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The MSHA Corporate Department of Research serves as the central office for multi-specialty research oversight in the Mountain States Health Alliance (MSHA) healthcare system that is composed of 13 hospitals and provides an integrated comprehensive continuum of care to people in 29 counties in Tennessee, Virginia, Kentucky, and North Carolina. The research department had participated in several large-scale, industry-sponsored multi-center trials with subject retention at a nearly unheard of 100% rate. Department received an excellent evaluation by sponsor’s auditors.
The Research Department is dedicated to:
- Providing consistent oversight and management of clinical research performed at MSHA
- Ensuring regulatory compliance and fiscal responsibility
- Creating a research culture across MSHA facilities
The research department is responsible for administrative functions required to manage projects (Class A), financial reconciliation of budgets, and maintaining regulatory compliance. Research Department receives support from CBO, Finance and the Legal Departments at Mountain States.
In addition to providing oversight for ALL types of research conducted at Mountain States facilities, the department supports Principal Investigators in a variety of therapeutic areas that historically included cardiology, oncology, rheumatology, endocrinology, pediatrics and orthopedics.
Mountain States Health Alliance Corporate Department of Research is located at 408 North State of Franklin Road, Suite 45, Johnson City, TN 37604. For more information, please email or call us at email@example.com, 423-431-5647.
- About Our Staff
Corporate Director of Research
Nonna Stepanov, MD, CCRC. , received Master Degree in Medicine from Kyrgyzstan. She has 20 years of combined clinical and research experience in both industry-sponsored and federal trials as well as investigator-initiated trials. She oversees the day to day functions of the department. She joined department in June 2011.
Responsibilities of Research Staff
- Plans, organizes and coordinates research activities at the Research Department within Mountain States
- Critically evaluates the institution's adherence to applicable federal regulations, state laws and accreditation standards, which govern human research
- Manages department and research budgets, sets up billing procedures; develops payment plans
- Reviews and develops research contracts (service agreements, CTA & CDA). Coordinates contract and billing compliance within MSHA. Coordinates research related activities between Legal, Central Billing Office, Finance and Accounting Departments
- Collaborates with sponsoring agencies; served as liaison with the IRB, ETSU, FDA, drug companies and other research institutions.
- Creates reports for VP/CMO of Washington County and SVP/CMO
- Serves as initial contact for new and potential study proposals
- Oversees research staff, assists with hiring, training and development of new employees
- Promotes the continuous education for quality assurance in research. Participates as appropriate, in training, education and development of individuals responsible for the oversight or conduct of human research at MSHA. Conducts monthly education sessions.
- Completes internal audits for open studies (Class A) and regulatory audits for Class B and C
- Participates in monitoring visits with sponsors (Class A; partially Class B)
- Conducts implementation meetings, research staff meeting
- Serves as a liaison between different departments (service arrangement for research studies)
- Assists in developing plans to meet requirements of new studies / protocols; prepares for external quality assurance and review
- Develops Procedural Manual and Standard Operation Procedures
- Actively participates in development of e-IRB and MSHA applications
- Participates in study-specific activities including conducting study visits, collecting samples, distributing IP, performing ECG, administering study questionnaires (Class A)
- Participates in IRB meetings as an active member
- Reports study data, develops source documents, responds to queries
- Manages trial documentation and reports (Class A)
- Maintains records of local and Central IRB submissions
- Maintains SAE/AE submissions / logs
- Assists other staff with daily activities
- Maintains and tracks internal invoices
The research department provides support to investigators in collaborative industry-sponsored and investigator-initiated studies, funded and non-funded studies. Available services include:
- 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
- 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
- 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
- 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
- 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
- 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.
- Events and Training
Additional sessions based on interest in specific areas such as development of the protocol, informed consent form, study budget, case report forms, etc. can be scheduled by request.
- Standard Operating Procedures and Working Instructions
Standard Operating Procedures
- Procedure Manual
- Audit Response
- Research Facilitation and Consulting Services Fees - MSHA Administrative and IRB Fees, RES-100-002
- MSHA Research Certification and Confirmation of Credentials and/or Privileges of Researchers
- Clinical Research Administration
- Informed Consent Process
- Research Chart Documents
- Code of Ethics
- Classification (Categories) of Research Studies
- Basic Administrative Procedures for Funded Studies
- Mountain States Health Alliance Research Definition
- MSHA Research Guidlines
- Application for Research Certification at MSHA
- Certified Researcher Agreement
- Confidentiality Agreement
- Administrative Forms and Working Templates
- Fee Waiver Request Form
- Research Participant Registration Form
- Procedures for Research Patients
- Standard Operating Procedure Review Letter
- MSHA Administrative Research Fees
Research Proposal Form 09252015 Word PDF
Research Proposal Request Form for External IRB 09252015 Word PDF
Research Proposal Request Form for Modification Submission 0 Word PDF
Submission request form for humanitarian use device for clinical treatment diagnosis or investigational use PDF
- Online Institutional Review Board (IRB)
Welcome to the Institutional Review Board.
