Chapter 16: Research Policies and Procedures

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 (OSP). 

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. 

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. 

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 Advancement and Alumni Engagement. 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. 

This policy provides guidance related to closing out a sponsored award which has ended with over the limit transactions (OLT)s and as a result has a deficit (overrun) which has to be funded I order for the sponsored award to be properly closed in the financial system (COMPASS). 

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. 

In addition to the aforementioned policies, the Office of Research Administration website has a section on other research policies and guidelines. 

• Health Insurance Portability and Accountability Act Policies (HIPAA) 
• Institutional Animal Care Use Committee Policies and Procedures (IACUC) 
• Institutional Review Board Policies and Procedures 
• Research and Administrative Compliance Policies and Procedures Program Manual 
• Sarbanes-Oxley Compliance