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Updates from MUSC's Offices of Research Administration


Updated Fringe Benefit Rates

Please begin budgeting with the new composite fringe benefit rates listed in the table below for all future proposal submissions.  Note these new rates will be required in all proposals submitted on or after August 15, 2017.

The effective date for the new fringe benefits rates to be charged to all sponsored projects is July 1st, 2017

The new rates have been updated on the Proposal Preparation section of the ORSP website: http://academicdepartments.musc.edu/research/orsp/proposal_preparation/.

Cayuse424 has also been updated with these rates to be the default budget rates.  Any pending proposals in Cayuse424 will need to be updated to the new rates.  To accomplish this please re-autofill each investigator on the proposal using the “Manage Key Persons” button on the budget page.  When the salary is updated, the system will capture the new fringe rate.  Please direct any questions about this to your assigned Grants Administrator in ORSP.

Employee Benefits Category

Fringe Benefits Rate

Applicable Employment Types

Staff

36.7%

Faculty
9-Month Faculty
Unclassified Non-Faculty
Classified, Research

Post-Doctoral Fellows

29.8%

Post-Docs
Residents

Temp Faculty/Temp non-Faculty

29.5%

Temporary Faculty
Temporary Non-Faculty

Students/Other

8.1%

Student
Ph.D. Students
Research Grant Employees- No Benefits


FY 2017 Kirschstein-NRSA Budgetary Levels

NIH Notice Number: NOT-OD-17-072 establishes the FY 2017 Ruth L. Kirschstein National Research Service Award (NRSA) Stipends, Tuition/Fees and Other Budgetary Levels.

From the Notice:

This revised Notice supersedes NOT-OD-16-062, and establishes stipend levels for fiscal year (FY) 2017 Kirschstein-NRSA awards for undergraduate and predoctoral trainees and fellows, as shown in the table below.  The Training Related Expenses and Institutional Allowances for predoctoral trainees and fellows and the Tuition and Fees for all educational levels remain unchanged.  

The budgetary categories described in this Notice apply only to Kirschstein-NRSA awards made with FY 2017 funds.  All FY 2017 awards previously issued using FY 2016 stipend levels (NOT-OD-16-062) will be revised to adjust stipends to the FY 2017 level.

Appointments to institutional training grants that have already been awarded in FY 2017 must be amended to reflect the FY 2017 stipend levels once the training grant award has been adjusted by the NIH.  Amended appointments must be submitted through xTrain in the eRA Commons.  Retroactive adjustments or supplementation of stipends or other budgetary categories with Kirschstein-NRSA funds for an award made prior to October 1, 2016 are not permitted.

Note: The FY 2017 stipend and other budgetary levels for postdoctoral trainees and fellows was issued on December 15, 2016: NOT-OD-17-003

Stipends for FY 2017
Effective with all Kirschstein-NRSA awards made on or after October 1, 2017, the following annual stipend levels apply to all individuals receiving support through institutional research training grants or individual fellowships, including the Maximizing Access to Research Career (MARC) and Building Infrastructure Leading to Diversity (BUILD) programs.

Undergraduates in the MARC and BUILD Programs:  For institutional training grants (T34, TL4), two stipend levels may be used for undergraduate candidates: Freshmen/Sophomores and Juniors/Seniors. 

Career Level

Stipend for FY 2017

Monthly Stipend

Freshmen/Sophomores

$8,988

$749

Juniors/Seniors

$12,588

$1,049

Predoctoral Trainees and Fellows:  For institutional training grants (T32, T35, T90, TL1) and individual fellowships (F30, F31, F99), one stipend level is used for all predoctoral candidates, regardless of the level of experience.

Career Level

Years of Experience

Stipend for FY 2017

Monthly Stipend

Predoctoral

All

$23,844

$1,987


Tuition and Fees, Training Related Expenses, and Institutional Allowance for Kirschstein-NRSA Recipients
The NIH will provide funds for Tuition and Fees, Training Related Expenses, and Institutional Allowance as detailed below.

