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Research Overview


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Conducting Research


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Guide to Research Compliance banner.

Conducting Research

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Compliance Item
Resource
BUDGET AND FINANCE
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Do you know about the Certified Approver program and how it relates to your research?
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Do you know who your certified approver is?
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Have you correctly allocated project expenditures to the appropriate research projects, especially those projects closely related in scope and objectives?
Department grant accountant or Certified Approver
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Are you charging indirect and direct costs appropriately and with adequate justification?
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Do you review project expenses to assure they are timely, allowable, allocable, necessary, and reasonable per sponsor guidelines?
Department grant accountant or Certified Approver
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Are you supplying adequate justifications and documentation for grant expenses?

Department grant accountant or Certified Approver


SPA

Job Aid

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Does your accounting staff alert you about inadvertent unallowable costs? If so, did they identify and remove them
Department grant accountant or Certified Approver

Examples

Removing uncollectible costs
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Are you and your administrators monitoring the financial status of your project, in particular, key high risk financial areas such as deficit spending, program income, cost sharing, and cost transfers?
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Are you required to report program income information to the sponsor? Have you received and reviewed your Notice of Program Income (NOPI) from SPA?
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Have you properly deposited and documented program income into the Sponsored Unapplied Program Income Account?
Department grant accountant

SFR accounts receivable representative

Policy
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Do you receive updates from your accounting staff about accounts receivable balances that identify sponsors not paying on time?
Department grant accountant

SFR accounts receivable representative
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If your sponsor is not paying on time, have you adjusted your spending accordingly to minimize your departmental liability?
Department grant accountant

SFR accounts receivable representative

Policy
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Do you review sponsor final and end of budget period reports or invoices prepared by SFR?
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Does your account have an overdraft? If so, did you contact SPA to ask your sponsor for additional funding?
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Does your account have a balance remaining? If so, did you contact SPA to ask your sponsor about proper handling of excess funds?
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Will your excess funds be treated as “carryforward” from one budget period to another? If so, what are your responsibilities regarding “carryforward” funds?
SPA grant administrator

Notice of Grant Award (NOGA)

Project Closure
PERSONNEL - HIRING AND TRAINING
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Have you followed University hiring policies and procedures?

Department human resources professional

Office of Human Resources

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Does your department, unit, or college have a standard offer letter? If so, did you use that template and complete the appropriate paperwork based on the type of researcher you hired?
Department research administrator
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Have you detailed clear project roles and responsibilities and, where appropriate, written job descriptions?
Department human resources professional

Office of Human Resources
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Have you classified student employees, employees, or independent contractors correctly?
Department human resources professional

Office of Human Resources
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Have you instructed staff on rules governing confidential or proprietary data?
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Does your team need additional education? For example, on issues like human subjects, animals, safety, occupational health and safety.
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Are your project volunteers trained and oriented and have they completed all proper documentation?
OGC
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If you are working with technology or data subject to export control regulations, have you ensured any international project team member is not unfairly restricted based upon country of origin?
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Does your proposal involve programmatic work conducted by others external to the University? For example, subcontractors or consultants.

Department research administrator

SPA grant administrator

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Are you and others who completed RCR Parts 1 & 2 up to date on RCR continuing education requirements?
PERSONNEL - DELEGATING DUTIES
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Is it appropriate to delegate the duties you seek to delegate?
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Does the person to whom you delegate have the competence, time, and resources to carry out the duties?

Principal investigator

Employee

Office of Human Resources

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Does the person to whom you have delegated understand his or her responsibilities?

Principal investigator

Employee

Office of Human Resources

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Is an oversight process in place to ensure delegated duties are carried out correctly?

Principal investigator

Employee

Office of Human Resources

PERSONNEL - TEAM DYNAMICS
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Has your project team discussed and reached consensus regarding authorship, inventor credit, data collection and management relating to your project?
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Have you defined each team member’s roles and responsibilities on the project?
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Have you identified potential disputes and tried to respectfully resolve them?
EQUIPMENT
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Do you, your laboratory staff, and your department know the University policies on equipment management?
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Has Inventory Services been given access to your research space and offices in order to affix identification labels (University or federal) to equipment?
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Has Inventory Services been given access to your research space and offices in order to conduct a biennial verification of the condition, use, and location of equipment under you (or your department's) custody? (Source: OMB A-21, OMB A-110, FAR 45.508.)
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Has Inventory Services been given access to your research space and offices in order to conduct a final verification of the condition, use, and location of equipment under you (or your department's) custody? (Source: FAR 45.508.)
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Has equipment excess to your project been reported to Inventory Services? Federal equipment and federally-funded equipment that is no longer needed for its corresponding project must immediately be reported as excess. This will allow other projects (University or otherwise) access to needed equipment. (Source: OMB A-110 and FAR 45.)
EFFORT AND COST SHARING
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Have you and other researchers on the project met the anticipated effort specified in your award?
Department effort coordinator
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Have you and other team members submitted effort reports by effort reporting deadlines?
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Did you correctly calculate effort? Effort includes all time spent conducting University business and may never be greater than 100%.

