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Services

Administrative Support
  • Leadership in the protection of the rights, welfare, and well-being of subjects involved in research supported by Mountain States
  • Evaluation of the  scientific value of new proposals
  • Developing collaborative network with other research organizations
  • Posting e-newsletter (quarterly)
  • Maintenance of Mountain States intranet/Internet web page
  • Monitoring studies for protocol and IRB compliance
  • Communication with leaders in research industry
Regulatory Support
  • Assistance with obtaining ETSU IRB Manager training
  • Assistance with completion of the IRB applications
  • Maintenance of IRB records (submissions/approvals)
  • Participation in local IRB meetings
  • Development of research form(s), Study Source Documents
Legal Support
  • Assistance with review and negotiation of the Confidentially Agreements and Study Contracts
  • Assistance with review and negotiation of ETSU- MSHA research related contracts
  • Confirmation of credentials and training (licenses, CV’s, CITI, etc.)
  • Development and implementation of SOP’s
  • Completion of audits for compliance purpose
Financial Support
  • Review and negotiation of study budgets (Class A and Class B/per request)
  • Assigning research rates/procedure cost in collaboration with Finance department
  • Coordination of hospital and physician billing for clinical research patients
  • Assistance with  monitoring of internal invoices
  • Maintaining Class A budget and PI payment plan
Service Arrangement
  • Notification of managers and arrangement of appropriate study training
  • Collaborative assessment of local resources
  • Assistance with service agreement development
  • Setting up billing arrangements
Clinical Support (Class A)
  • Completion of protocol assigned activities including but not limited to identifying research participants, scheduling study/test visits, collecting study samples,  collecting and reporting data, responding to queries
 Educational Support      
  • Setting up training sessions at least once a month ( mandatory MSHA Research Orientation  training or specific session per PI request)

  • MSHA Research Conferences (ex: nursing/evidence based; annual trauma)

  • Notice of available web training via ACRP, SCRP, etc.

Research Facilitation and Consulting Services
Fee Schedule

The Department of Research serves as the central office providing oversight for all Mountain States research activities.

Student / new PI Orientation Fee for funded studies 

 $100
Initial IRB Submission for Industry-Sponsored Studies  $2500
Continuing Review  $1250
Study Closure   $550
Modification: major   $1000
Modification: minor   $250
Informed Consent Document Preparation   $300
Budget/Contract Negotiation & Preparation   $350
Data Collection Tool Design   $75/hr
Literature Reviews   $125/hr
MSHA Administrative Approval fee   $500

Note: It is highly recommended to include our applicable fees in a study budget prior to signing a contract.

Non-payment of IRB Fees by Sponsor:

The Mountain States Administrative and IRB fees are assessments of real costs associated with protocol review by the MSHA Research Department and ETSU IRB. In cases when subjects are never enrolled, the study terminates before milestones are met, expenditures exceed revenue, or an external contract is never finalized, the investigator and department are responsible for all expenditures not covered by the sponsor, including the initial and any annual IRB fees. 

Fee Waiver Request Form