User Guide: Completing the Compliance Section in ARGO-SPI
Purpose: The Compliance section helps ensure that projects adhere to ethical and regulatory standards. This section covers the use of human and animal subjects, radiation, biological materials, responsible conduct of research, conflict of interest, controlled substances, and export control.
Sections and Field Requirements
- Use of Human Subjects - Institutional Review Board (IRB) (Required)
- Project with human subjects?: Select Yes if the project involves human subjects; otherwise, select No.
- Is there an IRB-approved study?: Select Yes if an IRB-approved protocol exists, and provide the protocol number. Note: IRB approval is required before beginning any research involving human subjects.
- Use of Animals - Institutional Animal Care & Use Committee (IACUC) (Required)
- Project with vertebrate animal subjects?: Select Yes if the project involves vertebrate animals; otherwise, select No.
- Has Laboratory Animal Resources been consulted?: Select Yes if consultations have occurred with Laboratory Animal Resources.
- Is there an IACUC-approved study?: If an IACUC protocol is in place, select Yes and enter the protocol number. IACUC approval is required for projects involving animals.
- Use of Radiation - Radiation Safety Committee (Required)
- Project with radioactive material/radiation?: Select Yes if the project involves the use of radiation or radioactive materials.
- Is there a Radiation-approved study?: Select Yes and provide the protocol number if the Radiation Safety Committee has approved the study.
- Use of Biological Materials - Institutional Biosafety Committee (IBC) (Required)
- Project with biohazards or rDNA?: Select Yes if the project involves biohazardous materials or recombinant DNA (rDNA).
- Is there an IBC-approved study?: Select Yes and enter the protocol number if the Institutional Biosafety Committee has approved the study.
- Responsible Conduct of Research (RCR) (Required)
- Project requires RCR training?: Select Yes if RCR training is required for the PI and Key Personnel. Note: If NSF-sponsored, RCR training is mandatory, as it upholds research integrity. Training resources are available through the CITI Program.
- Conflict of Interest (COI) Disclosure (Required)
- Financial interest or affiliation?: Indicate Yes if you or any covered family member has a financial interest or affiliation with any sponsor, collaborator, or entity mentioned in the proposal. If Yes, provide details in the text box. Covered Family Members include spouses, dependents, and financially interdependent individuals living in the same household.
- Drug Enforcement Administration (DEA) (Required)
- Use of controlled substances or alcohol?: Select Yes if the project involves DEA-controlled substances or alcohol.
- DEA Registration: If applicable, select Yes and provide the DEA registration number.
- Export Control (Required)
- Guidelines on approval/disapproval of publications?: Select Yes if the sponsor’s terms limit publications or public disclosure.
- Export regulations or Controlled Unclassified Information (CUI)?: Select Yes if there are export control regulations or security restrictions.
- Military application?: Select Yes if the project has a military application. Military Application includes tactical vehicle research, testing, or training.
- Involvement of non-U.S. persons?: Select Yes if any sponsor guidelines restrict the involvement of non-U.S. persons.
- Foreign parties involvement?: Select Yes if the project includes foreign entities and provide a list if applicable.
- High-technology items?: Select Yes if the project involves high-tech items such as lasers, drones, or encryption software.
- Exchange of proprietary/confidential information?: Select Yes if the project involves any exchange of proprietary or confidential information with external parties.
Additional Steps
- Consult Compliance Officers: For projects involving human or animal subjects, hazardous materials, or export controls, consult with relevant compliance officers early in the project planning.
- Save and Continue: After completing all required fields, click Save & Continue to proceed