The Catholic University of America
Responsibilities of Associate Provost for Research
E-Verify Final Rule, 73 Federal Register 67651 November 14, 2008
This rule requires certain contractors and subcontractors to use the USCIS E-Verify System to verify that certain employees are eligible to work in the United States. The rule is effective January 15, 2009. Under the final rule, institutions of higher education that qualify as federal contractors can choose to limit the E-Verify verification to only employees (existing or new hires) assigned to the federal contract in question. This rule is effective for government contracts awarded after 1/15/09 with a performance period of longer than 120 days and a value above $100,000. An e-verification must be done on all employees directly performing work on the contract.

Contractors have 30 days to enroll in E-Verify after the award of the contract, and must initiate verification within 90 days of enrollment. Existing employees assigned to the contract must be run through E-Verify within 90 days of enrollment or 30 days of assignment to the K, whichever is later. Federal Contractors already enrolled for 90 days or more have to start the verification process within 3 business days of hire. Subcontracts for services (except COTS) with a value of more $3,000 are also included, and CUA will require the E-Verify clause in the contract.

Responsibilities: Identify federal contracts in question to both HR and to the Provost's office. Insert the E-Verify clause in covered subcontracts. Also, send the ORG number and the PI name to HR.

The National Science Foundation Act of 1950 and The Public Health Service Act
Oversee Written Conflict of Interest Policy Institutions receiving research money from the National Science Foundation (NSF) or the Public Health Service (PHS)must maintain and enforce a written conflict of interest policy and take steps to prevent scientific misconduct.The Associate Provost is responsible for providing a copy of the CUA conflict of interest policy to each investigator assigned to a federal project. The responsibility for obtaining the annual disclosure from any faculty member engaged in sponsored research also belongs to the Associate Provost for Sponsored Research.

Ensure Institutional Compliance with Revised Policy on Enhancing Public Access to Archived Publicatios Resulting from NIH Funded Research:

The Director of the National Institutes of Health shall require that all investigators funded by the NIH submit or have submitted for them to the National Library of Medicine's PubMed Central an electronic version of their final, peer-reviewed manuscripts upon acceptance for publication, to be made publicly available no later than 12 months after the official date of publication: Provided, That the NIH shall implement the public access policy in a manner consistent with copyright law.

Resources: Complying with the NIH Public Access Policy-Copyright Considerations and Options: SPARC/Science Commons/ARL white Paper by Michael W. Carroll; Feb. 2008

NIH Open Access Mandate: A Careful Look at Two Options by Georgia Harper: Contains sample text for compliance

Investigate and Report on Misconduct
An awardee institution must have a policy for investigating and acting on suspected or alleged misconduct. In certain situations the NSF or PHS must be immediately notified of the apparent misconduct. The conflict of interest policy must identify, evaluate and resolve conflicts of interest, and if they cannot be resolved, report them to the NSF or PHS. The regulations on conflict of interest define and set standards for the management of financial interest that will, or may reasonably be expected to, bias a clinical research project, the evaluation of the safety or effectiveness of a drug, or a medical treatment or device. The PHS rule in this area applies to subgrants, the National Science Foundation (NSF) policy does not.

  • RecordkeepingFinancial disclosures must be updated annually. Keep records for three years after the expiration of an award or grant.
  • Provide administrative support to an Institutional Review Board (IRB) for all research involving human subjects.
  • Training Under proposed rules (69 FR 20778) issued April 16, 2004, one of the general responsibilities for compliance is to foster a research environment that promotes the responsible conduct of research and research training, discourages research misconduct, and deals promptly with allegations or evidence of possible research misconduct. *

Assurances
An institution is eligible for PHS funding when it has an assurance on file with ORI stating that is has developed and will comply with an administrative process for responding to allegations of research misconduct in PHS-supported research that complies with the PHS regulation cited above. An institution establishes an assurance when an official signs the face-page (SF 424 (R&R) or PHS 398) of the grant application form or when the institution files a separate assurance form. Once established, institutions maintain their assurance by filing the Annual Report on Possible Research Misconduct (between January 1 and March 1 each year), submitting their policy for responding to allegations of research misconduct for review when requested by ORI, revising their policy when requested by ORI to bring the policy into compliance with the PHS regulation, and complying with the PHS regulation. See http://ori.hhs.gov/assurance/ for more.

