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| Research Administration Handbook | |
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Download the RAH in a printable pdf format University of Iowa The University of Iowa Research Administration Handbook (RAH) serves as a basic guide for the effective administration of sponsored projects -- i.e., research, training, scholarship, and other creative and educational endeavors that receive financial support through external sources such as government agencies, private organizations, and business entities. The effective administration of sponsored projects requires a thorough understanding of University policies and procedures for requesting, accepting, and managing external funding, and a knowledge of how UI policies and procedures complement, reinforce, and integrate with federal regulations and individual sponsor requirements. The material in the following units will provide a foundation for developing a comprehensive understanding of the requirements when proposing and conducting sponsored projects. Index1. Gift, Grant, or Contract 2. Employment on Grants and Contracts Administered by the University 3. Proposal Routing and Processing and Award Acceptance 5. Award Terms and Conditions 6. Contracts 7. Master File Key (MFK) Setup and Pre-Award Spending 8. Corporate and Industry Sponsored Projects Policy 9. Direct and Facilities and Administrative (F&A) Costs 10. Matching Funds and Cost Sharing 11. Purchasing of Equipment, Professional Services, Goods & Materials 12. Travel 14. Professional Service Agreements (Consulting) 15. Effort Certification 16. Payroll 17. Cost Transfers 18. Program Income 21. Close Out and Property Management & Disposal b. Steps required to closeout projects 23. Audits 24. Processing Non-Financial Agreements 25. Intellectual Property 26. University Service Centers (Recharge Centers) 27. Conflict of Interest f. COI in Research Involving Human Participants 28. Use of Human Subjects 29. Use of Animals 30. Research Involving Recombinant DNA 31. Research Misconduct 32. Research Integrity (topics not covered elsewhere) 33. General Grant Compliance Requirements
1. Gift, Grant, or Contract
a. Types of AwardsWhether a financial award is made as a gift, grant, cooperative agreement, or contract depends on a number of factors and is sometimes a judgment call. Generally, as awards become more restrictive, they are defined along a continuum ranging from gifts to grants to cooperative agreements to contracts. Gifts and grants tend to result from University or investigator initiated projects whereas cooperative agreements and contracts generally result from sponsor-initiated activities.
b. Types of Funding SolicitationsFunding opportunities may be announced and applications/proposals invited though various types of solicitations, generally depending on the nature of the funding program and type of award.
c. What is processed by the Division of Sponsored Programs? * Proposals to and awards directly or indirectly from a governmental agency. d. What is processed by the Clinical Trials Office? Studies that are supported by a corporation and involve evaluation of the company's technology or product:
2. Employment on Grants and Contracts Administered by the University a. Nine- or Twelve-Month Project. The federal government and the University do not allow grant funds to be used to reimburse faculty members of the grantee institution for consulting or other time in addition to a regular full-time institutional salary covering the same general period of employment. Special exceptions may be made when the work to be performed is in addition to the individual's normal full-time duties and the additional compensation payment is commensurate with institutional policy. The University practice in this regard is as follows:
1. That the services to be provided are essential and cannot be provided by persons receiving salary support under the grant, or otherwise compensated for their services; * When an overload is indicated for training institute or workshop, and it is impossible to release the faculty member from any portion of usual duties. The "overload" will not be permitted for a longer period than one semester and the amount of "overload" permitted will not be greater than an average of one day per week. The compensation for this "overload" will in no case exceed the amount appropriate for one full working day a week, in terms of the faculty member's budgeted salary. * A faculty member holding an appointment for the academic year may be employed by the University outside the academic year on a part-time or a full-time basis in summer session teaching, in sponsored research or training programs, or in other activities. C. Relatives on Grants and Contracts. D. Retired Faculty. E. Other Personnel. F. Those Eligible to Apply for Research Grants. 3. Proposal Routing and Processing and Award Acceptance B. Frequently requested information on application forms: (http://research.uiowa.edu/dsp/main/?get=appformdata) C. Proposal Processing: (http://research.uiowa.edu/dsp/main/index.php?get=submit) D. Review, negotiation, and acceptance of grants and contracts The Division of Sponsored Programs has been designated as the responsible office for officially accepting on behalf of the University grant and contract awards for sponsored projects. This responsibility includes the negotiation of terms and conditions of the award. For contract awards, the Director of the Division of Sponsored Programs has signature authority to officially accept agreements that have been negotiated and found acceptable according to University policy. E. Award Activation Authorization Notice (AAAN) The AAAN is the official notification that an award has been accepted by the University and that an MFK has been established for the project. The notice identifies the sponsor, the sponsor’s identification number, the amount of the award, the begin and end dates of the current budget and project period, MFK number, name and phone numbers of contacts in Grant Accounting and Sponsored Programs. Comments may be included to emphasize unusual restrictions placed on the award or to explain the reason for a revised AAAN. The Award Amount should not be interpreted as a guarantee that funds will be available as stated. The amount indicated may be an estimate based on anticipated levels of award activity. F. Routing Form assurances and certifications Signature on the Proposal Routing Form and acceptance of the award by the department indicates that the principal investigator (PI) and all UI project personnel will comply with the UI Intellectual Property Policy (Section V, Chapter 30, of the UI Operations Manual) and UI Conflict of Interest Policy (Section II, Division I, Chapter 18, of the UI Operations Manual). The PI assumes the responsibility to expend funds under this project in accordance with sponsor and University policies; to review project expenditures monthly and take timely action to assure accurate accounting; to resolve any overexpenditures or unallowable costs and to channel through DSP for the countersignature of the University Authorizing Official, all documents to the sponsor such as revised budgets, extension of project ending dates, and interim and final technical/project reports. 4. Project Management Responsibilities A. Project Director Roles and Responsibilities. B. Departmental Executive Officer Roles and Responsibilities. C. Collegiate Administrative Officer (Dean) Roles and Responsibilities. D. Division of Sponsored Programs Roles and Responsibilities. E. Grant Accounting Office Roles and Responsibilities. A. Office of Management and Budget (OMB) Circulars: Federal Cost Principles (A-21) - This Circular establishes principles determining the costs applicable to research and development, training, and other sponsored work performed by colleges and universities under grants, contracts, and other agreements with the Federal Government. It provides the means for identification and assignment of facilities and administrative (F&A) costs and the determination and application of F&A cost rates. It also provides general provisions for selected items of costs in terms of whether they are allowable and allocable. B. Agency grant regulations and policy statements Federal agencies may provide specific terms and conditions in the form of specific policy statements that are in addition to what is required by A-110. Examples include the NIH Grants Policy Statement and the NSF Grant General Conditions. These take precedence over A-110 when they are referenced in award documents. C. Specific award restrictions Granting agencies may incorporate additional restrictions to awards that exceed the requirements of A-110 and general agency policies and regulations. Awards should be carefully reviewed so that the PI and administrative staff are made aware of all specific award restrictions. D. Federal Acquisition Regulations (FAR) FAR is the primary document in the federal procurement contracting system containing uniform policies and procedures that govern the acquisition activity of all federal agencies. The FAR consists of a set of uniform contract clauses for use in preparing contracts. E. General versus Special