Chapter 16: Research Policies and Procedures
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
16.1.A Investigational Drug Management for Clinical Studies (Policy 7.14)
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 (AAHRPP) human subjects protection program require a uniform and centralized plan for the management of investigational drugs used in human subjects 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 subjects research protocol.
16.1.B Financial Responsibility (Policy 7.23)
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 (OSP).
16.1.C Research Institutional Conflicts of Interest (Policy 7.24)
The purpose of this policy is to safeguard the objectivity, integrity, and credibility of Research by ensuring that the financial interests of Emory or its Institutional Leaders do not affect the design, conduct, reporting, review, or oversight of Research. This policy defines the standards and procedures that Emory University follows to identify and manage or eliminate Research Institutional Conflicts of Interest.
This policy applies to Emory University as an Institution and Institutional Leaders who have the capacity to affect, or could reasonably appear to affect, University processes for the design, conduct, reporting, review, or oversight of Research due to their position with the University. This policy does not limit Institutional Leaders’ obligations for disclosure and/or management of other financial interests by Institutional Leaders that are required by other Emory policies or procedures.
16.2 Sponsored Programs
16.2.A Policy on Research Facilities and Administration Costs (Policy 2.127)
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 (7.10) was established to properly allocate the F&A cost revenues among the participants in collaborative research projects.
16.2.B Policy for Consideration of Controversial Funding Offers (Policy 7.13)
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.
16.2.C Accounting for Service Centers (Policy 2.124)
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.
16.2.D Effort Reporting (Policy 2.126)
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.
16.2.E Administration of Gifts and Grant Awards through ORA and AAE (Policy 7.22)
This policy shall be used to ensure proper financial recording and reporting of grants, gifts, and other awards, and to determine whether an award agreement should be administered by the Office of Research Administration (ORA) or by the Office of Advancement & Alumni Engagement (AAE). Decisions related to intent, when in question, are reviewed and resolved by the Vice President for Research Administration or designee, and the Senior Vice President for Advancement & Alumni Engagement, or designee. The decision as to whether a particular award should be administered by ORA or AAE is not made based on the presence or absence of a single characteristic or criterion. The conditions of the award as a whole must be considered to determine proper classification.
16.2.F Sponsored Award Overrun and Unallowable Cost Policy (Policy 7.27 )
This policy addresses the management of overruns and unallowable cost related to sponsored award administration at Emory University. Overruns and unallowable cost must be addressed in a timely, consistent fashion to ensure proper stewardship of sponsored award funds in accordance with regulations outlined in OMB 2 CFR 200 (Uniform Guidance) and other applicable sponsor requirements.
16.3 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 (7.6) that includes associated procedures.
16.4 Other Research Policies, Guidelines, and Procedures
In addition to the aforementioned policies, the Office of Research Administration website has a section on other research policies and guidelines.