—provides the agency and applicant with perspectives of other experts about the ideas, proposed research approaches, and the capacity of the applicant and his or her research group to carry out the proposed research.² Regrettably, however, a significant portion of the information that must be submitted as part of a grant proposal package has little utility when it comes to evaluating the scientific merit of proposed research or the capabilities of the research team. Proposal preparation has become, in large measure, an administrative activity that dampens scientific ferment and imposes undue burdens on the researcher, his or her institution, and those engaged in proposal review.

Often, investigators apply for grants from multiple agencies to support their research programs. Individual federal agencies generally determine the information required in grant proposals; however, in certain instances, agencies are obligated by statute³ to obtain particular information resulting in agencies having differing statutory requirements for the acquisition of information. Agencies nevertheless have a great deal of discretion regarding the information that must be submitted as part of a grant proposal package. Items selected for inclusion are often determined by agency mission. If an agency wishes to request additional proposal information, such changes require approval by the White House Office of Management and Budget (OMB) as part of its periodic review of agency forms.

Nature of Concern

Most funding agencies require that applications include responses to all of the categories of requested information on the agency’s standard grant application form.⁴ For the past decade, funding success rates at the National Institutes

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²The reviewers of a proposal are typically anonymous so as to enhance the credibility of the review process.

³For instance, the America Creating Opportunities to Meaningfully Promote Excellence in Technology, Education, and Science (America COMPETES Act) Act, H.R. 2272, 110th Congress (2007), states that the director of the National Science Foundation “shall require that all grant applications that include funding to support postdoctoral researchers include a description of the mentoring activities that will be provided for such individuals, and shall ensure that this part of the application is evaluated under the Foundation’s broader impacts merit review criterion.”

⁴Some agencies adopt a different approach. In the case of investigators who wish to engage in scientific research funded by the Department of Defense, for instance, the proposal preparation process typically involves two stages. “Prospective awardees are encouraged to submit white papers to minimize the labor and cost associated with the production of detailed full proposals that have very little chance of being selected for funding. Based on an assessment of the white papers, the responsible Research Topic Chief will provide informal feedback notification to the prospective awardees to

of Health (NIH) and the National Science Foundation (NSF), among the largest nondefense funders of scientific research, have been at historic lows,⁵ and investigators typically submit many proposals to increase their chances of receiving an award. In the particular case of NIH, the approximate number of awards made by some institutes is less than 10 percent of submitted proposals.^6,7 These discouraging results lead to a highly inefficient process where investigators submit an enormous amount of information as part of a proposal that has a very small chance of success. Assembling and providing unnecessary information adds burden for the investigator, the institution, and those who review proposals at the agencies’ behest. Furthermore, an application process may take many months to complete (see Appendix G). As a result, applicants invest an inordinate amount of time updating and revising application packages and spend correspondingly less time conducting research. The amount of administrative burden associated with proposal preparation has been well documented.⁸

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encourage or discourage submission of full proposals. The Research Topic Chief may also on occasion, provide feedback encouraging reteaming to strengthen a proposal. “If an offer is not made an investigator may still submit a full proposal. However, the initial evaluation of the white papers should give prospective awardee some indication of whether a later full proposal would likely result in an award.” See, e.g., Fiscal Year (FY) 2015 Department of Defense Multidisciplinary Research Program of the University Research Initiative (ONRFOA 14-012), p. 7, http://www.arl.army.mil/www/pages/8/MURIFY15-14-012-Amendment-0001.pdf.

⁵For NIH success rates over time, see “Table #218, Success Rates of NIH R01 Equivalent and Research Project Grants Applications, Fiscal Years 1970–2014,” National Institutes of Health, Office of Extramural Research, Office of Planning, Analysis and Communications, Division of Statistical Analysis & Reporting, 2014, accessed August 12, 2015, http://report.nih.gov/FileLink.aspx?rid=665. For NSF, see National Science Foundation, Report to the National Science Board on the National Science Foundation’s Merit Review Process Fiscal Year 2013 (NSB-14-32) (Arlington, VA, 2014), http://www.nsf.gov/pubs/2014/nsb1432/nsb1432.pdf.

⁶See “Research Project Success Rates by NIH Institute for 2014,” National Institutes of Health, Research Portfolio Online Reporting Tools (RePORT), 2014, accessed August 12, 2015, http://report.nih.gov/success_rates/Success_ByIC.cfm.

⁷The success rate for grant funding across NIH was 15.9 percent in FY 2014 [see “Research Project Success Rates by Type and Activity for 2014,” National Institutes of Health, Research Portfolio Online Reporting Tools (RePORT), 2014, accessed August 12, 2015, http://report.nih.gov/success_rates/Success_ByActivity.cfm. This figure represents all grants awarded. The percentage of Research Project (R01) grants was slightly lower at 15.4 percent] and 20 percent across NSF in FY 2014 [see National Science Foundation, Report to the National Science Board on the National Science Foundation’s Merit Review Process Fiscal Year 2013 (NSB-14-32) (Arlington, VA, 2014), 20, http://www.nsf.gov/pubs/2014/nsb1432/nsb1432.pdf.]

⁸See, e.g., National Science Foundation, Reducing Investigators’ Administrative Workload for Federally Funded Research (NSB-14-18) (Arlington, VA, 2014), http://nsf.gov/pubs/2014/nsb1418/nsb1418.pdf and Sandra Schneider, Kristen Ness, Sara Rockwell, Kelly Shaver, Randy Brutkiewicz, Federal Demonstration Partnership (FDP): 2012 Facul-

Analysis

Grant proposals typically require the submission of the following components in a format determined by the agency: detailed budgetary information, descriptions of current and pending support, evidence of researcher compliance with required training, disclosure of financial conflicts of interest, post-doctoral research management plans, data management and sharing plans, and when applicable, approvals by institutional review boards (IRBs) and institutional animal care and use committees.⁹

In most instances, granting agencies have long-term relationships with the researcher’s academic institution and are well placed to make assessments regarding organizational legitimacy for managing funds and overseeing the conduct of research absent all of the detailed information currently required in proposal packages. Research institutions frequently seek accreditation of their programs and facilities by independent accrediting bodies, maintaining, for example, accredited human research protection and animal care and use programs. In addition, institutions must have valid assurances¹⁰ on file to receive federal funding. For example, NIH requires institutions conducting animal research to have an assurance on file with the NIH Office of Laboratory Animal Welfare (OLAW) in order to receive Public Health Service funding. If the institution does not have a valid assurance, the funding agency will ask OLAW to negotiate an assurance before the grant, contract, or cooperative agreement is awarded.¹¹ Similarly, an institution must have a valid assurance whenever it engages in nonexempt human subjects research.¹² In addition, most proposals come from institutions that have biosafety committees that report to NIH as well as to local and state authorities. Such institutions must register with the government before they can apply for federal funding. All of these certifications could be relied upon to relieve funding agencies and the investigators of the needless descriptive procedures used to assure the trustworthiness of their relevant activities.

