Participating Organization(s)	National Institutes of Health (NIH)
Components of Participating Organizations	National Center for Advancing Translational Sciences (NCATS)
Funding Opportunity Title	Limited Competition: Revision Applications to Advance Evidence-Based Research Related to Protections for Human Subjects (UL1)
Activity Code	UL1 Linked Specialized Center Cooperative Agreement
Announcement Type	New
Related Notices	None
Funding Opportunity Announcement (FOA) Number	PAS-12-167
Companion Funding Opportunity	N/A
Number of Applications	See Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestic Assistance (CFDA) Number(s)	93.350
Funding Opportunity Purpose	The purpose of this FOA is to seek revision applications to cooperative agreements that are supporting networks or consortia of researchers who conduct or will be interested in conducting research in the following areas: The effectiveness of current human subjects protections and the development of tools and methods to examine evolving, evidence-based approaches to improve human subjects protections. The feasibility, costs, benefits, and impacts of requiring consent for research on deidentified human specimens and data using novel models of consent, e.g., notification, opt-out, opt-in, broad consent.

Posted Date	April 20, 2012
Letter of Intent Due Date	Not Applicable
Application Due Date(s)	May 25, 2012 by 5PM local time of applicant organization.
AIDS Application Due Date(s)	Not Applicable
Scientific Merit Review	June 2012
Advisory Council Review	August 2012
Earliest Start Date(s)	September 2012
Expiration Date	May 26, 2012
Due Dates for E.O. 12372	Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the PHS398 Application Guide except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. While some links are provided, applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 1. Overview Information
Part 2. Full Text of Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

The NIH has an ongoing commitment to protecting human research subjects and to supporting bioethics research that will enhance the quality of biomedical research and inform the evidence base for sound practice and policy.

The FY 2012 budget for the Office of the Director, NIH, includes $5 million for the support of bioethics. In light of ongoing considerations concerning potential revisions in the Common Rule, the NIH Director has designated these funds for the support of research designed to develop and enhance the evidence base for the reform and evaluation of regulations governing human subjects research. Available as revision applications to existing awards, these funds will support:

• Research related to the effectiveness of current protections in regulations, rules, and policies governing research with human subjects; and/or
• Research on the use of broad, prospective consent for the use of human biospecimens and data.

The U.S. Department of Health and Human Services (HHS) and the Office of Science and Technology Policy are exploring possible revisions in the HHS regulations governing human subjects research (45 CFR 46, subpart A), known as the Common Rule. The goal of changes under consideration is to enhance the effectiveness of human subjects research protections while facilitating research and reducing burden, delay, and ambiguity for investigators. Possible areas for change include : (1) refining the existing risk-based regulatory framework; (2) using an alternative model for institutional review board (IRB) review of multi-center studies; (3) improving consent forms and the consent process; (4) establishing mandatory data security and information protection standards for all studies that involve identifiable or potentially identifiable data; (5) establishing an improved, more systematic approach for the collection and analysis of data on unanticipated problems and adverse events; (6) extending Federal regulatory protections to more research, and (7) improving the harmonization of regulations and related agency guidance. 

In addition, in its December 2011 report, Moral Science: Protecting Human Participants in Human Subject Research (available at http://bioethics.gov/cms/sites/default/files/Moral%20Science.pdf), the Presidential Commission for the Study of Bioethical Issues recommended that federal agencies that conduct and fund human subjects research should [S]upport the development of systematic approaches to assess the effectiveness of human subjects protections and expand support for research related to the ethical and social considerations of human subjects protections. (The Presidential Commission for the Study of Bioethical Issues, Moral Science: Protecting Human Participants in Human Subject Research, p. 7).

