Our application instructions provide guidance to submit a study record for each protocol. When in doubt, NIH supports lumping several aims or hypotheses into a single study record, to the extent that makes sense for your research.

Have other questions related to the new PHS Human Subject and Clinical Trial form or NIH clinical trial policies? Find more FAQs and their answers at grants.nih.gov.

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. ….

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 ….

“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 ….

“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….

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: ….

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, ….

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: ….

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: ….

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. ….