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Research Department (RD) Research Proposal Review Process
The MSHA RD serves to support MSHA staff and ETSU faculty by facilitating applications for research studies. Acting in the capacity of the MSHA's designated authorized official, MSHA RD staff reviews and approves all sponsored and non-sponsored research proposals on behalf of the Principal Investigator and the MSHA. MSHA RD staff serves as a resource for faculty and staff with questions regarding the myriad of sponsor proposal requirements. MSHA RD staff are committed to helping faculty to prepare their best and most competitive sponsored research proposals.
The review process represents collaboration between the Principal Investigator, the Corporate Director of the MSHA Research Department, other MSHA Departments or private offices (when appropriate). MSHA RD may provide a comprehensive pre-submission administrative review to ensure a complete and accurate proposal and compliance with sponsor and ETSU institutional policies. At times, MSHA RD requests changes that brings the proposal into compliance with guidelines and policies, or suggests changes to enhance funding success. When the proposal is completed, MSHA Research Department provides ETSU institutional endorsement of the proposal.
Please note that MSHA Research Department must frequently review and submit many different proposals for the same deadline, carefully allocating time to each. MSHA RD can provide the highest level of service to Principal Investigator when adequate lead time is given to review the proposal. Standard internal deadlines: initial notification and budget/administrative materials - 30 work days prior to IRB submission deadline; complete proposal - 2 weeks prior to the IRB submission deadline.
Once MSHA RD may review all study documentation via ETSU IRB Manager. Study documents will be forwarded for additional review and approval to Mountain States internal departments supporting study. That may include: Legal Department, Finance Department, Accounting, departments providing specific services (radiology, cardiology, etc.).
Process of approval may include but not limited to:
- Reviewing the solicitation, program announcement, or request for MSHA Research Request Proposal Form (RPRF) (if applicable)
- Gathering any past related proposals or awards (e.g., for non-competing continuations)
- Assuring that Principal Investigator, Department Chair (as applicable), MSHA Corporate Director of Research, MSHA VP/CMO and MSHA Senior VP/CMO have signed the RPR form
- Assuring that all required conflict of interest and training forms are available for review.
- Verifying credentials and/or privileges for all MSHA/ETSU personnel listed on the proposal and ensuring that coverage for unnamed research staff is appropriate and reasonable
- Reconciling effort commitments in the proposal with those indicated on the RPRF form; this ensures that all members of study team are aware of their responsibilities.
- Verifying that correct rates have been applied and calculated in the budget for fringe benefits and facilities and administrative (F&A); this helps to ensure both that awarded funding is adequate
- Confirming cost sharing requirements and MSHA/ETSU funding sources (when applicable)
- Reviewing equipment quotes, subcontract budgets, sponsor protocol approvals, etc. (when applicable)
- Reviewing the budget justification for Class A studies to ensure that the explanation of budget line items is reasonable and accurate, and includes only allowable costs.
- Confirming an administrative approval by collection of the signatures of MSHA Corporate Director of Research, MSHA VP/CMO, MSHA Senior VP/CMO and department managers supporting research project through ETSU IRB Manager
Collaborative Institutional Training
Clinical Trials Registry
HHS-Office for Human Research Protections
Human Subject Regulations Decision Charts
Food and Drug Administration Homepage
ICH/Good Clinical Practices
Association for the Accreditation of Human
Research Protection Programs, Inc.
Association for Clinical Research Professionals
Society of Clinical Research Associates
The Institutional Review Board Discussion and News Forum
Public Responsibility in Medicine and Research
National Counsel of University Research Administration