Conditions General Conditions are the standard contract clauses used by sponsoring agencies that apply to all contractors whereas the Special Conditions are those that apply to the specific project such as the amount or consideration, identity of contractor, statement of work, etc. A. Signature requirements for sponsored agreements The Board of Regents has delegated the authority to make contracts and agreements to the President of the University. This authority has been further delegated to the Director, Division of Sponsored Programs for the following agreements: Federal Research and Development Contracts, including Purchase Orders B. Major elements of a contract: Scope of Work -- A statement of all work that was fairly and reasonably within the contemplation of the parties at the time the contract was made; or Cost and Billing -- The portion of a contract that discusses costs, establishes the limitations on costs, and provides information on how the contractor will recover its costs. Term and Termination -- Term establishes the time period for the project -- i.e., the beginning and ending dates of the times for which funds are provided. Termination describes the process for early termination by either party and the disposition of other contract terms in the event of early termination. Indemnification -- The agreement of a contracting party to hold the other party harmless, to secure the other party against loss or damage, or to give security for the reimbursement of the other party in case of an anticipated loss. Insurance -- Protection against risk of loss or harm. Publication Rights -- Protects the rights of the investigator and the University to publish the results of the research and establishes freedom from the imposition of restrictions by the sponsor. Technical Reports -- Describes requirements for reporting research results to the sponsor, the University’s fundamental responsibility under the contract. Confidential/Proprietary Information -- Confidential Information is information exchanged between two parties that the receiving party is required to keep confidential and not disclose to a third party. Proprietary Information is designated as that constituting a trade secret and or information that is commercial or financial and confidential or privileged. Proprietary Data is technical data submitted to the sponsor under a contract and subject to protection by the contractor. Intellectual Property -- Defines and describes the ownership and disposition of copyrights and inventions resulting from the sponsored project. Governing Law -- Indicates the laws under which legal disputes would be resolved. In general, Iowa law should govern University contracts. Other -- There are unlimited clauses that sponsors may add, especially federal contracting requirements to promote federally legislated social programs. 7. Master File Key (MFK) Setup and Pre-Award Spending A. Officials authorized to sign proposals and accept grants and contracts The authority and responsibility for the Division of Sponsored Programs to sign proposals acting for the Vice President for Research and to accept grants and contracts for the University is described in Part V, Ch. 5 - Policy and Procedures on Gifts, Grants, and Contracts , of the University Operations Manual. B. Pending awards and pre-award expenditures Expenses cannot be charged against sponsored agreements prior to the start date of the agreement unless specifically authorized in writing by the sponsor. Many federal agencies provide for 90-day preaward costs when the award is subject to “expanded authorities.” When it is certain that an award has “expanded authorities” and when it is known that an award will be made effective on a specified date, an advance MFK may be obtained by processing the Request for Advance Master File Key form designed for that purpose. The department must agree to accept full responsibility for these expenditures if the project is not eventually funded. C. Developing proposal budgets The Grant Accounting Office (GAO) requires a copy of the budget approved by the sponsor prior to establishing a Master File Key (MFK) for the project. The budget is the basis for preparing the Financial Management Summery (FMS) report on monthly expenditures by major budget category. Typical major budget categories are listed below. Budget D. MFK (Master File Key) Setup 8. Corporate and Industry Sponsored Projects Policy Statement A. Unrelated Business Income Tax (UBIT) Is a Corporate Sponsored Project Subject to Unrelated Business Income Tax (UBIT) or is it Tax-Exempt? The conduct of scientific research is an exempt activity and should not generate UBIT. The Internal Revenue Service (IRS) has determined that some activities carried on incident to commercial or industrial operations are not research. The University, therefore, may be required to demonstrate that the project is substantially related to its mission by establishing that: * The project is designed and supervised by professionals to solve a problem via the scientific method, i.e., hypothesis, design, test, data analysis; adds to knowledge within a scientific field; can only be performed with advanced scientific or technical expertise; involves the development of new ideas, skills, methods; or, * The project is conducted in the public interest, e.g. seeks a cure or treatment for disease, provides treatment opportunity not otherwise available to patients, tests for public safety, etc. The results will be made available to the public; or, * The project furthers an educational purpose. Students or trainees involved in the project will have specific tasks and duties. Investigators are free to publish findings in a timely manner. The following documents are required for the assignment of a MFK (to establish an account): * University of Iowa Proposal Routing Form C. Fees and other accounting issues * Corporate and industry sponsored clinical trials will be charged a minimum F&A rate of 25% on total direct costs. Investigators are encouraged to charge up to the federally approved rate. Corporate and industry sponsored projects, excluding clinical trials, will be assessed facilities and administrative (F&A) costs based on the federally approved on-campus F&A rate, currently 50% of modified total direct costs. (MTDC excludes patient care, subcontract amounts in excess of $25,000, building repair, utilities, tuition, and facility lease and equipment purchases.) * Investigators must exercise diligence to only charge expenses against the project that are reasonable, allowable, and allocable. All revenues and expenses will be accounted for in the University accounting system. Investigators engaged in corporate or industry sponsored projects are responsible for notifying their departmental administrator upon the completion of the project. The administrator will then notify DSP. Each investigator will provide a copy of the final report (that was given to the sponsor) to the Clinical Trials Office for clinical trials agreements or Division of Sponsored Programs for all other awards. The Grant Accounting Office will initiate closure of the project account upon notification of project completion by the DSP/CTO, or, according to the project end date. The Principal Investigator and his/her department will be allowed a 90-day period following the completion of the project to make appropriate adjustments and corrections and to determine if a residual balance exists. The Grant Accounting Office will review the account for appropriateness of costs prior to closing the account. When applicable, UBIT will be assessed on the residual balance. The tax rate is based on the prevailing federal, state and local corporate income tax rate for taxable income (currently 34% Federal, 8% State and 0% local). Grant Accounting will retain in a project account all Federal and State Income Taxes assessed on the project’s net balance. After full F&A costs* and UBIT are assessed, the remaining balance will be transferred to an Organized Activity (fund 240) account. The account will be administered by the department with expenditures directed by the principal investigator who originally obtained the funds. The expenditure of funds will be to support research of the principal investigator who originally obtained the funds as long as the investigator is a regular faculty or staff member of the University. If the investigator leaves the University, the expenditure of the funds will be determined by the departmental executive officer to support departmental programs. * If an award ends in a surplus and a reduced F&A rate was negotiated with the University Sponsored Programs Office, then up to the full F&A rate will be assessed on incurred expenses (full F&A rate is 25% TDC on clinical trials or 50% MTDC on all other awards unless a maximum rate is stipulated in sponsor’s written policies). In no case will the application of additional F&A costs drive the account into a deficit balance. If, after audit, the project is not exempt from UBIT or it is determined that certain expenditures charged to the project were done so in error, the department will be responsible for any errors as well as additional tax, interest and associated penalties due to the taxing