For the relatively few investigators whose grant applications are selected for funding, agencies often require updated information immediately prior to the

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ty Workload Survey Research Report (2014), 19-20, http://sites.nationalacademies.org/cs/groups/pgasite/documents/webpage/pga_087667.pdf.

⁹The NIH requirement that grant applications contain extensive animal research protocols for review by study sections, when the same materials are also reviewed by institutional review entities, highlights a burdensome redundancy.

¹⁰An assurance is a documented commitment to comply with certain institutional policies or federal requirements.

¹¹See “Office of Laboratory Animal Welfare: Obtaining Assurance,” National Institutes of Health, Office of Extramural Research, 2015, accessed August 12, 2015, http://grants.nih.gov/grants/olaw/obtain_assurance.htm.

¹²See “Frequently Asked Questions from Applicants: Human Subject Research – Assurances,” National Institutes of Health, Office of Extramural Research, 2010, accessed August 12, 2015, http://grants.nih.gov/grants/policy/hs/faqs_aps_assurances.htm#271.

time when the application receives tentative approved for funding because, as noted, 8–9 months may elapse between the submission of a grant application and the release of funds. The government understandably wants affirmation that the information previously submitted remains accurate. For agencies and programs that follow such practices, the presence of valid institutional assurances should be sufficient for the purpose of proposal review; detailed information could be submitted later for those proposals that have a reasonable prospect of being funded.

Findings

Much of the information requested by different federal funding agencies is the same. Regrettably, agencies often require the submission of the same information in dissimilar forms and formats. A relatively small portion of the required information may be agency-specific or unique, perhaps as the result of statute or regulation (e.g., the current requirement for NIH to collect information regarding financial conflicts of interest at the time of proposal submission, rather than, for example, after the completion of the merit review process).¹³ The burden associated with providing such particular additional information could be reduced or even eliminated by revisions to specific statutes, regulations, or agency policies.

Research agencies and universities have worked diligently through both the Research Business Models Subcommittee of the National Science and Technology Council and the Federal Demonstration Partnership to standardize the forms and formats involved in the grant application process. Yet, despite best efforts, formats still vary widely across agencies, leaving faculty and their institutions to track and respond to very different and burdensome requirements. The lack of harmony and standardization has also frustrated efforts to create standard datasets that can be submitted either uniformly through federal portals (e.g., Grants.gov) or through third-party providers (e.g., SciENcv or My Bibliography).

Currently, each agency application and progress report form is individually reviewed and approved by OMB’s Office of Information and Regulatory Affairs (OIRA), under the Paperwork Reduction Act (see Appendix E). Each document is reviewed on a unique cycle for a 3-year period.¹⁴ In the course of that review, the public may have an opportunity to comment on the proposed formats and information collection and on agency estimates of the burden associated with the completion of the forms. A review of the individual estimates of the

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¹³See Responsibilities of Institutions Regarding Investigator Financial Conflicts of Interest, 42 CFR 50 § 604 (e) (1) (2015), which requires “that each Investigator who is planning to participate in the PHS-funded research disclose to the Institution’s designated official(s) the Investigator’s significant financial interests (and those of the Investigator’s spouse and dependent children) no later than the time of application for PHS-funded research.”

¹⁴Or sooner as required by OMB.

time required and the costs to complete the forms indicates a wide variation in burden estimates between and among agencies. This raises questions about the accuracy of the estimates, over and above the variance due to the degree of complexity in completing the forms.¹⁵ In addition, agencies may have concurrent proposal preparation related submissions to OIRA. This makes it difficult for the public to understand the full burden of providing information to funding agencies.

A substantial increase in the use of “just-in-time” procedures could streamline the grant application process. Just-in-time (JIT) refers to information that is sent to a federal funding agency after an application package goes through initial scientific merit peer review and is deemed likely to be funded. Certain NIH programs and award mechanisms currently use JIT procedures for some information, and according to NIH, the “procedure reduces the time to award while ensuring the accuracy and timeliness of information needed to award NIH grants”¹⁶ while decreasing “the administrative burden for the 75-80 percent of the applications that will not receive funding.”¹⁷

If JIT procedures were employed for the submission of all documents that do not bear directly on the scientific merit of a proposal or provide critical assurances and biographical and budgetary information, a grant application might be reduced to the following components:

• Details on the Applying Institution
• Biosketch of Principal Investigator and Key Research Personnel
• Abstract Describing the Proposed Research
• Research Plan
• Total Estimated Budget Amount

  and

• If human subjects, animals and/or select agents are involved, the application package would demonstrate that the institution has the necessary

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¹⁵Burden estimates are split between various OMB approval numbers and are inconsistent with regard both to the estimates listed on the forms and approvals. Agencies often seem to require information collections that have not been approved by OMB. Even in instances where estimates are approved and consistent, the estimates do not seem to be related to the actual time expended by the individuals completing these forms. In addition, the burden estimates for the same forms vary widely by agency. These types of issues are not limited to grant proposal forms. Burden estimates for other required forms, for example, progress reporting forms (see Progress Reporting section of this report), exhibit similar problems.

¹⁶See Notice of Requirement for Electronic Submission of Just-in-Time Information and Related Business Process Changes Beginning April 20, 2012 (NOT-OD-12-101) (Bethesda, MD: National Institutes of Health, 2012), http://grants.nih.gov/grants/guide/notice-files/NOT-OD-12-101.html.