The Public Health Security and Bioterrorism Preparedness and Response Act
All colleges and universities that possess select agents, which are certain biological agents and toxins need to register with the Secretary of the U.S. Department of Health and Human Services. It is the role of the Associate Provost of Sponsored Research to alert the Director of the Environmental Health and Safety Office if the Associate Provost becomes aware of any research proposal to use a select agent.

The Anti-Kickback Act of 1986
Prohibits any payment or gratuity made for the purpose of inducing award of a subcontract or prime contract with the federal government. The Associate Provost for Research is responsible for ensuring that the university has reasonable procedures in place to prevent and detect violations of the Anti-Kickback Act. See 48 CFR 52. 203-7.

Drug Free Workplace Act

Ensure that all PI's on grants receive the following text, and distribute it to all those working on a federal grant or contract:

Every employee (including students) employed on a federal grant must understand that as a condition of being employed under the grant, the employee acknowledges and agrees to abide by the CUA Drug and Alcohol Abuse Policy online at http://policies.cua.edu/employment/other/drugsalcohol.cfm.The unlawful manufacture, distribution, dispensation, possession or use of a controlled substance or alcohol by a student or employee on university property or as any part of a university-sponsored program off campus is strictly prohibited. The Drug Free Policy applies to all members of the community, not just those employed under a grant. As a condition of enrollment and employment, each student, faculty member and staff member will abide by the terms of this policy and will notify the dean of students (in the case of students), the provost (in the case of faculty) and the director of human resources (in the case of staff) no later than five days after any conviction for a criminal drug statute offense or alcohol offense committed on university property or as any part of a university-sponsored program off campus. Failure to comply with these conditions will constitute unsatisfactory conduct and lead to appropriate sanctions. Violations of the CUA drug and alcohol policy which are also violations of federal or local law may be referred to the appropriate agencies. In such situations, cases may proceed concurrently at the university and in the criminal justice system.

The Bayh-Dole Act of 1980

  • Establish and implement an employee invention reporting policy.
  • Report all subject inventions to the federal funding agency within 60 days after the inventor discloses the invention to the university.
  • Elect title (or waive title) within two years.
  • File for a patent within one year of electing title, or public disclosure, whichever comes first (patents not required for biological material). The university must, within 10 months of the U.S. filing, notify the agency wither it will file foreign applications.
  • Provide a confirmatory license to the government.
  • Acknowledge federal government support in the patent application.
  • Notify the federal agency of any decision not to pursue patent rights (or licensing).
  • Submit an annual utilization report for all patented and licensed inventions.
  • Submit a final invention statement and certification within 90 days of the end of the project period.
  • Ensure that sponsored research agreements preserve the freedom for academic researchers to select projects, collaborate with other scientists, determine the types of sponsored research activities they wish to participate in, and communicate their research findings at meetings and by publication and through other means.
  • Ensure that the timely dissemination of research findings is not adversely affected by the conditions of a sponsored research agreement. A delay of disclosure of findings of 30 -60 days is generally viewed as a reasonable amount of time for the industrial sponsor to secure intellectual property rights. Recipients should not enter into sponsored research agreements that permit a sponsor to tie up the development of a technology by acquiring exclusive licensing rights to the product of given research results before deciding whether or not it will actively develop and commercialize that product.

There is a requirement that products developed with federal funds and used and sold in the U.S. be substantially manufactured in the U.S.

