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Updates from MUSC's Offices of Research Administration


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


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.


Final Research Performance Progress Reports (Final RPPR)

NIH Notice NOT-OD-17-022 announced NIH’s implementation of Final Research Performance Progress Reports (Final RPPR or F-RPPR) effective January 1, 2017.

The Final RPPR will replace the Final Progress Report (FPR) and will be submitted via a new eRA Commons module.

A significant change with implementation of the F-RPPR is that in order to maximize public transparency, NIH will not maintain the current Type 2 policy which in accordance with NIHGPS Chapter 8.6.2 states that "whether funded or not" the progress report contained in the Type 2 application may serve in lieu of a separate final progress report.

NIH will request that organizations submit an "Interim-RPPR" while their renewal application (Type 2) is under consideration. In the event that the Type 2 is funded, NIH will treat the Interim-RPPR as the annual performance report for the final year of the previous competitive segment. If the Type 2 is not funded, the Interim-RPPR will be treated by NIH staff as the institution's Final-RPPR.

NIH is aligning its reporting requirement with other Federal research agencies and therefore will not be making any changes to the deadline for submitting the final report- i.e., the Final RPPR or Interim-RPPR must be submitted via eRA Commons no later than 120 calendar days from the period of performance end date. If a recipient fails to comply with this reporting requirement, NIH may take one or more enforcement actions, such as a decision not to make a non-competing continuation award, consistent with NIHGPS Chapter 8.5.2. NIH also plans to maintain the business rule in the RPPR module enabling institutional signing officials (SOs), at their discretion, to delegate submission of the Final RPPR or Interim-RPPR to the Program Director/Principal Investigator (PD/PI).

Note: Implementation of the Final RPPR for Small Business Innovation and Research (SBIR) and Small Business Technology Transfer (STTR) grants will occur approximately 2 months after implementation for all other NIH grants due to unique final reporting requirements under the Small Business Administration's SBIR/STTR Policy Directive.

FAQs and additional information pertaining to NIH's implementation of the F-RPPR will be available on the NIH RPPR website.


eRA Commons Option Available to Submit an Unsolicited Application exceeding $500K in direct costs

NIH has a longstanding policy that states any applicant requesting $500,000 or more in direct costs (excluding consortium F&A costs) in any one budget period within a competitive segment is required to contact the NIH Institute or Center (IC) Program Official (PO), in writing or by telephone, as early as possible during development of the application but no later than 6 weeks before submission for prior approval. Since NIH supports projects with large budgets, the purpose of this policy is for fiscal planning and therefore it provides NIH ICs the appropriate amount of time to consider the possibility of such awards as early as possible in the budget and program planning process.

Notice number NOT-OD-17-005 informs NIH applicants that requests to submit an unsolicited application that will exceed $500,000 in direct costs will now have an option to submit this request electronically through eRA Commons, under a new Prior Approval Module.


Grant Submissions/Deadlines Affected by Hurricane Matthew and MUSC's Closure

A primary concern of NIH applicants is how to handle when an institution is closed due to natural disaster or other emergency situation. In these cases it is not necessary to get permission in advance for delays in grant application submissions.  Instead, electronic and paper applications submitted late must include a cover letter indicating the reasons for the delay.  The delay should not exceed the time period that the applicant organization is closed. More information can be found here:  NIH Grant Policy.


NIH Salary Cap Revised

The National Institutes of Health (NIH) announced the revision of the salary cap to $185,100 effective January 10, 2016. Please see the link below for more details. More information can be found here: NOT-OD-16-045.