¹⁷See “Just-in-Time Procedures for First and Career Awards,” NIH Guide 25, no. 10 (1996), http://grants.nih.gov/grants/guide/notice-files/not96-081.html.

Additional researcher and key personnel information [e.g., references, complete curriculum vitae (CV), lists of all publications] could ideally be accessed through a unified, online, third-party database via a unique researcher identifier. A model for such a database exists in the form of ORCID, an open, nonprofit, community-driven effort to create and maintain a registry of unique researcher identifiers that transparently links research activities and outputs to the researcher identifier.¹⁸

Investigators’ biosketch information is routinely collected by agencies, and much of that collected information is identical across funding agencies. For example, NIH, NSF, Department of Defense, and U.S. Department of Agriculture biosketch forms all require the following information: (1) name and address/contact information; (2) professional/employment history; (3) professional activities and/or honors/awards; and (4) relevant publications.¹⁹ Yet, despite the uniformity of the information required, such information must be entered into forms and in formats unique to each agency.²⁰ The NIH biosketch form also requires a personal statement and a statement regarding how the proposed research contributes to science. While this information is certainly relevant, there is no reason why it should be included as part of a biosketch when it is provided in the component of the application that details the scientific merit of the project (e.g., as part of an abstract) rather than in the revised format that adds substantial investigator burden.

Although agencies have moved towards use of online databases²¹ for the collection of data, they make use of diverse databases. In addition, the infor-

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¹⁸See “ORCID,” ORCID, Inc., accessed August 12, 2015, http://orcid.org/.

¹⁹In January 2015, NIH introduced a new biosketch form (see Biographical Sketch (OMB No. 0925-0001/0002) (Bethesda, MD: National Institutes of Health, 2015) http://grants.nih.gov/grants/funding/424/SF424R-R_biosketchsample_VerC.docx) that substitutes a “Contribution to Science” section for the “Selected Peer-reviewed Publications” section that was part of the earlier formulation. The Contribution to Science section asks applicants to “describe up to five of your most significant contributions to science,” and to for each contribution, to “indicate the historical background that frames the scientific problem; the central finding(s); the influence of the finding(s) on the progress of science or the application of those finding(s) to health or technology; and your specific role in the described work.” The Selected Peer-Reviewed Publications section had asked applicants to list selected publications “based on importance to the field, and/or relevance to the proposed research.”

²⁰In addition, websites used to collect application information vary from agency to agency, and grant applicants applying to multiple agencies must become familiar with the idiosyncrasies of the various interfaces.

²¹The most recent version of the NIH biosketch form, for instance, asks investigators to “provide a URL to a full list of your published work as found in a publicly available

mation contained within these databases may be inaccurate or outdated, which means the investigator may need to invest significant time and effort to make certain that the information in multiple databases is corrected and/or up to date.²² Furthermore, the information in current databases is generally limited to biological sciences, and this presents challenges for investigators in other disciplines, such as the physical and computing sciences. Moreover, at a time when science is increasingly collaborative and interdisciplinary, use of multiple diverse databases creates difficulties with research proposals that involve researchers from diverse disciplines. Additionally, in some cases, agency funding restrictions preclude administrative staff from assisting with data entry and management and administrative tasks are shifted to faculty and investigators.

When a proposal is deemed likely to be funded, the investigator and his or her institution could be asked to provide any additional documentation just in time. Such documents could include human institutional assurances with protocol numbers and IRB approval, animal institutional assurances with protocol numbers, select agent approval, conflict-of-interest disclosures, detailed budgets, resource requirements (with the exception of specialized equipment necessary to conduct the research), and so forth.

Agencies funding research designed to provide specific deliverables should employ a contract mechanism or cooperative agreement rather than a research award mechanism.

RECOMMENDATIONS

4.1. The committee recommends that Congress, in concert with the White House Office of Management and Budget, conduct a transparent and comprehensive review of agency research grant proposal documents for the purpose of developing a uniform format to be used by all research funding agencies.

• Information collection and formats should be simplified and standardized to take advantage of both federal and third-party portals for submission of information across federal funding agencies.
• In instances where requested information beyond the common standard is deemed as bearing directly on an agency’s particular mission, the agency should be required to provide legitimate and credible justification for the collection of such information.

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digital database such as SciENcv or My Bibliography” (See Biographical Sketch (OMB No. 0925-0001/0002) (Bethesda, MD: National Institutes of Health, 2015), http://grants.nih.gov/grants/funding/424/SF424R-R_biosketchsample_VerC.docx).

²²All NIH grantees must list all their publications in PubMed (a full-text archive of biomedical and life sciences journal literature at NIH’s National Library of Medicine).

• Agency-specific information collections should be restricted to a minimal portion of the material contained in an application package.

4.2. The committee recommends that research proposal information should be limited to the minimal information necessary to permit peer evaluation of the merit of the scientific questions being asked, the feasibility of answering those questions, and the ability of the researcher/research team to carry out that research. For proposals demonstrating these characteristics, any supplementary information should, if requested, be provided just-in-time.²³

• Materials provided as part of an initial proposal should be limited to the following:
  1. Details on the Applying Institution and Research Team.
  2. Biosketch of Principal Investigator and other Key Personnel. The information in a biosketch should be limited to
     1. Name and address/contact information;
     2. Professional/employment history;
     3. Professional activities; and
     4. Relevant publications.
  3. Abstract Describing the Proposed Research.
  4. Research Plan.
  5. Total Estimated Budget Amount.
  6. If humans, animals and/or select agents are involved, the application package should demonstrate that the institution has the necessary federal assurance to conduct the research and will provide appropriate institutional approval protocol numbers before funding takes place.

4.3. The committee recommends that research agencies develop a central repository to house assurances similar to the Single Audit Clearinghouse of the Federal Demonstration Partnership (FDP).

4.4. The committee recommends that Congress task a single agency with overseeing and unifying efforts to develop a central database of investigator information.