authority (eg: IRS, State Department of Revenue and Finance). In cases where the Principal Investigator transfers to another institution or organization prior to completing the study, , the Principal Investigator and department should consult the Grant Transfer Policy (see “Grant Transfer” at http://research.uiowa.edu/dsp/main/?get=pandp). In cases where the Principal Investigator leaves The University of Iowa after the project has been closed out, funds remaining will be transferred to the DEO of the Investigator’s department for discretionary use in research at The University of Iowa. 9. Direct and Facilities and Administrative (F&A) Costs A. Allowable costs -- those project costs that are: eligible, reasonable, necessary, and allocable to the project. B. Allocable costs -- costs that are assignable or chargeable to one or more cost objectives in accordance with the relative benefits received or other equitable relationships defined or agreed upon by contractual parties. For example, allocating a percentage of someone’s salary to conform to effort devoted to the project. C. Reasonableness of costs - A cost may be considered reasonable if the nature of the goods or services acquired or applied, and the amount involved, reflect the action that a prudent person would have taken under the circumstances prevailing at the time the decision to incur the cost was made. Major considerations involved in the determination of the reasonableness of a cost are: (a) whether the cost is of a type generally recognized as necessary for the operation of the institution or the performance of the sponsored agreement; (b) the restraints or requirements imposed by such factors as arm's-length bargaining, Federal and State laws and regulations, and sponsored agreement terms and conditions; (c) whether the individuals concerned acted with due prudence in the circumstances, considering their responsibilities to the institution, its employees, its students, the Federal Government, and the public at large; and, (d) the extent to which the actions taken with respect to the incurrence of the cost are consistent with established institutional policies and practices applicable to the work of the institution generally, including sponsored agreements. Cost Accounting Standards (CAS) are rules established by the Cost Accounting Standards Board (CASB) of the Federal government that are designed to achieve uniformity and consistency in the cost accounting practices governing measurement, assignment, and allocation of costs. In other words, every organization should have cost accounting practices that govern the way costs are treated within their organization in a uniform and consistent manner. If you are involved with activities in your department that receive federal support, you should understand how CAS affects the process of budgeting and allocation of funds to complete the sponsored activities. The Federal government provides significant funding to universities in support of research, training and public service activities and is asking that those funds be accounted for appropriately. Costs that are directly associated with project performance such as the salaries of the PI and his/her research staff and lab supplies can be easily identified and budgeted in accordance with the project's proposed activities. Costs that are indirectly associated with project performance such as facilities costs (utilities and maintenance of space) or administrative costs (general administrative support and office supplies) cannot be easily identified and budgeted in accordance with the project's proposed activities. Universities are normally reimbursed for the latter costs through an indirect cost allowance (now called a facilities and administrative or F&A cost allowance) determined by a rate applied to the approved direct cost budget (less certain costs such as equipment). CAS states that costs incurred for the same purpose in like circumstances must be treated either as a direct cost or as an F&A cost. If the circumstance is not the same, then a cost normally considered an F&A cost may be direct charged. Interpreting what is an unlike circumstance will no doubt result in differences of opinion between auditors and university faculty and staff. The underlying reason for this rule is the Federal government does not want to reimburse universities twice for the same cost. Consequently, universities must have cost accounting practices in effect to prevent this from happening. As departmental personnel associated with the fiscal administration of federal awards, you must exercise care in preparing budget proposals and in the proper allocation of the budgeted costs to meet project objectives. This Circular establishes principles determining the costs applicable to research and development, training, and other sponsored work performed by colleges and universities under grants, contracts, and other agreements with the Federal Government. It provides the means for identification and assignment of facilities and administrative (F&A) costs and the determination and application of F&A cost rates. General provisions for selected items of costs in terms of whether they are allowable and allocable: Direct costs are those costs that can be identified specifically with a particular sponsored project, an instructional activity, or any other institutional activity, or that can be directly assigned to such activities relatively easily with a high degree of accuracy. Costs incurred for the same purpose in like circumstances must be treated consistently as either direct or F&A costs. Where an institution treats a particular type of cost as a direct cost of sponsored agreements, all costs incurred for the same purpose in like circumstances shall be treated as direct costs of all activities of the institution. Examples include salary costs, travel, equipment, supplies, etc. * Definition and examples of F&A costs: F&A costs are those that are incurred for common or joint objectives and therefore cannot be identified readily and specifically with a particular sponsored project, an instructional activity, or any other institutional activity. Examples include costs for building and equipment depreciation and use allowances, interest, physical plant operation and maintenance expenses, general administration and general expenses, departmental administration expenses, sponsored projects administration, library expenses, and student administration and services. See Facilities and Administrative Costs -- for an article providing a better understanding of facilities and administrative costs, formerly known as indirect costs. F. Unacceptable direct cost charging practices Certain costs are defined in A-21 as unallowable either as a direct or as an F&A cost, e.g. alcoholic beverages, entertainment, fund raising, lobbying. A-21 was revised in 1993 to eliminate costs that formerly were being charged either way to eliminate or reduce instances of double charging. This revision dealt with costs for clerical and administrative salaries, certain general office supply costs, telephone charges, postage, and membership in professional and scientific organizations. See Administrative/Clerical Salaries charged to a grant. For a complete discussion of the practices required for compliance with this revision. G. Charging normal F&A costs as direct costs See Administrative/Clerical Salaries charged to a grant for a complete discussion of acceptable practices. H. Resolving cost overruns 10. Matching Funds and Cost Sharing A-110 Definition - Cost sharing or matching means that portion of project or program costs not borne by the Federal Government. * When mandated by the sponsor B. A-110 requirements for Cost sharing or matching. Mandatory cost sharing is required by a sponsor as a condition for making an award and usually refers to an overall percentage of total projects costs to be contributed. * Committed cost sharing is not required by the sponsor but is shown on the budget usually in the form of contributed effort of the principal investigator or other project staff and paid from University or non-federal funds. C. Distinguishing mandatory cost sharing from committed or voluntary cost sharing according to University definitions. Because it is established by the sponsor, mandatory cost sharing is more rigid than committed or voluntary cost sharing. The former is usually shown on the notice of award and permits no decreases in amount without sponsor approval. D. Including cost sharing or matching in proposals If required, contributed effort should be shown as a contribution of salary and associated fringe benefits and F&A costs. In general, refrain from budgeting non-personnel-related cost sharing unless it can be easily documented in the accounting system. Cost sharing is expensive to document and adversely affects the University’s F&A rate and therefore should always be kept to a minimum. E. Accounting for cost sharing and matching after award acceptance If cost sharing or matching is subsequently accepted by the University as a condition of the award, the University must maintain accurate records to verify these funds have been provided to meet the project’s objectives. The institutional portion of cost sharing or matching funds may also be used in calculating F&A rates. Excessive or unnecessary cost sharing can have the effect of reducing the F&A cost rates, and therefore cost sharing should follow the guidelines outlined below: * Salaries and their associated fringe benefits and F&A costs can be verified in accordance with the guidelines provided for the Personnel Activity Reporting (PAR) System. F. University Equipment and Non-Equipment Cost Sharing Program The Office of the Vice President manages two programs for providing funds for costs sharing. Priority is given to external funding programs with specific written guidelines requiring cost sharing making it mandatory that the University share in the costs of the project as a condition for accepting an award. The following forms must be completed and submitted through the required channels at least two weeks in advance of the external grant application deadline: Equipment Cost Sharing Request Form and Non Equipment Cost Sharing Request Form. When approved and after the grant is funded, Grant Accounting will assign an MFK specifically for the cost sharing and ensure that the funds are allocated for the cost sharing portion, thereby documenting to the sponsor that the funds were allocated and spent accordingly. 