Submit reports and disclosures, and communicate with sponsors

The Program Officer (also referred to as the Program Manager) is a good resource to understand the funding interests of the sponsor and key points of their funding programs. It is generally best for the PI or delegate to send a brief introductory email and ask if there is a good time to set up a call to discuss research goals and which of their programs are applicable or best fit the research idea.

Examples of scientific or programmatic communications include:

• Describing a project idea

  • Questions about whether a project idea is the type of project the sponsor funds

  • Questions about specific aims and their relevance to the sponsor’s mission

  • Discussion of the level of pilot data for feedback

• Questions about shortcomings/problems often seen in applications

  • What sorts of problems often keep proposals from being funded

  • How to avoid those problems

• Asking about traits of successful proposals

  • Are there any areas/activities the agency would like to see represented in projects but which have been overlooked by other applicants?

• Confirming proposal guidelines and funding priorities

  • Questions about any matters that were unclear or puzzling

  • Confirmation of the funding priorities and checks for any changes

  • Who reviews the proposals?

  • How many people review the proposals?

  • How are reviewers chosen?

  • Can investigators suggest reviewers?

Faculty members should contact their grant manager for administrative concerns on funded projects, and can access the Faculty Communication to External Sponsors on Administrative Issues policy for more information. These issues must be addressed by authorized Duke representatives (e.g., ORA, ORS, ORC).

Examples of administrative issues include:

• Interpretation of sponsor policy or guidelines
• Budget allowability
• Appealing a rejection of an application
• Appealing a sponsor’s decision to decrease budget categories for salary and personnel costs.
• Submitting a request for a No Cost Extension
• Requesting prior approval for adding a foreign component or a change in project personnel (such as PI Disengagement)
• Program officer asks about unobligated balances or reductions in effort.

Contact Foundation Relations First List

Administrative communication with certain sponsors is coordinated by the Office of Foundation Relations. Please contact the designated individual noted on this list, in lieu of reaching out directly to the sponsor. This pertains to pre-award and post-award actions, including, but not limited to, questions about allowable budget categories or indirect rate, request for budget revisions or end-date extensions, return of unspent funds, and approval of press releases. Although not required, faculty members are encouraged to alert the designated Foundation Relations representative when they communicate with these sponsors about prospective or on-going projects.

Protocols are in place for reporting various emergencies and incidents, including fires, personal injuries, and biological, chemical, and radiological exposures and spills.

Access the Duke Occupational Health and Safety website for specific guidance on response and reporting procedures.

Protocol deviations (an inadvertent act in which the protocol is not followed) and protocol violations (an intentional act in which the protocol is not followed) must be reported to the IRB if any of the following apply:

• Subject rights and welfare are affected
• Subject safety is affected
• The integrity of study data is affected
• The subject's willingness to continue in the study is affected
• If specifically requested by a government agency, internal/external auditor, medical monitor, or the IRB.

Unanticipated risks or adverse events include any study-related unexpected events that may increase harm to a participant (a new risk, or an event occurring in greater frequency or intensity than expected) or result in a breach of confidentiality.

• For protocols approved by the DUHS IRB, access the policy on unanticipated events for reporting procedures and timelines.
• For protocols approved by the Campus IRB, all protocol deviations and unanticipated risks should be reported as soon as they are identified by filling out a Protocol Deviation Form and emailing it to campusirb@duke.edu.

When amendments are needed to an IRB or IACUC approved protocol, a request must be submitted and approved before those changes to the research project can take place.

Access the Manage study and maintain institutional approval page for information about amending Campus IRB, DUHS IRB, and IACUC protocols.

Any Duke researchers considering transferring or sharing research materials or human subjects data with outside collaborators must alert the Office of Research Contracts (ORC).

Access the Navigate contracts and agreements page for more information.

If any inventions or new technologies arise from research, an Invention Disclosure Form should be submitted to the Duke Office for Translation and Commercialization to begin the process of protecting the idea.