• Each investigator should be assigned a unique identifier linked to the database and accessible to all federal funding agencies.
• In order to assure the currency of information in the database, information in the database should be maintained by individual investigators.

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²³That is, sent to a sponsor after a proposal package goes through initial peer review and is deemed likely to be funded.

• The database should include each investigator’s relevant personally identifiable information,²⁴ CV, and a list of the investigator’s publications or links to a third-party site listing the investigator’s publications.

PROGRESS REPORTS

Recipients of federal grants “are responsible for managing and monitoring each project, program, subaward, function or activity supported by the award.”²⁵ For each award, when required, performance reports are to be submitted to the awarding agency. Performance reporting requirements are specified in OMB Circular A-110 “Monitoring and Reporting Program Performance”²⁶ and the Common Rule implementing OMB Circular A-102. OMB Circular A-110 states that reports “shall generally contain, for each award, brief information on each of the following: (1) A comparison of actual accomplishments with the goals and objectives established for the period, the findings of the investigator, or both. Whenever appropriate and the output of programs or projects can be readily quantified, such quantitative data should be related to cost data for computation of unit costs; (2) Reasons why established goals were not met, if appropriate; (3) Other pertinent information including, when appropriate, analysis and explanation of cost overruns or high unit costs.”²⁷ Awarding agencies prescribe the frequency with which the performance reports must be submitted.²⁸

Recognizing that there was “inconsistency in interim research progress reporting among federal agencies,” that interdisciplinary and interagency research is increasingly complex, and that “unnecessary variations” in progress reporting requirements “contribute to administrative burdens, take research time from investigators, and increase associated costs involved in the management of research programs, the Research Business Models Subcommittee of the Committee on Science launched an initiative that resulted in the creation of a “uniform Research Performance Progress Report (RPPR) format for use by agencies and awarding offices that support research and research-related activities.”²⁹

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²⁴But not social security numbers or financial information. In establishing such a database, it will be important to ensure that all privacy concerns relating to the collection and amalgamation of any other personally sensitive information are recognized and addressed.

²⁵See Monitoring and Reporting Program Performance, 2 CFR 2 § 215.51(a) (2010).

²⁶See Monitoring and Reporting Program Performance, 2 CFR 2 § 215.51 (2010).

²⁷See Monitoring and Reporting Program Performance, 2 CFR 2 § 215.51(d) (2010).

²⁸See Monitoring and Reporting Program Performance, 2 CFR 2 § 215.51(b) (2010).

²⁹Peter R. Orszag and John P. Holdren (2010) Policy on Research Performance Progress Report (RPPR) [Memorandum]. Washington, DC: The White House, http://www.nsf.gov/bfa/dias/policy/rppr/policyletter.pdf.

The RPPR is to be used by agencies that fund research for the collection of reports submitted by grantees for annual or other interim performance reporting on grants and cooperative agreement awards. The RPPR was expected to replace other performance-reporting formats currently in use by agencies funding research to address progress for the most recently completed period, at the frequency required or designated by the agency. Each category in the RPPR is a separate reporting component that must be filed independently.³⁰

In general, information regarding project financial expenditures is provided by recipient institutions as separate reports generated by institutional payment management systems (e.g., the weekly, monthly, or quarterly cash transaction report, and annual and end-of-project financial reports) as required by the terms of the award.

Nature of Concern

While the intent of the RPPR was and is to harmonize progress reporting, funding agencies have the latitude to use the RPPR to collect unneeded information, undermining its objective. They may, for instance, use optional components of the RPPR format to request additional information³¹ and provide additional program-specific instructions necessary to clarify a requirement for a particular program. Agencies may also develop additional agency- or program-specific reporting components³² and use other reporting formats, such as the Performance Progress Report, if those formats are better suited to the agency’s reporting requirements, for example, for research centers and institutes, clinical

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³⁰The RPPR format was implemented under 2 CFR Part 215 [OMB Circular A-110, Uniform Administrative Requirements for Grants and Agreements with Institutions of Higher Education, Hospitals, and Other Non-Profit Organizations (2012)] and the Grants Management Common Rule implementing OMB Circular A-102, Grants and Cooperative Agreements with State and Local Governments (published 1994, amended 1997). See Peter R. Orszag and John P. Holdren (2010) Policy on Research Performance Progress Report (RPPR) [Memorandum]. Washington, DC: The White House, http://www.nsf.gov/bfa/dias/policy/rppr/policyletter.pdf.

³¹“Within a particular component, agencies should direct recipients to complete only those questions that are relevant to the award or agency.” See “Final Format: Research Performance Progress Report,” National Science Foundation, 2010, p.1. Accessed August 12, 2015, https://www.nsf.gov/bfa/dias/policy/rppr/format_ombostp.pdf.

³²“However, to maintain maximum uniformity, agencies are to minimize the degree to which they supplement the standard categories. Such agency- or program-specific requirements require additional OMB review and clearance under the Paperwork Reduction Act.” See “Final Format: Research Performance Progress Report,” National Science Foundation, 2010, accessed August 12, 2015, https://www.nsf.gov/bfa/dias/policy/rppr/format_ombostp.pdf.

trials, or fellowship and training awards or in connection to reporting on program performance.³³

Analysis

Most federal funders of scientific research have implemented or are in the process of adopting the RPPR to collect progress report data on all federally funded research and research-related awards.³⁴

Standard cover page data elements, as well as mandatory and optional components, comprise the complete RPPR format.³⁵ If an agency elects to collect the complete suite of data for all mandatory and optional components, the information collected may be considerable.

For the cover page alone, the elements are as follows:

• Federal Agency and Organization Element to Which Report is Submitted
• Federal Grant or Other Identifying Number Assigned by Agency
• Project Title
• Program Director/Principal Investigator Name, Title and Contact Information (e-mail address and phone number)
• Name of Submitting Official, Title, and Contact Information (e-mail address and phone number), if other than Program Director/Principal Investigator
• Submission Date
• DUNS³⁶ and EIN³⁷ Numbers
• Recipient Organization (Name and Address)

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³³See Peter R. Orszag and John P. Holdren (2010) Policy on Research Performance Progress Report (RPPR) [Memorandum]. Washington, DC: The White House, http://www.nsf.gov/bfa/dias/policy/rppr/policyletter.pdf.