11. Purchasing of Equipment, Professional Services, Goods & Materials A. Monetary Thresholds for purchasing decisions * Goods and services from $0-2,000 may be purchased by procurement cards or by non--PO voucher-invoice forms. B. Assuring a reasonable price for purchase Price reasonableness can be accomplished and documented several ways: Encumbering funds for the purchase of services, supplies, and equipment can only be accomplished by submitting an approved requisition to the Purchasing Department. When a purchasing decision as to the price and vendor has been made, an electronic purchase order is approved by the Purchasing Agent, and a purchase order is written. The total amount of the order and its distribution of MFK’s are then encumbered. Once the need for professional or consultant services is determined at the department level, the general process for acquiring services is as follows: Once professional or consulting services have been rendered, departments evaluate the quality of the vendor’s performance. All payments for professional or consultant costs are reviewed and paid by University of Iowa Accounts Payable. To accommodate emergency procurements requiring a sole source, the above-described process is modified accordingly with appropriate supporting documentation. E. Procedures, policy, and process for purchase of supply, goods, and materials The full detail can be found at http://www.uiowa.edu/~purchase or a copy can be obtained by contacting Purchasing at 335-0379. The University of Iowa Procurement Card is a purchasing tool for low dollar transactions up to $2,000. Procurement cards are issued to a department under an individual staff member’s name with the agreement to observe specific rules and procedures. It is primarily used for operating expenses but its applications are frequently expanded. All University employees are eligible and may attain a card by submitting a completed Procurement Card Application Form to Purchasing. Monthly limits are set at $10,000 but may be increased upon request by the cardholder’s department head. The department head or their designee must approve the application form or the request to increase monthly limits. Stamped signatures are not acceptable. Refer to the procurement card manual on the web site www.uiowa.edu/~purchase . Individuals traveling on University business, whether in state or out of state should secure approval from their department. The appropriate University officials have to assure that the travel is approved and that funds are available for reimbursement. Each department is responsible for establishing internal approval processes, defining its signature authority, and informing its travelers of these processes and travel regulations. B. Allowable Business Travel Expenses Transportation— Non-Allowable Expenses For specific travel allowance information, consult the UI Travel Manual at http://www.uiowa.edu/~fustd/travel/Trav%20Policy/Travel_Manual.htm Travel expenses must be itemized on an official travel expense voucher for reimbursement. By approving the voucher the traveler signifies that the listed expenses are correct and complete and will not be claimed for reimbursement from any other source or claimed as a tax deduction. Departmental approvals indicate that all expenses have been reviewed and are approved by the department. However, the department may not approve expenditures that are outside the established University travel regulations. In special circumstances, where exception to policy is deemed essential, a written request with explanation must be submitted to the Travel Office and approval must be received prior to the expense being incurred. Information regarding the UI travel reimbursement system, ProTrav, is available at: See Procurement Card information at -http://www.uiowa.edu/~purchase/PCard/. E. Travel Under Externally Sponsored Agreements In addition to compliance with University travel regulations, travel funded under externally sponsored agreements (contracts, grants and other awards) is often subject to additional regulations of the sponsoring organization(s). For example, travel under federally sponsored agreements generally follows the cost principles set out in Office of Management and Budget Circular A-21. Federal agencies are required to incorporate these cost principles into their policy guidelines. Some agencies, such as the Public Health Service and the National Science Foundation, have delegated authority to grantee institutions to approve non-budgeted travel. Sponsoring organizations may restrict the use of funds for certain types of travel or require sponsor approval under specific sponsored agreements. In most instances, travel restrictions are set out under the special terms and conditions section on the award notification or agreement for both federal and non-federal sponsors. Questions pertaining to externally sponsored travel should be directed to the accountant specified on the University's Award Activation Authorization Notice accompanying the notice of award from the sponsoring organization. ***NOTE****In general, under federally sponsored agreements, travelers must use U.S. flag air carriers for international air transportation. For the full policy on use of US Flag Carriers please see http://www.nsf.gov/pubs/policydocs/papp/aag_6.jsp The University of Iowa issues subcontracts when a substantive portion of the work related to an externally funded project is to be performed by a third party. The Division of Sponsored Programs works with the investigator and department to draft the subcontract. The Division of Sponsored Programs negotiates the general administrative terms, while the PI is responsible for negotiating the scope of work and budget. The PI is responsible for reviewing the subaward draft as well as monitoring performance of the work, invoices, and compliance with the terms of the subaward and the prime award. An example of compliance monitoring is working with DSP to ensure UI reports to the sponsor as appropriate subrecipient disclosure and management of conflicts of interest. Grant Accounting, Purchasing, Accounts Payable and the Division of Sponsored Programs assist with implementation of the subaward and the financial reporting requirements. Information regarding choosing a subcontractor, the competitive bidding process, prior approval, and roles and responsibilities is available at http://research.uiowa.edu/dsp/main/index.php?get=subkmain. 14. Professional Service Agreements (Consulting) A written Professional Services Agreement (PSA) must be used for consultants who are not University employees and who receive payments from the University in excess of $5,000 per project year.
15. Effort Certification The University of Iowa Personnel Activity Report (PAR) is a two-part form used to identify how faculty and selected staff effort is distributed to a broad variety of activities. Federal guidelines (primarily OMB Circular A-21) and Board of Regents directives govern who is surveyed, how frequently they are surveyed, allowable variances between federal salary and federal effort, and the time frame in which surveys must be distributed and completed. Data retrieved from effort reports is compiled, analyzed and used to prepare summary reports for the State Board of Regents and for University Hospitals and Clinics. Effort reports are also used to verify individual effort on federally sponsored grants and contracts.
PARs are required for all senior faculty members.
Anyone having first hand knowledge of the individual's effort may complete the form. Faculty forms must be reviewed and signed by the faculty member (or the departmental chair or executive officer if the faculty member is not available). P&S, Student Faculty, and Merit forms should be reviewed and signed by the individual surveyed or by appropriate supervisory personnel. Individuals completing PARs should fully understand the instructions included with PAR distribution.