Department effort coordinator

SPA effort information

ECRT

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Are all your University projects, including nonsponsored projects, included in the effort reports you complete?
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Do you have direct, first-hand knowledge of others’ time before you approve their effort reports?
SPA
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Did you amend your effort reports if your proposed effort allocation changed by five percent or more?
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Does your NOGA specify that you are required to report your cost share information to the sponsor?
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Have you properly documented your cost share requirements?

Department grant accountant

Policy

Examples

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Did you submit proper documentation to SFR when cost sharing is reportable back to the sponsor?

Department grant accountant

Policy

SFR

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Did you certify all effort that is listed as cost share, even if you are not required to report it to the sponsor?
Department grant accountant or effort coordinator
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Are you meeting and documenting your cost sharing requirements?

Department grant accountant

SFR grant accountant

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If you know you will not meet your cost sharing requirements, have you contacted your SPA grant administrator to notify the sponsor?
CHANGES TO WORKSCOPE
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Have you obtained appropriate prior approvals for administrative or programmatic changes during the project period? For example, budget, no-cost extension, key personnel, or carryforward of funds.
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Have you obtained sponsor-required approvals for administrative or programmatic changes from the department head and SPA authorized signer?
Department research administrator
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Have you contacted the IBC, IACUC, IRB, CPRC, Radiation Protection Committee, or other review committees as appropriate, for changes to your protocol?
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Are you conducting your research under active protocols?
Contact appropriate approving committee (such as IRB, IBC, etc.)
SUBAWARDS AND SUBRECIPIENTS
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Did you review subrecipient work for satisfactory progress and approve the invoices prior to submission for payment?

Department grant accountant

SPA grant administrator

TECHNOLOGY COMMERCIALIZATION
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Have you identified potential intellectual property (IP) created during your research that you must disclose under terms of the grant?
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Have you alerted Office for Technology Commercialization (OTC) of any IP, and completed an IP disclosure form?
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Do you have mechanisms in place for participants in the project that generated the IP to identify and report their involvement according to the grant?
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Have you carefully documented the following IP details: when was research conducted leading to the IP, what funding sources contributed to the IP, who worked on the IP, and records demonstrating the IP?
CONFLICT MANAGEMENT
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Have you identified all research team members who must disclose potential conflicts of interest? For example, anyone responsible for the conduct, design, or reporting of the research.
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Has the research project or your personal situation changed any of the answers you made on your most recently filed REPA? If so, have you updated and filed a new REPA?
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Are you disclosing potential conflicts by filing a REPA form for every reporting period?
CONFIDENTIALITY
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Have you taken measures to protect the confidentiality of your research subjects?
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Have you taken measures to protect the privacy of personal information contained in your data sets?
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Have you ensured that the personal records of your project staff are kept confidential?
DATA AND DOCUMENTATION
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Have you ensured that any designated confidential information provided to you by a sponsor or third party is kept confidential?
OGC
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Does your computer, server, and other equipment have up-to-date security and antivirus software and are your electronic research data stored in a secure manner?
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Are your physical research data stored in a secure place?
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Do you have a contingency plan in place for recovery or duplication of any important materials, documents or electronic records in the event of unanticipated loss, disaster or business interruption?
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Prior to any presentation or publication, have you reviewed and met all obligations required by your sponsor? For example, prior notice or copies, review period, or verification regarding sponsor’s confidential information.
SPA
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Do you have procedures in place to track progress of the research, who is responsible for what development, and when it happened?
Principal investigator and employees
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Are you maintaining the required documentation for the project: cost sharing, progress reports, effort, scientific data?

SPA grant administrator

NOGA
Sponsor’s award notice

SAFETY
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Have you identified everyone needing to enroll in an occupational health program?
PROGRESS REPORTING
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Are you meeting your due dates for scientific progress reports and other deliverables?

