The Catholic University of America

Responsibilities of the Associate Provost for Research and Director of Technology Transfer

E-Verify: 74 Federal Register 17793

As a federal contractor the University must use the USCIS E-Verify System to verify that employees performing work on federal contracts with a performance period of longer than 120 days and a value above $100,000 or federal subcontracts for more than $3,000 are eligible to work in the United States. The rule is effective for government contracts awarded after September 8, 2009. The verification process must occur within 3 business days of hire. Existing employees assigned to the contract also must be verified through the E-Verify system within 90 days of enrollment or 30 days of assignment to the contract, whichever is later.   

Responsibilities:  With respect to E-Verify the Associate Provost for Research is responsible for the following:

1.  Identifying federal contracts subject to the requirements;

2.  Providing the name of all individuals working on the contracts, along with the ORG number and the name of the Principal Investigator, to the Associate Vice President for Human Resources and Chief Human Resources Officer who will conduct the E-Verify check; and

3.  Inserting the E-Verify clause in covered subrecipient agreements.

Conflicts of Interest: The National Science Foundation Act of 1950 and The Public Health Service Act

The National Science Foundation (NSF) requires that institutions receiving NSF research money maintain and enforce a written conflict of interest policy that: 1) Identifies, evaluates and resolves conflicts of interest; 2) provides for reporting to NSF if the conflict cannot be resolved; 3) updating financial disclosures annually; and 4) maintaining records of disclosures for 3 years after expiration of the award. 

The Public Health Service (PHS) Policy regarding Responsibility for Promoting Objectivity in Research applies to conflicts of interest as they relate to funding received from a PHS Awarding Component, including the National Institutes of Health (NIH), for grants, cooperative agreements, and contracts.  PHS requires that all investigators’ significant financial interests be reported, and that any conflicts be managed, reduced or eliminated.  PHS requires that the University certify that it has conflict identification and management processes that prevent use of positions for private financial gain, and that describe how outside activities, relationships, and interests are reviewed by an objective institutional official.   The University also is required to post on a publicly-accessible website, prior to expending and funds, the details regarding any significant financial interest the institution deems to be a financial conflict of interest.  The PHS requirements flow-down to subrecipients of PHS awards.

Responsibilities: With respect to NSF and PHS conflict of interest requirements the Associate Provost for Research is responsible for the following:

1.  Implementing the University’s conflict of interest policy for researchers.

2.  Obtaining and evaluating disclosure statements from researcher.

3.  Reporting conflicts to the NSF or the PHS, when applicable.

4.  Maintaining records of disclosures, including any management action taken.

5.  Certifying that the University has a compliant conflicts process.

Resources:

National Institutes of Health, Financial Conflicts of Interest – resource page

Research Misconduct: Public Health Service Policies on Research Misconduct (42 CFR Part 93) and United States Department of Agriculture Final Research Misconduct Rule (Federal Register, August 13, 2010, Volume 75, Issue 156)

The University must have a research misconduct policy that complies with the Department of Health and Human Services (DHHS), Public Health Service (PHS) requirements applicable to federally-funded research.  Research misconduct is "fabrication, falsification or plagiarism in proposing, performing, or reviewing research, or in reporting research results."  The University has primary responsibility for prevention and detection of misconduct and for inquiry, investigation and adjudication.  The federal policy provides detailed guidelines for developing proper procedures for responding to allegations and reporting to DHHS/PHS.  The DHHS/PHS regulations require that the University appoint a Research Integrity Officer (RIO) responsible for:

1.         Implementation of institutional policy/procedure.

2.         Filing the institutional assurance.

3.         Filing all reports regarding investigations as well as an annual report with the Office of Research Integrity (ORI) that includes the University’s research misconduct policy.  Reporting is done electronically. 

The United States Department of Agriculture (USDA) further requires that the University:

1.         Prevent and detect research misconduct.

2.         Investigate and adjudicate reported allegations of research misconduct

3.         Promptly notify the Office of Inspector General (OIG) and the USDA Research Integrity Officer (RIO) of all allegations involving USDA funds if an allegation warrants investigation.

