COMPLIANCE RESPONSIBILITY
Compliance is everyone’s responsibility. The institutional and personal consequences of non-compliance are significant. Fines and penalties, additional oversight and monitoring, and suspension or debarment are only a few of the actions the federal government can impose. There is also the reputational damage to the institution and individuals involved.
Principal Investigators (PI) and Department Administrators (DA), along with Mass General Brigham Research Management and Research Compliance, all play an important role in ensuring that Mass General Brigham institutions comply with federal regulations. This shared responsibility is reinforced on a daily basis throughout the lifecycle of the award. It begins with application submission and a formal acknowledgement by the PI of their compliance responsibilities. In place of signing the grant application, federal sponsors typically require the institution to obtain the PI’s signature to a compliance assurance. At Mass General Brigham, this is handled through the PI Assurance in Insight.
By signing off in Insight, the PI:
1. Approves of the research project and accepts responsibility for compliance with all regulations, laws, policies, as well as the use of space, salary verification, cost-sharing, and disclosure of conflict of financial interest.
2. Acknowledges compliance with the NIH Notice Dated April 7, 2006 – Mandatory Assurance Certification:
I certify that the statements herein are true, complete and accurate to the best of my knowledge. I am aware that any false, fictitious, or fraudulent statements or claims may subject me to criminal, civil, or administrative penalties. I agree to accept responsibility for the scientific conduct of the project and to provide the required progress reports if a grant is awarded as a result of this application.
3. Agrees to monitor subrecipients and New Proposals:
I confirm that I have reviewed all sub-awards included in this proposal. All direct costs have been reviewed and appear reasonable given the proposal statement of work. All fringe benefits and indirect cost rates have been verified with the sub awardee organization as being current for the proposed duration. There is a reasonable expectation that the sub-award PI and the sub-award institution will competently perform the technical and administrative tasks required for the successful completion of the project. Furthermore, I acknowledge scientific and financial oversight of this study.
4. Ongoing projects:
I attest that I have been monitoring the sub-recipient technical progress by: (i) Communication regularly with sub-recipient PI, (ii) Monitoring receipt of technical report for timelines and content, and (iii) Communicating with Research Management if changes need to be made to the Statement of Work (SOW), reporting requirements, or budgets.
When Research Management signs the grant application on behalf of the Mass General Brigham institution, it is certifying, acknowledging, and accepting responsibility for the project. Additionally, Chief and SVP approval is collected through Insight when appropriate. When facilitating the management of a grant with the PI, the DA acts as a corporate agent and manager for the hospital making them an important part of the institutional compliance matrix.