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Research Compliance

Office of Sponsored Programs

Elizabeth City State University (ECSU) pursues federal, state and local resources to support teaching, research and community outreach activities. Resources are sought and received from federal agencies, state government, foundations, organizations, and individuals. The mission of the Research Compliance Office is to provide exceptional service as a liaison for researchers, study participants, federal agencies, and the research committees to ensure efficient processes related to the ethical conduct of research at Elizabeth City State University ensuring that its privilege of receiving external support is protected.

Research Compliance Policies

Compliance policies have been established regarding the implementation of sponsored projects which include monitoring research on human and animal subjects and hazardous materials to ensure compliance with federal and state regulations as well as ECSU policies. Export Control policies have been established regarding the implementation of these activities with the goal to recognize the importance of compliance with all applicable export control regulations in the conduct of university activities.
For additional information refer to ECSU Policy Manual -Compliance Policy and Procedures (300.4.1.4-300.4.1.6)

Animal Welfare

Federal regulations require ECSU, when using animals as research subjects, to carefully monitor their care and use. ECSU is committed to observing federal regulations pertaining to animal care. ECSU's Institutional Animal Care and Use Committee (IACUC) shall make recommendations to the ECSU Administration on all matters of animal care. Forty-five (45) days prior to the submission of proposals that incorporate the use of laboratory animals, ECSU's "Protocol for the Use of Live Vertebrates for Research, Teaching or Demonstration" shall be completed. This protocol shall be reviewed by members of the IACUC.  Animal research shall be further governed as follows:

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 Export Controls

Export control regulations were established to protect U.S. national security and foreign policy interests. These regulations govern the export of all items of U.S. origin as well as information and/or software that may be shared with foreign nationals in the U.S. or abroad. Federal law and regulations limits the export of certain ‘protected technologies' (equipment & related manuals, software, data and/or other intellectual property) to foreign counties. The laws and regulation includes among its restrictions the sharing of information about these ‘protected technologies' with foreign nationals who are visiting or studying in the US (called deemed exports). Although most basic research performed in universities is exempt from these federal restrictions, there are numerous exceptions to this exemption.

Within the university, we possess a wealth of information of interest to foreign powers and entities. Because of access to personnel, facilities, and information, you present an opportunity for a foreign entity to expand their knowledge about US technology, capabilities and vulnerabilities. For that reason if international travel will be a part of your research, and international travel briefing for all travelers needs to be schedule prior to traveling.

Each ECSU faculty, staff, and student who is involved in research must take reasonable precautions for safeguarding sensitive and export controlled data and information from disclosure to foreign persons without proper authorization. A license from the U.S. government is required before a foreign national has access to hardware or technology controlled by either the U.S. Department of Commerce or the U.S. Department of State.

The Research Compliance Officer (RCO) for ECSU shall serve as the Export Control Empowered Official (ECEO) and consult with the Director of Sponsored Programs on export control matters at ECSU. The ECEO shall have overall responsibility to administer the University's export control compliance with this policy. Principle Investigators (PI)/Program Directors (PD) shall be responsible for insuring that all research project staff (including consultants and students) are knowledgeable of the ECSU Export Control Policy.

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Training Resources

For complete information refer to ECSU Policy Manual -Export Control Policy (300.4.1.5)

Human Subjects Protection and the Institutional Review Board (IRB)

ECSU has established an IRB to review all research involving the use of human subjects and to implement institutional guidelines and procedures regarding such research. ECSU adheres to all the rules and regulations governing human research as contained in the Department of Health and Human Services (DHHS) Part 46 of Title 45 Code of Federal Regulations( 45 CFR 46) and the Food and Drug Administration (FDA) 21 CFR Parts 50 and 56. The use of human subjects in research imposes both ethical and legal responsibilities upon the researcher, faculty sponsor, project director, and the University to ensure that the rights and welfare of those subjects are adequately protected as defined by federal and state regulations.

All research involving the use of human subjects conducted by researchers (ECSU faculty, staff, or students); or sponsored, in part or in whole, by ECSU; must be reviewed and approved prior to start of the project and then conducted in full compliance with IRB guidelines and procedures. Researchers must assure through verified training that the welfare of their research participants is of paramount importance.

All ECSU personnel, whether faculty, staff, or students, shall be IRB-certified before conducting human subjects research. Key personnel are defined as individuals who contribute in a substantive way to the scientific development or execution of a project, whether or not they receive compensation from the grant supporting that project. ECSU key personnel shall take the Collaborative IRB Training Initiative (CITI) online for certification at https://www.citiprogram.org/default.asp or provide documentation of certification by other means approved by ECSU's Compliance Officer. Recertification of key personnel will be required every two years if project is still in active status.

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Training Resources

For complete information refer to ECSU Policy Manual - Compliance Policies and Procedures (300.4.1.4)

News

U.S. Department of Health and Hhttp://www.ecsu.edu/OSP/forms.cfm Human Services (HHS) published an Advance Notice of Proposed Rulemaking and a summary of the proposed changes for their regulations governing human subject research.

Responsible Conduct in Research

ECSU expects the highest standards of professional and ethical conduct. The major responsibility for maintaining standards of intellectual integrity rests with the individual scholars and with the departments in which they work. To that end, unethical behavior in research represents a breach of the confidence among faculty, staff, and students as well as other research scientists that is central to the advancement of knowledge.

