Notable NIH Changes January 2018

NIH Changes Effective 1.25.18

National Institutes of Health (NIH) has made a number of changes to support accountability & transparency in Human Subjects & Clinical Trials Research.  

Notable changes for proposal preparation are coming this January, and apply to applications due on or after 1.25.18. 

Use the Right FORMS Package

All NIH and AHRQ applications with an intended due date on or after January 25, 2018 must be submitted using the new FORMS-E.

FORMS-E Changes & Human Subjects / Clinical Trials form

Most of the changes in the FORMS-E application package are reflected in a new human subjects / clinical trial (HS/CT) form. This form consolidates HS/CT information and collects it at the study-level. 

It requires a significant amount of “science” information. We recommend reviewing  the HS/CT form early in the proposal development process.

Select the Right Funding Opportunity Announcement (FOA)

If your research meets the NIH Definition of a Clinical Trial  you must apply to the FOA that allows Clinical Trials. This definition is broad and some researchers may not be aware NIH considers their study a Clinical Trial. Reviewing NIH’s Clinical Trial Decision Tree and  Case Studies can help with this determination.

NIH Clinical Trials Resources:

·         Definition of a Clinical Trial

·         Clinical Trial Decision Tree

·         Clinical Trial Case Studies

·         Policy on FOAs for Clinical Trials (NOT-OD-18-106)

Confirming Form Version & FOA:

·         Does your human subjects research study meet the NIH definition of a clinical trial?

·         Do I Have the Right Form Version For My Application?

·         Competition ID indicates FORM version

·         Validations built into SAGE Grant Runner and NIH ASSIST can help prevent incorrect FORM submissions and help ensure you are responding to the correct FOA.

FORMS-E Resources:

·         Annotated Form Sets

·         Application Forms, Form Updates, Choosing Correct Forms FAQs

·         NOT-OD-18-009

New Single IRB Policy

Many NIH applications for multi-site research submitted on or after January 25, 2018 must include a plan for using a single IRB for all domestic sites. The Human Subjects Division provides detailed information for:

·         Which grants need to include the Single IRB Plan attachment

·         What to put in your Single IRB Plan

·         How to select a Single IRB and how to address the costs of a Single IRB

NIH Guidance:

·         Implementation Guidance, includes information about the single IRB plan

·         How to Request an Exception to the Single IRB Policy 

SAGE Grant Runner Updates Support NIH Changes

Using Grant Runner for many NIH Opportunities reduces duplicate entry & routes with the eGC1. 

Grant Runner applications created with FORMS-D cannot be converted to FORMS-E.

With the SAGE release on 12.21.17, SAGE users now have the option of either manually entering data in the HS/CT form directly in SAGE, or to import the fillable PDF for a given study. This blank fillable PDF form can be downloaded from the HS/CT home page in SAGE. Partially completed HS/CT PDFs can be imported, and users can make final edits directly in SAGE thereafter.

Validations in SAGE using “Check for Errors” help inform if the correct FOA and FORMS version are being used.

Review more information on federal proposal submission options:  Grants.gov Adobe Form s Are Going Away!

Other Post Award Clinical Trial Stewardship Reminders

Good Clinical Practice (GCP) Training

·         NIH: Good Clinical Practice (GCP) Training

·         Access GCP training records from CITI in: MyResearch Training Transcript

·         Access Online GCP training options

Clinical Trials Registration & Reporting Requirements

·         CT.gov Registration & Reporting Requirements

·         UW Human Subjects Division: Clinical Trial Registration & Reporting

Certificates of Confidentiality (CoC)

The CoC definition of Human Subjects is broader and a Certificate of Confidentiality is now automatically applied to all active NIH awards.

·         NIH Certificate of Confidentiality (CoC) Policy

·         Office of Research CoC Guidance

Thank you,
Carol Rhodes
Director
Office of Sponsored Programs