SPA grant administrator

NOGA
Sponsor’s award notice

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Do you know your sponsor’s deliverable requirements and their relationship to the payments made to your project?
PUBLISHING AND PRESENTING
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Have you reviewed the terms of the award to confirm ownership and rights to any intellectual property developed under the award and reporting requirements?
SPA
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If your presentation or publication may describe a potentially patentable invention, have you contacted Office for Technology Commercialization (OTC)?
OTC
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Does your presentation or publication include someone else’s copyrightable work? If so, have you obtained a copyright permission or concluded your use of the material is permissible as “public domain” or “fair use”?
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Have you reached agreement with your collaborators and research team about authorship?
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Have you registered your work with the U.S. copyright office? This is recommended.
LABORATORIES
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Do you know who your research safety officer (RSO) is, and have you informed him or her of the nature of your research in regards to safety?
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Have you done a risk assessment for your research and selected appropriate personal protective clothing and equipment? Is the use of protective clothing and equipment included in your SOPs?
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Have you provided training on your Research Safety Plan, lab specific safety, and SOP (Standard Operating Procedure) for all lab staff? Training needs to be documented and updated annually.
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Has everyone in your lab that needs to ship dry ice and/or other hazardous materials (biological or chemical) completed shipper training in the past two years?
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If applicable, do you have radiation safety, hazardous waste, and bloodborne pathogen/infectious agent training records for yourself and staff updated within the last year?
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If you have a laboratory, have you filed A Report of Materials used in Education and Research (ARMER) form for every reporting period?
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Do you have procedures in place to prevent staff from inadvertently mixing materials subject to material transfer agreements?
HAZARDOUS MATERIALS - BIOHAZARDS
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Are you fulfilling your IBC continuing review reporting requirement?
IBC
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If you need to make changes in your IBC protocol (added genes, infectious materials, hazardous reagents, or changed procedures etc.), have you contacted the IBC?
IBC
HAZARDOUS MATERIALS - CHEMICALS
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Are you collecting chemical waste in compliance with University procedures? Are you using the chemical waste program for all your waste chemicals?
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If you dispose of any chemical wastes via the sewer or trash, do you have prior written approval to do so for those specific materials?
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Are you complying with waste container management guidelines?
HAZARDOUS MATERIALS - CONTROLLED SUBSTANCES
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Do you have the required storage and record keeping procedures in place for your controlled substances?
RADIOACTIVE MATERIAL/IONIZING RADIATION PRODUCING
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Are you meeting all the requirements of your Radioactive Materials Permit including, training, waste disposal, inventory control, contamination surveys, and quarterly reports?
HUMAN SUBJECTS
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Are you following the appropriate procedures concerning human subjects? For example, compensation and consent forms.
IRB
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Are you fulfilling your IRB continuing review reporting requirement?
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If you need to make changes in your human subject protocol, have you contacted the IRB?
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Do you know the requirements for reporting unanticipated problems?
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If you have added personnel to your human subject research have they completed their research education requirements?
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Consent Forms: Are staff who are obtaining consent forms from subjects authorized and trained to obtain consent?
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Did you adequately document the consent process?
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Pharmaceuticals: If you are a sponsor-investigator using an investigational new drug (IND) or an investigational device exemption (IDE), do you have a monitoring plan in place for routine review of research records?
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If you are a sponsor-investigator do you have case report forms to document adequate and accurate case histories recording all data pertinent to the investigations for each research subject?
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Have you registered your research with Fairview Investigational Drug Service if you are using an IND?
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Are you using the required labeling for the investigational product?
ANIMALS
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Are you fulfilling your IACUC continuing review reporting requirement?
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If you need to make changes in your animal protocol, have you contacted the IACUC?
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If you have added personnel to your animal subject activity, have they attended the orientation seminar and enrolled in the occupational health program?
AGRICULTURAL MATERIALS AND EQUIPMENT
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Are you aware of the Distribution and Release of Plant Germplasm and Related Plant Materials policy?
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Are you planning to release a public plant variety, to license crops (soybean or horticultural), to release a new cell line, etc?
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Have you properly disposed of agricultural-related waste? For example, pesticide testing, “run-off ” from feed lots, greenhouse drainage, etc.
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Have you properly stored your agricultural-related materials? For example, pesticides, exotic pathogens, etc.

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