Roles and Requirements for Institutions and Researchers ......Roles and Requirements for Institutions and Researchers Receiving External Funds Marti Dunne, Associate Vice Provost for

Roles and Requirements for Institutions and Researchers Receiving External Funds

Marti Dunne, Associate Vice Provost for Research Compliance and Administration

Mark Righter, Office of General Counsel

Jane McCutcheon, Associate Professor, College of Dentistry

February 2011

Who are we?

Sr. Vice Provost for ResearchPaul Horn

Associate Vice Provost for Research Compliance & Admin

Marti Dunne

Office of Sponsored ProgramsRichard Louth, Director

Office of Industrial LiaisonAbram Goldfinger, Director

Regulatory Functions

Univ Committee on ActivitiesInvolving Human Subjects

Univ Animal Welfare Committee

Office of Veterinary Resources

Contradictory Roles

Roles and Responsibilities of Central Offices Supporting Research at NYU Office of the Senior Vice Provost for Research

(www.nyu.edu/provost)

Office of Sponsored Programs (www.nyu.edu/osp) and Contracts Office Pre-award and non-financial post award management of sponsored

projects Negotiation of agreements and issuance of subcontracts

Sponsored Program Accounting (www.nyu.edu/financial.services/cdv/spa)

Post-award financial management of sponsored projects

University Development and Alumni Relations Corporate and foundation gifts, endowments, etc.

Office of Legal Counsel (www.nyu.edu/legal.counsel/)

Legal advice; export controls information Office of Industrial Liaison

Patents and Licensing of Intellectual Property (http://oil.med.nyu.edu/)

Why are we doing this to you? Because we are required to by the Federal Government

NIH mandated training for training and fellowship awards

NSF mandated training for all undergraduates, graduate students and postdocs being paid by NSF funds

Responsible Conduct in Research results in good (better) research

By better understanding the various roles and responsibilities, you know where to go when problems arise

Institutional Responsibilities Whose award is it?

Awards applied for by our faculty and students are granted to NYU and not to the individual

NYU is responsible for creating and overseeing certain policies which the Federal Government regulates

Each federal agency has a staff whose job it is to audit compliance with those regulations

Recent audits have resulted in significant fines for non-compliance

Regulatory Compliance Research involving human subjects

Research involving animal subjects

Research impacting the environment

Conflict of Interest

Scientific Misconduct

Fiscal Accountability

Export Control Regulations

Regulatory Changes Since 1991 NIH Guidelines for Research Involving Recombinant DNA Molecules (1994) Lobbying Disclosure Act of 1995 (Amended 2007) Cost Accounting Standards (CAS) in OMB Circular A‐21(1995) Health Insurance Portability & Accountability Act of 1996 (HIPAA) Privacy Rule (Amendments Proposed 2010) OMB Elimination of Utility Cost Adjustment (UCA) (1998) Data Access /Shelby Amendment (FY 1999 Omnibus Appropriations Act) Policy on Sharing of Biomedical Research Resources (NIH, 1999) HHS Centers for Medicare and Medicaid Services (CMS) National Coverage Determination for Routine Clinical Trials (Clinical Trials Policy), 2000 Executive Order 13224, Blocking Property and Prohibiting Transactions With Persons Who Commit, Threaten to Commit or Support Select Agents & Toxins (under CDC and USDA/APHIS) Public Health Security & Bioterrorism Preparedness & Response Act of 2002; companion to the FISMA Federal Information Security Management Act Security of Federal Automated Information Systems CIPSEA Confidential Information Protection and Statistical Efficiency Act Data Sharing Policy (NIH, 2003) Homeland Security Presidential Directive (HSPD) – 12, Common Identification Standards for Federal Employees and Contractors (2004) Higher Education Act, Section 117 Reporting of Foreign Gifts, Contracts and Relationships Model Organism Sharing Policy (NIH, 2004) Constitution & Citizenship Day (2005, Consolidated Appropriations Act FY 2005) Genomic Inventions Best Practices (2005) Office of Management & Budget Guidance for Governmentwide Debarment and Suspension Federal Acquisition Regulations [FAR] Flowdown of Debarment/Suspension to Lower Tier Subcontractors (December 2010; amendment to FAR Subpart 9.4) Combating Trafficking in Persons (2008) Code of Business Ethics & Conduct (FAR) 2008 Homeland Security Chemical Facilities Anti‐Terrorism Standards (CFATS) 2008 E‐Verify 2009 Military Recruiting and ROTC Program Access (2008, Solomon Amendment) Fingerprinting and Criminal History Records Check Requirements for Unescorted Access to Certain Radioactive Materials (Feb 2008) National Institutes of Health Public Access Policy (2008,) Certification of Filing and Payment of Federal Taxes Health and Human Services/FDA Clinical Trials Registry Federal Funding Accountability and Transparency Act (FFATA) Executive Compensation and Subrecipient Reporting (2006) (FAR, July 2010; OMB Open Government Directive, April 2010) USAID Partners Vetting System (re: EO 13224 et al re: terrorist financing) National Institutes of Health Guidelines for Human Stem Cell Research (2009) National Science Foundation Post‐Doctoral Fellows Mentoring (America COMPETES Act 2006; implemented 2009) Executive Order 13513, Federal Leadership on Reducing Text Messaging While Driving (October 2009) National Science Foundation Responsible Conduct of Research Training (America COMPETES Act 2006; implemented 2010) National Science Foundation Public Outcomes Reporting (America COMPETES Act 2006; implemented 2010) Federal Acquisition Regulations (FAR) and Office of Management & Budget Federal Awardee Performance and Integrity Information System (FAPIIS) and Guidance for Reporting and Use of Information Concerning Recipient Integrity and Performance (2010) National Institutes of Health, Budgeting for Genomic Arrays for NIH Grants, Cooperative Agreements and Contracts (2010) Deemed Export Certification for H1B Visitors (November 2010; implementation postponed to February 2011)

