The following templates can be used to gather information for human subjects forms associated with NIH FORMS-F.

FORMS-F:

• PHSHumanSubjectsAndClinicalTrialsInfo_2_0-V2.0
• PHSHumanSubjectsAndClinicalTrialsInfo_3_0-V3.0

For information about the human subjects form associated with the latest formsets, refer to our resource articles on the subject.

FORMS-F and Data/Specimens

With the release of the FORMS-F formset, one change has been more confusing to investigators and support personnel than any other. This post will attempt to explain NIH’s change to allow BOTH human subjects and data/specimens on a single proposal.

To begin, NIH provides a helpful diagram for deciding whether an aspect of the proposed project is human subjects or data/specimens, available here.

In the past, users who answered ‘Yes’ to the human subjects question in Coeus never saw a question about data/specimens because NIH rules forbid proposals from including both.

Under the new FORMS-F rules, proposals must answer both questions, and submitters can answer ‘Yes’ to both questions. Here is the exact question wording:

• Does the proposed project include human subjects?
• Does the proposed research involve human specimens and/or data?

The most common confusion about this change occurs when users are determining whether their project includes data. It should be understood that almost any project with human subjects or human biological specimens will generate data. Just because a human study generates data, does not mean both questions should be answered ‘Yes.’ For example, data collected from human subjects in a previous phase of the study, such as that reported on the Cumulative Inclusion report, would not be considered data/specimens for purposes of the second question.

Proposals that answer ‘Yes’ to both questions should include human subjects and a separate set of data or specimens connected to a different group of people than those considered human subjects in the project. For example, a de-identified dataset purchased from a third party.

In situations where the proposal answers ‘Yes’ to both questions, the submitter needs to provide the eCat details about human subjects AND upload a separate PDF narrative explaining the data/specimens. If the proposed data/specimens are fully explained in the human subjects eCat information, the answer to the data/specimens question should be “No.”

Submitters can also answer ‘No’ to human subjects and ‘Yes’ to data/specimens if they determine – via the NIH diagram above – there will be no human subjects on the project. In such cases, only the PDF narrative explaining the data/specimens is allowed – no information will be permitted in eCat.

As always, our goal is to help ensure successful proposal submissions to sponsors that garner favorable reviews. While sponsor rules and guidelines can be ambiguous and sometimes contradictory, OSP develops our interpretations based on all published guidance, extensive experience, audit reports, informal sponsor communication, and reviewer comments when available. We are also open to discussions of rules, guidelines, and interpretations with concerned investigators.