Agencies periodically update application forms in order to remain current with the most recent form sets available through Grants.gov and approved by the Office of Management and Budget and to align data collection with current policy.
NIH will require the use of application packages with a Competition ID of ‘FORMS-E’ for due dates on or after January 25, 2018. Applications prepared using “FORMS-D” application packages for due dates after January 24, 2018 will not be reviewed.
The majority of form changes introduced in FORMS-E packages relate to the consolidation of human subjects and inclusion enrollment report information previous collected across multiple forms into a new PHS Human Subjects and Clinical Trials Information form. The new form also expands clinical trial data collection to ensure the appropriate level of information for review and to improve oversight.
Multiple resources have been developed by NIH to help the community navigate this change. We encourage all investigators and administrators to review these materials prior to the January effective date:
Are you unsure if your project classifies as a clinical trial? Please review the following:
If you have questions or need assistance, please contact Drexel’s Office of Human Research Protections or Moira McAndrews.
Updated NIH Application Guide
NIH recently revised their general application guide in an effort to simplify and streamline the language and presentation of their application instructions.
Updated NIH Application Guide available here
A recent Guide notice highlights the changes which include:
- completely rewritten form instructions for clarity.
- headings and labeling to distinguish instructions from supporting information.
- clarification of what is required and optional throughout the instructions.
- updated instructions are highlighted with a new symbol: In the web (HTML) version of the application instructions, you can use your mouse to hover over the icon to read an explanation of the change.
Changes are summarized in the Significant Changes section of the application instructions.
Limit on Appendix Materials for Applications
Limit on Appendix Materials for Applications submitted or due after January 25th
For all applications, allowable materials include:
- 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.
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.
In an effort to continue to support the research activities of DSPH faculty and strengthen the quality of applications being submitted by our school, the DSPH Research Office will now be offering an optional proposal pre-submission peer review for eligible investigators on eligible proposals.
The goal of the pre-submission peer review is to provide useful feedback regarding the strengths and weaknesses of the research narrative in order to aid the investigator in submitting the strongest application possible. The process also provides an opportunity to gain an opinion on the project from someone other than a collaborator. Thorough review prior to the submission of an application is an essential component of successful applications.
The program is voluntary but open to all full-time faculty with a primary appointment in the Dornsife SPH.
Eligible proposals must also have:
- Average annual direct costs >$100K
- An F&A rate >= the University’s currently negotiated federal Other Sponsored Projects rate (36.5% for FY2017)
- Both new applications and resubmissions are eligible.
Investigators should submit, at minimum, the specific aims and research strategy/plan section of the grant for review. Resubmission applications should also include any previous funding agency reviews (i.e., “pink sheets”, summary statement, etc.) and responses to those critiques. Review of these sections will be prioritized, but reviewers will also be asked to look at other available sections (which can impact scores on personnel and environment) if they are made available. Deadlines (see Timeline below) must be met for notification of intent to submit and submission of draft proposal to the DSPH Research Office.
Notification of intent to submit a proposal for pre-submission peer review should be done by sending an email to firstname.lastname@example.org.
Each proposal submitted will be reviewed by one Drexel University faculty member and one outside reviewer. Both internal and external reviewers will receive an honorarium for their time which will be paid by the DSPH Research Office. DSPH Investigators submitting proposals will be asked to discuss with the DSPH Research Office the type of reviewers whose input they feel will be most valuable and attempts will be made to solicit those types of reviewers. The DSPH Research Office will contact candidate reviewers and manage the process of receiving feedback. Reviewers will be asked to score and give comments on proposals using the review criteria associated with the mechanisms the investigator is pursuing (if available). Reviewers will also be directed to provide specific advice on changes that can be made to improve the proposal.
(Relative to Grant Deadline)
6 weeks before
Notify DSPH Research Office of intent to submit proposal for pre-submission peer review, share draft Aims, and discuss candidate reviewers with Research Office. [Research office will contact reviewers.]
4 weeks before
Submit draft proposal to DSPH Research Office (must include Aims and Research Plan at minimum – plus critiques and response to critiques for resubmissions). [Research Office will transmit proposal to reviewers.]
2 weeks before
Feedback is received and transmitted to faculty.
2 weeks after
Submit evaluation of pre-submission review (form provided by Research Office).