For more information visit the Departmental PAR Coordinator & Supervisor Guide at A. Labor charges are authorized by an Appointment form created by the employing department, signed by the appropriate departmental official and forwarded to central Human Resources for processing. B. Payroll distributions for charging a Master File Key or Keys are provided as part of the detailed information included with the Appointment form. Approvals of this form include the Project Director, Department Head, Collegian Dean and Central Administration. Subsequent changes to the payroll distribution can be made with an “Accounting Only” Change In Status form. C. Fringe benefits are charged as a percentage of the salary paid to an employee. The percentages are determined each year based upon the cost experience of the fringe benefit pool for different classes of employees. The rates for current fiscal year are available at http://www.uiowa.edu/~fusas//fringe.htm. D. An employee’s accrued vacation, paid out when an employee terminates or transfers into a position that does not earn vacation, is charged against the fringe benefit pool. Also, for eligible employees who retire at age 55 or greater, their unused sick leave will be paid to a maximum of $2,000 from the fringe benefit pool. The monthly expense for fringe benefits includes the cost of paying off both accrued vacation and sick leave balances. E. Payroll corrections are made in a variety of ways depending upon the type of error. For instance, if the Employee Time Record is submitted with incorrect information then a Corrected Employee Time Record is submitted to correct the error. If the wrong Master File Key (MFK) is charged for a payroll or benefit expense then a Pay CV is made to correct the current accounting error. Also, a Change In Status form is created and processed to change the MFK on the payroll system for the charging of future payroll/benefit expenses. A cost transfer is an expense that is transferred from one account to another after the expense was initially recorded in the financial accounting system. External sponsors expect that costs are charged appropriately at the time incurred and that significant adjustments should not be required if adequate financial management practices and policies exist. The Federal government has established policies, concerning the assignment of costs to federally sponsored agreements, in OMB Circular A-21 and within specific agency policies on cost transfers. To comply with cost allowability and allocability requirements of OMB Circular A-21, it is necessary to explain and justify transfers of charges onto federal awards from other federal accounts, non federal accounts or University accounts. Timeliness and completeness of explanation of transfer are important factors in supporting allowability and allocability in accordance with the principles of the Circular. NIH Grants Policy Statement To comply with the policy of NIH, our largest source of federal research funding, and the requirements of other federal and non-federal sponsors, the following policy and accompanying guidance sets forth the procedures and approval necessary for the processing of cost transfers at The University of Iowa. Each department is responsible for complying with and enforcing the following policies and procedures. Any penalties, disallowance, or losses of funding caused by non-compliance with this policy will be assessed against the department in violation of the policy. It is expected that the Principal Investigator (PI) or their delegate will review the fiscal status of their sponsored project accounts regularly (monthly review is recommended) and promptly correct expense transactions that are incorrectly recorded. Departmental personnel are responsible for preparing and submitting the cost transfer with the knowledge and approval of the PI. The University recognizes that transfers of costs from one sponsored project account to another are occasionally necessary to correct bookkeeping or clerical errors in the original charges. The University also recognizes that closely related work may be supported by more than one funding source and that in such cases a transfer of costs from one funding source to another may be proper. However, frequent, delayed, or unexplained cost transfers, particularly when they involve projects with cost overruns or unexpended fund balances, raise serious questions about the propriety of the transfers themselves as well as the overall reliability of the University’s accounting system and internal controls. When the need for a cost transfer to a sponsored project account (fund 500 or 510) arises, the Cost Transfer Explanation and Justification Request form must be completed and certified by the PI or their delegate. The explanation for the cost transfer must be clearly stated and must be sufficient for an independent reviewer (i.e., an auditor) to understand the transfer and conclude that it is appropriate. According to Federal regulations, “An explanation which merely states that the transfer was made ‘to correct an error’ or ‘to transfer to correct project’ is not sufficient.” Cost transfers should be accomplished within 90 days of the effective date of the original entry. The 90-day time limitation applies when transferring expenses on to a sponsored project account. If a particular sponsor policy on cost transfers is more restrictive than 90 days, the more restrictive policy will apply. No time limit exists for removing expenditures from a sponsored project account. If inappropriate expenditures are discovered on sponsored projects, they must be moved to a non-sponsored departmental account without regard to time limits. Cost transfers that are made only for the intention of spending down sponsored project funds or as a matter of convenience are not allowed. Expenses transferred on to a sponsored project account are very prone to audit and must be clearly supportable. Transferring costs because of a deficit or other reasons of convenience is not appropriate. Any shared costs should be pro-rated among the applicable accounts at the time the costs are incurred to the maximum extent possible. Charging costs to one sponsored project with the intention of repaying that sponsored project when an award is received is also not appropriate. * Transfer of non-salary expenditures A. A-110 definition and requirements * Definition: Program income means gross income earned by the recipient that is directly generated by a supported activity or earned as a result of the award (see exclusions in paragraphs .24 (e) and (h)). Program income includes, but is not limited to, income from fees for services performed, the use or rental of real or personal property acquired under federally-funded projects, the sale of commodities or items fabricated under an award, license fees and royalties on patents and copyrights, and interest on loans made with award funds. Interest earned on advances of Federal funds is not program income. Except as otherwise provided in Federal awarding agency regulations or the terms and conditions of the award, program income does not include the receipt of principal on loans, rebates, credits, discounts, etc., or interest earned on any of them. * Requirements: .24 Program income (1) Added to funds committed to the project by the Federal awarding agency and recipient and used to further eligible project or program objectives. B. When an agency authorizes the disposition of program income as described in paragraphs (b) (1) or (b) (2), program income in excess of any limits stipulated shall be used in accordance with paragraph (b)(3). c. In the event that the Federal awarding agency does not specify in its regulations or the terms and conditions of the award how program income is to be used, paragraph (b)(3) shall apply automatically to all projects or programs except research. For awards that support research, paragraph (b)(1) shall apply automatically unless the awarding agency indicates in the terms and conditions another alternative on the award or the recipient is subject to special award conditions. C. Reporting of program income The Grant Accounting Office should be contacted for advice on how program income should properly be accounted for prior to the generation of any revenues derived from sponsored agreements. D. Methods of accounting for program income * Depending on the terms and conditions of the sponsored agreement program income may be handled in one or more of the following ways: 1. If the deduction alternative is to be followed or if the income is used to cover the costs incurred to produce the revenue under the sponsored agreement, the income should be directly credited to the sponsored account (MFK). Renewals of sponsored agreements may or may not be subject to a competitive review process. A project that has been approved for funding for multiple years is usually funded on a year-by-year basis. Each subsequent year’s funding is dependent upon a renewal request that includes a progress report of the prior year’s activities and a budget for the upcoming year depending upon sponsoring agency requirements. These progress reports are referred to as non-competing continuations or extensions and are required to be processed through University channels with a Proposal Summary Form the same as new proposals. If the funding agency does not require a budget, routing is still required with a copy of the approved budget for internal purposes. Federal Regulations (A-110) requires that the University monitor and track progress reports and therefore DSP must keep continuation requests on file. Competitive renewal requests are processed in the same way as new proposals. At the end of each budget period, the Grant Accounting Office will prepare a financial report according to the sponsor’s requirements. During the course of a sponsored project, there is often the need to make changes or alterations to the project as originally proposed to the sponsor. These changes may be financial in nature or related to project personnel or have to do with timing of project milestones. Generally a sponsor will impose certain restrictions on changes that will require the project director and the University to obtain prior approval in advance of the change. For federal grants, the minimal requirements for sponsoring agency prior approval are contained in A-110, Subpart C -- Postaward Requirements, Financial and Program Management, Section 25 Revision of budget and program plans. For more information on post-award policies and procedures, see Administration. University procedures for transferring a grant and equipment when a PI leaves are also discussed here. (See Transfer of Grant / Change of Project Director and Transfer of Equipment) 21. Close Out and Property Management and Disposal At the conclusion of a sponsored agreement, the terms of the award generally require that a written final technical or progress report and a report of expenditures be submitted to the sponsor within a specified period of time. These reports are generally viewed as the University’s