³⁴The Department of Energy, for example, implemented the Research Performance Progress Report format on November 22, 2010. While all Department of Defense components awarding grants and cooperative agreements for research activities are subject to the implementation of the RPPR, it is not clear that the RPPR is used uniformly by the Department of Defense. At NIH, the RPPR has replaced all interim performance reports used by grantees to report on research and research-related activities. The Department of Homeland Security continues to work with the DHS Component program and awarding offices that administer research awards and intends to implement the RPPR no later than the end of fiscal year 2016. Information on agency implementation plans may be found at “Research Performance Progress Report (RPPR),” National Science Foundation, accessed August 12, 2015, http://www.nsf.gov/bfa/dias/policy/rppr/.

³⁵See “Final Format: Research Performance Progress Report,” National Science Foundation, 2010, accessed August 12, 2015, https://www.nsf.gov/bfa/dias/policy/rppr/format_ombostp.pdf.

³⁶Data Universal Numbering System. A DUNS number is a unique nine-digit identification number that identifies business entities on a location-specific basis.

• Recipient Identifying Number or Account Number, if any
• Project/Grant Period (Start Date, End Date)
• Reporting Period End Date
• Report Term or Frequency (annual, semiannual, quarterly, other)
• Signature of Submitting Official (signature shall be submitted in accordance with agency specific instructions)³⁸

In addition to cover page information, the only mandatory reporting component is “Accomplishments.” The information provided in this section allows the agency to assess whether satisfactory progress has been made during the reporting period. Respondents are responsible for answering the following questions:

• What are the major goals and objectives of the project?
• What was accomplished under these goals?
• What opportunities for training and professional development has the project provided?
• How have the results been disseminated to communities of interest?
• What do you plan to do during the next reporting period to accomplish the goals and objectives?³⁹

Optional reporting components of the RPPR are (1) Products (designed to enable agencies to evaluate what the project-related publications demonstrate about the excellence and significance of the research and the efficacy with which the results are being communicated to colleagues, potential users, and the public); (2) Participants and Other Collaborating Organizations (designed to inform agencies regarding who has worked on the project to gauge and report performance in promoting partnerships and collaborations); (3) Impact (designed to assess how knowledge, techniques, people, and infrastructure are drawn upon again and again for application to commercial technology and the economy, to health and safety, to cost-efficient environmental protection, to the solution of social problems, to numerous other aspects of the public welfare, and to other fields of endeavor); (4) Changes [for instances where changes were not previously reported in writing, the section allows the investigator to provide the following additional information, if applicable: (a) changes in approach and reasons for change, (b) actual or anticipated problems or delays and actions or plans

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³⁷Employer Identification Number. An EIN number is also known as a Federal Tax Identification Number. It is used to identify a business entity.

³⁸See “Final Format: Research Performance Progress Report,” National Science Foundation, 2010, accessed August 12, 2015, https://www.nsf.gov/bfa/dias/policy/rppr/format_ombostp.pdf.

³⁹Ibid.

to resolve them, (c) changes that have a significant impact on expenditures, (d) significant changes in use or care of animals, human subjects, and/or biohazards]; (5) Self Reporting Requirements (allowing investigators to respond to any special reporting requirements specified in the award terms and conditions, as well as any award-specific reporting requirements); and (6) Budgetary Information (used to collect budgetary data from the recipient organization for use in the conduct of periodic administrative and budgetary reviews).⁴⁰

NIH requires grant recipients to provide information for all six “optional” sections. In many cases, such as the “Products” (publications) section, the information required of respondents is extensive. The amount of information collected by other agencies is significantly less (see Box 4-1).

Findings

The RPPR requires more work than previous progress reports, and each section of the report must be uploaded independently. The frequency with which reports are required may interrupt research productivity and discourage research on difficult, long-term problems. In addition, at the early phase of a grant period, there is little tangible output (e.g., publications) to provide metrics for assessing investigator progress.

The purpose of progress reporting is to demonstrate to the funding agency that the research is progressing. While a standard interagency RPPR is desirable, the reality is that there is a great deal of flexibility with regard to agency implementation of the RPPR, as agencies selectively request that grantees include or exclude data from the common dataset encapsulated by the RPPR. Additional

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⁴⁰Ibid. On July 23, 2015, the National Science Foundation issued a request for public comment on a proposed update to the RPPR. Proposed changes include the use of “one report format for both interim and final reports” and the addition of a seventh optional report category: “Project Outcomes: What were the outcomes of the award?” According to the draft format for the proposed updated RPPR, “This component is used to provide information regarding the cumulative outcomes or findings of the project.” Those completing this section would be required, for the final project RPPR, to “provide a concise summary of the outcomes or findings of the award (no more than 8,000 characters) that:

• is written for the general public in clear, concise, and comprehensible language;
• is suitable for dissemination to the general public, as the information may be available electronically;
• does not include proprietary, confidential information or trade secrets; and
• includes up to six images (images are optional).”

See “Components and Significant Changes,” National Science Foundation, accessed August 12, 2015, http://nsf.gov/bfa/dias/policy/rppr/frppr_sigchanges.pdf, and “Draft Format For Use in Submission of Interim and Final Research Performance Progress Reports,” National Science Foundation, accessed August 12, 2015, http://nsf.gov/bfa/dias/policy/rppr/frpprformat_fedreg.pdf.

award-specific requirements can be added, and multiple systems can (and are) used for RPPR submission. Unfortunately, the ease of electronic data collection may have inadvertently stimulated overzealous agency information collection.

In addition, by asking pointed questions regarding the direction research is taking or has taken, funding agencies may affect the course of scientific discovery, as investigators may feel the need to adhere strictly to the goals of the proposal rather than pursue promising avenues of inquiry as they appear. An investigator may feel safer reporting that the major goals and objectives of the project have not changed rather than providing an explanation for new directions given uncertainties as to how deviations from stated objectives might be viewed by the funder. Agencies with a focus on discovery-based science, such as NIH, or other agencies seeking to support discovery science should make it clear that investigators have the latitude to explore diverse avenues of research if promising leads emerge during the course of research.

