Like all NIH application forms, the new PHS Human Subjects and Clinical trials Information form is accessed through the submission method you are using. ASSIST, Workspace and all system-to-system solutions provide a way to access and complete the forms. …. Continue reading
The type of FOA you will need depends on whether you anticipate that your delayed onset human subject study will meet the definition of a clinical trial.
If it will, you will need to choose a funding opportunity that explicitly allows clinical trials (it will be designated ‘Clinical Trial Optional’ or ‘Clinical Trial Required’). Be sure to check the ‘Anticipated Clinical Trial’ box when completing your Delayed Onset Study record within the application.
If no clinical trial is involved, you will need to choose a funding opportunity designated as ‘Clinical Trial Optional’ or ‘Clinical Trial Not Allowed.’
When completing your application, follow the SF 424’s Delayed Onset Study instructions …. Continue reading
“Delayed Onset” generally means that human subjects research is anticipated within the period of award but definite plans for this involvement cannot be described in the application. It does not apply to a study that can be described but will not start immediately.
Have other questions about clinical trials? Visit …. Continue reading
“We’re preparing a training grant application but don’t have all the historical data requested in the new data tables, such as the length of prior, full-time research experience for trainees entering the program five years ago. What should we do?”
Because reviewers are asked to assess a training program and its record based, in part, on data presented in the tables, applicants should provide as much data…. Continue reading
NIH institutional training grant applications request past and present faculty and trainee data, which are used by peer reviewers and NIH program staff in the evaluation of the application and making funding decisions. For active training grants, NIH requests trainee and faculty data to assess the progress of these ongoing training awards. These data provide insight into: …. Continue reading
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
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
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
To withdraw an application after it has been validated by eRA Commons and moved on to the Center for Scientific Review, there are two ways you can request the withdrawal. …. Continue reading
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