2. What are my responsibilities?
The university policies on research administration are grouped under four headings on the university
Policies and Procedures website: General Policies, Research Compliance, Sponsored Programs, and Technology Transfer. This section briefly summarizes policies most relevant to faculty. Other research policies, guidelines, and procedures are also found on the
Research Administration website.
Because many research policies arise from federal and state regulations that change from time to time, faculty are encouraged to review the policies regularly for updates.
16.1 General Policies
The Federal Drug Administration (FDA) drug accountability regulations, Joint Commission on the Accreditation of Healthcare Organizations (JCAHO) hospital accreditation standards, and accreditation standards of the Association of Human Research Protection Program (AHRPP) human subjects protection program require a uniform and centralized plan for the management of investigational drugs used in human subject research. The purpose of this policy, in keeping with Emory University's comprehensive approach to research integrity, is to assist principal investigators in further protecting human subjects who participate in research protocols at Emory through improved drug security, safety, and accountability. This policy applies to principal investigators who will use an investigational drug or a drug provided free of charge by an external entity in a human subject research protocol.
Pertaining to all sponsored programs administered through the Office of Grants and Contracts Accounting, this policy establishes that the Principal Investigator is responsible for the management and administration of the sponsored program within the administrative constraints imposed by the sponsor and in accordance with university policy and requires that changes to project budgets that require institutional or sponsor prior approval must be reviewed and approved by the Office of Sponsored Programs.
Emory University is committed to ensuring that its research involving human subjects is conducted with integrity and free from any actual or apparent bias due to institutional financial interests. This policy provides the standards and detailed procedures that Emory University follows when Emory has significant institutional financial interests that are related to human subject research conducted by its investigators. When Emory conducts university business with entities that have a financial relationship with the university, the policy provides that certain relationships must be identified promptly and resolved appropriately to ensure that the welfare of human subjects and the integrity of the research are not compromised.
16.2 Research Compliance
This policy seeks to foster research by providing guidelines and mechanisms for managing Investigator's Significant Financial Interests and when necessary resolving conflicts of interest. All members of the Emory community responsible for the design, conduct, or reporting of research are required to follow the procedures described in this policy.
The validity of research and other scholastic endeavors is based on the implicit assumption of honesty and objectivity by the investigator and on the explicit premise that research data can be verified. An academic institution and its faculty, students, and staff must uphold this principle and endeavor to maintain public trust in the research process. An academic institution's primary responsibility is to create and maintain an academic environment that fosters ethical behavior in scholarship and prevents misconduct in research and to promote research that is carried out in accordance with all applicable regulations and policies.
This policy sets forth the policies and procedures that should be followed in reporting, inquiring into, and investigating allegations of research misconduct and/or violation of research related laws, regulations, or policies. Further, the policy provides administrative actions and sanctions that might be implemented.
These guidelines describe a standard of practice for the conduct of scholarship and research at Emory University, based on the principles of: (1) the university's obligation to protect and foster the academic freedom and intellectual integrity of all members of the university community in their pursuit of knowledge; (2) the university's accountability to outside funding sources that support the research and scholarship of its faculty; and (3) every scholar's responsibility for the accuracy and validity of his/her own work and that of junior co-investigators, fellows, and students, a responsibility that is shared with colleagues and collaborators. The guidelines address the following concerns: the scholar's authority and responsibility for research activities; the establishment of the quality of research; authorship of publications, including multiple publications and requisites for authorship; the supervision of students and other trainees; the education of trainees in research ethics and integrity; access to and retention of scientific research protocols and data; and the social responsibility of the scholar.
Emory University's Policy on Export Controls is to ensure that instruction, research, and education activities are carried out openly, without prohibitions on the publication of research results or academic activities, except for certain limited prepublication review by research sponsors to protect their proprietary interests. This policy provides information about the empowered official who oversees the university's export licensing or approval activities and signs license applications or other documentation relating to such licensing or to export approval; and about the duties of Principal Investigators, penalties for noncompliance, and other agencies that have export control responsibilities for certain items.