A. Tuition and Fees

Undergraduate and Predoctoral Trainees and Fellows:  For institutional training grants (T32, T34, T35, T90, TL1, TL4) and individual fellowships (F30, F31, F99), an amount per predoctoral trainee equal to 60% of the level requested by the applicant institution, up to $16,000 per year, will be provided.  If the trainee or fellow is enrolled in a program that supports formally combined, dual-degree training (e.g., MD/PhD, DO/PhD, DDS/PhD, AuD/PhD, DVM/PhD), the amount provided per trainee or fellow will be 60% of the level requested, up to $21,000 per year.

B. Training Related Expenses on Institutional Training Grants
For institutional training grants (T32, T35, T90, TL1), these expenses (including health insurance costs) for predoctoral trainees will be paid at the amounts shown below for all competing and non-competing awards made with FY 2017 funds.  

  • Predoctoral Trainees: $4,200

C. Institutional Allowance for Individual Fellows
This allowance for predoctoral fellows will be paid at the amounts shown below for all competing and non-competing awards made with FY 2017 funds.

Institutional Allowance for individual fellows (F30, F31, F99) sponsored by non-Federal Public, Private, and Non-Profit Institutions (Domestic & Foreign, including health insurance):

  • Predoctoral Fellows: $4,200

Institutional Allowance for individual fellows (F30, F31, F99) sponsored by Federal and For-Profit Institutions (including health insurance):  

  • Predoctoral Fellows: $3,100

Relevant Policies
Current stipend levels are to be used in the preparation of future competing and non-competing NRSA institutional training grant and individual fellowship applications.  They will be administratively applied to all applications currently in the review process.

NRSA support is limited to 5 years for predoctoral trainees (6 years for dual-degree training, e.g., MD/PhD, DO/PhD, DDS/PhD, AuD/PhD, DVM/PhD).

It should be noted that the maximum amount that NIH will award to support the compensation package for a graduate student research assistant remains at the zero level postdoctoral stipend, as described in NOT-OD-02-017.

Frequently Asked Questions Related to NRSA Tuition, Fees, and Health Insurance Policies: http://grants.nih.gov/training/nrsa_tuition_q&a.htm.


Important REMINDER: NIH, AHRQ & NIOSH Policy on Appendix Materials

This message serves as a reminder for everyone at MUSC to adhere to the policy on Appendix Materials in funding applications submitted to the National Institutes of Health (NIH), the Agency for Healthcare Research and Quality (AHRQ), or the National Institute for Occupational Safety and Health (NIOSH). 

These federal agencies will administratively withdraw applications that include any disallowed materials in the Appendices.  Such an oversight will prohibit the application from getting peer reviewed and scored.

This information has been added to the ORSP web page for quick reference (http://academicdepartments.musc.edu/research/orsp/policies_procedures/appendix_materials_NIH_AHRQ_NIOSH). 

NOTE: the NIH FAQ link (https://grants.nih.gov/grants/policy/appendix_policy.htm) has been included to help clarify what is or is not allowed to be included in the Appendix Materials.

Background

Notice NOT-OD-16-129 alerted the scientific research community of the elimination of most appendix materials for applications submitted to NIH, AHRQ or NIOSH for due dates on or after January 25, 2017. 

The NIH, AHRQ, and NIOSH strive to ensure fairness in peer review for all grant applicants by specifying the types and amount of application material that are accepted for peer review.  At the same time, these agencies appreciate both the need for applications to provide sufficient information to allow for an informed, expert review process and the importance of limiting the burden on peer reviewers.

Elimination of most appendix materials is intended to rectify inequities in the peer review process that can arise from submission of inappropriate or excessive appendix materials by some applicants and consideration of appendix materials in peer review by some, but not all reviewers. 

Policy

Appendix materials in peer review

All information submitted with an application except the cover letter, assignment request form and appendix information are assembled into a single application image for funding consideration. The different sections within the application image are specified in the application instructions and correspond to the standard review criteria.

Therefore:

  • All information required for the peer review process must be contained within those designated sections of the application image, unless the Funding Opportunity Announcement (FOA) specifies otherwise. 
  • Information that expands upon or complements information provided in any section of the application -- even if it is not required for the review -- is not allowed in the appendix unless it is listed in the allowed appendix materials (below).  (NOT-OD-11-080)
  • Unless the FOA requires that certain information be included in the appendix, failure of reviewers to address appendix materials in their reviews is not an acceptable basis for an appeal of initial peer review (NOT-OD-11-064).