4.         Implement procedures to ensure:

a.         Separation of responsibility for inquiry, investigation and adjudication.

b.         Objectivity.

c.         Due process.

d.         Whistleblower protection.

e.         Confidentiality.

f.          Limitation of subject and informant identity to those who need to know.

g.         Timely resolution of investigations.

The University must provide its research misconduct policy and procedures to the USDA RIO for determination of appropriateness, and must communicate the policy and procedures to relevant staff.

Responsibilities: With respect to compliance with the foregoing research misconduct regulations the Associate Provost for Research is responsible for assisting the Provost (the University’s RIO) with respect to the following:

1.         Implementing and maintaining the University’s research misconduct policy and procedures.

2.         Investigating allegations of research misconduct.

3.         Reporting findings to DHHS/PHS/USDA as applicable.

4.         Filing the institutional assurance and annual report with DHHS/PHS.

Resources:

Office of General Counsel web site – Public Health Service Requirements

Office of Research Integrity - Assurance regarding Research Misconduct

Responsible Conduct of Research: America Creating Opportunities To Meaningfully Promote Excellence In Technology Education and Science Act of 2007 (America COMPETES Act, 74 Fed. Reg. 42126)

The America COMPETES Act requires that each institution that applies for financial assistance from the National Science Foundation (NSF) for science and engineering research or education must describe in its grant proposal a plan to provide appropriate training and oversight in the responsible and ethical conduct of research (RCR) to undergraduate students, graduate students, and postdoctoral researchers participating in the proposed research project. The University’s authorized organizational representative must certify that it has an RCR training and oversight plan.

Responsibilities:  With respect to the America COMPETES Act the Associate Provost for Research is responsible for the following:

1.         Ensuring inclusion of an RCR training and oversight plan in applicable grant proposals.

2.         Providing and tracking RCR training by required individuals.

3.         Certifying that the University has an RCR training and oversight plan.

Resources:

Responsible Conduct of Research - Frequently Asked Questions

Protection of Human Research Subjects (45 C.F.R. § 46.103 and 21 C.F.R. § 56 and 74 Fed. Reg. 2399)

As an institution conducting human subject research subject to Department of Health and Human Services (DHHS) regulations, the University must provide assurance to the DHHS that it will comply with the agency's Policy for Protection of Human Research Subjects. For any proposed research involving human subjects the University must certify to the department or agency head that the research has been reviewed and approved by an Institutional Review Board (IRB) that has been provided for in the University’s assurance, and will be subject to continuing review by that IRB.  In addition, the University must ensure that:

1.          Researchers obtain legally effective informed consent from human beings before they become research subjects.

2.          Unanticipated Problems (as defined by DHHS) and Adverse Events (as defined by the Food and Drug Administration (FDA)): Any suspension or termination of approved IRB research due to non-compliance with IRB requirements or unexpected serious harm to subjects must be reported promptly to:

a.         The investigator.

b.         The appropriate institutional officials.

c.         DHHS or the FDA, as applicable. 

The report must include the reasons for the action.                  

Responsibilities:  With respect to human subject research the Associate Provost for Research is responsible for the following:

1.         Maintaining and providing to DHHS’ Office for Human Research Protections (OHRP) the University’s assurance that it will comply with the agency’s Policy for Protection of Human Research Subjects.

2.         Maintaining IRB registration.

3.         Chairing the IRB, maintaining IRB records, and providing IRB certifications to DHHS.

4.         Ensuring informed consent forms are on file for applicable research projects.

5.         Ensuring completion of human subject research training by applicable researchers.

6.         Reporting suspension or termination of IRB approval, or unanticipated problems or adverse events to DHHS or the FDA as applicable.

