Research Administration

The Sponsored Programs Office supports the Clinical Research Center in its efforts to promote research initiatives throughout the EMMC and EMHS communities.

Its functions include:
  • Identifying funding opportunities
  • Establishing and keeping a networking system with internal and external local collaborative groups
  • Project development and strategic planning
  • Negotiating grant and contract awards for EMMC with funding agencies
  • Reviewing and approving consulting agreements
  • Providing central oversight for the post-award activities of all grants and contracts
  • Monitoring compliance with Federal and other sponsoring agency regulations
PRE- AND POST-AWARD ASSISTANCE WITH PROPOSALS AND/OR GRANTS

The Clinical Research Center’s Sponsored Programs Office serves as the primary support for sponsored research at EMMC.

The office supports pre- and post-award research efforts by promoting the development, implementation, and coordination of sponsored research. We work closely with investigators to obtain EMMC and EMHS approval to seek funding, identify potential funding sources, and develop and submit proposals to funding agencies. In the case of electronic submissions, the authorized EMMC representative (the Director or the Manager of Sponsored Programs of the Clinical Research Center) electronically signs and submits the proposal. The Sponsored Programs Office also manages projects, and makes sure that research is compliant with sponsor guidelines, hospital policies, and federal regulations. Sponsored Programs is responsible for communicating with the funding agency regarding any significant changes to grants, such as changes in PI or PD, changes in effort devoted to the project, budget revisions, extension of the grant period, and changes in scope of the project, as well as submitting Progress Reports according to the timeline required by the funder.

Grant and contract awards are made to EMMC on behalf of the investigator. The Sponsored Programs Office works closely with Legal services (EMHS Vice President and General Counsel) and Financial services (EMHS Grant Accounting) on all newly-awarded grants and contracts.
LEGAL
 
CONTRACTS AND SUBRECIPIENT AGREEMENTS
Sponsored Programs staff consult with the office of the EMHS Vice President and General Counsel (VPGC) on all legal matters related to sponsored research.
 
The VPGC reviews all sponsored proposals, contracts, memoranda of understanding, consortium agreements, and subawards intended for an individual or entity external to EMMC prior to their submission. This comprises determination of agreement mechanisms and negotiation of all business terms and conditions. All documents prepared by the Clinical Research Center’s Sponsored Programs Office are reviewed and approved by the VPGC.



FINANCE
 
GRANT ACCOUNTING
Clinical Research staff in Sponsored Programs work closely with the EMHS Grant Accounting Office, which reviews all Notices of Grant Award and establishes a new fund number for a newly-awarded grant or contract. The Grant Accounting Office in collaboration with Sponsored Programs develops line-item budgets, including the budgeting of facilities and administrative costs, that are in accordance with the award budget and funding agency regulations.  Budget statements are reconciled on a monthly basis for each funded study.
 
The EMHS Grant Accounting Office is responsible for financial audits of federal grants and for all financial reporting requirements of funded studies.  
INSTITUTIONAL REVIEW BOARD
 
HUMAN SUBJECTS RESEARCH
Human Subjects Research conducted at EMHS Member organizations must comply with 45 CFR Part 46 and 21 CFR Part 56 and is subject to review by an Institutional Review Board (IRB).

Under FDA regulations, an IRB is an appropriately constituted group that has been formally designated to review and monitor biomedical research involving human subjects. In accordance with FDA regulations, an IRB has the authority to approve, require modifications in (to secure approval), or disapprove research. This group review serves an important role in the protection of the rights and welfare of human research subjects.

Eastern Maine Medical Center holds a Federal Wide Assurance with the U.S. Department of Health and Human Service’s Office for Human Research Protections, and has one Institutional Review Board (IRB) registered under this Assurance. The IRB is composed of physicians, pharmacists, scientists, ethicists, and community members, who meet once a month. Each IRB member reviews research protocols guided by the ethical principles in:

 
  • The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research, Report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, or
  • Other appropriate ethical standards recognized by Federal departments and agencies that have adopted the Federal Policy for the Protection of Human Subjects, also known as the Common Rule.

The IRB reviews all protocols for scientific merit, assesses the risks and benefits to study participants, and reviews data collection materials and the informed consent documents to ensure that participants are provided with sufficient information to allow them to make an informed decision to participate in research.