Allowable appendix materials

Beginning with applications submitted to the NIH, AHRQ, or NIOSH for due dates on or after January 25, 2017, the only allowable appendix materials are:

For applications proposing clinical trials (unless the FOA provides other instructions for these materials):

  • Clinical trial protocols
  • Investigator's brochure from Investigational New Drug (IND), as appropriate

For all applications:

  • Blank informed consent/assent forms
  • Blank surveys, questionnaires, data collection instruments
  • FOA-specified items. 
    • If appendix materials are required in the FOA, review criteria for that FOA will address those materials, and applications submitted without those appendix materials will be considered incomplete and will not be reviewed.

Consequences for submitting disallowed appendix materials

Applications submitted for due dates on or after January 25, 2017 will be withdrawn and not reviewed if they are submitted with appendix materials that are not specifically listed in this Notice or the FOA as allowed or required.

FAQs on the NIH/AHRQ/NIOSH Appendix Policy

Related Announcements

NOT-OD-17-035
NOT-OD-17-023
NOT-OD-16-130
NOT-OD-11-064
NOT-OD-11-080


Save the Date - PCORI Workshop
Save the Date - PCORI Workshop

The Office of Research Development is hosting a PCORI Workshop on July 18, 2018. The details are underdevelopment but I wanted to have faculty Save-the-Date.  The workshop will be 3-hours and two program officers from PCORI will be on campus to provide details regarding the organization, funding opportunities available, and an overview of the engagement requirements.  Dr. Kathleen Brady asked that PCORI also discuss plans for their sustainability. 
 


Introducing ... the Office of Clinical Research!

Since the memo of understanding was signed in October 2016 to establish a new Office of Clinical Research, much of the activity has involved setting up MUSC’s newest Research Administration Office.  Most of the staff have been hired and space secured in Suite 170 in the Roper Medical Office Building, just down the hall from the SCTR offices.  New workflow processes and training are being developed, as well as tools and metrics, to guide study teams in understanding what research billing compliance entails. Clinical research billing compliance in this context is often referred to as prospective reimbursement analysis.

The purpose of the Office of Clinical Research is outlined below, but to better understand how the OCR fits into the MUSC Research community, this organization chart illustrates how we are positioned.

 

Important to note, is that the OCR is a collaboration between MUSC Administration, College of Medicine, and MUSC Health.

Effective May 1, all new clinical research studies must have a clinical billing compliance review called a Prospective Reimbursement Analysis (PRA).  The OCR has been busy providing information for faculty members, and meeting and providing more detailed training to study team about the new PRA workflow process.  The OCR PRA Team is seeking information from departments and the research community to improve the OCR and research processes.

The goal of the billing compliance review process is to facilitate the research study activation process as well as to ensure compliance, so please submit studies early in the study activation process.  The OCR PRA Team will work alongside the study team to complete the PRA in parallel with the study team completing the budget.  The PRA will provide valuable information to support budget development and contract negotiation.  Eventually, the prospective reimbursement process (PRA) should improve the process and reduce the time of setting up a clinical research study.

We encourage the MUSC Research Community to visit the OCR internal website at: http://horseshoe.musc.edu/research/ocr.  Browse the pages for Training and Resources, Announcements and updates both from the OCR and the Epic Research Team.  Our external-facing website is primarily for industry sponsors.

The horseshoe sites are most easily accessed if you are on campus. If off campus, you may have use a VPN to log in.  In addition, you can contact the OCR office at 843-792-7900 or at musc-ocr@musc.edu.


NIH Notice NOT-OD-17-062

Notice NOT-OD-17-062 announced a transition from the current NIH grant application forms (“FORMS-D”) to the next iteration of forms (“FORMS-E”) for due dates on or after January 25, 2018.

Highlights of the new FORMS-E will include:

  • Consolidation of human subjects, inclusion enrollment, and clinical trial information previously collected across multiple agency forms
  • Expansion and use of discrete form fields for clinical trial information to
    • provide the level of information needed for peer review;
    • lead applicants through clinical trial information collection requirements;
    • present key information to reviewers and agency staff in a consistent format; and
    • align with ClinicalTrials.gov (where possible) and position us for future data exchange with ClinicalTrials.gov
  • Incorporation of recent Grants.gov changes to R&R Budget and SBIR/STTR Information forms

Application guides for FORMS-E application packages will be posted to the How to Apply - Application Guide page no later than October 25, 2017.