fundamental obligation to the sponsor. For Federal awards, Circular A-110 lists the following requirements: Technical -- Unless otherwise indicated, “final performance reports are due 90 calendar days after the expiration or termination of the award. When required, performance reports shall generally contain, for each award, brief information on each of the following. * A comparison of actual accomplishments with the goals and objectives established for the period, the findings of the investigator, or both. Whenever appropriate and when the output of programs or projects can be readily quantified, such quantitative data should be related to cost data for computation of unit costs. The PI is responsible for preparing and submitting the report. A dated copy of the report or letter of transmittal should be sent to DSP to provide audit verification that the report was filed. Financial -- The Financial Status Report (Form 269) is prepared by the Grant Accounting Office and sent to the PI for approval prior to being submitted to the Federal Awarding Agency. Inventions -- The grantee (University) must submit a Final Invention Report or Statement and Certification, whether an invention(s) results from work under the grant. The final invention report or statement/certification must be signed by the PI and an authorized institutional official and must list all inventions that were conceived or first actually reduced to practice during the course of work under the project, from the original effective date of support through the date of expiration or termination, whether or not previously reported. If there were no inventions, the statement should indicate "None." The PI is responsible for generating this report and it should be processed through DSP for signature. Property -- The University must account for any real or personal property acquired with the use of federal funds. A report is prepared using agency forms identifying the equipment purchased, acquisition cost, make, model number, serial number, UI inventory number, and condition. If the terms of the award do not automatically give title to the University, a letter is sent to the agency requesting transfer of title to the University. B. Steps required to closeout projects (A-110 Closeout Procedures): 1) Recipients (i.e., the University) shall submit, within 90 calendar days after the date of completion of the award, all financial, performance, and other reports as required by the terms and conditions of the award. The Federal awarding agency may approve extensions when requested by the recipient. C. Situations where closeout is appropriate Cost-reimbursement-type sponsored agreements with fixed end dates generally require some close out procedures. The fundamental obligation of the University for every Sponsored Agreement is a final written report. Some agreements such as fixed price agreements will not require expenditure reports. Sponsor policies and award terms and conditions should be consulted for closeout procedures. D. Procedures for disposing of or transferring equipment Unless stated otherwise in the terms and conditions of the award, the title to equipment acquired under a sponsored agreement belongs to the University. The University is obligated to keep track of and account for all federally acquired equipment. The process for disposing of or transferring equipment to other institutions whenever a PI terminates his or her position must follow the University Policy on Transfer of Equipment . The UI Office of Property Management provides advice on procedures and forms for initiating requests for disposal or transfer of equipment. The University is in the process of completing a Records Management Program. A guidebook on Records Management has been finalized and has been put on the web for anyone to use. In addition, the records management policies have been officially incorporated into the University Operations Manual. Business Office personnel have been working with colleges and departments in completing their records retention schedules. The schedules include: a description of the types of records, who is the custodian of the records, the records retention requirements, whether the records are official, confidential or vital and the format of the records. The information from the retention schedules is entered on the web and is available to anyone needing this information. While the University Secretary has the overall responsibility for University records management the ultimate responsibility for records management is with the administrators of the various colleges, departments and units of the University. The administrators should be knowledgeable about any records utilized in their areas and how long these will be needed. Any questions about legal retention requirements may be addressed to the University Business Office. OMB Circular A-133 sets forth standards for obtaining consistency and uniformity among Federal agencies for the audit of States, local governments, and non-profit organizations including universities expending Federal awards. Under this circular the University is required to have a single audit of both the financial statement and Federal awards as long as total Federal expenditures are $500,000 or more for a given year. The scope of the audit shall include: Financial Statements The auditor shall determine whether the financial statements of the auditee are presented fairly in all material respects in conformity with generally accepted accounting principles. The auditor shall also determine whether the schedule of expenditures of Federal awards is presented fairly in all material respects in relation to the auditee's financial statements taken as a whole. Internal Controls The auditor shall perform procedures to obtain an understanding of internal control over Federal programs sufficient to plan the audit to support a low assessed level of control risk for major programs. Compliance The auditor shall determine whether the auditee has complied with laws, regulations, and the provisions of contracts or grant agreements that may have a direct and material effect on each of its major programs. For each Federal program identified by a Catalog of Federal Domestic Assistance (CFDA) number, the following types of compliance requirements and the total amount of any questioned costs are indicated: Activities allowed or unallowed Under A-133 Auditor is a public accountant or a Federal, State or local government audit organization, which meets the general standards specified in generally accepted government auditing standards (GAGAS). Therefore the Office of Auditor of State for the State of Iowa conducts the A-133 audit of the University. Most awards, federal and private, provide the sponsor the opportunity to review the financial records of a sponsored project. This may involve a complete audit of all expenditures after the completion of the project. 24. Processing Non-Financial Agreements In addition to the award documents that provide funding for University projects, there are other agreements processed by the Division of Sponsored Programs that relate to the conduct of research. A. Material Transfer Agreements (MTAs) Defines the terms under which research materials are exchanged between investigators and institutions and are to be used in research. MTAs can either apply to materials coming to the University of Iowa or materials owned by the University that are being transferred to researchers outside the University. A routing form is required for either purpose and the explanation of purpose and procedures for each are described in further detail at the above site. B. Confidential Disclosure Agreements (CDA) Also referred to as Non-Disclosure Agreements, these documents are executed whenever confidential information is disclosed, received or exchanged by and within the University of Iowa. The purpose of the agreements is to protect the disclosing party’s information from being disclosed to third parties without the knowledge or prior approval of the disclosing party. The most common use of the CDA is to protect proprietary information on industrial technology or products and/or University intellectual property or unpublished research advances so that information can be exchanged during the development of industrial sponsored agreements with the University. The following standard model agreements have been developed: An arrangement in which two or more parties form a joint venture to act as a potential prime contractor or when a prime contractor agrees with one or more parties to have them act as subcontractors. Teaming agreements are frequently executed prior to the development of proposals to preset certain terms prior to the submission of the proposal and to provide assurance to the sponsor that the parties have agreed to establish the necessary contractual arrangements for the successful conduct of the project. 25. Intellectual Property 26. University Service Centers (Recharge Centers) A. Recharge Centers are established for the purpose of providing goods and services to University customers. The Centers are expected to offer goods and services that are unique, convenient or not readily available from external sources. B. Any University department intending to establish a recharge center must submit a written request, approved by the departmental executive officer, to the Business Office for review. The rates charged for goods and services are computed by the Recharge Centers and are reviewed and approved by the Business Office. Rates charged to University departments should be set to break even. C. The cost of purchasing capital assets cannot be included in the calculation of the billing rates. However, it is appropriate to include depreciation on the capital assets in the rates. The depreciation should be based on the cost and life of the capital assets and computed on a straight line basis. D. The Recharge Centers should maintain detailed records supporting charges to Conflict of interest in research involves situations in which an investigator has a significant financial interest that may compromise, or have the appearance of compromising, professional judgment in the design, conduct, or reporting of research. The University of Iowa policy for disclosing and managing potential conflicts of interest embraces the same requirements for all sponsored research, irrespective of the funding source, be it a governmental agency or private entity. The UI policy incorporates key elements from federal regulations; Iowa state laws governing the activities of state employees; and the University's commitment to the principle of free, open, and objective inquiry in the conduct of its teaching, research, and service missions. The full policy is available in the UI Operations Manual Part II, Division I, Chapter 18, at: http://www.uiowa.edu/~our/opmanual/ii/18.htm. UI-specific information is also available through the Office of the Vice President for Research Conflict of Interest website at: http://research.uiowa.edu/vpr/?get=coi . The following sections summarize key aspects of the policy.
