OVPR - Research Guidelines - Regulatory Compliance

X. Regulatory Compliance

A. Introduction
In the past few years, governmental agencies promulgated many new and revised regulations which require University compliance. Many of the governmental compliance issues are handled by different administrative units at the University, including the Office of the Vice President for Research (OVPR). When a faculty member applies for external funding to a governmental agency, the Sponsored Projects Administration (SPA) in OVPR must certify on the application, or at the time of an award of a contract, that the University complies with all applicable regulatory issues. To be able to do this, OVPR must maintain communication with other departments to ensure that we are in compliance with the regulations. In some instances, SPA participates in the development, revision, or implementation of regulations. Faculty must certify on the SPAF (Appendix A) that they are eligible for receipt of federal funds and will comply with applicable federal regulations and University policies and procedures. Private, non-profit organizations, governmental agencies, and some industries also may impose similar or additional requirements on programs that they fund.

The federal government provides the majority of external support for sponsored activities. Therefore, this section divides then summarizes the major federal regulations that effect the University if it accepts external support into fiscal and regulatory compliance. Some issues apply to all grants and contracts, and others to particular funding mechanisms. If you have any questions, please contact OVPR.

B. Fiscal Compliance
The Office of Management and Budget (OMB) has established the following circulars that describe how the federal government monitors funds provided through federal assistance or procurement. The appropriate federal funding agency applies these circulars in monitoring the activities of its programs.

COST PRINCIPLES FOR EDUCATIONAL INSTITUTIONS
OMB Circular A-21 (Appendix OO) establishes cost principles for grants, co-operative agreements and contracts with educational institutions. These issues are handled jointly by SPA and Grants & Contracts Accounting (G&CA). Any questions about allowable direct/indirect costs should be directed to G&CA.

GRANTS AND AGREEMENTS WITH INSTITUTIONS OF HIGHER EDUCATION, HOSPITALS, AND OTHER NON-PROFIT ORGANIZATIONS
OMB Circular A-110 (Appendix PP) describes uniform administrative standards for consistency among federal agencies in administration of grants and other agreements. These issues are handled jointly by SPA and G&CA.

AUDITS OF INSTITUTIONS OF HIGHER EDUCATION AND OTHER NON-PROFIT INSTITUTIONS
OMB Circular A-133 (Appendix QQ) establishes audit requirements and federal responsibilities for institutions of higher education and non-profit institutions that receive federal funding. SPA and G&CA jointly handle these issues.

FEDERAL ACQUISITION REGULATIONS
These regulations describe the policies and procedures that the agencies of the executive branch of the federal government must follow for all acquisitions. These include research contracts to Universities. While SPA and G&CA jointly handle these issues, please direct questions to SPA.

C. Regulatory Compliance
Regulatory compliance deals with several federal compliance issues relating to administrative issues involving individual rights, protection of employee safety, protection of living organisms, employee rights, and scientific administrative requirements. For additional information and examples of the following requirements, investigators can access the federal web site at www.whitehouse.gov/circulars

In many instances, predicated on conditions of award for a grant, OVPR signs any assurances necessary to certify regulatory compliance in submitted proposals. The President or Vice President, Chief Financial Officer and Treasurer sign Assurances for contracts certifying compliance with approval regulations. Please see Table I at the end of this section for specific signature requirements or contact OVPR with questions.

ADMINISTRATIVE REQUIREMENTS FOR SPONSORED PROJECTS
– Acknowledgement of Federal Support
The federal government requires that awardees, when issuing statements, press releases, requests for proposals, bid solicitations, and other documents describing projects or programs funded in whole or part by federal money, shall state the percent of the project supported by federal funds, the dollar amounts of the project, and the percentage and dollar amount of total costs that are financed by non-governmental sources.

Faculty should inform OVPR that a news release about their program is being prepared because OVPR provides the news bureaus with information about the types and percentages of federal funds used in the project as well as sources of support.