  • New FOAs posted before October 25, 2017 with initial due dates on or after January 25, 2018 will be posted without application forms. Application packages will be added to these FOAs by November 10, 2017.

All NIH "parent" announcements that use standard due dates will be expired and reissued with new FOA numbers, FORMS-E application packages and instructions. The FORMS-E parent announcements will be posted no later than 60 days before their standard due date. For a transition period, both FORMS-D and FORMS-E parent announcements will be active. Applicants must choose the announcement with the appropriate application package for their due date (see table below).

All active FOAs with due dates both before and after January 25, 2018 will be updated to add FORMS-E application packages between October 25, 2017 and November 25, 2017. For a transition period, both FORMS-D and FORMS-E application packages will be active. Applicants must choose the appropriate application package for their due date when presented with both FORMS-D and FORMS-E application packages on the same FOA (see table below).

If your due date is…

You must use…

On or before January 24, 2018, including:

  • Applications submitted for due dates on or before January 24, 2018
  • Applications submitted under NIH Late Policy 2-week window of consideration for intended due dates on or before January 24, 2018
  • Applications submitted by February 7, 2018 under NIH Continuous Submission Policy for January 7, 2018 AIDS intended due date

FORMS-D application package

On or after January 25, 2018, including:

  • Applications submitted for due dates on or after January 25, 2018
  • All application types (New, Resubmission, Renewal, Revision)
  • Applications submitted early for intended dues dates on or after January 25, 2018

FORMS-E application package

Additional guide notices for individual FOAs with unique due date considerations will be issued as needed and referenced in the Related Notices section of each FOA.

Form Update Timing for Administrative Supplement, Successor-in-Interest (Type 6) and Change of Institution (Type 7) Parent Announcements

Parent announcements for administrative supplements and post award administrative actions (successor-in-interest and change of institution applications) do not have set due dates and, consequently, will follow a different timeline than other parent announcements.

The FOAs in the table below will be reissued with new FOA numbers, FORMS-E application packages and instructions on January 25, 2018. Applications started on or after January 25, 2018 must use the new FOAs and FORMS-E application packages.

These FOAs will expire on February 25, 2018 giving applicants one month to complete their initiated FORMS-D applications.

 FOA#

FOA Title

 PA-16-285

 Change of Grantee Organization (Type 7 Parent)

 PA-16-286

 Successor-in-Interest (Type 6 Parent)

 PA-16-287

 Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Admin Supp)

 PA-16-288 

 Research Supplements to Promote Diversity in Health-Related Research (Admin Supp)

 PA-16-289

 Research Supplements to Promote Re-Entry into Biomedical and Behavioral Research Careers (Admin Supp)

 

Applications Proposing Clinical Trials

As previously announced, all applications involving clinical trials must be submitted to FOAs specifically designed for clinical trials beginning with due dates on or after January 25, 2018 (NOT-OD-16-147, NOT-OD-17-043).

NIH will take the following steps to accommodate this new policy:

  • Issue new clinical trial FOAs with clinical trial-specific review criteria, FORMS-E application packages, and FORMS-E instructions for due dates on or after January 25, 2018
  • Add a new "Clinical Trials" item to the table in Section II of all FOAs (just below "Application Types Allowed") which will include one of the following statements:
    • Only accepting applications that propose clinical trial(s)
    • Only accepting applications that do not propose clinical trials
    • Accepting applications that either propose or do not propose clinical trial(s)
  • Expire existing (FORMS-D) clinical trial FOAs by January 24, 2018

Resources:


NIH Encourages Use of Preprints and Other Interim Research Products

A new notice from the NIH (Reporting Preprints and Other Interim Research Products, NOT-OD-17-050) indicates that interim research products, including preprints, can soon be cited where other research products are cited. This includes the NIH Biosketch and Section C of the Research Performance Progress Report (RPPR), among others. The change is effective for all applications submitted for the May 25, 2017 due date and beyond, and for RPPRs submitted on or after May 25, 2017.

  • The NIH encourages investigators to use interim research products but does not require their use.
  • Preprints do not apply under the NIH Public Access Policy.
  • This guide notice does not apply to clinical trial registration. See ClinicalTrials.gov about registration of clinical trial protocols.

What are Interim Research Products?