Ensure that the rights to inventions made with federal funding are not assigned without federal agency approval, that royalties are shared with the inventors, with the balance going to the support of scientific research or education, and that reasonable efforts are made to attract licensees of subject inventions that are small business firms.

Federal Policy on Recombinant DNA
Ensure review by Biosafety Committee, and insure required petitions are submitted to NIH.

Animal Welfare Act
Oversee development and implementation of an institutional program for activities involving animal research.This includes the following:

*Training

*Animal Welfare Assurance

*Institutional Animal Care and Use Committee (IACUC)

* Recordkeeping Requirements

*Reporting Requirements

Export Administration Act (EAA) and the Arms Export Control Act (AECA)

Regulations are EAR and ITAR. The Export Administration Regulations (EAR at 15 CFR §§ 730-774) govern export of goods and services on the Commerce Control List (CCL), and are promulgated and implemented by the Department of Commerce. The International Traffic in Arms Regulations (ITAR at 22 CFR Part 120 et seq.) govern the export of defense articles and defense services, i.e. those items with a military application.

  • Oversight for ensuring that the university has not accepted restrictions on publication of results, so review of contracts that might contain such non-disclosure clauses.
    Accepting restrictions would trigger EAA rules and the requirement to apply for a license prior to access by non-U.S. persons or foreign nationals to regulated products or technology.
  • Oversight on the shipment of physical or electronic equipment, including encryption software when professors travel abroad. While Microsoft Office is not considered "publicly available" for purposes of the export regulations, it does fall under an exception as a mass market operating system, so there is not a prohibition with professors taking laptops that simply contain Microsoft Office. While an area of research might fall under the fundamental research exemption the physical object may not be taken out of the country if it contains protected data, for example a laptop with military research.
Compliance with Federal Policy on Institutional Review Boards

Assurances
There should be a copy of the application for a FederalWide Assurance (to Office for Human Research Protections) that was filed by the institution, and a copy of the application for Registration of the IRB that was also filed with the federal government. Ensure that these assurances are kept current.

IRB Review of Research
Report to appropriate institutional officials and the Federal funding agency with regard to any unanticipated problems involving risks to subjects or others or non-compliance with policy, or any suspension or termination of IRB approval.

Training
Ensure proper training for all those working with human subjects.

Recordkeeping
Keep records as detailed in the Procedures for the IRB.

Reporting
When federal funding is involved, required follow- up reports must be sent to the federal agencies?
Reports required by law must also be sent to OHRP.

Monitor Cooperative Agreements with other Institutions

Conflict of Interest
Oversight to ensure these guidelines are being followed.No IRB member may participate in initial or continuing review when he/she has a conflict of interest, except to provide information to the IRB.

Institutional Review Boards; Registration Requirements; 74 Fed. Reg. 2399

January 15, 2009 Effective July 14, 2009, with all committees to be registered by Sept. 14, 2009

This rule adds a new subpart E which requires institutional review boards (IRB) that review human subjects research conducted or supported by HHS and that are designated under an assurance of compliance approved for federalwide use by OHRP to register with HHS every three years. This is stricter than the voluntary system which is currently in place, and expands the range of information collected. The registration information includes contact information, approximate numbers of all active protocols and active protocols involving research conducted or supported by HHS, and staffing for the IRB. Schools will be able to register online, for both the FDA and the US Dept. of Health and Human Services at the same time. For any IRB currently registered with OHRP, the institution or organization operating the IRB must submit all information required under this rule by the three-year expiration date previously assigned by OHRP or within 90 days of any changes regarding the contact person who provided the IRB registration information or the IRB chairperson.

Use of Bond Financed Facilities
The IRS will look at the type of bond issued for the university's benefit, and whether the funds are being used for exempt purpose or private activity. The general rule is that if a bond financed facility is used by an exempt organization for purposes not related to its exempt purpose, the use is treated as impermissible private use. If the use were to be found to be a private use, the bonds used to finance the facility might become taxable. See Revenue Procedure 2007-47 for rules on federally sponsored research. The APR is responsible for monitoring any research use in bond funded facilities that would be considered private use.