– Anti-Kickback
This provision deters the contractor or sub-contractor from making and receiving payments for the purpose of improperly obtaining a prime contract or rewarding favorable treatment in connection with either a contract or sub-contract relating to the contract. The University has appropriate policies against kickback activities.

– Blood Borne Pathogens
National Institutes of Health (NIH) requires certification on training grant applications related to Title VII or VIII of the Public Health Service Act that "all trainees will, as appropriate, receive instruction in the utilization of universal precautions and infection control procedures for the prevention of the transmission of blood borne diseases."

OVPR certifies that trainees will receive the instruction. Training related to blood borne pathogens is provided by the Office of Environmental Health and Safety, which also is responsible for maintaining appropriate training records.

– Buy American Act
The federal government requires the University to certify that in the purchase of equipment, supplies, and services supported by a federal contract, it, or it's sub-contractors, will acquire the above within the United States. The Purchasing Department is responsible for compliance with this clause in federal contracts.

– Certificate of Accuracy of Indirect Costs
The federal government requires that all recipients of contract funds that are subject to DFARS certify as to the accuracy of their indirect costs. This applies only to Department of Defense (DOD) contracts.

– Certificate of Current Cost and Pricing Data
The federal government requires a current certificate of cost and pricing data for most contracts or contract modifications in excess of $100,000.

– Certificate of Technical Data Conformity
The DOD requires that all contracts include a clause about technical data conformity. The University has determined that this item is best handled by the PI, but please direct specific questions to OVPR.

– Conflict of Interest
The National Science Foundation and NIH are proposing federal regulations on conflict of interest. The University currently has a Policy on Conflict of Interest (Appendix DD). In any sponsored activity, faculty must avoid any apparent or real conflict of interest. Any questions should be addressed to OVPR.

– Covenant Against Contingent Fees
This policy ensures that improper influence is not used to secure government contracts and applies to all solicitations for contracts in excess of $25,000.OVPR certifies at the time of the proposal whether a person or company has been retained to solicit or obtain the contract.

– Debarment and Suspension
This regulation serves to identify and punish individuals and entities for fraudulent or improper use of government funds. Applicants are asked to certify that to their best knowledge and belief that neither they, nor their principal, nor researchers:

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are presently disbarred, suspended, proposed for debarment, declared ineligible, or voluntarily excluded from covered transactions by any federal department or agency;

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have, within a 3-year period preceding an application, been convicted of or had a civil judgement rendered against them for commission of fraud or a criminal offense in connection with obtaining, attempting to obtain or performing a public transaction or contract under a public transaction; violation of federal or state antitrust statutes or commission of embezzlement, theft, forgery, bribery, falsification or destruction of records, making false statements, or receiving stolen property;

- are presently indicted or otherwise criminally or civilly charged by a government entity (federal, state, or local) with commission of any of the offenses enumerated in the immediately proceeding stipulation; and

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have within a three-year period preceding this application, had one or more public transactions (federal, state, or local) terminated for cause or default.

This regulation is applicable to the University, the President and senior administrators, members of the Board of Trustees, and the project PI. The PI signs for him or herself on the SPAF, the Department Chairs and Deans sign for themselves, and OVPR signs on behalf of the rest of the University and its principles.

– Fly American Act
When receiving funds for a federal grant or contract, a grantee agrees to use U.S. air carriers in the transportation of personnel or property. Each faculty member is required to abide by this policy. When a federal grant or contract supports travel, especially a trip outside the U.S., the faculty member should notify World Travel that a U.S. carrier is required.

– Invention Rights
Recent federal patent laws and presidential orders have reformed the areas of patent law. The laws allow non-profit organizations, including universities, to elect to retain title to inventions made in the process of government research. However, the government retains certain rights such as a non-exclusive license.

The Office of Technology Transfer in OVPR is responsible for all patent questions and issues. Please refer to Section IX of this manual for additional information.