Travel reporting requirements exist for all Duke faculty and staff who receive payments from a Public Health Service grant (NIH, CDC, AHRQ, Dept. of Defense, etc.). If the investigator, their spouse (or spousal equivalent), or dependent children have sponsored travel paid by someone other than Duke, a domestic government agency, or another educational institute, it must be reported to Duke within 30 days of the travel.

Access the Sponsored Travel information page for more information or to submit a sponsored travel disclosure form.

Investigators are required to disclose all resources, including financial, available in support of the individual’s research endeavor, whether the support originates from Federal and non-Federal (including foreign governments, state and local), commercial or institutional sources. If an investigator receives any new support (not disclosed during proposal submission or JIT), it must be disclosed to the institution and the sponsor. 

Access the Disclose activities (Other Support/Current and Pending) page for details, processes, and resources.

Federal sponsors have reporting requirements when a PI/Co-PI has been disciplined due to concerns about harassment, bullying, retaliation, or hostile working conditions. Access the Research Work Environment page for reporting requirements by sponsor. 

• For Campus IRB protocols, a Periodic Check-In Form must be submitted annually for the IRB to review and renew the protocol. For more information about continuing reviews and post-approval monitoring, access the Campus IRB website.
• For DUHS IRB protocols, a continuing renewal must be submitted in iRIS 60 to 45 days prior to the protocol expiration date. Access the DUHS IRB website for more information about continuing reviews and protocol expirations.
• For IACUC protocols, annual reviews are required for all previously approved, ongoing IACUC protocols that indicate use of a USDA regulated species or are supported with VA funds. Access the IACUC continuing review protocol guidance for more information.

Sponsors generally require quarterly or annual reports to provide updates on the scientific progress and financial status of the project. Research teams should coordinate to complete progress reports to the sponsor. Requirements for the final report should be stated in the terms and conditions of the award or contract.

Progress reports often include disclosures of Other Support/Current and Pending. Access the Disclose Activities (Other Support/Current and Pending) page for details, processes, and resources.

Annual project reports should address progress in all activities of the project and should disclose activities such as international travel, participant support activities and other components as required by the award’s sponsor.

An annual outside activities disclosure form is required from all faculty and staff who participate in research at Duke to relay any potential conflicts of interest or conflicts of commitment. Outside activities disclosures should also be updated whenever there is change in status outside of the annual reporting period. Access the DOSI website for more information and access to the disclosure form.

COI form status and access to management plans can be accessed from investigator's profiles in myRESEARCHhome.

Studies that require a Clinical Quality Management Plan (CQMP) will need to complete and enter regulatory and participant chart reviews into the CQM Database within 30 days of the end of the review period according to the respective study complexity level.

For more information, access the DOSI CQMP page.

If a project has a Data Safety Monitoring Board, a report from the Board will likely need to be included with scheduled reports to the sponsor. The notice of award should include details surrounding expectations for Data Safety Monitoring Board reports.

For IACUC approved protocols, investigators are required to track and document the approximate number of animals acquired or generated (through breeding or other means). Reports should be provided on animal numbers used at the request of IACUC, other members of the Duke Animal Program, or other appropriate internal or external oversight bodies.

Access the animal tracking SOP for more information about process and policies.

Sponsors generally require a final report to be submitted within a set time frame of the award ending. Research teams should coordinate to complete the final reports to the sponsor as they often include both scientific and financial updates. Requirements for the final report should be stated in the terms and conditions of the award or contract.

If the final report requires an intellectual property report, a request should be emailed to tonya.peace@duke.edu for a Final Inventions Statements Form (sometimes referred to as DD882) signed off by the Duke Office for Translation and Commercialization.

If any inventions or new technologies arise from research, an Invention Disclosure Form should be submitted to the Duke Office for Translation and Commercialization to begin the process of protecting the idea.

• For DUHS IRB protocols, a final report must be submitted in iRIS (located under the Submissions tab, Submission Forms header) to formally closeout a protocol. Access the Close out the project page for closeout procedures that need occur prior to submitting a final report. 
• IACUC and Campus IRB protocols do not require a formal final report, but should follow all applicable closeout procedures. Access the Close out the project page for more information about closeout procedures.