The term "responsible conduct of research" encompasses important shared principles of honesty, accuracy, efficiency and objectivity that guide research. As research has advanced, issues of research integrity have received substantial public attention. Cases of researchers falsifying and fabricating results, unearned authorship and ghost writing, concerns of corporate influence through undisclosed corporate income to researchers and instances of plagiarism have all been featured in the recent news. In order to strengthen the integrity of research and creative scholarship, instruction in the responsible conduct of research must be considered a vital part of research and creative scholarship.
Federal laws and regulations are mandating RCR education. National Science Foundation (NSF) requires all undergraduate student, graduate students, and postdoctoral researchers supported by NSF research funding to receive RCR training. National Institute of Health (NIH) requires that all trainees, fellows, participants and scholars receiving support through any NIH training , career development award (individual or institutional), research education grant, and dissertation research grant must receive instruction in responsible conduct of research.

Comprehensive web based training is provided through the Collaborative Institutional Training Initiative (CITI) for RCR. Disciplines include: Biomedical, Social and Behavioral, Physical Science, Art and Humanities, Engineers and Administrative. Instructional areas include: data acquisition, management, sharing and ownership, human participants, animal welfare, conflict of interest and commitment, peer review, publication, practices and responsible authorship, collaboration, mentor/trainee relationships, research misconduct, intellectual property, and lab safety.
In conjunction with the online course, researchers will have an opportunity to participate in RCR workshops. These workshops, using case studies and interactive discussion are designed to allow researchers to expand upon the information gained through online training with their peers. Workshops will be scheduled at least twice each semester to include fund recipients and research training faculty. These workshops will be open the entire educational community to attend.

A key component to effective training is in the context of day-to-day activities of the researchers. Principal Investigators are expected to incorporate RCR as a part of their discussions with postdoctoral researchers, graduate students, and undergraduate students.

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Hazardous Materials

ECSU conducts academic research and other activities that involve the use of hazardous materials. The purpose of this policy is to ensure compliance with all local, state, and federal regulations regarding hazardous materials. Hazardous material is defined as radioactive waste, biohazard waste, PCB waste, asbestos waste or other specially regulated waste that is no longer of use. These materials, if not properly used, stored, transported, and disposed of, may pose a risk to persons or the environment by virtue of properties such as toxicity, corrosiveness, reactivity, flammability, or infectivity among others. It is ECSU's position that it shall provide an environment free from recognized, significant hazards and comply with local and federal regulations regarding environmental and occupational safety and health, such as those promulgated by the Occupational Safety & Health Administration (OSHA) and the
Environmental Protection Agency (EPA). Accordingly, all projects involving the use of hazardous materials shall adhere to normal chemical hygiene procedures as follows:

For complete information refer to ECSU Policy Manual - Compliance Policies and Procedures (300.4.1.46)

News

U.S. Department of Health and Human Services (HHS) published an Advance Notice of Proposed Rulemaking and a summary of the proposed changes for their regulations governing human subject research.

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Conflict of Interest and Commitment

All EPA faculty members, Non faculty EPA staff, SPA employees and other key personnel or students who make a significant contribution to a sponsored project of Elizabeth City State University (ECSU) are subject to policies concerning conflicts of interest and conflicts of commitment affecting ECSU employment and external professional activities. This policy is based on policies and guidelines adopted by the UNC system Board of Governors, federal and state law, and federal agency sponsor requirements. (University Policy Manual, 300.4.1.7)

Covered Employees shall recognize and avoid potential and perceived conflicts of interest that may compromise; may involve the potential for compromising; or may have the appearance of compromising the Covered Employee’s objectivity in fulfilling ECSU Employment responsibilities, including and other sponsored research activities. Accordingly, outside activities and financial interests must be disclosed by Covered Employees on an annual basis. This notwithstanding, Covered Employees have a continuing obligation to timely update these disclosures as new external interests develop. Outside activities and financial interests should be arranged to avoid circumstances that do or may prevent or limit objectivity in the performance of ECSU Employment Responsibilities or that otherwise do or may adversely affect any ECSU interests.

ECSU seeks to appoint and to retain, as employees, individuals of exceptional competence in their respective fields of professional endeavor. Because of their specialized knowledge and experience, such persons have opportunities to apply their professional expertise to activities outside of their ECSU employment, including secondary employment consisting of paid consultation with or other service to various public and private entities. Through such practical, compensated applications of their professional qualifications, ECSU employees enhance their own capabilities in teaching, research, and administration. Thus, participation of employees in external professional activities for pay, typically in the form of consulting, is an important characteristic of academic employment that often leads to significant societal benefits, including economic development through technology transfer.

All covered employees can now complete their Annual Conflict of Interest Disclosures through an online disclosure management system called “AIR” to report their Activities, Interests and Relationships. The AIR system can be accessed at https://testecsu.myresearchonline.org/air/index.cfm Annual disclosure is stipulated by University Policy and remains a condition of employment for all covered employees. All Covered Employees must receive COI training. The COI training program developed by the Office of Research Compliance will be made available to all Covered Employees in a fashion that encourages and facilitates training. Training must be completed every four years and immediately under these designated circumstances: ECSU COI Policy changes in a manner that affects Covered Employees requirements; a Covered Employee is new the ECSU; and/or ECSU finds that a Covered Employee is not compliant with the COI Policy or management plan. Training can also be assessed through the AIR online disclosure management system.

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The federal regulation governing financial conflict of interest in research has changed. In August, 2011, the U.S. Department of Health and Human Services issued the final rule that amends the Public Health Service (PHS) regulations on Responsibility of Applicants for Promoting Objectivity in Research for Which PHS Funding is Sought (45 C.F.R. Part 50) and Responsible Prospective Contractors (45 C.F.R. Part 94).Institutions are required to comply with this regulation no later than August 24, 2012.

Michelle MooreMichelle W. Moore,
Research Compliance Officer | IRB Administrator
110 McLendon Bldg., CB#864
252-335-3823