– Lobbying
The federal government requires that institutions certify that:

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no appropriate funds were, or will be, expended to pay any person for influencing or attempting to influence an officer or employee of any agency, a member of Congress, an officer or employee of Congress, or an employee of a member of Congress in connection with a specific award; and

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they will disclose certain information if the recipient has used, or intends to use, non-appropriated funds to pay for the lobbying activities of an individual or organization not regularly employed by the applicant. Disclosure forms must be filed prior to the award, and thereafter at the end of each calendar quarter in which there occurs any event that requires disclosure or affects the accuracy of the information contained in any previously filed disclosure. Certifications are made to the funding agency.

Disclosure is required if the University has made, or agreed to make, payment with non-federal funds for the purpose of influencing a specific award over $100,000. If lobbying were done, however, by a regularly employed individual, disclosure is not necessary. Remember that individuals who are paid with, or travel on, federal funds must not engage in lobbying activities while utilizing such federal funds.

These regulations apply to all grants and contracts. The University has a lobbying policy and procedures in place (Appendix EE). Faculty must indicate on the SPAF if they have engaged in any lobbying activity related to the project.

– Non-Delinquency of Federal Debt
All federal funding programs require that those receiving federal funds assure that they are not delinquent on loans or other accounts to the federal government. This does not apply to debts owed to the IRS, Social Security payments, tariff laws, and state and local governments. The PI must sign the SPAF form indicating whether or not he or she has a delinquent federal debt.

– Officials Not to Benefit
Most government contracts state that no member of Congress shall personally benefit from a federal contract over $2,500.

– Procurement Integrity
This is applicable to all recipients of funds from federal contracts of, or above, $100,000. A contractor or any officer, employee, representative, agency, or consultant shall not knowingly offer or promise future employment, offer or give money or other items of value, or solicit or obtain information regarding the contract to a federal contracting officer.

– Responsible Conduct of Research
In addition to the University, the Public Health Service and the National Science Foundation have regulations regarding the issue of misconduct in science. The University's Policy on Misconduct in Research and Creative Work is in Appendix FF. NIH also requires that all training grants provide training in responsible conduct of research to pre-doctoral students and post-doctoral trainees supported by a training grant.

All applications for training grants to NIH must include a discussion of training in responsible conduct of research. The Associate Dean of Graduate Students at the School of Medicine routinely conducts seminars, meetings, and discussions on the issue. The meetings and seminars are open to all students, post-doctoral employees, faculty, and staff. The Dean of the Graduate School on the Main Campus is developing a separate training program for graduate students on Main Campus.

– Student Unrest
The Department of Health and Human Services (DHHS) states that an institution of higher education cannot provide DHHS funds to an individual applying for admission, attending, employed by, teaching at, or doing research at an institution of higher education who has engaged in conduct on, or after, August 1, 1969, that involves the use of (or assistance to others in the use of) force, threat of force, or the seizure of property under the control of an institution of higher education to require or prevent the availability of a certain curriculum, or to prevent the faculty, administrative officials, or students in such institutions from engaging in their duties or pursuing their studies at such institution.

– Utilization of Labor Surplus Area Concerns
In contracts that exceed the small purchase limitation of $25,000 but do not exceed $500,000, contractors are required to use their best efforts to sub-contract with Labor Surplus Area (LSA) concerns when such sub-contracting is consistent with the efficient performance of the contract and at prices no higher than are attainable elsewhere. In contracts exceeding $500,000, contractors are required to take affirmative action to sub-contract with LSA concerns when such sub-contracting is consistent with the efficient performance of the contract and at prices no higher than are attainable elsewhere. The Purchasing Department assists in identifying and utilizing appropriate sub-contractors to comply with the requirements of the contract.

– Utilization of Small and Small Disadvantaged Business Concerns
Contractors receiving a contract in excess of $10,000 must agree that small and small/disadvantaged business concerns have the opportunity to participate in contract performance consistent with its efficient performance. Contractors must also establish procedures to ensure the timely payment of amounts of payments due to small business sub-contractors. The Purchasing Department assists in identifying and utilizing small and small/disadvantaged businesses to comply with the requirements of the contract.