Conflict of Interest 

The purpose of EMMC's Conflict of Interest policy (801-006-Financial-Disclosures-(COI)-(1).pdf) is to promote the highest ethical standards in situations where conflicts of interest may occur in the conduct of research. This policy applies to all sponsored projects, including government and non-government funded projects (such as industry or foundation sponsors), EMMC-funded projects, gift-funded projects, clinical trials and also to unfunded research projects.
 

The EMMC IRB requires any investigator conducting research with human participants to understand and comply with the Conflict of Interest policy.



COMPLIANCE
 
COMPLIANCE OFFICE
The EMMC Compliance Office functions as an independent and objective body that reviews and evaluates compliance issues/concerns within the organization. The office ensures that all practices are in compliance with the rules and regulations of regulatory agencies, that hospital policies and procedures are being followed, and that behavior in the organization meets the hospital’s Standards of Conduct.

Discoveries resulting from creative work in healthcare may result in valuable intellectual property. EMHS and its Members have a common interest in protecting and capitalizing on intellectual property through the use of patents and copyrights. EMHS assumes right, title and interest in all inventions and related intellectual property created by its employees. The EMHS Office of Innovation (43 Whiting Hill Road, Suite 500, Brewer, Maine, 04412) oversees the commercialization of technologies created at EMHS and its Member organizations. Employees are required to notify the Office of Innovation of any inventions or other forms of intellectual property in accordance with EMHS policy.

Copyright is the ownership and control of the intellectual property in original works of authorship that are subject to copyright law. It is the policy of EMHS that all rights in copyright shall remain with the creator unless the work is a work‐for‐hire (and copyright vests in EMHS under copyright law), is supported by a direct allocation of funds through EMHS for the pursuit of a specific project, is commissioned by EMHS, makes significant use of EMHS resources or personnel, or is otherwise subject to contractual obligations. 
To ensure that all EMMC staff involved in research are aware of ethical principles, regulations, and policies and procedures that apply to human subjects research, education – including on-line education for key research personnel – is required. This training includes Protection of Human Subjects, Protection of Animal Subjects (if applicable), Good Clinical Practice, Financial Conflict of Interest, and Responsible Conduct of Research.
 
CITI and NIH web-based tutorials are required training for all staff conducting research involving human participants.
 
These courses fulfill the the EMMC IRB requirement for performing a clinical research study and the NIH human subjects training requirement for obtaining federal funds.
 
Also see 
Research Education.
The EMMC Clinical Research Center assists investigators in identifying potential funding sources, and works with the EMHS Community Health & Grants Office for grant prospecting.

The first step consists
of completing an online Request for Assistance, after which one of the CRC staff will contact the investigator. A meeting will be scheduled with CRC staff to discuss the proposed research and to identify the need/problem addressed by the project, specific aims/goals, design of the study, its potential impact, and a description of the innovative aspect of the study. Frequently this requires a search of relevant current literature and several follow-up meetings, after which time a Concept Paper is prepared to assist the grant prospecting process.

As per EMMC policy, an investigator is required to obtain authorization from his/her department head/ administrator/supervisor and from the appropriate EMMC vice president before seeking external funding, by completing the EMHS Request to Seek Grant & External Funding. The  purpose is to ensure that the project aligns with the strategic plan and goals of the organization.
 
Once a funding opportunity is identified and a grant application is written, the investigator must obtain executive and fiscal authorization to submit the application, by completing the EMHS Grant Proposal Submission Authorization Form. 

 
Eastern Maine Medical Center’s Research Advisory Council assists the Director of Clinical Research and the Chief Medical Officer in strategic visioning and program development for the EMMC Clinical Research Center.
The Council’s objectives include:
  • Serving as a venue to discuss research policies and procedures
  • Suggesting potential strategies to improve program effectiveness
  • Providing advice and recommendations on research related topics
  • Assisting as a source of mentorship for new investigators
  • Reviewing research protocols applying for internal funding and awards
  • Reviewing clinical research fellowship applications
There are currently 24 voting members of the Research Advisory Council. Members are from Eastern Maine Medical Center, Eastern Maine Healthcare Systems, Eastern Maine Healthcare Foundation, The Acadia Hospital, Husson University, University of Maine, University of New England, and Penobscot Respiratory.
 
The Research Advisory Council meets quarterly.