Samson Vowles

The latest formsets require human subjects researchers to parse their human subjects information into numerous text fields, drop-down menus, and several new narrative attachments.

NIH claims the new form set “Expands the use of discrete form fields to capture [human subject] information to provide the level of detail needed for peer review.” Also, this new format “presents key information to reviewers and agency staff in a consistent format” that “aligns with ClinicalTrials.gov (where possible) and positions the NIH for future data exchange with ClinicalTrials.gov.”

In other words – the new form set is intended to make peer review faster and more consistent. The new form set also allows NIH to use proposal information to create large comparable data sets that lend themselves to analysis.

However, the new form set may tempt proposal writers into using similar language in multiple text fields and attachments. This should be avoided!

According to NIH: “avoid redundancies [in human subjects proposal information]. Be especially careful to avoid redundancies with your research strategy.”

“The PHS Human Subjects and Clinical Trials Information form will capture detailed information at the study level. Although you are encouraged to refer to information in the PHS Human Subjects and Clinical Trials Information form in your discussion of the Research Strategy, do not duplicate information between the Research Strategy attachment and the PHS Human Subjects and Clinical Trials Information form.”

NIH also warns: “Do not use the [human subjects attachments] to circumvent the page limits of the Research Strategy.”

Conclusion: Carefully read FOA instructions and NIH’s guidelines for the Human Subjects and Clinical Trial Information form. NIH has provided instructions for each question, data field, and attachment (marked with blue question marks in eCat.) Providing the requested information in the appropriate location will make the review process easier and improve chances of a positive review.