– Utilization of Women-Owned Small Businesses
To encourage the use of women-owned small businesses in sub-contracting, federal contracts include a clause when the contract is expected to exceed the small purchase limitations of $25,000. The Purchasing Department assists in identifying and utilizing women-owned small businesses to comply with the requirements of the contract.

EMPLOYMENT REGULATIONS
– Drug-Free Workplace
The Drug-Free Workplace Act provides that an institution certify that it will notify all its employees who work on projects funded in whole, or in part, by federal grants or contracts in excess of $25,000 that the unlawful manufacture, distribution, dispensation, possession or use of controlled substances is strictly prohibited.

The University has a written Drug and Alcohol Policy (Appendix GG), and the Office of Personnel Services (OPS) is responsible for issues related to the policy.

– Drug-Free Schools and Communities Act
An institution must adopt and implement a drug prevention program to prevent the unlawful possession, use, or distribution of illicit drugs and alcohol by all students and employees on institutional premises or as part of any of its activities. This provision is applicable to all federal grants and contracts.

The University has adapted programs that comply with the provisions of the Act (Appendix GG).

– Drug-Free Work Force
This regulation (48 CFR 222.570-4) is contained in all DOD solicitations and contracts that involve classified information or when necessary for national security or for protecting the health and safety of those affected by the outcome of the contract. In addition to the requirements for a drug-free work force, by requiring employee drug testing, the regulation involves identifying illegal uses of controlled substances.

If the DOD contract contains the clause of this regulation (48 CFR 252.233-7004), then the University will not execute the contract. Due to its classification, DOD will subsequently waive the contract provision for the University. OVPR is responsible for negotiating the removal of the clause from DOD proposals and contracts.

– Occupational Health And Safety
The award stipulates that its performance will not take place under conditions that are unsanitary or hazardous to the health and safety of employees covered by a grant or contract in excess of $2,500. Specific information related to blood borne pathogens and other environmental health and safety issues are found elsewhere in this chapter.

Questions of unsanitary or hazardous conditions should be directed to the Office of Environmental Health and Safety.

– Davis Bacon Act
All contractors receiving support for construction, renovation, or repair in excess of $2,500 must pay wages to laborers and mechanics at a rate not less than the minimum wage and not less than once a week.

Issues related to wages and compensation should be directed to OPS. OVPR attaches a copy of prevailing-wage determinations issued by the Department of Labor to each construction proposal.

– Walsh-Healey Public Contracts Act, Service Contract Act, and Contract Work Hours and Safety Standards Act

These three acts require payments of minimum wages and restrict employment of children and convicts. They are applicable to all federal contracts. Issues related to minimum wages and provisions of these acts should be directed to OPS.

INDIVIDUAL RIGHTS
– Civil Rights Act of 1964
The Act bars the recipient from excluding persons because of their race, sex, color, or national origin from participation in receiving benefits or otherwise subjecting them from discrimination under federal assistance or supported programs.

As a condition of a federal award an institution must have an Assurance of Compliance. Compliance with the Civil Rights Act is a responsibility of every employee of the University. The Office of Affirmative Action is responsible for monitoring compliance with Civil Rights issues.

– Rehabilitation Act of 1973
As a condition for an award, the institution must assure that federally funded activities are to be available and accessible to handicapped individuals and that there will be no discrimination in employment based on an individual's handicap. The Public Health Service has modified applicable regulations to require that drug and alcohol abusers not be denied medical treatment on the basis of their substance abuse.

Every University employee responsible for federally funded activities, inclusive of employees participating in the activity, is to comply with the Act. The Office of Affirmative Action is responsible for overall compliance with the Act.

– Americans With Disabilities Act
The Act (Appendix D) extends to disabled individuals rights similar to those under the Civil Rights Act of 1964. Employment cannot be denied to disabled individuals except if the handicap puts the employee or co-workers at risk.

– Sex Discrimination
This statute prohibits exclusion of an individual on the basis of sex from any educational program that receives federal support or assistance. Some federal agencies generally do not require additional certification. However, the Public Health Service does require additional certification that there is no discrimination on the basis of sex.