a. Federal Government Regulations Several federal funding agencies have issued conflict-of-interest regulations relating to the research enterprise, so that investigators conducting research funded by a Public Health Service Agency, such as the National Institutes of Health, by the National Science Foundation, or by the Food and Drug Administration are subject to agency-specific COI regulations. These regulations are designed to ensure that federally funded research is performed without the presence or appearance of bias due to financial interests within the research team, setting forth the investigator, sponsor, and institutional obligations when research involves significant financial or other conflict of interest. Affected parties are advised to review the relevant regulations before submitting a research proposal or application. Web links to the actual federal regulations may be found on the OVPR COI website at: http://research.uiowa.edu/vpr/?get=coi.
University of Iowa investigators must disclose, in writing, any significant financial interests prior to the submission of a proposal for external funding or, for non-sponsored research, prior to initiation of the activity. If, when routing your proposal, you answer "Yes" to question #19 on the University of Iowa Proposal Summary, you must complete and submit the UI Financial Interest in Research Disclosure Form, available electronically at https://uiris.research.uiowa.edu/coi/index.php. The Division of Sponsored Programs cannot sign or submit proposals until Investigators with potential conflicts of interest have submitted the Financial Interest in Research Disclosure Form. The research may not begin and no expenditures may be made until until the University has reviewed the disclosure and all parties have agreed to any necessary management strategies. Any change in the nature or amount of the interest -- if a new significant financial interest is created, or if a new investigator with a significant financial interest is hired to work on the research project -- that interest must be disclosed within 60 days.
c. Who is Subject to the COI Disclosure Requirements? Investigators with a significant financial interest in the research must disclose that interest. Investigator means the principal investigator and any other person -- whether faculty, staff, or student -- who is responsible for the design, conduct, or reporting of research funded, or proposed for funding, by an external sponsor. In this context, the term Investigator includes the Investigator's spouse and dependent children.
d. What is a Significant Financial Interest? A significant financial interest means anything of monetary value, including, but not limited to, salary or other payments for services (e.g., consulting fees or honoraria); equity interests (e.g., stocks, stock options, or other ownership interests); and intellectual property rights (patents, copyrights, and royalties from such rights) held by an investigator or the investigator's immediate family, individually or in aggregate, when such interest involves:
e. Disclosure, Review, and Management Procedures The Principal Investigator is responsible for seeing that all Investigators disclose any significant financial interest, using the UI Financial Interest in Research Disclosure Form available electronically at https://uiris.research.uiowa.edu/coi/index.php. The Principal Investigator's signature on the UI Proposal Summary Form at routing certifies that he/she has requested such information from all Investigators. Disclosures are reviewed and managed as follows:
f. COI in Research Involving Human Participants Special consideration will be given to conflicts of interest when the research involves human participants. In addition to the procedures outlined above, the existence of the conflict must be disclosed on the IRB application form. In these situations, the IRB will communicate with the Conflict of Interest Office regarding the elimination, disclosure and/or management of such conflicts.
The University of Iowa operates a centralized program to review all human subjects research. All human subjects research carried out at the University or under its auspices must be reviewed and approved by a University of Iowa Institutional Review Board (IRB) prior to the start of the research. A. The University of Iowa Human Subjects Office, located at 300 CMAB (335-6564), provides administrative support for the Institutional Review Boards. This office provides assistance to investigators and research staff who are preparing IRB applications and maintains records of IRB reviews and approvals. University of Iowa IRBs are charged with the protection of human subjects in all research. The IRBs review all projects when: * the research is sponsored by the institution, Research is defined as a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. Activities that meet this definition constitute research even if they are a component of a larger non-research activity (e.g., instruction, demonstration). Federal regulations define a human subject as a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information. All human subjects protocols are reviewed in accordance with federal regulatory requirements set forth in 21 CFR 50 & 56 and 45 CFR 46 regardless of sponsorship. Primary responsibility for assuring that the rights and welfare of the individuals involved are protected continues to rest with principal investigators conducting the research. This responsibility is shared by others engaged in the conduct of the research. Faculties who assign or supervise research conducted by students have an obligation to consider carefully whether those students are qualified to safeguard adequately the rights and welfare of subjects. B. The Review Process In addition, the IRB reviews the information to determine whether subjects are informed about the nature of the study, the details of their participation, and the voluntary nature of their participation, and whether the risks and benefits of the research are evenly distributed among the possible subject populations. Additional information may be found on the Human Subjects Office website at: http://www.research.uiowa.edu/hso/. All research and education using live, vertebrate animals and conducted by faculty, staff and students of the University of Iowa is required to conform to regulations in the US Department of Agriculture Animal Welfare Act, the Public Health Service Policy on Humane Care and Use of Laboratory Animals, and the Guide for the Care and Use of Laboratory Animals (National Research Counsel). The Animal Care Unit (400 ML, 335-7985) is responsible for managing and administering a centralized program of laboratory animal care in accordance with these regulations. The functions of the ACU encompass service and regulatory responsibilities, including: procuring and housing of animals and equipment, monitoring of compliance with regulatory requirements, providing veterinary and husbandry care, planning animal facilities building and maintenance, cost accounting and recharging, program planning and maintenance, assisting the Institutional Animal Care and Use Committee (IACUC), organizing the utilization of space, providing technical services in support of research, providing consultation to UI personnel regarding animal care and use, training of UI personnel in humane and technical aspects of animal care and use, and providing expertise for undergraduate and graduate courses where presentation of information on use and care of animals is appropriate. For each protocol involving the care and use of vertebrate animals, the Principal Investigator (PI) is required to submit an Animal Care and Use Review Form (ACURF) directly to the Animal Care Unit. In signing an ACURF, the PI makes a commitment to notify the IACUC of any significant changes regarding the use of animals in ongoing activities. Examples of significant changes include changing the species, using larger numbers of animals, changing the use of pain-relieving drugs, changing post-procedural care procedures, and utilizing more painful procedures. Notification may be accomplished by submitting an updated ACURF and referencing the pending approval number that is being modified (acurf@uiowa.edu ). The IACUC determines that the proposed animal care and use meets the following requirements: * Procedures with animals will avoid or minimize discomfort, distress, and pain to the animals, consistent with sound