7.         Monitoring Cooperative Agreements with other Institutions for compliance with the foregoing.

Resources:

Office of General Counsel - IRBs

Office for Human Research Protections (OHRP)

DHHS Office of Research Integrity (ORI)

Animal Welfare Act

The Act requires:

1.         Registration of the animal research facility with the Secretary of Agriculture.

2.         Establishment of an Institutional Animal Care and Use Committee (IACUC) comprised of at least 3 members of sufficient ability to assess the animal care needs of the facility (one must be a veterinarian and one must be unaffiliated with the facility).

3.         Compliance with standards for handling, housing, transportation, feeding, watering, sanitation, ventilation, veterinary care, and practices to ensure pain and distress are minimized.  (The 8th edition of the Office of Laboratory Welfare (OLAW) Guide for the Care and Use of Laboratory Animals is in effect and should be followed).

4.         That researchers consider alternatives to procedures likely to produce pain/distress, and for any such practice they must consult a veterinarian in planning the procedure and pre and post-surgical care.

5.         Semiannual inspection by the IACUC of all animal facilities and study areas, practices involving pain to animals, and the condition of animals

6.         Filing by the IACUC of an inspection certification report at the research facility citing any deficiencies and corrective action.  (Report must remain on file for at least 3 years at the research facility and be available for inspection)

7.         An annual report signed by the institutional official and submitted to the Secretary before December 31st making assurance that the provisions of the act are being followed and that professionally acceptable standards governing care, treatment and use of animals are being followed by the facility during research or experimentation. 

Per the Animal and Plant Health Inspection Service (APHIS) Final Rule issued December 31, 2012, written contingency plans must be developed for response to and recovery from emergencies most likely to happen to the respective facility and employees must be trained on those plans.

Responsibilities:  With respect to the Animal Welfare Act the Associate Provost for Research is responsible for assisting the IACUC Chairman in the development and implementation of an institutional program for activities involving animal research that includes the following:

1.         Training.

2.         An Animal Welfare Assurance.

3.         An Institutional Animal Care and Use Committee (IACUC).

4.         Recordkeeping requirements for IACUC documents.

5.         Reporting requirements.

Resources:

Public Health Service Policy on Humane Care and Use of Laboratory Animals

National Institutes of Health (NIH) Office of Laboratory Animal Welfare (OLAW)

Approval and Conduct of Clinical Trials (Federal Food, Drug and Cosmetic Act and Food and Drug Administration (FDA) Amendments Act of 2007)

The Acts require that for an investigational new medical device, biologic or drug to be used in a federally-funded clinical investigation, the University must ensure the sponsor submits an Investigational New Drug Application and complies with all applicable requirements with respect to the regulations pertaining to human subjects and IRB review and approval.  In addition, clinical investigators must disclose financial arrangements with sponsor(s) of the studies (e.g. payment or royalties), and interests in the product under study or sponsor entity. Registration and reporting of the results of applicable clinical trials must be made via ClinicalTrials.gov. If the clinical trial is funded in whole or in part by a grant from any DHHS agency, any grant or progress report must include a certification that the responsible party has made all required submissions for the applicable trial to ClinicalTrials.gov. The responsible party for registering with ClinicalTrials.gov is either the sponsor or the principal investigator (PI).  Sponsors of certain clinical trials of drugs/devices regulated by the FDA must obtain informed consent from potential research subjects to submit their de-identified data to the ClinicalTrials.gov database.

Responsibilities:  The Associate Provost for Research is responsible for implementing policies and procedures to promote compliance with the requirements of the Acts.

Federal Policy on Recombinant DNA

Recombinant DNA (rDNA) research conducted at the University, irrespective of funding source, must comply with the NIH Guidelines.  The University must: 

1.         Implement policies for safe conduct of rDNA research in compliance with the Guidelines.

2.         Establish an Institutional Biosafety Committee (IBC).

3.         Appoint a Biological Safety Officer (BSO).

4.         Ensure IRB approval where human subjects are involved.

5.         Train the IBC Chair and its members, as well as the BSO, the PIs, and the lab staff regarding laboratory safety and Guidelines implementation.