– Age Discrimination Act
This act prohibits unreasonable discrimination on the basis of age in any program or activity receiving federal assistance. Some federal agencies require that a certification of compliance must be placed on file.

– Equal Employment Opportunity
This Executive Order requires that recipients of federal awards provide equal opportunity without regard to race, color, sex, or nationality to individuals employed or seeking employment. It is applicable to all grants providing construction funds, all non-construction contracts to contractors or sub-contractors with five employees or more and the contract is in excess of $50,000, and all construction grants in excess of $10,000.

– Affirmative Action for Special Disabled and Vietnam Veterans
The purpose of this Act is to require federal contractors to list all suitable employment openings with local employment service offices and to take affirmative action to employ and advance employment-qualified, special disabled veterans and veterans of the Vietnam Era without discrimination based on their disability or veteran's status. It applies to all contracts for supplies and services of $10,000 or more.

– Privacy Act
This Executive Order establishes procedures that "authorize an individual's access to records maintained about him or her, limit the access of other persons to those records, and permit an individual to request the amendment or correction of records about him or her." When a federal agency examines an individual's records on behalf of the agency, the requirements of the Act apply. This is especially true for the collection, use, dissemination, and maintenance of records containing information pertaining to specific individuals, which are subject to strict control.

Any faculty member receiving federal support, who collects information from an individual is required to disclose to the individual his or her rights under the Privacy Act. All questions regarding this Act should be directed to OVPR.

– Freedom of Information Act
This Act applies primarily to federal agencies and states that information be made available to the public. While universities are generally not subject to the provisions of the Act, materials produced by them may be subject to Freedom of Information requests through the federal government.

If an investigator is contacted by an individual requesting information about his or her federal grant or contract under the Freedom of Information Act, you should not provide the information. Instead, you should direct the request to OVPR.

– Confidentiality of Patient Records
The Drug Abuse Office and Treatment Act authorizes confidentiality of patient records. Records of patients seeking treatment for drug and alcohol abuse are to be kept confidential and disclosed only with prior written consent of the patient except when necessary for medical treatment personnel. Other exceptions to non-disclosure include disclosure to research personnel when the patient's identity is withheld and when authorized by the courts. The records are specifically prohibited from being used to initiate or substantiate criminal charges against a patient or to conduct any investigation of the patient. Additional information is available at OVPR.

PROTECTION OF THE ENVIRONMENT
– Aquatic Nuisance
The Non-indigenous Aquatic Nuisance and Control Act ensures that research carried out does not result in the introduction, or dispersal of, non-indigenous aquatic species into the waters of the United States.

Prior to submitting a proposal to a federal agency that includes non-indigenous aquatic species, the PI must submit a research protocol to an institutional committee for review and

approval. The investigator is encouraged to contact OVPR early in the proposal development stage for specific proposal guidelines.

– Blood Borne Pathogens
Under the Blood Borne Pathogen Standard of the Occupational Health and Safety Administration, institutions using potentially infectious materials are required to provide annual training, engineering controls, personal protective equipment, free hepatitis B vaccine, waste handling procedures, incident reporting, post exposure medical follow-up, and record keeping. NIH also requires a special certification on training grants applications that "all trainees will, as appropriate, receive instruction in the utilization of universal precautions and infection control procedures for the prevention and transmission of blood borne diseases."

Every PI is responsible for ensuring that their laboratories are in compliance with the regulations, and that training is to be provided to any trainees on a training grant. The Office of Environmental Health and Safety has oversight responsibility for compliance with the regulations.

– Chemical Safety
The Occupational Health and Safety Administration requires institutions to apprise employees about all hazardous materials to which they may be exposed, relative symptoms and appropriate emergency treatment, and conditions and precautions for safe use and exposure. Material Safety Data Sheets must be maintained and available to workers.

Every PI is responsible for ensuring compliance within their laboratories. The Office of Environmental Health and Safety is responsible for administration and comprehensive program of Chemical Hygiene for the University (Appendix HH).