Specific information on the two research areas:

1. An evidence base is needed to enable evaluations of the adequacy and effectiveness of current protections in regulations, rules, and policies governing research with human subjects and, going forward, the effectiveness of potential reforms. Applications are invited to develop baseline measures that can be used to evaluate the outcomes and impact of existing protections for human subjects and assure their adequacy and relevance and to provide tools for ongoing measurement and evaluation. These measures and tools should also enable assessments of proposals for change and the development of an evolving, evidence-based approach to ensuring the effectiveness of human subjects protections. Studies with this aim could address a number of issues including, but not limited to, issues such as:

• Novel models of IRB review, including the use of a single IRB of multi-site studies;
• Differences in protections, if any, between expedited and full IRB review, or no review at all;
• Levels of risk, and the implications of informational risk and more than minimal psychological, social, economic, or legal risk;
• Informed consent, including the use of simplified forms and/or templates for informed consent, and strategies for enhancing or assessing subject understanding;
• Data security and information protection standards for studies involving identifiable or potentially identifiable data, and their impact on the quality and usability of the data; and
• Participant attitudes about differing oversight and governance models for research data sharing and mechanisms for privacy protections.

2. Investigators are invited to submit revision applications designed to help inform the development of policy on permitted future uses of human biospecimens and data, especially with respect to the question of whether consent should be required for the acquisition of biospecimens in clinical settings. Studies with this aim could address such issues as:

• The resources, infrastructure, and mechanisms that are necessary to implement a process for seeking broad consents from patients in clinical settings and tracking them for future use of data and biospecimens;
• The factors that could impinge on the feasibility of implementing such a process within academic health centers, community hospitals, and individual/group practices;
• The costs of implementing and maintaining the requisite resources and infrastructure;
• The optimal design for the consent process, e.g., an optimal process for seeking consent from patients in clinical contexts, in terms of timing, personnel involved, etc.;
• The extent to which therapeutic misconceptions could arise within clinical settings during the consent process for research uses of specimens and data; and
• The acceptability of broad consent to the general public and prospective participants as well as factors that influence the provision of broad consent in clinical settings and the impact on available specimens for future research. 
• The differences in using broad consent, an opt-out approach, or notice, taking into consideration issues such as feasibility, costs and the availability of biospecimens for future research.
• Public preferences for no consent, broad consent, repeated specific consent, opt-out, or notice for secondary research uses of their biospecimens.

In both areas, the preceding questions do not exhaust the potential topics that could be addressed; applications for studies addressing related questions are invited.

Funding Instrument	Cooperative Agreement
Application Types Allowed	Revision The OER Glossary and the PHS398 Application Guide provide details on these application types.
Funds Available and Anticipated Number of Awards	The number of awards is contingent upon NIH appropriations, and the submission of a sufficient number of meritorious applications. NIH intends to commit approximately $5 million in FY 2012 to fund up to 8 awards.
Award Budget	Application budgets are not limited, but need to reflect actual needs of the proposed project. Applicants must submit a budget using the same budget format as was used for the parent award.
Award Project Period	Scope of the proposed project should determine the project period. For revision applications, the proposed project period cannot extend beyond the program end date of the parent award(s).  If a no-cost extension is needed to complete the work to be proposed in the revision, the no-cost extension must be in place before the application is submitted.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Eligibility is limited to institutions with existing cooperative agreements from one of the participating components identified in Part 1.

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.

Applicant organizations must complete the following registrations as described in the PHS398 Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

• Central Contractor Registration (CCR) must maintain an active registration, to be renewed at least annually
• eRA Commons

All Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least 4-6 weeks prior to the application due date.

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

To be eligible, the parent award on which the revision application is based must be an active at the time the revision application is submitted. The project period of the revision application may not extend beyond that of the parent award.

For all revision applications, the Project Director(s)/Principal Investigator(s) (PD(s)/PI(s)) must be the same as the PD(s)/PI(s) on the parent award. For revision applications to multiple PD(S)/PI(s) parent awards, the Contact PD(s)/PI(s) must be the PD(s)/PI(s) listed on the parent award. A revision application does not allow a change in the Multiple PD(s)/PI(s) team nor a conversion from a single PD/PI to multiple PD(s)/PI(s). 

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed.

Applicants are required to prepare applications according to the current PHS 398 application forms in accordance with the PHS 398 Application Guide.