experimental design. B. Approval Prior to Initiating Projects All protocols involving live, vertebrate animals must be reviewed and approved before they are initiated. It is the responsibility of the PI to ensure that every animal involved in experimentation is covered by and traceable to an approved protocol. Each proposal is allowed a specific number of animals which cannot be exceeded without approval from the IACUC. It is therefore important that the investigator correctly specify the approved protocol number when ordering animals. C. Animal Procurement, Housing and Care All animals must be purchased through the Animal Care Unit unless specific prior approval has been obtained for a variance from this requirement. The ACU provides housing and care for all vertebrates on the UI campus. Daily animal care is the responsibility of animal technicians who work for ACU. University policy limits housing animals in the laboratory to no more than 12 hours unless previously approved by the IACUC. Generally housing animals outside of Animal Care Unit facilities is not permitted due to the structural and physical plant requirements embodied in the regulations. Additional information regarding the use of animals in education and research may be found at: http://research.uiowa.edu/animal/ . 30. Research Involving Recombinant DNA As a recipient of NIH funding, the University of Iowa is required to insure that all recombinant DNA research, irrespective of the source of funding, complies with the NIH Guidelines. A. In the context of the NIH Guidelines, recombinant DNA molecules are defined as either: (i) molecules that are constructed outside living cells by joining natural or synthetic DNA segments to DNA molecules that can replicate in a living cell, or (ii)molecules that result from the replication of those described in (i) above. The purpose of the NIH Guidelines is to specify practices for constructing and handling recombinant deoxyribonucleic acid (DNA) molecules, and organisms and viruses containing recombinant DNA molecules. The NIH Guidelines outline procedures involving use of recombinant DNA and describe the roles, responsibilities, and relationships among the principal investigator, the Institutional Biosafety Committee (IBC), and the National Institutes of Health/Office of Biotechnology Activities (OBA). The manner in which experiments are classified in the Guidelines determines the required review procedures. B. Investigators wishing to use rDNA in their research should consult the federal guidelines. These may be found on the OBA website at: http://www4.od.nih.gov/oba/ . Experiments covered by these guidelines must also be submitted to the University of Iowa IBC for review and approval prior to initiation. C. Research that involves testing in humans of materials containing recombinant DNA require review by the OBA Recombinant DNA Advisory Committee before the University’s Institutional Biosafety Committee and Institutional Review Board (human subjects) take the project under review. Further information, including the UI rDNA application process can be obtained from the UI Health Protection Office (335-8501) or from their website at: http://www.uiowa.edu/~hpo/ . Policy on Ethics in Research (see Operations Manual, Section II, 27.6) Assurance of Compliance with Department of Public Health Service Policy Regarding Procedures for Dealing with and Reporting Possible Misconduct in Science 27.8 Anti-Retaliation Policy for Reporting of Misconduct in Research A. Research Integrity in general: On Being a Scientist (http://stills.nap.edu/html/obas/) B. Data acquisition, management, sharing, and ownership: Access to and Retention of Data (COGR) (http://www.cogr.edu/docs/AccessWebSeptember2003.htm ) NIH Report on Sharing Research Tools (1998) (http://www.nih.gov/news/researchtools ) C. Mentor/trainee responsibilities: NIH Mentoring Guide http://www1.od.nih.gov/oir/sourcebook/ethic-conduct/mentor-guide.htm Advisor, Teacher, Role Model, Friend (National Academy of Sciences, 1997) (http://www.nap.edu/readingroom/books/mentor) D. Publication practices and responsible authorship: Responsible Conduct Regarding Scientific Communication (Society for Neuroscience) (http://www.sfn.org/guidelines) Authorship Task Force (Council of Science Editors) (http://www.councilscienceeditors.org/services/authorship.cfm) E. University of Iowa Policies: Principles for Determining the Suitability of Research Done in the University (see Operations Manual, Section II, Chapter 27.1) Principles Governing Restricted Access Research (see Operations Manual, Section II, Chapter 27.2) Access to Research Information (see Operations Manual, Section II, Chapter 27.3) Policy on Administrative Surveys and Questionnaires (see Operations Manual, Section II, Chapter 27.5) 33. General Grant Compliance Requirements A. Debarment and Suspension The Drug-Free Workplace Act of 1988 (Public Law 100-690, Title V, Subtitle D, as amended) requires that all grantees receiving grants from any Federal agency agree that they will maintain a drug-free workplace. By signing the application, the authorized institutional official agrees that the grantee will provide a drug-free workplace and will comply with requirements to notify the federal funding agency in the event that an employee is convicted of violating a criminal drug statute. Failure to comply with these requirements may be cause for debarment. Recipients of Federal grants, cooperative agreements, contracts, and loans are prohibited by 31 U.S.C. 1352, "Limitation on Use of Appropriated Funds to Influence Certain Federal Contracting and Financial Transactions," from using Federal (appropriated) funds to pay any person for influencing or attempting to influence any officer or employee of an agency, a Member of Congress, an officer or employee of Congress, or an employee of a Member of Congress with respect to the award, continuation, renewal, amendment, or modification of any of these instruments. The Federal Debt Collection Procedure Act, 28 U.S.C. 3201(e), provides that an organization or individual that is indebted to the United States, and has a judgment lien filed against it, is ineligible to receive a Federal grant. Before a grant can be awarded, the applicant organization must certify that neither it nor any person to be paid from grant funds is delinquent in repaying any Federal debt. If the applicant discloses delinquency on a debt owed to the Federal Government, the federal funding agency may not award the grant until the debt is satisfied or satisfactory arrangements are made with the agency to which the debt is owed. In addition, once the debt is repaid or satisfactory arrangements made, the funding agency will still take that delinquency into account when determining whether the applicant would be responsible with respect to a grant, if awarded. E. Civil Rights F. Acknowledgement of Federal Funding All grantees must acknowledge Federal funding when issuing statements, press releases, requests for proposals, bid solicitations, and other documents describing projects or programs funded in whole or in part with Federal money. Grantees are required to state (1) the percentage and dollar amounts of the total program or project costs financed with Federal money, and (2) the percentage and dollar amount of the total costs financed by nongovernmental sources. The Freedom of Information Act (FOIA), 5 U.S.C. 552, requires federal funding agencies to release certain grant documents and records requested by members of the public, regardless of the intended use of the information. These policies and regulations apply to information in the possession of the federal agency and do not require grantees or contractors under grants to permit public access to their records. The regulations also indicate types of information that are generally exempt from release. The Privacy Act of 1974, 5 U.S.C. 552a, provides certain safeguards for information about individuals maintained in a system of records, as identified by the Act (i.e.,, information may be retrieved by the individual's name or other identifying information). These safeguards include the rights of individuals to determine what information about them is maintained in Federal agencies' files (hard copy or electronic) and how it is used, to have access to such records, and to correct, amend, or request deletion of information in their records that is inaccurate, irrelevant, or outdated. I. Export Control | ||||||||||||||