There has been considerable discussion on Sally Rockey’s Rock Talk blog and elsewhere about NIH’s pilot advisory council review of applications from investigators who have received more than $1.5 million in NIH research project grant support. As you may know, NIGMS has a longstanding policy of advisory council review of well-funded laboratories, but it differs from the NIH policy in several respects. At its May meeting, the NIGMS Advisory Council voted to continue our existing policy, which sets the threshold for special review at $750,000 in direct costs for all support. The chart below outlines some of the differences between the NIH and NIGMS policies.

	NIH	NIGMS
Funding source	NIH only	NIH and non-NIH
Threshold	$1.5M total costs on existing grants	$750K direct costs including the pending application
Exclusions	RFAs, P01s, some multi-PI awards	Resource awards

The revised regulations on extramural investigators’ financial conflicts of interest have been published in the Federal Register. The final rule is based on input NIH received from the community. The revised regulations, as outlined by NIH’s Sally Rockey, now:

• Require investigators to disclose to their institutions all of their significant financial interests related to their institutional responsibilities as opposed to only those that they see as related to Public Health Service (PHS)-supported research.

• Lower the monetary threshold for disclosure of significant financial interests, from $10,000 to $5,000.

• Require institutions to report to the PHS awarding component more comprehensively on identified financial conflicts of interest and how they are being managed.

• Require institutions to make certain information concerning identified financial conflicts of interest held by senior/key personnel accessible to the public.

• Require investigators to be trained on the regulations and their institution’s financial conflict of interest policy at designated times.

NIH is developing training materials, which will be posted on its Financial Conflict of Interest website. For more details, visit the “quick links.”

NIH has rescinded the earlier notice regarding the status of applications and grants involving human embryonic stem cells. The new notice states that the receipt, processing, review and awarding of NIH applications and proposals involving human embryonic stem cells will continue. It goes on to list the following actions:

• The suspension of further NIH activity to implement, apply or act pursuant to the NIH Guidelines is hereby lifted.
• The suspension of the issuance of all pending competing, and noncompeting continuation hESC awards and contracts approved for funding is hereby lifted.
• The suspension of the peer review of all pending competing hESC applications and proposals is hereby lifted.
• The NIH Human Embryonic Stem Cell Registry will resume accepting submissions of information about hESC lines for the purpose of establishing eligibility for funding under the NIH Guidelines. The NIH review of hESC lines for inclusion on the Registry under the NIH Guidelines will also resume.

NIH has issued a notice describing the status of applications and grants that propose research using human embryonic stem cells (hESC). Among its points are:

• Any further NIH activity to implement, apply or act pursuant to the NIH Guidelines is hereby suspended until further notice.
• Issuance of all pending competing, and noncompeting continuation hESC awards and contracts is suspended until further notice.
• The peer review of all pending competing hESC applications and proposals is suspended until further notice.

Grants affected include all types of research and training. We expect more guidance soon and will let you know when it’s posted.

The August issue of NIH’s Extramural Nexus includes two announcements that might interest you.

Impact Score Paragraph in Summary Statements

Starting with September grant application reviews, reviewers will include a summary paragraph to explain what factors they considered in assigning the overall impact score. This should help investigators better understand the reasons for the score.

Plain Language in Public Sections of Grant Applications

The director’s column talks about the importance of communicating research value in your grant application.

Your grant title, abstract and statement of public health relevance are very important. Once a grant is funded, these items are available to the public through NIH’s RePORTER database. Many people are interested in learning about research supported with taxpayer dollars, so I encourage you to be clear and accurate in writing these parts of your application. Reviewers are being told to expect plain language in these sections.

The Nexus column includes links to these helpful resources:

• Communicating Research Intent and Value in NIH Applications
• All About Grants Podcast Series
• Tips for Using Plain Language
• Tips on Writing Your Application