RECOMMENDATION

4.5. The committee recommends that the White House Office of Management and Budget require that research funding agencies use a uniform format for research progress reporting.

• All investigator progress reports should be limited to performance outcomes, submitted no more frequently than annually, and commensurate with both the size of the award and use made of the report by the recipient agency.
• Requests for additional data should be restricted to information that is essential for the assessment of compliance and performance.
• If additional information is to be requested, agencies must provide legitimate and credible justification for the collection of such information.

SUBRECIPIENT MONITORING

A subrecipient relationship exists when an institution, as a pass-through entity, disburses funds from a federal award to another entity for the performance of a portion of the work or to accomplish certain objectives specified in the award.⁴¹ Institution A, wishing to collaborate on a research project with Institution B, might, for example, enter into an agreement with Institution B wherein Institution A disburses funds from a federal grant to pay researchers at Institution B to perform a certain task. Organizations acting as pass-through entities (in the above example, Institution A) are tasked with monitoring the programmatic and financial activities of subrecipients (Institution B in the above example) so as to ensure proper stewardship of federal funds. Organizations are further charged, in addition to achieving performance goals, with ensuring that subrecipients are in compliance with federal laws and regulations and with provisions of agreements that govern the subaward.

Subrecipient relationships at research institutions occur frequently as researchers from one institution collaborate with researchers at another. In such cases, a research institution receiving the initial (or prime) award from a federal research agency issues a subaward for that portion of the research activity that will be carried out at another institution. Such collaborations may occur for a variety of purposes (e.g., to obtain additional scientific expertise or resources, to incorporate a specialized methodology, to build multi-institutional teams, to enhance patient recruitment for clinical studies). Historically, if a subrecipient was a research institution, the pass-through entity was responsible for oversight of the work performed by the subrecipient, and the subrecipient institution was responsible for other aspects of its institutional conduct (e.g., business practices, investigator conduct, research subject participant protections).

Subrecipient monitoring requirements are found in the Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards, hereafter the Uniform Guidance.⁴² The Uniform Guidance (see Box 4-2) is cur-

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⁴¹A subrecipient “is an entity that expends awards received from a pass-through entity to carry out a project.” A “pass-through entity means a non-Federal entity that provides a subaward to a subrecipient to carry out part of a Federal program.” See Pass-Through Entity, 2 CFR 2 § 200.74 (2014).

⁴²These requirements originated in the Single Audit Act of 1984. This act standardized audit requirements for states, local governments, and Indian tribal governments receiving and using federal financial assistance. It provides audit requirements to ensure that federal grants to nonfederal entities “are expended properly.” “A single audit is intended to provide a cost-effective audit for non-Federal entities in that one audit is conducted in lieu of multiple audits of individual programs.” See “Office of Federal Financial Management Single Audit,” The White House, Office of Federal Financial Management Single Audit, accessed September 9, 2015, https://www.whitehouse.gov/omb/financial_fin_single_audit. In 1985, the United States Office of Management and Budget (OMB) issued OMB Circular A-128 (Audits of State and Local Governments) to assist with the implementation of the

rently the principal document governing the administrative, financial management, and audit requirements for federal awards.

Nature of the Concern

The Uniform Guidance⁴³ specifies two kinds of responsibilities for pass-through entities when making subawards to other organizations. The first set of responsibilities involves providing administrative information to ensure that every subaward is clearly identified to the subrecipient as a subaward.⁴⁴ The requirements of this section are relatively clear and limited in scope to the specific subaward.

The second set of requirements⁴⁵ is significantly more burdensome. These requirements intermix responsibilities that may be viewed as appropriate and limited to the performance of a specific subaward with provisions that may be viewed as putting the pass-through entity in a position to review the subrecipient’s business systems and standing in the context of federal audit requirements. The following examples are requirements that, if misapplied or misinterpreted, put the pass-through entity in an untenable position:

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new single audit, and in 1990, administratively extended the Single Audit process to nonprofit organizations with the issuance of OMB Circular A-133 (Audits of States, Local Governments and Non-Profit Organizations). These changes were subsequently incurporated into the Single Audit Act Amendments of 1996.

⁴³Requirements for Pass-Through Entities, 2 CFR 2 § 200.331 (a) (2014).

⁴⁴Required information includes: “(1) Federal award identification…; (2) All requirements imposed by the pass-through entity on the subrecipient so that the Federal award is used in accordance with Federal statutes, regulations and the terms and conditions of the Federal award; (3) Any additional requirements that the pass-through entity imposes on the subrecipient in order for the pass-through entity to meet its own responsibility to the Federal awarding agency including identification of any required financial and performance reports; (4) An approved federally recognized indirect cost rate negotiated between the subrecipient and the Federal government or, if no such rate exists, either a rate negotiated between the pass-through entity and the subrecipient…or a de minimis indirect cost rate…; (5) A requirement that the subrecipient permit the pass-through entity and auditors to have access to the subrecipient’s records and financial statements as necessary for the pass-through entity to meet the requirements of this […section]; (6) Appropriate terms and conditions concerning closeout of the subaward.” See Requirements for Pass-Through Entities, 2 CFR § 2.200.331 (2014).

⁴⁵These are delineated in Requirements for Pass-Through Entities, 2 CFR 2 § 200.331 (b–h) (2014).

1. the results of previous audits;
2. whether the subrecipient has new personnel or new or substantially changed systems; and

3. the extent and results of Federal awarding agency monitoring (e.g., if the subrecipient also receives Federal awards directly from a Federal awarding agency).

