Completing the Compliance Review Page for Funding Proposals

The following are compliance review questions for a funding proposal. Answer these questions carefully to ensure your proposal meets all necessary compliance requirements.

Add additional WVU resources & links to the compliance review

Instructions:

  1. Read each question thoroughly.

  2. For Yes/No questions, select the appropriate answer based on whether it applies to your project.

  3. If you answer "Yes" to a question, be prepared to provide additional information as requested.

  4. For questions with checkboxes, select all options that apply to your project.

  5. Some selections may trigger automatic Ancillary Reviews (AR) or reports, so answer accurately. Tell users which selections trigger

Compliance Review

  1. *Human Subjects Involvement In this Project

  1. *Human Subjects Involvement In this Project

  • Indicate if human subjects are involved in the project (Yes/No). If Yes:

    • Specify if it is a clinical trial

    • Select the IRB review status of this research. Provide relevant dates and protocol numbers based on the status.

  • Approved – If Approved is selected you need to provide:

    • *IRB approval date

    • *Primary IRB protocol number

    • Additional IRB protocol numbers

  • Pending - If Pending is selected you need to provide:

    • *Date protocol submitted to IRB

    • Primary IRB protocol number

    • Additional IRB protocol number

  • Exempt - If Exempt is selected you need to provide:

    • IRB approval date

    • Date protocol submitted to IRB

    • If NIH-funded, select the appropriate IRB exemption codes

    • Primary IRB protocol number

    • Additional IRB protocol numbers

    • Type any additional information that might be useful for this review

  • Not Yet Submitted

Type any additional information that might be useful for this review.

  1. *Laboratory Animals Involvement In this Project

  1. *Laboratory Animals Involvement In this Project

  • Indicate if laboratory animals are involved in this project (Yes/No). If Yes:

    • Provide the approval date, protocol numbers, and other requested information.

  • Select the IACUC review status

    • Approved – If Approved is selected you need to provide:

      • * IACUC approval date

      • * Primary IACUC protocol number

      • Additional IACUC protocol numbers

    • Pending - If Pending is selected you need to provide:

      • * Date protocol submitted to IACUC

      • Primary IACUC protocol number

      • Additional IACUC protocol numbers

    • Not Yet Submitted

  1. *Are Risk Group 4 Or Select Agents Involved in This Project

  1. *Are Risk Group 4 Or Select Agents Involved in This Project

  • Indicate if these are involved (Yes/No) If Yes:

    • Select the IBC review status. Provide approval date, protocol numbers, and other requested information

  • Approved – If Approved is selected you need to provide:

    • * IBC approval date

    • * Primary IBC protocol number

    • Additional IBC protocol numbers

  • Pending - If Pending is selected you need to provide:

    • * Date protocol submitted to IBC

    • Primary IBC protocol number

    • Additional IBC protocol numbers

  • Not Yet Submitted

  1. * Are Toxic Gases or Explosives Required For This Project

  1. * Are Toxic Gases or Explosives Required For This Project

  • Indicate if these are required (Yes/No). If Yes:

    • Select the Safety committee review status of this research. Provide approval date, and registration number

  • Approved – If Approved is selected you need to provide:

    • * Safety committee approval date

    • * Registration number

  • Pending - If Pending is selected you need to provide:

    • * Safety committee submission Date

    • Registration number

  • Not Yet Submitted

  1. * Are Radiation producing devices involved in this project

  1. * Are Radiation producing devices involved in this project

  • Indicate if these are involved (Yes/No)

  1. * Radioisotopes involved in this project

  1. * Radioisotopes involved in this project

Indicate if these are involved (Yes/No)

  1. * Human embryonic stem cells involved in this project

  1. * Human embryonic stem cells involved in this project

  • Indicate if these are involved (Yes/No). If Yes:

    • Specific stem cell cannot be referenced at this time, one from the registry will be used:

    • List the embryonic stem cell lines

  1. * International Considerations

  1. * International Considerations

Select all applicable international aspects of the project.

