Coeus In-Person: eCat and Human Subjects Proposals

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.

Including the Required ‘Inclusion Across the Lifespan’ Information Within an NIH Application

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.

New DISCOVR-E Enhancements

Vanderbilt’s Human Research Protections Program recently debuted changes to its DISCOVR-E system: ‘Single IRB Performance Sites’ table ‘New Site’ option under ‘Add Submission’ to add one or more relying sIRB sites ‘Performance Sites’ table to capture other not engaged or engaged sites For more information please visit VHRPP’s single IRB webpage.

eRA Commons System Update: New Two-Step Submission Process for RPPRs Containing Inclusion Enrollment Data

As you may recall from previous communication, last summer eRA Commons replaced its Inclusion Management System (IMS) with the Human Subject System (HSS). The new system allows grantees to report and update human subjects and clinical trial data to NIH. Effective immediately, all investigators submitting RPPRs with inclusion enrollment updates must undergo a two-part RPPR submission process: one in ASSIST for inclusion data and a separate submission for the fully completed RPPR.    If inclusion enrollment updates are required, the investigator should first save the RPPR and then select the “Human Subjects” link from “G.4.b – Inclusion Enrollment Data.” This will automatically open the “Human Subjects and Clinical Trials (HSCT)” form in ASSIST. Upon completion of any updates, the PI must mark the ASSIST file status as “Ready for Submission.” This will trigger an email from Commons to OSP’s central email box. An OSP specialist must review and submit inclusion enrollment updates prior to the submission of the full RPPR file. Only

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Implementation of the Revised Common Rule

Last year the Department of Health and Human Services, along with a number of other federal agencies, announced revisions to regulations surrounding human subjects research (i.e., the Common Rule). The Revised Common Rule (NOT-OD-19-050) is set to go into effect on January 21, 2019 (changed from the previous date of January 19), and applies to all studies initiated on or after this date. Key changes include the following: Modifications to continuing review requirements New categories of studies now excluded from mandatory IRB review Additions and modifications to exemption categories Modifications to informed consent requirements (including the required publication of consent documents on http://www.ClinicalTrials.gov) Introduction of broad consent (though VUMC will not implement at this time) Expansion of single IRB for multi-site research (compliance date: January 19, 2020) Please note that we have updated Coeus to reflect the addition of the two new exemption categories. Furthermore, we would like to clarify that NIH’s upcoming exemption label change (from an ‘E’ to

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“Basic Experimental Studies with Humans Required” FOAs

In October 2014 NIH debuted a new clinical trial definition: “a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include a placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.” Since then, NIH has noted concerns that not all studies meeting this new clinical trial definition are “clinical” in nature; as such, NIH recently introduced new funding opportunities that are designated “Basic Experimental Studies with Humans Required” for those studies that meet the definition of basic research and are subject to clinical trial policies, as outlined in the definition above. Please note, however, that many institutes/centers will still accept basic experimental studies with humans within existing FOAs that accept clinical trials (i.e., Clinical Trial Required or Clinical Trial Optional). Please consult the relevant FOA for clarification and/or confirmation. NIH has provided a helpful comparison chart to differentiate among “Clinical Trial Not

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Updated Form: Protection of Human Subjects Assurance Identification/IRB Certification/Declaration of Exemption (Common Rule)

HHS recently updated the “Protection of Human Subjects Assurance Identification/IRB Certification/Declaration of Exemption (Common Rule)” form that is often submitted during JIT for NIH and other federal agencies. Please note this document is used to demonstrate VUMC’s certification of compliance regarding IRB review and approval in accordance with the Common Rule (federal policy for the protection of human subjects).  The form can be accessed here, or through OSP’s website, under “Forms.” Please be sure to update your files with the new form.

eRA Commons System Change: Human Subjects System (HSS) and Impact on Upcoming RPPR Submissions

As you may know, eRA Commons replaced its Inclusion Management System (IMS) with the Human Subject System (HSS) this past weekend (June 8). The new system allows grantees to report and update human subjects and clinical trial data to NIH. Now that OSP has navigated and independently tested the new system, we want to provide an update to the VUMC research community. Based on our understanding of established eRA HSS system validations and communications with NIH, please note the following: The new HSS system allows access rights for inputting data to only the PI or SO; as such, there is no “Delegation of PI” role within HSS as part of the RPPR process. Data should be entered by the PI. The PI enters the system through Section G.4.b of the RPPR. This link directs the PI to a newly created “Post-Submission” record within NIH’s ASSIST system. The form-set mirrors the “Human Subjects and Clinical Trial Information” (HSCT) form used in the

read more eRA Commons System Change: Human Subjects System (HSS) and Impact on Upcoming RPPR Submissions

What Happens When OSP Requires More Documentation Than the Sponsor?

In the event that a sponsor does not request a particular item that is required for OSP review and approval, that item must still be included within the Coeus proposal. As a reminder, the following items are required for Coeus routing and approval: Sponsor guidelines – PDF or permanent link Scope of work (SOW) Final budget Final budget justification As applicable: Facilities and other resources Human subjects and/or vertebrate animals Outgoing subcontract narratives (i.e. LOI, budget, budget justification) Please contact your OSP specialist with any questions or concerns.

IRB and IACUC Amendments

Are you looking to add a funding source to an existing IRB or IACUC protocol as part of your grant application? Please note that any IRB or IACUC protocol amendments must be completed at JIT. If the protocol amendment is not completed in time for submission with other JIT materials, OSP will only be able to submit the respective IRB or IACUC protocol as ‘pending.’ Once these materials have been received, OSP will submit the final approvals to NIH. Please note that the failure to submit approved IRB or IACUC protocols during JIT may result in a delay in award issuance or a restriction on an issued award. For further questions please contact your OSP specialist.