16.3 Sponsored Programs
Emory University's Policy on Research Facilities and Administration Costs addresses the role of the university and the researcher as recipients of federal awards. As a recipient, the university is obligated to comply with costing rules and regulations promulgated by various federal offices. This policy has been established to meet the compliance standards set forth in Office of Management and Budget (OMB) Circular A-21 Cost Principles for Educational Institutions. Adherence to these cost principles and practices by the university is necessary to prevent cost disallowances by the federal government. It is the responsibility of principal investigators, department heads and administrators to understand and comply with this policy. An additional
Policy on F&A Costs in Collaborative Research (see full Policy 7.10) was established to properly allocate the F&A cost revenues among the participants in collaborative research projects.
Emory University regularly seeks and receives offers of funding for the purpose of research sponsorship, endowment creation or support (restricted or unrestricted), conference, lecture or performance sponsorship, sponsorship of athletics, improvement of physical facilities, acquisition of equipment or collections, and the like. This policy addresses factors to be considered when faculty and Emory evaluate whether to seek funding offers from companies or for projects that may prove controversial or inappropriate. The policy also provides the process for addressing disagreements resulting from decisions in the Woodruff Health Sciences Center.
This policy statement establishes Emory University's policy and procedures for the financial management and accountability of service centers that charge federal funds. The purpose is to ensure compliance with federal cost principles and consistency in cost accounting practices for the wide variety of service centers within the university community. As a recipient of federal funds, the university must comply with OMB Circular A-21 Cost Principles for Educational Institutions section J.47. Noncompliance with federal regulations and costing principles may result in repayment to the government, in addition to adverse publicity that could have long-term effects on future funding.
The university uses an after-the-fact web-based effort reporting system to account for an employee's effort, in compliance with the federal Office of Management and Budget's Circular A-21 Section J 10. This policy also meets the requirements of other sponsors for certifying that effort expended on a project is at least equal to the percentage of payroll dollars charged against the sponsored project during the effort reporting period. The policy applies to anyone performing effort on a sponsored project. The policy provides definitions of key terms, roles and responsibilities regarding reporting of effort, effort reporting periods, committed effort, cost sharing, salary caps, K awards, VA appointments, summer salary, and no-cost extensions.
This policy provides the criteria for the decision on whether projects and contributions are gifts or grants. Its purpose is to ensure proper financial recording and reporting of grants versus gifts and to determine whether a grant agreement should be administered by the Office of Sponsored Programs or by the Office of Development and Alumni Relations. The policy also provides that decisions related to intent, when in question, are reviewed and resolved by the Vice President for Research Administration or designee and by the Associate Vice President for Development and Alumni Relations or designee.
16.4 Technology Transfer
Emory encourages faculty to pursue areas of study of their choice and to share the results of their intellectual efforts with colleagues and students and recognizes their need to retain traditional academic freedoms in the conduct of scholarly and scientific work. Although the university does not undertake research or developmental work principally for the purpose of commercial application, patentable inventions and other commercializeable works sometimes result from the activities carried out by Emory personnel. To address these needs and support the university's mission and its commitment to use knowledge to improve human well-being, the university has established this
Intellectual Property Policy (see full Policy 7.6) that includes associated procedures.
16.5 Placeholder – Residual Policy (add when available)
16.6 Other Research Policies, Guidelines, and Procedures
3. What should I expect if is determined that I have a conflict of interest? How do I get a management plan?
As outlined in
Policy 7.7: Policy for Investigators Holding a Financial Interest in Research, Emory through its Conflict of Interest Review Committee (“the Committee”), or its delegates, will recommend whether the interest must be managed, reduced or eliminated or whether a Financial Conflict of Interest exists. Per federal regulations and this policy,
Investigators cannot make the decision about whether a Significant Financial Interest must be managed or whether it is a Financial Conflict of Interest; this determination is made through the review process.
The Conflict of Interest in Research Committee will review the materials related to your financial interest(s) and the proposed research. The Committee will recommend to the Vice President for Research Administration which significant financial interests are related to a specific research project, whether a management plan is necessary, and whether the interests are a Financial Conflict of Interest. As required by federal regulations, Emory will report to the funding agency Financial Conflicts of Interest for PHS supported projects and provide information to the public when a written request is received.
When the Committee advises that an Investigator’s Significant Financial Interest Requiring Disclosure must be managed, reduced, or eliminated, the Committee will inform the Vice President for Research Administration and the Investigator’s Dean of this recommendation and the management plan.
Then a written management plan will be sent to you for your review and signature. You may contact the Conflict of Interest in Research Office if you want to discuss your management plan.