NEWTON-WELLESLEY HOSPITAL Research Related Guidelines and Procedures Last Updated – 2/15/01 Summary This policy is to be used as a guideline for research related policies and procedures at Newton-Wellesley Hospital. This guideline directly impacts pre and post grant award administration. Their function is to establish consistency in the following areas: A. Research proposal and budget development B. Research proposal approval process C. Award notification and assignment of NWH account number D. Expense request processing E. Cash Receipt processing F. Grant reporting G. Closing out of Completed Projects Please note that in the case of federal grants or sub-contracts, NIH and DHHS guidelines for the pre and post administration of grants will prevail. A. Research Proposal and Budget Development Research proposals are to be developed in conjunction with the Manager of Research and must include the following: A detailed description of the proposed research. A detailed budget for the research project. A pharmacy charge form (for drug studies utilizing the NWH Pharmacy) A Research Budget Justification and Approval Form (see attached sample). A Conflict of Interest Certification Form Research Budget The budget must include a detailed listing of all direct and indirect costs. Direct costs include salaries, fringe benefits, consultant, equipment, supplies (including postage and photocopy), travel, patient care and sub-contract expenses. Fringe benefits are to be calculated as a flat percentage of salaries. Indirect costs, a.k.a. overhead or facilities and administration costs are to be calculated as a flat rate of all direct expenses except those not includable as per current NIH guidelines, generally equipment, patient care costs, alterations and renovations, sub-contract and a portion of consultant expenses. Research Related Guidelines and Procedures cont’d. p. 2 of 4 Research Budget Justification and Approval Form The purpose of this form and the attached narrative is to describe in summary, the proposed research project and its relevance and importance to Newton-Wellesley Hospital. It will be used to facilitate the approval process for the proposed research project. Highlights include: Total direct costs Total indirect costs Proposed Fringe Benefit Rate Proposed Overhead Rate B. Research Proposal Approval Process The following approval process must be followed for any proposed research to occur at Newton-Wellesley Hospital and for the Hospital to accept receipt of funds for research. The completed research proposal and Research Budget Justification and Approval Form is routed to the Medical Staff Research Committee to approve the proposed project. The Medical Staff Research Committee indicates their approval or denial of the project by signing the Research Budget Justification and Summary Form. If timing does not permit the proposed budget to be reviewed at a Medical Staff Research Committee meeting, the Chairman of the Medical Staff Research Committee will have the authority to make the decision. If approved, the package is routed by the Manager of Research to the Director of Finance to begin the financial review. The Director of Finance will review the budget and work with the Manager of Research to resolve any questions. The Director of Finance will then make a recommendation to the Chief Financial Officer regarding budget approval by indication on the Form. The Chief Financial Officer will have final sign-off as to whether the Hospital will accept funds at Newton-Wellesley Hospital for the research project. C. Award Notification and Assignment of NWH Account Number Once notification has been received from the granting institution of pending award, it is the responsibility of the Principal Investigator (if he or she receives notification first) to inform the Manager of Research. The Manager of Research is responsible for informing the Director of Finance of the pending award and final budget. The Controller’s Office will set up a NWH account number for the new research project and notify the Manager of Research of that account number. This account number must be used to charge any and all expenditures to the grant. Research Related Guidelines and Procedures cont’d. p. 3 of 4 D. Expense Request Processing Salaries and Wages The Manager of Research is responsible for allocating hospital employees’ salary and wages to the appropriate NWH grant number via the weekly payroll timesheet. All hospital staff working on grants are responsible for filling out Time and Effort Reports. The Manager of Research is responsible for insuring that the employee has signed their time and effort report and that the amount of payroll hours charged to the grant corresponds with the time and effort report and the grant budget. Supplies and Other Expenses Principal Investigators must forward all purchase orders and check requests for goods and services to the Manager of Research for approval. The Manager of Research must review expense requests to insure the following: The expense is allowable under the appropriate research guidelines The expense is coded with the appropriate NWH account number. There are sufficient funds left on the grant to support the purchase. In the case of grants funded from the Lot Page endowment, the Vice President of Development must approve all expenditures in addition to the Manager of Research. The Manager of Research must forward approved expenses to the Purchasing Department (for purchase orders) or the Accounts Payable Department (for check requests) for processing. E. Cash Receipt Processing Federal funds are generally obtained via a cash draw down system and are requested from NIH as they are spent on a monthly basis. The Controller’s Office will be responsible for drawing down these funds and will request the funds at the beginning of the month for the previous month’s activity. A Financial Status Report (FSR) is completed annually by the Controller’s Office which is the official reconciliation of funds drawn down v. actual expenditures (see Section F Grant Reporting). Non-federal funds are generally obtained in two ways: Pre-payment or installment payments by awarding agency/institution - the awarding agency/institution sends a check(s) to the recipient institution based upon a predetermined schedule in the agreement. Sometimes the entire amount is awarded up front and the recipient institution spends down the funds as it works on the study. Cost Reimbursement basis - The Controller’s Office will be responsible for the submitting an invoice to the awarding agency/institution at the beginning of the following month in which the expenses are incurred. The Controller’s Office will work closely with the Manager of Research to insure that the bill is an accurate representation and that checks are received on a timely basis. Cash receipts should be mailed from the awarding agency/institution to the Manager of Research’s office. The Manager of Research is responsible for coding the check with the appropriate account number and forwarding it to the Controller’s office for deposit. Research Related Guidelines and Procedures cont’d. p. 4 of 4 F. Grant Reporting Internal Reporting Process The Finance Department will prepare and distribute Unexpended Balance Reports and Detail Trial Balances to the Manager of Research on a monthly basis. The Manager of Research will forward these to the appropriate Principal Investigators. The Unexpended Balance Reports will include the following information: Demographic information - grant name, grant number, grant period and principal investigator name. Financial information - approved grant budget amount, life-to-date expenses incurred, unexpended balance, life-to-date cash receipts received. The Manager of Research is responsible for reviewing the unexpended balance reports and reporting any suspected discrepancies to the Controller’s Office. The Manager of Research will distribute copies of the reports to the appropriate Principal Investigator and the ECR as needed. External Reporting Process Grant and sub-contract reporting requirements vary between awarding agencies, foundations, etc. In general, federal grants require a Financial Status Report (FSR) to be completed on an annual basis. The Manager of Research and Director of Finance must work together to insure that all necessary reporting requirements are completed on a timely basis. G. Closing out of Completed Project The allowable timetable to close out grants and sub-contracts at the end of a grant year vary between awarding agencies, foundations, etc. In general, federal grants must be closed out within ninety (90) days after the grant year-end date. This means expenses can not be charged to that grant after the 90 day window. The Manager of Research must insure that all grants are closed within the allowable time frame for that specific award. Carryover of Unexpended Funds Federal Awards – In general, unexpended funds must be returned to the awarding agency. If the grant is a multi-year project, funds may be able to be carried over to the next grant year, but the Manager of Research will need to work with the awarding agency to determine this. Non-Federal Awards – The use of unexpended funds varies between awarding agencies, foundations, etc. The Manager of Research must review the guidelines of the grant award to determine whether the funds must be returned to the awarding agency. If the unexpended funds can be retained by the institution, it is at the discretion of Newton- Wellesley Hospital administration or the previously determined contractual arrangement as to how they will be used.