Set-Up Award

Final Regulatory Documents Needed to Process an Award

Background

When an award document is received in the Office of Grants, Contracts and Compliance (OGCC) and negotiation of the award is complete, OGCC must ensure all administrative requirements are in place prior to acceptance of the award and notification to the University and the Principal Investigator. The Internal Notice of Award (INOA) will not be issued until all regulatory documents are received. The most common delays in release of funding include lack of regulatory committee approvals, conflict of interest disclosure, and the award to protocol verification match.

Regulatory Committee Approvals

Most sponsors do not require proof of regulatory committee approval until the award stage. Any scope of work which requires approval from one or more of the regulatory committees must have approval prior to the release of the award synopsis in most cases. Since most of the CDU regulatory committees only meet once per month, Principal Investigators should submit their protocol applications to the appropriate committee as soon as an award appears to be forthcoming.

If a scope of work includes human subjects research, approval from the Institutional Review Board (IRB) may be required. For more information, please contact the Office for the Protection of Human Subjects at 323-563-5902.

If a scope of work includes animal research, approval from the Institutional Animal Care and Use Committee (IACUC) may be required. For more information, please contact the administrative office for IACUC.

If a scope of work includes the use of pathogens or recombinant DNA, approval from the Institutional Biosafety Committee (IBC) may be required. For more information, please contact the administrative office for Biosafety.

Conflict of Interest Disclosure

Depending on the sponsor of a project, Principal Investigators are required to disclose potential conflicts of interest, both financial and in obligation.

For the Public Health Service (PHS) and the National Science Foundation (NSF), as well as those sponsors who adopt the federal requirements, OGCC and the University Auditor must receive the appropriate disclosure form prior to the acceptance of the award.

For non-governmental sponsors, OGCC and the University Auditor must receive the appropriate disclosure form prior to acceptance of the award. For non-governmental sponsors, this is forwarded to OGCC along with the proposal for review.

In cases where a positive interest is identified, the disclosure must be reviewed by the Conflict of Interest Committee (COIC). For more information, please contact the University Auditor.

Award to Protocol Verification

OGCC is responsible for verifying that all federally funded research procedures and activities are authorized by the applicable regulatory committee. This is done to protect both the institution and the investigator from inadvertently spending award dollars to perform unauthorized research procedures or activities in violation of funding agreements (grants or contracts) and/or regulatory requirements. As CDU is subject to unannounced audits by federal regulatory and granting agencies and by private sponsors, it is very important that award information is consistent with regulatory committee approval documentation.

The verification process is completed for federally funded awards within OGCC. If any inconsistencies between the approved protocol and the scope of work in the award are identified, the Principal Investigator or Lead Researcher is contacted by OGCC for resolution. Once again, the OGCC Specialist must verify the match prior to release of funding.