The Byrd Amendment
Prohibits lobbying with federal funds. Requires disclosure of lobbying activities when receiving federal contracts, grants, loans or cooperative agreements. Requires certification and disclosure with each submission for consideration of a federal contract, grant or cooperative agreement exceeding $100,000 or an award of a federal loan or commitment providing for the U.S. to insure or guarantee a loan exceeding $150,000. Federal contractors, grantees and those receiving federal loans and cooperative agreements must also report lobbying expenditures from non-federal sources which they used to obtain such federal program monies or contracts.
The Associate Provost for Research is responsible for compliance with the certification and disclosure provisions of this law, and for reporting any lobbying expenditures from non-federal sources.

Certification of Principals for Federal Funding

Colleges and universities receiving federal funding are required to make certain certifications. The applicant for federal funding must certify, among other things, that neither it nor its principals have been debarred or suspended from participating in any federal program, and that they have not been convicted of or had civil judgments entered against them for fraud or certain other offenses. The regulations provide that participants in federal funding programs may decide the method and frequency by which they determine the eligibility of their principals. Principals include officers, directors, key employees, and other persons with management or supervisory responsibilities. The school must provide immediate notice to the Department of Education (the office with which it contracted) if it learns that the certification was erroneous or becomes erroneous after it is submitted See 34 CFR 85.350. The school must obtain the same certification from the subcontractor. 34 CFR 85.300. The school must verify that any person entering into a subcontract with the school as principal is qualified. This can be done by checking the Excluded Parties List System before entering into a subcontract, or collecting a certification from the person if allowed by the regulations, or adding a clause or condition to the covered transaction.

The Associate Provost for research has oversight of the notification of ED if there is an an error or change in the certification, must ensure a process for compliance with the subcontractor requirements, and is the person at CUA responsible for signing the form.

Controlled Substances Act of 1970
This law brings together a number of laws regulating the manufacture and distribution of narcotics, stimulants, depressants, hallucinogens, anabolic steroids, and chemicals used in the illicit production of controlled substances. All substances are placed in one of five schedules, based on medicinal value, harmfulness, and potential for abuse or addiction, with Schedule 1 reserved for the most dangerous drugs that have no recognized medical use.

Use of controlled substances for the purpose of research is, under federal law, subject to extensive licensing, registration, storage, security, use, and disposal requirements. Researchers are also subject to state registration and other regulatory requirements.

The Associate Provost for Research is responsible for ascertaining if any controlled substances are being used in research at CUA, and if so, for setting up a system that meets the requirements of this law.

Federal Acquisition Regulation (FAR)

48 C.F.R. Parts 1-99

These regulations establish uniform policies and procedures that individual government agencies may supplement with their own regulations. Parts of the FAR are incorporated into government solicitations and contracts by reference. Federal government contractors are required to establish and maintain internal controls and compliance programs to detect and prevent improper conduct in connection with the award or performance of government contracts; and to timely disclose to the applicable agency Office of Inspector General whenever in connection with the award, performance or close-out of a government contract or subcontract the contractor has credible evidence of a violation of federal criminal law involving fraud, conflict of interest, bribery or gratuity found in Title 18 of the U.S. Code, or a violation of the civil False Claims Act. The Associate Provost for Research is responsible for

Resource
Acquisition Central: Web site for the government's business partners. Includes a link to the FAR.

Resources

Resources: Memorandum titled Mandatory E-Verify for Research and Educational Institutions with Federal Contracts (December 2008) by Denise C. Hammond, Esq. Hammond Claxton, P.C.

National Science Foundation Research Administrator Workshop PowerPoint Presentation

OGC Page On IRBs

OGC Page on Research

OGC Web Page on PHS Research

Office of Research Integrity

Office for Human Research Protections (OHRP)

Memo from OGC dated 2/7/2007 #070042 on Export Controls