Information for Researchers

• 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 Northern Light Health 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 Grants

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

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 Northern Light Health approval to seek funding, identify potential funding sources, and develop and submit proposals to funding agencies.

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 Northern Light Health on behalf of the investigator. The Sponsored Programs Office works closely with legal services (Northern Light Health vice president and general counsel) and financial services (Northern Light Health grant accounting) on all newly awarded grants and contracts.

Sponsored Programs staff consult with the office of the Northern Light Health 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 sub awards intended for an individual or entity external to Northern Light Health 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.

Clinical research staff in Sponsored Programs work closely with the Northern Light Health Grant Accounting Office, which reviews all Notices of Grant Award and establishes new fund numbers for newly awarded grants or contracts. 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 Northern Light Health Grant Accounting Office is responsible for financial audits of federal grants and for all financial reporting requirements of funded studies.

Human Subject Research conducted at Northern Light Health 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.

Northern Light Health 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.

The purpose of Northern Light Health's Researcher Financial Conflict of Interest Disclosure (26-101) 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), Northern Light Health-funded projects, gift-funded projects, clinical trials and also to unfunded research projects.

The Northern Light Health IRB requires any investigator conducting research with human participants to understand and comply with the conflict of interest policy.

The Northern Light Health Compliance Office functions as an independent and objective body that reviews and evaluates compliance issues and 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. Northern Light Health and its members have a common interest in protecting and capitalizing on intellectual property through the use of patents and copyrights. Northern Light Health assumes right, title and interest in all inventions and related intellectual property created by its employees.

Northern Light Health oversees the commercialization of technologies created within the organization and at  its member organizations. Employees are required to notify Northern Light Health of any inventions or other forms of intellectual property in accordance with Northern Light Health policy, Innovations, Inventions and Patents (10-016).

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 Northern Light Health that all rights in copyright shall remain with the creator unless the work is a work‐for‐hire (and copyright vests in Northern Light Health under copyright law), is supported by a direct allocation of funds through Northern Light Health for the pursuit of a specific project, is commissioned by Northern Light Health, makes significant use of Northern Light Health resources or personnel, or is otherwise subject to contractual obligations.

To ensure that all Northern Light Health staff involved in research are aware of ethical principles, regulations, and policies and procedures that apply to human subjects research, education – including online 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.

The Collaborative Institutional Training Initiative (CITI) and the National Institutes of Health (NIH) web-based tutorials are required training for all staff conducting research involving human participants. These courses fulfill the IRB requirement for performing a clinical research study and the NIH human subjects training requirement for obtaining federal funds.

The Clinical Research Center provides education that facilitates our providers in their pursuit of independent research. To accomplish this, the center:

• Supports and fosters scholarly work within the Northern Light Health investigator community, which includes support for junior investigators.
• Implements tailored education for fellowships and summer internships in clinical research.
• Provides in-house training in Good Clinical Practice.

Investigators, research support staff, research fellows, students, and volunteers are required to obtain training and pass an exam as part of a comprehensive Responsible Conduct of Research Program. The Northern Light Clinical Research Center offers online training to all staff involved in any aspect of clinical research. NIH’s “Protecting Human Research Participants” and CITI’s “Responsible Conduct of Research on Human Subjects” are required training.

All Northern Light Health medical staff (IRB members, investigators and their support staff, research coordinators, etc.) and any other individuals, including students, in contact with human research subjects and/or human research subject data are required to complete human subjects training.

Any investigator and his/her staff conducting research involving humans must complete the training before approval of their proposal is granted by the IRB. The principal investigator(s) should ensure that all key personnel have completed the training prior to submitting their new proposals or progress reports on continued projects.

Northern Light Health is a Collaborative Institutional Training Initiative (CITI) institution. Employees can register and participate in educational sessions. Continuing Education Credits will be available to those who successfully complete a minimum of 12 modules. The Northern Light Health IRB requires proof of CITI training by all investigators submitting an application to the IRB.

NIH requires all investigators receiving federal funding to take the Protecting Human Research Participants training modules: Protecting Human Research Participants Modules, Office of Extramural Research.

NIH requires all investigators to complete the Financial Conflict of Interest tutorial: Financial Conflict of Interest (FCOI) Tutorial, Office of Extramural Research.

The Northern Light Clinical Research Center assists investigators in identifying potential funding sources and works with the Northern Light Community Health & Grants Office for grant prospecting.

The first step consists of completing an online request for assistance, after which one of the Clinical Research Center staff will contact the investigator. A meeting will be scheduled with Clinical Research Center staff to discuss the proposed research and identify the need or 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. This frequently 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.

Per Northern Light Health policy, Grant Submissions and Awards (13-000), an investigator is required to obtain authorization from his/her department head/administrator/supervisor and from the appropriate Northern Light Health vice president before seeking external funding, by completing the Northern Light Health 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 Northern Light Health Grant Proposal Submission Authorization Form.

Northern Light Health’s Research Advisory Council assists the director of clinical research and the chief medical officer in strategic visioning and program development for the 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 Northern Light Eastern Maine Medical Center, Northern Light Health, Northern Light Health Foundation, Northern Light Acadia Hospital, Husson University, University of Maine, University of New England, and Penobscot Respiratory.

The Research Advisory Council meets quarterly.

Each year, Northern Light Health’s Clinical Research Center offers a Clinical Research Fellowship to well-qualified candidates.

The fellowship program offers research training to candidates with an MD, DO, DDS, PhD, PharmD, RN, MSN, or BSN interested in investigator-sponsored research or clinical trials sponsored by pharmaceutical or biomedical companies.

If you’re interested in pursuing a Clinical Research Fellowship or want to learn more, reach out to the Clinical Research Center by calling 207-973-4767.