Note: If any box other than ‘None of the above’ is selected: a. Identify all countries involved b. Provide details about the foreign activity c. Provide foreign component justification

  • Export Administration Regulations (EAR) / International Traffic in Arms (ITAR)

    • International Travel – Remember to Register in Terra Dotta Travel Registry

    • Foreign Subawardee or Vendor (entity or person)

    • Foreign Person (including faculty, student, visiting scholar, unpaid collaborator)

    • Financial or in-kind support from a foreign entity

    • Sponsor or Collaborator to loan or provide equipment to the University

    • Sponsor Requires foreign person approval prior to participation or payment

    • Research involves Iran, Cuba, North Korea, Syria, Russia, Crimea, or Occupied Regions of Ukraine (e.g., entities associated with or travel to one of these countries)

    • None of the above

  1. * Sponsor-specific Compliance Requirements and Budget Considerations

  1. * Sponsor-specific Compliance Requirements and Budget Considerations

  • Select all applicable sponsor-specific requirements. If any box other than ‘None of the above’ is selected, provide a description

    • Does the federal funding agency require an assertion of rights to inventions, technical data, and/or computer software or an intellectual property management plan as part of the proposal?

    • The Sponsor requires annual invention reporting

    • A PI may not publish research results without the Sponsor’s approval, except for the Sponsor’s right to review and exclude their proprietary data from publication.

    • A Diversity Equity Inclusion & Belonging Plan is required. (Add a DEI Ancillary Review)

    • This is an NSF proposal that will include off-site/off-campus research or activities requiring a SAIF plan.

    • This is an NSF or USDA NIFA proposal, and a Mentor Training Plan or an RCR Training Plan is required.

    • None of the Above

  1. * WVU Institutional Policy Compliance and Budget Considerations

  1. * WVU Institutional Policy Compliance and Budget Considerations

  • Select all applicable institutional policy considerations. If any box other than ‘None of the above’ is selected, provide a description

    • Background Intellectual Property (IP) will be used

    • There is a high probability that Foreground Intellectual Property (IP) will be generated

    • The Research will be conducted in locations not owned or managed by the University or the Health System

    • The research will be conducted at a WVU Farm or Forest (e.g., J.W. Ruby Research Farm, Willow Bend Demonstration Farm, University Forest).

    • The research requires renovation, alteration, or unassigned space, expanded utility services (e.g., fume hoods, air conditioning, the purchase or installation of major equipment)

    • This proposal involves a clinical trial or a prospective clinical observational study.

    • This proposal involves third parties accessing WVU Health System (hospital) software or networks or installing/using new software or technology components (cameras, iPads, etc.) on WVU Health System networks or technology environments.

    • None of the above

  1. * Select the species of laboratory animals involved in the project. Select the species of laboratory animals involved.

  1. * Select the species of laboratory animals involved in the project. Select the species of laboratory animals involved.

  • Mouse/Rat

  • Rabbit

  • Pigeons

  • Zebrafish

  • Other (Add an Office of Lab Animals Resources Ancillary Review)

If "Other" is selected, specify the species

  1. * Select the agents involved in the project

  1. * Select the agents involved in the project

  1. * Describe the Radiation producing devices involved in this project

  1. * Describe the Radiation producing devices involved in this project

  1. * Describe the Radioisotopes involved in this project

  1. * Describe the Radioisotopes involved in this project

  1. * WVU Data Management & Protection Compliance AND Technology Budget Considerations

  1. * WVU Data Management & Protection Compliance AND Technology Budget Considerations

  • Select all applicable data management & protection compliance and technology budget considerations

    • The dataset is estimated to be over 2 Terabytes and is high-risk according to WVU policy.

    • WVU baseline data storage services cannot be used.

    • Approved baseline technology (hw/sw/services) cannot be used (including HPC services) and new technology will be purchased or used.

    • The data has regulatory requirements not supported by WVU (CUI, NIST 800/171, CMMC.)

    • The funding agency has specific cybersecurity requirements (an SSP, a form, a Cybersecurity Plan, etc.).

    • This proposal requires information related to Covered Defense Information Controls and Compliance including DFARS 252.204-7020 or DFARS 252.239.7010.

    • This proposal requires a Data Management & Sharing Plan to comply with Public Access policies.

    • The PI requires assistance with the Data Management and Sharing Plan budget (storage, results repository, curation, and other costs).

    • This proposal involves third parties accessing WVU (University) software or networks or installing/using new software or technology components (cameras, iPads, etc.) on WVU networks or technology environments.

    • The research will produce scientific data

    • None of the above

Note: For each section, pay attention to the specific instructions and provide all requested information. Some selections may trigger automatic Ancillary Reviews (AR) or reports.