1. verify that every subrecipient is audited as required by Subpart F [of the Uniform Guidance] – Audit Requirements;⁴⁶
2. consider whether the results of the subrecipient’s audits…or other monitoring indicate conditions that necessitate adjustments to the pass-through entity’s own records; and
3. consider taking enforcement action against noncompliant subrecipients.^47,48

If these requirements are interpreted literally, they require institutions to evaluate subrecipients’ compliance with all federal statues without qualification. ⁴⁹

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⁴⁶Audit Requirements, 2 CFR § 200.501 (f) (2014), “sets forth standards for obtaining consistency and uniformity among Federal agencies for the audit of non-Federal entities expending Federal awards.” For example, “a non-Federal entity that expends $750,000 or more during the non-Federal entity’s fiscal year in Federal awards must have a single or program-specific audit conducted for that year” [2 CFR 2 § 200.501(a) (2014)] and “a non-Federal entity that expends less than $750,000 during the non-Federal entity’s fiscal year in Federal awards is exempt from Federal audit requirements for that year, except…in...relation to other audit requirements [Audit Requirements, 2 CFR § 200.501 (d) (2014)].

⁴⁷If “a pass-through entity determines that noncompliance cannot be remedied by imposing additional conditions, the…pass-through entity may…

(a) Temporarily withhold cash payments pending correction of the deficiency by the non-Federal entity or more severe enforcement action by the Federal awarding agency or pass-through entity.

(b) Disallow (that is, deny both use of funds and any applicable matching credit for) all or part of the cost of the activity or action not in compliance.

(c) Wholly or partly suspend or terminate the Federal award.

(d) Recommend that [suspension or debarment] proceeding[s] be initiated by a Federal awarding agency.

(e) Withhold further Federal awards for the project or program.

(f) Take other remedies that may be legally available.” See Remedies for Noncompliance, 2 CFR § 200.338 (2014).

⁴⁸The complete list appears at Audit Requirements, 2 CFR § 200.501 (b-h) (2014).

⁴⁹The expansion of subrecipient monitoring is not limited to financial practices. For instance, with regard to the use of animals in research performed by a subrecipient, a previous NIH grants policy statement stated that the prime institution “must ensure that all

The ambiguity of the requirements is at odds with the intent of the Single Audit Act and inappropriately transfers what is essentially the federal responsibility of auditing institutional compliance from the government to research institutions. Research institutions are not equipped to meet this requirement.

Analysis

Requirements for subrecipient monitoring were originally enacted to monitor state governments receiving large federal block grants. Such assistance programs were and continue to be very large,⁵⁰ and subawards are disbursed to multiple subrecipients of varying size, sophistication, and organizational experience. Funds generally flow down from the state in a “one-to-many” relationship to agencies and to local and nonprofit organizations within the state. Often, pro-

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sites engaged in research involving the use of live, vertebrate animals have an appropriate animal welfare assurance.” (See “Administrative and Other Requirements,” NIH Grants Policy Statement, December 1, 2003, p. 226, http://grants.nih.gov/archive/grants/policy/nihgps_2003/nihgps_2003.pdf). The 2015 NIH Grants Policy Statement is more prescriptive and states that the primary recipient is responsible for including in its agreements with collaborating organizations requirements of accountability for the performance of the project and the appropriate expenditure of grant funds by all parties (as well as other specified obligations) and for ensuring that all sites engaged in research involving the use of live vertebrate animals have an approved animal welfare assurance and that the activity has valid IACUC approval.” (See NIH Grants Policy Statement (Washington, DC: U.S. Department of Health and Human Services, Bethesda, MD: National Institutes of Health, 2015), IIA-13, http://grants.nih.gov/grants/policy/nihgps/nihgps.pdf). Similar language exists with respect to the monitoring of subrecipient human subject research: “In accepting an award that supports human subjects research, the recipient institution assumes responsibility for all research conducted under the award, including protection of human subjects at all participating and consortium sites, and for ensuring that an FWA and certification of IRB review and approval exists for each site before human subjects research may begin.” (See NIH Grants Policy Statement (Washington, DC: U.S. Department of Health and Human Services, Bethesda, MD: National Institutes of Health, 2015), IIA-27, http://grants.nih.gov/grants/policy/nihgps/nihgps.pdf). In both examples, the implication is that prime recipients are responsible for monitoring subrecipient institutions for any noncompliance.

⁵⁰The Congressional Research Service identified 23 block grant programs for FY 2014 with budgets totaling $50,843,354,662 [Robert J. Dilger and Eugene Boyd, Block Grants: Perspectives and Controversies (CRS Report No. R40486) (Washington, DC: Congressional Research Service, 2014), https://fas.org/sgp/crs/misc/R40486.pdf.] FY 2015 allocations to states for one such program—Social Services Block Grants (SSBG)—totaled $1,575,246,254, and allocations to individual states ranged from $2,888,318 (Wyoming) to $190,019,689 (California). See “Fiscal Year 2015 SSBG Allocations,” Administration for Children and Families and U.S. Department of Health and Human Services, 2015, accessed August 24, 2015, http://www.acf.hhs.gov/sites/default/files/ocs/ssbg_fy2015_3rd_quarter_allocations_0.pdf.

posals are received and funds awarded only once or a few times a year. State organizations are frequently in a hierarchical relationship with subrecipient organizations, and accordingly in a position to conduct subrecipient monitoring, including with regard to the ability to make determinations of competency and to take action against noncompliant subrecipients. What may be appropriate for state agencies when monitoring the expenditure of federal funds in the context of a generally hierarchal relationship is not appropriate for research institutions when managing research awards, 80 percent of which are awarded to 100 institutions.⁵¹

While the extension of subrecipient monitoring requirements to research institutions may have, at one time, seemed logical and commonsensible, subrecipient relationships among research institutions differ fundamentally from those between states and constituent organizations. Researchers engage in collaborative research activities with many institutions, and such collaboration has only increased as science has become increasingly interdisciplinary, interinstitutional, and team based. Relationships are more typically “many to many,” and the funds for such collaborations may be received from multiple funding agencies and awarded throughout the year. Further, one institution may be both a “prime” recipient of multiple grants from federal research agencies and simultaneously a “subrecipient” collaborating on many research projects. Given that the vast majority of federally funded research takes place within the top 100 institutions that receive such funding, this means that the majority of subrecipient activity takes place between and among peer institutions that are subject to the same single audit requirements.⁵² In fact, in FY 2013, research institutions reported awarding approximately $5.7 billion in grants as prime recipients⁵³ and receiving about $6.6 billion as subrecipients.⁵⁴ These peer research institutions are placed in an unsupportable position when providing appropriate oversight of the compliance of subrecipients with federal statutes, regulations, and financial accounting systems.

