Since NIH’s release of the new human subjects and clinical trial data form in January 2018, VUMC has submitted more than 750 human subjects proposals using the new form. We have all learned a lot from this experience. This month the Coeus team invites interested administrators to discuss best practices for submitting human subjects and clinical trial proposals to NIH. Potential topics include: Granting investigators permission/access to eCat Determining data/specimens vs. human subjects Dividing a clinical trial proposal into multiple studies Exemption 4 vs. data/specimens The ‘Date of First Enrollment’ field There is limited room available, so if you are interested, please complete the form below. Interested parties will receive further communication regarding time, place, and content. Please feel free to contact us with any questions. The Coeus team is also open to additional relevant topics and hopes this session is more of a discussion than purely an informational session.
As a reminder, as of January 25, 2019, applicants utilizing human subjects (including those whose research is considered exempt) are required to include both a rationale for the age-range of study participants and justification for age-based exclusion. This new requirement seeks to ensure that NIH-funded research is applicable to all individuals affected by a condition and address concerns that certain groups (i.e., children and older adults) are disproportionately absent from clinical research. For VUMC applicants, this information will be captured in eCat as part of the FORMS-E PHS Human Subjects and Clinical Trials Information form. This information should be included in the attachment for “Inclusion of Women, Minorities, and Children (Section 2.4).” Please consult NIH’s detailed FAQ page regarding this policy, and do not hesitate to reach out to OSP with any questions or concerns.
OSP would like to remind all applicants to verify that any NCT numbers listed on a grant application (Section 1 in the FORMS-E human subjects section, i.e., eCat) link to an existing clinical trial within ClinicalTrials.gov. Any incorrectly listed identifiers will error out upon submission to NIH. To check an NCT number: Visit ClinicalTrials.gov Select “Advanced Search” from either the home page or under the “Find Studies” ribbon at the top of the page Enter the NCT number in the “Study IDs” field under “Targeted Search” To locate an NCT number, use the same general search process as above but with different search terms/fields. Upon finding the intended result, the NCT number will be located under “Contacts and Locations.” If you need assistance or information on registering a new clinical trial at ClinicalTrials.gov, please visit VUMC’s ClinicalTrial.gov resource page.
OSP consistently receives questions about the ability of applicants to exchange and/or edit narratives after the department has routed a proposal for review and approval. This is indeed allowed; in fact, VUMC is unique in providing researchers the ability to exchange and edit narrative documents throughout the routing and approval process. These permissions are not limited to the proposal aggregator, either. Additional persons (including the PI) can be given the specific ability to upload and replace narratives through the use of the “Narrative Writer” role. To apply this role, open the proposal in edit mode, navigate to the “Proposal Roles” (Edit ⇒Proposal Roles), and click the “Users” button to search for the individual. Finally, drag the intended individual to the Narrative Writer role. The processes for replacing narratives within the relevant VUMC systems are as follows: In Coeus Once the proposal routes and has “Approval in Progress” status, the proposal is locked for editing, with the exception of those narratives that have
OSP and the Coeus team are excited to announce that eCat–VUMC’s new tool for completing the upcoming PHS Human Subjects and Clinical Trial Information form–is now available in Coeus. Detailed information regarding gaining access and navigating the new tool can be found on the Coeus Help website.
The new FORMS-E application package debuting January 25, 2018, will include a mandatory Human Subjects and Clinical Trial Information form. While the form is required for all studies, proposal creators can simply answer “no” to the human subjects question in Coeus for those proposals that do not include human subjects. For projects that do include human subjects, the Coeus team has developed a new web tool called eCat. eCat replaces the old “Inclusion Enrollment Questionnaire” in Coeus and allows users to answer the new detailed, mandatory form. The tool links to Coeus and gives proposal creators a user-friendly way to answer questions, upload human subjects narratives, and check answers against known NIH validations. eCat will be made available no later than December 15. In the meantime please consult the attached PDF showing which human subjects narratives are required based on how certain questions within the form are answered. Additional documentation and educational opportunities regarding FORMS-E and Coeus will be released throughout December and January.