The Institutional Review Board (IRB) is a committee established to review research involving human subjects. The primary purpose of ETSU IRBs is to protect the rights and welfare of human subjects involved in research under their authority. The ETSU Medical/VA and Campus IRB departments are an important part of ETSU's Human Research Protection Program.
- Research Compliance Committee
The Research Compliance Committee meets every 6 months or as necessary to review urgent cases.
- Corporate Director of Mountain States Compliance Department
- HIPAA Officer
- Corporate Director of Mountain States Research Department
The purpose of MSHA's Compliance Program is to:
- Promote the prevention, detection and resolution of instances of conduct that may not conform to federal and state law and federal, state and private payor health care program requirements, as well as MSHA's Code of Ethics and Business Conduct.
- Define team member responsibility to comply with the laws and regulations governing MSHA's operations
- Establish accountability for compliance at the highest operational level of responsibility and sustain a culture where ethical conduct is recognized, valued and exemplified
- Work closely with the MSHA departments responsible for billing accuracy and integrity to ensure that third party claims reflect a strong organizational commitment to uphold honest and responsible conduct.
- Provide a process by which team members can identify and report potential fraud, waste and abuse exposure without fear of retaliation or retribution
- Provide guidance to management staff regarding the need for preventive and self-check measures through the use of education, training and monitoring to ensure compliance with all applicable laws and regulations.
- Create a centralized source for the distribution of information relative to guidance and assistance with adherence to applicable federal and state laws, regulations, statues and other requirements.
- Minimize, through early detection and reporting, any potential loss to the government and private payors from erroneous claims, as well as reduce MSHA's potential exposure to damages and penalties that might result from questionable activities.
- Research Proposal Review Process
The MSHA Research Department (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 is 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 man
- Protected Health Information / ICD
Per MSHA HIPAA officer, below is the content that must be in an authorization form for access to PHI for research purposes at MSHA.
Per the Privacy Rule, 45 C.F.R. §164.508
The authorization to use and disclose Protected Health Information (PHI) for research purposes must include the following:
- Description of PHI to be accessed, used or disclosed. Identify the information in a specific and meaningful manner, such as demographic information, date of birth, social security number, blood test, x-rays, medical record, etc.
- The name(s) or other specific identification of person(s) or class of persons authorized to make the requested use or disclosure
- The name(s) or other specific identification of the person(s) or class of persons who may use the PHI or to whom the covered entity may make the requested disclosure. Inform participant that MSHA representative will have an access to the study documents (Confidentiality and HIPAA section)
- Description of each purpose of the requested use or disclosure, specific to research study, not for future unspecified research
- Authorization expiration date or event of the authorization
- Signature of the individual
- If Authorization is signed by an individual’s personal representative, a description of the representative’s authority to act for the individual
- Date signed by the individual
- The individual's right to revoke his/her Authorization in writing and either (1) the exceptions to the right to revoke and a description of how the individual may revoke Authorization and who/how to contact
- Notice of the covered entity's ability or inability to condition treatment, payment, enrollment, or eligibility for benefits on the Authorization, including research-related treatment, and, if applicable, consequences of refusing to sign the Authorization
- The potential for the PHI to be re-disclosed by the recipient and no longer protected by the Privacy Rule.
Also, if potential research candidate decides not to sign the authorization, she/he has to be informed how collected data will be managed. It is highly recommended to include a language presented below:
- It will not affect my treatment, payment, enrollment in any health plans nor affect my eligibility for benefits.
- I cannot be allowed to participate in this research study.
After signing the Authorization, I can change my mind and:
- Not let the researchers disclose or use my protected health information (revoke the Authorization).
- If I revoke the Authorization, I will send a written letter to: [name and contact information] to inform him/her of my decision.
- If I revoke this Authorization, researchers may only use and disclose the protected health information already collected for this research study.
- If I change my mind and withdraw the authorization, I may not be allowed to continue to participate in the study.
This Authorization does [or does not] have an expiration date. The expiration date is [State clearly what the expiration date is if there is one]
- Important Research and Education Links
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
FDA Good Clinical Practice Consolidated Guidance