NIH defines interim research products as complete, public research products that are not final.  A common form is the preprint, which is a complete and public draft of a scientific document. Preprints are typically manuscripts written in the style of a peer-reviewed journal article that have not been subject to peer review. Scientists issue preprints to speed dissemination, establish priority, obtain feedback, and offset publication bias.

Citing Interim Research Products

When citing an interim research product, applicants and awardees must include the Digital Object Identifier and the Object type (e.g. preprint, protocol) in the citation. They should also list any information about the document version (e.g. most recent date modified), and if relevant, the date the product was cited.

Example:

Bar DZ, Atkatsh K, Tavarez U, Erdos MR, Gruenbaum Y, Collins FS. Biotinylation by antibody recognition- A novel method for proximity labeling. BioRxiv 069187 [Preprint]. August 11, 2016 [cited 2017 Jan 12].  Available from: https://doi.org/10.1101/069187.

For more information, see: NIH NOT-OD-17-050: Reporting Preprints and Other Interim Research Products.

Background

In October 2016, the NIH requested information on the use of interim research products and standards for reporting them (Request for information (RFI): Including Preprints and Interim Research Products in NIH Applications and Reports, NOT-OD-17-006). The NIH received 351 responses and nearly all respondents supported increasing the use of interim research products in NIH award processes. Specific benefits of interim research products include speeding dissemination of results, enhancing the rigor of the research and avoiding publication bias. For more information about the responses, see the Background and Public Comments section of: NIH NOT-OD-17-050: Reporting Preprints and Other Interim Research Products.


Research Terms and Conditions Implementing the Uniform Guidance

The Final Notice of Research Terms and Conditions (RTC) To Address and Implement the Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards Issued by the U.S. Office of Management and Budget (OMB) was published in the March 14 Federal Register.

These RTCs are the successor to the terms developed with the Federal Demonstration Partnership, and they have been written to comply with the requirements set out in the Uniform Guidance (2 CFR 200). Agencies are planning to implement the RTCs at different dates in 2017.

Agencies participating, with implementation dates, are:

Note that the Department of Defense is not included; but will implement award terms in compliance with 2 CFR 200.

While the Uniform Guidance outlines provisions that are specific to research, these terms and conditions:

  • Incorporate the entire Uniform Guidance by reference, clarifying or supplementing select provisions where appropriate and consistent with government-wide research policy.

  • Incorporate the latest version of the Frequently Asked Questions for the Office of Management and Budget's Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards at 2 CFR 200.

  • Apply to an award when included as part of the award or when incorporated in the award by reference. Use of the RTCs is envisioned as a streamlined approach that supports the implementation of the Uniform Guidance by providing clarification, supplementary guidance, and, where appropriate, selected options, while meeting the spirit and intent of a uniform implementation.

In addition to the RTCs, three companion resources will be developed: Appendix A, Prior Approval Matrix; Appendix B, Subaward Requirements Matrix; and Appendix C, National Policy Requirements Matrix.


NIH Notice NOT-OD-17-049: FY2017 NIH Salary Cap - Interim Guidance

Per NIH notice NOT-OD-17-049, the new NIH salary cap is $187,000 effective January 8, 2017

Salaries up to this new $187,000 level are allowed to be charged starting January 8, 2017, to NIH funded grants provided the necessary funds are available.

NOTE: No additional funds will be provided by NIH.

Once the Department of Health and Human Services Appropriation for FY 2017 is enacted, NIH will publish the annual Notice of legislative mandates to provide information on any statutory provisions that limit the use of NIH grant funds in FY 2017.  Additional guidance on the salary cap will also be provided at that time. 

For those planning to make payroll adjustments due to this salary cap increase, we encourage using February 1st, 2017, as the start date for any changes.  Start dates other than the first day of the month may lead to errors due to the manual calculations required.

When preparing all future NIH grant proposals, please use the new salary cap maximum.  Both the ORSP Proposal Preparation page and Cayuse data are being updated to reflect the new NIH Salary Cap level.


Shared Instrumentation Grant (S10) Program
Shared Instrumentation Grant (S10) Program

NIH Shared Instrumentation Grant (S10) Applications

Additional Information link:  http://academicdepartments.musc.edu/research/ord/fundingops/secure/SIG_SIFAR.pdf