6.         Report significant problems, Guideline violations or research-related accidents/illnesses to NIH Office of Biotechnology Activities (OBA) within 30 days.

Responsibilities:  The Associate Provost for Research is responsible for:

1.         IRB approval of rDNA research.

2.         Reporting to NIH/OBA when necessary.

3.         Assisting, as necessary, Environmental Health and Safety, which office oversees establishment of the IBC, appointment of the BSO, implementation of required policies, and provision of required training.

Resources:

National Institutes of Health (NIH) Guidelines for Research Involving Recombinant DNA Molecules

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

The Export Administration Regulations (EAR at 15 C.F.R. §§ 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 C.F.R. Part 120 et seq.) govern the export of defense articles and defense services, i.e. those items with a military application.

University personnel must have a license to export to another country, re-export, or share with certain foreign nationals inside the U.S. (“deemed export") subject commodities, software or technology, or items deemed to have military application.  Educational information is not subject to the prohibition if released by instruction in catalog courses and associated teaching labs of academic institutions. Basic and applied research in science and engineering, where resulting information is ordinarily published or shared broadly within scientific community (“fundamental research”) also is excluded. 

Responsibilities:  The Associate Provost for Research is responsible for the following with respect to export control:

1.         Oversight for ensuring that the University has not accepted restrictions on publication of research results, such as non-disclosure clauses in research agreements that could trigger EAA rules and the requirement to apply for a license.

 

2.         Oversight on the shipment of physical or electronic equipment, including encryption software when researchers 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.

 

National Institutes of Health (NIH) Public Access Policy (NOT-OD-08-033)

All final, peer-reviewed articles funded in whole or in part by NIH that are accepted for publication on or after April 7, 2008, must be submitted in electronic form to PubMed Central to be made publicly available no later than 12 months after the official date of publication.  Beginning May 25, 2008, all applications, proposals or progress reports submitted to the NIH must include the PubMed Central NIH Manuscript Submission reference number when citing applicable articles that arise from their NIH funded research.

Responsibilities: The Associate Provost for Research is responsible for notifying all University researchers who are recipients of NIH awards of the NIH public access requirements.

Patent and Trademark Law Amendment Act of 1980 (Bayh-Dole Act)

The Act requires that the University:

1.         Establish and implement an employee invention reporting policy.

2.         Report all subject inventions to the federal funding agency within 60 days after the inventor discloses the invention to the University.

3.         Elect title (or waive title) within two years.

4.         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 whether it will file foreign applications.

5.         Provide a confirmatory license to the government.

6.         Acknowledge federal government support in the patent application.

7.         Notify the federal agency of any decision not to pursue patent rights (or licensing).

8.         Submit an annual utilization report for all patented and licensed inventions.

9.         Submit a final invention statement and certification within 90 days of the end of the project period.

10.       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.

11.       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.

12.      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.

13.       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.

Responsibilities:  The Associate Provost for Research is responsible for implementing and administering the University’s patent policy and for ensuring that the foregoing requirements are adhered to.

Resources:

U.S. Patent and Trademark Office

Cooperative Research and Technology Enhancement Act of 2004 (CREATE Act)

The Act promotes patentability of inventions created between universities and the private sector by treating inventions as having a sole owner.  The invention is patentable only if:  1) There was a joint research agreement in place beforehand; 2) the invention was made as a result of the activities per the agreement; and 3) the patent application discloses the names in the joint research agreement.  Failure to follow these steps results in non-patentability or patent invalidation. 

Responsibilities:  The Associate Provost for Research is responsible for implementing and administering the University’s patent policy and for ensuring that the foregoing requirements are adhered to.

Additional Resources

Office of General Counsel Page on Research

Related Policies

Compensation from External Consulting Policy

Conflicts of Commitment Policy

Conflicts of Interests Policy - Externally-Funded Research

Grants and Contracts Policy

Non-Retaliation Policy

Patent Policy

Protection of Human Subjects in Research Policy

Reporting Financial Irregularities Policy

Research Misconduct Policy

Sponsored Grants and Contracts Policy