What Kind of Information Should I Include in the “Authentication of Key Biological and/or Chemical Resources” Attachment?

Applicants proposing to use established key biological and/or chemical resources are expected to include an authentication plan in the “Authentication of Key Biological and/or Chemical Resources” attachment, even if the key resources were purchased or obtained from an outside source that provided data on prior authentication. The authentication plan must include only a description of the methods proposed to authenticate key resources prior to use and at regular intervals, if appropriate. The plan should be no more than one page. Key resources and the methods for authentication will vary by research field. For example, …. Continue reading

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What Are “Key Biological and/or Chemical Resources” That Should Be Addressed In My Application’s Authentication Plan?

The quality of resources used to conduct research is critical to the ability to reproduce the results, so to address scientific rigor in your NIH application, we ask you to include an authentication plan.

Key resources refer to established resources that will be used in the proposed research.

Key biological and/or chemical resources include, but are not limited to, cell lines, specialty chemicals, antibodies and other biologics. Key biological and/or chemical resources may or may not have been generated with NIH funds and: …. 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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How Can I Check If I Am Eligible to Submit an Application Under NIH’s Continuous Submission Policy?

NIH’s continuous submission policy provides members of review and advisory groups and reviewers with recent substantial service the benefit of submitting R01, R21, and R34 applications at any time in response to active funding opportunity announcements (FOAs) that have standard due dates. You can check your eligibility to submit applications under NIH’s continuous submission policy by logging into eRA Commons …. NIH recently published consolidated guidance on continuous submission. …. Continue reading

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Does NIH Expect Completion of GCP Training by the January 1, 2017 Effective Date?

Institutions need not regard the NIH Good Clinical Practice (GCP) policy’s effective date as a deadline by which we expect NIH-funded investigators and clinical trial staff involved in the design, conduct, oversight, or management of clinical trials to complete GCP training. Rather, as long as steps are being taken to meet the expectation, e.g., staff who have not yet been trained have signed up for a course, the training itself can be completed after the effective date. For more information, …. Continue reading

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