Extramural Nexus: What you're missing!

The National Institutes of Health (NIH) Office of Extramural Research (OER) has a monthly newsletter called "Extramural Nexus".  This newsletter provides many helpful articles and tips to prepare your NIH proposal!

A quick FAQ of sorts is the "You Ask, We Answer" portion. Here is a sample of the questions:

• Is There a Time Limit for Resubmission?
• How Do I Fill Out the Budget Form for an AREA App?
• For a Resubmission, May I Request a Different Study Section or IC?

Read: http://nexus.od.nih.gov/all/category/you-ask-we-answer/

OER also provides an extensive archive of podcasts specifically designed for investigators by those that know the information best! Topics include:

• Prepare a Successful Grant Application?
• Be an NIH Investigator?
• Understand How Your Grant is Reviewed?

Listen: http://grants.nih.gov/podcasts/All_About_Grants/

New resources are posted on a regular basis on a variety of new regulations and policies. Examples include:

• Tutorial on new regulations regarding Financial Conflict of Interest (FCOI)
• Sample funded R-21 applications with summaries
• Peer review news and advicee

Learn: http://nexus.od.nih.gov/all/category/new-resources/

Dr. Sally Rockey is NIH's Deputy Director for Extramural Research. Her blog "Rock Talk" is updated frequently with new information straight from the NIH.

• Postdoctoral Researchers—Facts, Trends, and Gaps
• What We’ve Learned About Graduate Students

Rock: http://nexus.od.nih.gov/all/rock-talk/

NCURA's YouTube Tuesday - America Invents Act

Cathy Innes of the University of North Carolina at Chapel Hill, gives an overview of what is changing with the new Leahy-Smith America Invents Act of 2011.



Summary of the Bill:
On September 16, 2011, President Obama signed into law the Leahy-Smith America Invents Act (H.R. 1249), a bill that updates the United States patent system to encourage innovation, job creation and economic growth. Much-needed reforms to the patent system are long overdue. The last major patent re¬form was nearly 60 years ago. The Act implements a first-inventor-to-file standard for patent approval, creates a post-grant review system to weed out bad patents, and helps the Patent and Trademark Office (PTO) address the backlog of patent applications. 

For those interested, the full text of the Act can be found at the United States Government Printing Office as a PDF.

From NIH OER: OMB Asks for Comments on Potential Reforms to Federal Grant Policies

The Office of Management and Budget just published a notice in the Federal Register asking for public comment on potential reforms to federal grant policies contained in OMB circulars such as A-21, A-133, and A-122. These include ideas that would standardize information collection across agencies, adopt a risk-based model for single audits, and provide new administrative approaches for determining and monitoring the allocation of federal funds. These ideas reflect the input of a number of groups that have been considering these issues over the past few months, including the A-21 Task Force, which I have mentioned here before.

I encourage you to read the notice in full. To give you an idea of the scope of the proposed reform, here are some of the ideas discussed:

• Exploring alternatives to time-and-effort reporting requirements for salaries and wages 
• Charging directly allocable administrative support as a direct cost Including the cost of certain computing devices as allowable direct cost supplies 
• Consolidating the cost principles into a single document, with limited variations by type of entity 
• For indirect (“facilities and administrative”) costs, using flat rates instead of negotiated rates 

As you can see, some of these changes, if implemented, will have a broad, long-lasting effect on how federal grants are administered. Therefore, it is important to take advantage of this opportunity to provide input to OMB as they consider the proposed reforms.

You can submit comments at http://www.regulations.gov. The comment period closes on March 29, 2012.

Read the original post on the Extramural Nexus Rock Talk here.

Researchers Face Tighter Conflict of Interest Rules

From Grants Resource Center (GRC):

On August 25, 2011, the U.S. Department of Health and Human Services (HHS) issued a final rule that amends the 1995 Public Health Service (PHS) regulations on applicant responsibilities for promoting research objectivity. The new ruling establishes standards to ensure that the design, conduct, and reporting of research funded under PHS grants and cooperative agreements will be free from bias resulting from investigator financial conflicts of interest (FCOI). Institutions have until August 24, 2012 to be in full compliance with the new requirements.

The reasons for the amendments are twofold. First, the growing complexity of biomedical and behavioral research and the increased interaction among the government, research institutions, and the private sector, especially drug companies, suggest that a more rigorous approach to investigator disclosure, institutional management of financial conflicts, and federal oversight is required. Second, the promises of translational research, the challenges of technology transfer, and intense expectations at all levels of government that universities function as engines of socio-economic development generate new pressures on institutions and their faculty members to expand their relationships and deepen their engagement with industry.

The amended regulations include a number of changes with which PHS applicants must comply:

• Designating institutional officials to solicit and review disclosures of significant financial interests (SFI) from each investigator participating in the PHS-funded research. Each investigator planning to participate in the PHS-funded research must disclose to the institution's designated official the investigator's SFIs (and those of the investigator's spouse and dependent children) no later than the time of application for PHS-funded research;
• Lowering the SFI threshold from $10,000 to $5,000 for payments, equity interests, and any equity interest in non-publicly traded entities;
• Excluding income from seminars, lectures, teaching, or service on advisory or review panels;
• Expanding investigator disclosure requirements to include SFIs that are related to an investigator's institutional responsibilities, with institutions responsible for determining whether a disclosed SFI relates to the research for which PHS funding is sought and constitutes a FCOI.
• Requiring that institutions maintain an up-to-date, written, enforced policy on FCOIs that is available via a publicly accessible website;
• Requiring FCOI training for each investigator on any PHS-funded grant or contract prior to engaging in research, and at least every four years thereafter;
• Requiring PHS-funded awardee institutions to take reasonable steps to ensure that any subrecipient investigator complies with the institutional policy;
• Expanding the scope of the regulations to include Small Business Innovation Research and Small Business Technology Transfer (SBIR/STTR) Phase I applications; and
• Requiring each investigator who is participating in the PHS-funded research to submit an updated disclosure of SFIs at least annually.

GRC will continue to follow this issue and SPO will post updates as they appear. Additional details are available online.

NIH Policy Changes: A Summary

Policy Change/Update	Effective Date
All applications must be submitted in response to an funding opportunity announcement	9/25/10
New policy on post-submission application materials	9/25/10
Revised NIH Grants Policy Statement effective	10/1/10
Transparency Act reporting for all new awards	10/1/10
Multi-year funded award progress reports submitted electronically	12/22/10
Mandatory use of XTrain	1/1/11
New page limits for career awards	1/7/11
End of A2 submissions	1/7/11
Time limit for resubmissions	1/25/11
Adobe forms B1 required for F,K,T, and D apps	1/25/11
End of two-day error correction window	1/25/11
Expenditure data submitted via FFR	2/1/11
New reference letter due dates	4/8/11 and 6/12/11
Adobe forms B1 for all electronic apps	5/7/11
Late submission policy	n/a

**Taken from NIH Extramural Nexus Blog**