It is critical that applicants follow the instructions in the PHS398 Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Applications must be prepared using the PHS 398 research grant application forms and instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and five signed photocopies in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

All page limitations described in the PHS398 Application Guide and the Table of Page Limits must be followed, with the following exceptions or additional requirements:

The UL1 application Research Strategy section of the PHS398 is limited to 12 pages including tables, graphs, diagrams, and charts.

All instructions in the PHS398 Application Guide must be followed, with the following additional instructions:

Facilities & Other Resources

Institutional Environment Resources. Any institution submitting an application in response to this FOA must show evidence of an existing research infrastructure that can support various aspects of the research program. Features of the institutional environment that are relevant to effective implementation of the overall program must be described.  Available and existing resources (e.g., clinical and laboratory facilities, patient populations, space, etc.) should be described.

Research Strategy Requirements

Organizational and Administrative Infrastructure

The chain of responsibility for decision-making and administration, beginning at the level of the institution's leadership and including all key staff should be described, in detail and by diagram, if appropriate.  Individuals responsible for the day-to-day administrative details, program coordination, and planning and evaluation of the program should also be identified.  Provisions for significant changes in key personnel should be included.

Research Program

The existing research program that is the basis for the grant application should be described along with future plans and how this award will enhance the research capabilities at the institution.

A timeline outlining the key activities and milestones must be included.

Resource Sharing Plan

Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the PHS398 Application Guide, with the following modification:

• All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

Appendix

Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix (please note all format requirements) as described in the PHS398 Application Guide.

Part I. Overview Information contains information about Key Dates. 

Information on the process of receipt and determining if your application is considered on-time is described in detail in the PHS398 Application Guide.

Applicants may track the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

This initiative is not subject to intergovernmental review.

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

Applications must be received on or before the due dates in Part I. Overview Information. If an application is received after that date, it will not be reviewed.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH. Applications that are incomplete will not be reviewed.

If a no-cost extension is needed to complete the work to be proposed in the revision, the no-cost extension must be in place before the application is submitted.

Applications should include a 1-page Introduction that describes the nature of the revision and how it will influence the specific aims, research design, and methods of the parent grant.

Not Applicable

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115:

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance

Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD(s)/PI(s), do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? 

If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact/priority score, but will not give separate scores for these items.

Protections for Human Subjects

For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children 

When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Vertebrate Animals

Not Applicable.

Biohazards

Not Applicable.

Resubmissions

Not Applicable

Renewals

Not Applicable.

Revisions

For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

Not Applicable.

Applications from Foreign Organizations

Not Applicable.

Select Agent Research

Not Applicable.

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS).

Budget and Period of Support

Not Applicable.

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) in accordance with NIH peer review policy and procedures, using the stated review criteria. Review assignments will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

• May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact/priority score.
• Will receive a written critique.

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center and will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the appropriate National Advisory Council or Board. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.

After the peer review of the application is completed, the PD(s)/PI(s) will be able to access his or her Summary Statement (written critique) via the eRA Commons. 

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.      

Any application awarded in response to this FOA will be subject to the DUNS, CCR Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General  and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

Note: Terms and conditions existing on current cooperative agreement awards will continue unless the results of initial or secondary peer review of the revision applications require modifications to terms or conditions. The terms and conditions below are current NIH terms for inclusion in Notices of Award for cooperative agreements. They will generally be followed for awards in response to this FOA. Individual variation in terms and conditions will be negotiated at the time of award when appropriate and cleared through NIH prior to award.

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.

A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-435-0714
TTY 301-451-5936
Email: [email protected]

eRA Commons Help Desk (Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: [email protected]

Applicants are encouraged to discuss their plans for responding to this FOA by Phone or e-mail. Scientific inquiries should be directed to the IC Program Director who oversees the parent grant associated with the supplement request and to the NIH contact for this announcement.

Valery Gordon, Ph.D., M.P.H.
Deputy Director, Clinical Research Policy Analysis and Coordination Program
The Office of the Director (OD)
Telephone: 301-496-9838
Email: [email protected]

Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).

Irene Haas
National Center for Advancing Translational Sciences (NCATS)
Telephone: 301-435-0836
Email: [email protected]

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.