Certificates of Confidentiality for NIH Grants

Earlier this year I wrote a post about the 21st Century Cures Act and its changes that directly affect the NIH. One part of this new legislation contains provisions to improve clinical research and privacy through certificates of confidentiality.

Currently, certificates of confidentiality (or “CoCs”) are provided upon request to researchers collecting sensitive information about research participants. Soon, CoCs will be automatically provided for NIH-supported research, as set forth in the 21st Century Cures Act. …. Continue reading

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Updated Resource for Clinical Regulations Across the Globe

NIH’s National Institute of Allergy and Infectious Diseases (NIAID) ClinRegs website provides clinical regulations for countries around the world. Since its initial release, the site has undergone several functionality upgrades to make the site easier to use. The updated site includes: a new interactive map on the homepage to provide a clearer picture of the countries included; hyperlinked table of contents on each country ….. Continue reading

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Applications, Resubmissions, and the Relative Citation Ratio

Measuring the impact of NIH grants is an important input in our stewardship of research funding. One metric we can use to look at impact, discussed previously on this blog, is the relative citation ratio (or RCR). This measure – which NIH has made freely available through the iCite tool – aims to go further than just raw numbers of published research findings or citations, by quantifying the impact and influence of a research article both within the context of its research field and benchmarked against publications resulting from NIH R01 awards.

In light of our more recent posts on applications and resubmissions, we’d like to go a step further by looking at long-term bibliometric outcomes as a function of submission number. In other words, are there any observable trends in the impact of publications resulting from an NIH grant funded as an A0, versus those funded as an A1 or A2? And does that answer change when we take into account how much funding each grant received? …. Continue reading

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A Reminder of Your Roles as Applicants and Reviewers in Maintaining the Confidentiality of Peer Review

Imagine this: you’re a reviewer on an NIH study section, and receive a greeting card from the Principal Investigator (PI) on an application you are reviewing. A note written inside the card asks that your look favorably upon the application, and in return, the PI would put in a good word with his friend serving on your promotion committee. Do you accept the offer, or just ignore it? Or, do you report it? …. Or maybe several days after the initial peer review of your application, you receive a phone call from a colleague you haven’t spoken to in quite a while. The colleague is excited about a new technique you developed and wishes to collaborate. You realize the only place you’ve disclosed this new technique is in your recently reviewed NIH grant application. What do you do? …. Continue reading

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NIH Fiscal Operations and Interim Salary Cap Guidance

NIH continues to operate under a continuing resolution, meaning that we will issue non-competing research grant awards at a level below that indicated on the most recent Notice of Award (generally up to 90% of the previously committed level), as we have in past years. See our March 17 Guide notice for details. We have also issued interim guidance on salary limits for NIH grants and cooperative agreements. …. Continue reading

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What is a “Person Month” & How Do I Calculate It?

A “person month” is the metric for expressing the effort (amount of time) principal investigators (PIs), faculty and other senior personnel devote to a specific project. The effort is based on the type of appointment of the individual with the organization; e.g., calendar year (CY), academic year (AY), and/or summer term (SM); and the organization’s definition of such. For instance, some institutions define the academic year as a 9-month appointment while others define it as a 10-month appointment.

Conversion of percentage of effort to person months is straight-forward. To calculate person months, multiply the percentage of your effort associated with the project times the number of months of your appointment. For example: …. Continue reading

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Following Up On Interim Research Products

The role of preprints — complete and public draft manuscripts which have not gone through the formal peer review, editing, or journal publishing process – continues to be a hot topic in the biological and medical sciences. In January, three major biomedical research funders – HHMI, the MRC, and the Wellcome Trust, changed their policies to allow preprints to be cited in their progress reports and applications.

Thinking about preprints also raises questions about the broader class of interim research products, and the role they should play in NIH processes. Other interim products include products like preregistration of protocols or research methods, to publicly declare key elements of a research project in advance. While, under current policy, NIH does not restrict items cited in the research plan of an application, applicants cannot claim preprints in biosketches or progress reports.

So, in October, we issued a call for comments to get a fuller understanding of how the NIH-supported research community uses and thinks about interim research products. Today I’d like to follow up with what we’ve learned from your input, and the policy changes this feedback suggests. …. Continue reading

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