– Clean Air Act and Clean Water Act
At the time of submission of a contract proposal, or at the time of a grant award, the institution must certify whether any facilities to be used in the proposed work are listed by the EPA. The awardee agrees to comply with the requirements of the Clean Air Act and the Clean Water Act relating to inspection, monitoring, entry, reports, and information related to facilities and to implement regulations and guidelines as required under the Acts. The certification requires an institutions "best efforts" to comply with the standards.

The Office of Environmental Health and Safety is operationally responsible for implementing the EPA standards and assuring that the University is in compliance with the standards.

– Recombinant DNA and Biohazards in Research
NIH Guidelines for Research Involving Recombinant DNA Molecules are applicable to all recombinant DNA research within the United States conducted at or sponsored by an institution that receives support for recombinant DNA research from NIH. The regulations are specifically applicable to research funded by public or private agencies external to NIH if the institution receives NIH funds for related research. The National Science Foundation has incorporated NIH Guidelines in their regulations.

The University requires that all investigators involved in research involving recombinant DNA, infectious agents, or other biohazards, whether funded externally or internally, have protocols registered with and, when appropriate, approved by the Institutional Biosafety Committee (IBC). There is one university-wide IBC that includes each University affiliate. Through OVPR, the Provost implements IBC policies.

Institutions are responsible for ensuring that recombinant DNA activities comply with the Guidelines. All Guidelines must be met before initiation of any experiments. The PI is responsible for registering research involving recombinant DNA with IBC and indicating appropriate information on the SPAF.

PROTECTION OF LIVING ORGANISMS
– Animal Research
The Animal Welfare Act prevents the sale or use of stolen animals, prohibits animal fighting ventures, and ensures that animals used in research, for exhibition, or as pets receive humane care and treatment. The law provides for regulation of the transport, purchase, sale, housing, care, handling, and treatment of vertebrae animals. Regulatory authority resides in the Department of Agriculture. Prior to receiving an award involving the use of vertebrae animals, an institution must provide an acceptable written assurance to the Office for Protection from Research Risks (OPRR), at NIH that the institution will comply with the Animal Welfare Act and the Guide for the Care and Use of Laboratory Animals.

The University requires that all investigators involved in teaching, testing or research involving vertebrate animal, whether funded externally or internally, have protocols reviewed and approved by the Institutional Animal Care and Use Committee (IACUC). There is one university-wide IACUC that includes each University affiliate. The IACUC determines University animal care policies and through OVPR, the Provost implements them.

The PI is responsible for applying for IACUC approval prior to submission of an application, and indicating appropriate information on the proposal and SPAF.

– Human Subjects
There are several federal policies that relate to the protection of human subjects. The policies apply to all research involving human subjects conducted, supported, or otherwise subjected to regulation by any federal department or agency. Federal regulations also apply to research conducted or supported outside the United States.

The University requires that all investigators who are involved in studies, such as clinical, behavioral, or social, that involve humans or human by-products, whether supported by an outside agency or not, must have protocols reviewed by one of the Institutional Review Boards (IRB) of the University. There are two IRBs, one for the Main Campus, and one for HSC. The Main Campus primarily oversees protocols in the social or behavioral sciences. HSC monitors medical related research. The IRBs are part of OVPR. All questions related to the IRB should be directed to the appropriate IRB office or to OVPR.

Each faculty member is responsible for applying for IRB approval prior to submission of an application, and indicating appropriate information on the proposal and SPAF.

– Marine Mammals Act
The law was passed to protect certain species of marine mammals deemed in danger of extinction or depletion as a result of human activities. An organization must apply for, and receive, a permit that specifically states the number and kinds of animals to be taken, the location and manner of their being taken, and the period for the permit. The PI must complete a report of all activities conducted under the permit and include a statement of compliance in every proposal.

If you plan to use marine mammals in research activities you should discuss the issue with OVPR early in the proposal development process.

The above federal fiscal and regulatory compliance issues are some of the more common compliance issues which arise involving federal grants and contracts. The proceeding is not intended to be a complete list. All questions about other regulations should be directed to OVPR.

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