Implementation of the Uniform Guidance creates a chaotic situation wherein universities and research institutions are potentially required to review one another’s business practices (e.g., procurement, property management). Yale

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⁵¹“Higher Education Research and Development Survey, Fiscal Year 2013: Table 21 Ranked by all Federal R&D expenditures, by R&D field: FY 2013,” National Science Foundation, 2013, accessed August 24, 2015, http://ncsesdata.nsf.gov/herd/2013/.

⁵²Ibid.

⁵³“Higher Education Research and Development Survey, Fiscal Year 2013: Table 71 Total and Federally Financed, by Highest Degree Granted and Institutional Control, Passed through to Subrecipients,” National Science Foundation, 2013, accessed August 24, 2015, http://ncsesdata.nsf.gov/herd/2013/.

⁵⁴“Higher Education Research and Development Survey, Fiscal Year 2013: Table 70 Total and Federally Financed, by Highest Degree Granted and Institutional Control, Received as a Subrecipient,” National Science Foundation, 2013, accessed August 24, 2015, http://ncsesdata.nsf.gov/herd/2013/.

University reports, for example, that it served as a prime recipient and issued approximately 750 new and modified subawards in FY 2014 to approximately 250 different institutions. The university was a subrecipient on approximately 1,100 subawards from approximately 295 unique, prime organizations during FY 2014–2015 to date (federal awards only).⁵⁵ These numbers provide some indication of the enormity of the task that falls upon institutions as they comply with the subrecipient monitoring requirements mandated by the Uniform Guidance.

In a recent survey by the Council on Governmental Relations, 51 institutions reported engaging in approximately 12,000 subawards, an average of 235 subawards per institution. These institutions reported that it takes on average 2.8 FTEs⁵⁶ to manage this level of subrecipient activity at an estimated total cost of over $7.5 million dollars independent of the time investment by faculty or departmental level staff.⁵⁷

Further, in addition to the administrative burden that increased subrecipient monitoring imposes on research entities, institutions serving as partners in research will inevitably face conflicts by virtue of their position as both overseers and collaborators.

Findings

One of the purposes of the Single Audit Act was to reduce burdens on nonprofit organizations by promoting sound financial management of federal awards “administered by non-Federal entities.” Research institutions are not administering federal awards per se. Rather, they are collaborating in scientific research supported largely by grants or other funding mechanisms.

The new Uniform Guidance, rather than reducing regulatory burden, has increased the prescriptiveness of subrecipient monitoring, and placed institutions in a position of reviewing one another’s audit standing and the compliance of their organizational business systems without evidence that the new guidelines will reduce the risk of fraud, waste, or abuse.

Research institutions judiciously engage in ad hoc institutional risk assessment and oversight, particularly with new recipients under the authority of the Uniform Guidance, ⁵⁸ that allows the prime recipient to impose specific terms and conditions for the management of subawards in order to meet the require-

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⁵⁵Staff of the Office of Sponsored Projects, Yale University, Personal Communication to Committee Member Geoff Grant, President, Research Advocates, July 30, 2015.

⁵⁶Full-time Equivalent. The number of total hours worked divided by the maximum number of compensable hours in a full-time schedule as defined by law. An FTE of 1.0 is equivalent to a full-time worker or student.

⁵⁷“Initial Findings and Recommendations of the AAU-COGR-Yale Review of Compliance Costs,” (Presentation, Council on Governmental Relations, June 4-5 2015).

⁵⁸See Requirements for Pass-Through Entities, 2 CFR 2 § 200.331 (2014).

ments of the federal award (including ensuring access, as necessary, to the subrecipient’s records and financial statements). However, this form of oversight appropriately focuses on project-specific requirements, that is, financial monitoring, supervision of the terms on the award, and so forth. This oversight does not require that institutions engage in inappropriate reviews of other institutions’ business systems.

Institutions also engage in substantial oversight of the “programmatic” aspects of subrecipient agreements in accordance with the Uniform Guidance,⁵⁹ most importantly by reviewing scientific progress and managing other essential programmatic terms and conditions. These terms often address the use of scientific data developed in the course of the agreement; the potential transfer of research materials developed during the project; specific issues with respect to the conduct of overseas activity, if any, and so forth. To this end, research institutions and research funding agencies have successfully worked together for years through FDP to refine standard subagreement terms and conditions that address essential programmatic issues in a substantive yet streamlined fashion. While these issues represent a significant burden for faculty and administrators to negotiate at the time of the agreement, they are far more germane to the process of monitoring subrecipient conduct than the prescriptive, institutional monitoring requirements imposed on research institutions by the Uniform Guidance.

It is crucial to clarify the role of research institutions with respect to subrecipient monitoring as stewards of federally sponsored projects, both programmatically and financially. Recipient institutions monitor and review the programmatic and financial activities of subrecipients so as to ensure appropriate performance of specified research. If a subrecipient is a research institution, it is not appropriate for another research institution to act as auditor by overseeing subrecipients’ compliance with federal statutes and regulations, the competence of their institution-wide business systems, or to oversee the resolution of outstanding audit findings.

RECOMMENDATIONS

4.6. The committee recommends that the White House Office of Management and Budget amend the Uniform Guidance to clarify that subrecipient monitoring requirements apply to institutions of higher education only to the extent necessary for prudent project and performance monitoring, and do not require more extensive monitoring of subrecipients’ institutional compliance with all federal statues, regulations, policies, and institution-wide business practices.

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⁵⁹See Requirements for Pass-Through Entities, 2 CFR 2 § 200.331 (a) (2014).

As an immediate, interim measure, the committee recommends that the Office of Management and Budget permit research institutions to use subrecipients’ publicly available Single Audit Reports to verify that subrecipients have not been otherwise debarred or suspended with respect to the receipt of federal funds. For those with a clean Single Audit Report, the prime institution should be allowed to rely on the Single Audit Act oversight process as an alternative to conducting a review of the adequacy of the subrecipient’s institutional systems and business practices.

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