The School of Dentistry is pleased to announce the latest FIT award. Based on the combined scores of the reviewers one project was selected for funding in the amount of $50,000 for the 24 month project:

Wu Zhang, MD (School of Dentistry) and Julia Unternaehrer-Hamm, PhD (School of Medicine): Co-Principal Investigators; Project Title: Alveolar Bone Regeneration via Reprogrammed GMSCs and Periodontal Therapy.

Please join us in congratulating Drs. Wu Zhang and Julia Unternaehrer-Hamm.

This notice (link below) informs the biomedical research community of updates to application instructions and review language intended to enhance the reproducibility of research findings through increased scientific rigor and transparency. These updates will take effect for most research grant applications (including small business and complex research grant applications) submitted for due dates on or after January 25, 2016. For research contracts, this policy will be effective for proposals received on/after January 25, 2016 and expected to result in contract awards in Fiscal Year 2017 and beyond. 

http://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-011.html

At an NIH Regional seminar this year the session on “Rigor and Reproducibility” received conspicuous attention.  According to the NIH, the advancement of science is based on “rigor in designing and performing scientific research, and the ability to reproduce biomedical research findings.”

Addressing the rigor and reproducibility of a research plan will become mandatory for applications submitted after January 25, 2016.  The seminar also reported the expectation for careful consideration of “relevant biological variables, such as sex, age, weight and any other factors affecting health or disease” and the requirement for “authentication of key biological and/or chemical resources.”

There are revised instructions for applications due on and after January 25, 2016:

1. The scientific premise of the proposed research (research plan)

Applicants must state the scientific premise that forms the basis for the proposed research question(s).  NIH expects applicants to describe the general strengths and weaknesses of prior research cited by the applicant, including the rigor of previous experimental designs, their examination of relevant biological variables and their authentication of key resources

2. Rigorous experimental design for robust and unbiased results (research plan)

Scientific rigor is the strict application of the scientific method to ensure robust and unbiased experimental design, methodology, analysis, interpretation and reporting. This requires full disclosure of experimental details so that others may reproduce and extend the findings.

3. Consideration of relevant biological variables (human and/or animal subjects)

Biological variables, such as sex, age, weight, and underlying health conditions are often critical factors affecting health or disease. NIH expects that sex as a biological variable will be factored into research designs, analyses, and reporting in vertebrate animal and human studies. Strong justification must be provided for applications proposing to study only one sex.

4. Authentication of key biological and/or chemical resources (other attachments)

Key biological and/or chemical resources include, but are not limited to, cell lines, specialty chemicals, antibodies and other biologics. These may differ between laboratories or over time, and may influence the research data and the ability to reproduce the results. Investigators must determine which resources used in their research fit these criteria and are therefore key to the proposed research.

The links below provide additional information on the principals and guidelines governing Rigor and Reproducibility, a training module and application instructions for your upcoming grant proposals.

https://www.nih.gov/research-training/rigor-reproducibility/updated-application-instructions-enhance-rigor-reproducibility

http://grants.nih.gov/reproducibility/index.htm

Refer to Examples of Serious or Minor Protocol Violations to help you determine if a violation is:

• serious (submit the Protocol Violation Report Form within 5 working days of awareness) or
• minor (record event on the Minor Protocol Violation Log and submit with the study’s Research Report Form at the end of the IRB approval period).

Call Anu Diekmann at x86215 if you have any questions.  

https://m.era.nih.gov/cmb

This new mobile access means it will be significantly easier for PIs to track and manage grant applications and awards because the Status screen will be easily viewable on a range of devices such as tablets and smartphones. PIs can simply go to the eRA Commons mobile login page and provide their credentials as they normally would when accessing eRA Commons.

The mobile site is designed to provide the basic and necessary information PIs need to track their application submissions and awards. The status screen, resizable due to responsive design, provides a table of all their applications. The applications are grouped based on status, going from Received, Awarded, Pending, Withdrawn, to Not Funded. The column headings are Project Number, Status, Project Title and Date.

Each application can be expanded to show important information such as Priority Score, Percentile, Scientific Review Group (SGR) information and links to other resources, such as the application image and/or summary statement. There is also a Contact section that provides access to a PI’s assigned Scientific Review Officer (SRO), Grants Management Specialist (GMS) and Program Official (PO).

Additionally, at the top of the screen is a large search/filter field. When a PI simply starts to type in any information from any of the columns, the results will be dynamically updated as they type.

The general responsibilities of investigators submitting genomic data sharing plans are listed below. More specific details of non-human and human genomic data sharing plans are found within the policy.

“Investigators seeking NIH funding should contact appropriate IC Program Official or Project Officer as early as possible to discuss data sharing expectations and timelines that would apply to their proposed studies.  NIH expects investigators and their institutions to provide basic plans for following this Policy in the “Genomic Data Sharing Plan” located in the Resource Sharing Plan section of funding applications and proposals.  Any resources that may be needed to support a proposed genomic data sharing plan (e.g., preparation of data for submission) should be included in the project's budget.  A more detailed genomic data sharing plan should be provided to the funding IC prior to award.  The Institutional Certification (for sharing human data), should also be provided to the funding IC prior to award, along with any other Just-in-Time information.  NIH expects intramural investigators to address compliance with genomic data sharing plans with their IC scientific leadership prior to initiating applicable research and are encouraged to contact their IC leadership or the Office of Intramural Research for guidance.  The funding NIH IC will typically review compliance with genomic data sharing plans at the time of annual progress reports or other appropriate scientific project reviews, or at other times, depending on the reporting requirements specified by the IC for specific programs or projects….

Genomic data undergo different levels of data processing, which provides the basis for NIH’s expectations for data submission and timelines for the release of the data for access by investigators.  These expectations and timelines are provided in the Supplemental Information. ”

In a March 2015 notice (NOT-OD-15-083), NIH reminded the research community that:

• Grant applications are expected to state in the cover letter that the studies proposed will generate large-scale human and/or non-human genomic data. 
  Applications proposing such research are expected to include a genomic data sharing plan.  Guidance on developing data sharing plans may be found here: http://gds.nih.gov/pdf/NIH_guidance_developing_GDS_plans.pdf.
  Applicants who wish to use controlled-access human genomic data from NIH-designated data repositories as a secondary user, to achieve the specific aim(s) of the research proposed, in the Research Plan of the application should:
  briefly address their plans for requesting access to the data, and
  state their intention to abide by the NIH Genomic Data User Code of Conduct. “

Additional information on the GDS Policy may be found at: http://gds.nih.gov/index.html.