NYU

What are NYU’s Responsibilities? To have policies and procedures in place to respond to

the Federal Government’s requirements

To make those policies and procedures available to our community

To train our community in the practical implementation of those policies

To monitor our own compliance

To provide an avenue for complaints and questions

How do we fulfill those responsibilities? To have policies and procedures in place to respond to

the Federal Government’s requirements

The Senior Vice Provost, with the Office of General Counsel and the University’s Compliance office ascertain that NYU’s policies are up-to-date and in compliance with federal law and regulations

Fulfilling the requirements, cont’d To make those policies and procedures available to our

community

Community announcements and e-mails

NYU’s Research Website http://www.nyu.edu/research/resources-and-support-offices/getting-started-withyourresearch/office-of-sponsored-programs/policies.html

Faculty Handbook http://www.nyu.edu/content/dam/nyu/compliance/documents/FacHbk2008.pdf

Fulfilling our Responsibilities To train our community in the practical

implementation of those policies

RCR training program

Research Administrators’ forums

Guest speakers

To monitor our compliance

Through Internal Audits and self-assessments

Through Outside Consulting Firms such as Price Waterhouse Cooper

Fulfilling our Responsibilities, cont’d To provide an avenue for complaints and questions

Policies contain procedures for complaints and/or perceived violations

University Compliance Office

Compliance Reporting Hotline: http://www.nyu.edu/about/policies-guidelines-compliance/compliance/compliance-reportingline.htmls Hotline

What happens if we don’t?Recent Institutional Settlements 2008 $7.6M Yale – Effort Reporting

2006 $2.5M U Connecticut – Service Center Billing Rates

2005 $4.4M Cornell – Grant Money Paid to Non-Research Staff

2005 $6.5M Mayo Clinic – Improper Cost Transfers

2005 $11.5M Florida International – Improper Cost Transfers

2004 $2.4M Harvard – Grants Billed for Unrelated Salaries

2004 $2.6M Johns Hopkins – Faculty Effort Reporting

2003 $5.5M Northwestern – Faculty Effort Reporting

What are the Researcher’s Responsibilities? To be informed about the University’s policies and

procedures

To act in an ethical manner

To follow your discipline’s code of conduct and its conventions regarding such things as authorship; good laboratory practices; data management, etc.

To report any suspected non-compliance to your mentor, another faculty member, the Chair of your department, SVPR, or Compliance Hotline

What Happens if You Don’t?Recent Settlements – Individual Penalties High Profile Misconduct cases – Johns Hopkins, Harvard,

Yale Debarred from applying to PHS for funding

Journals must be notified

May not serve as reviewer for PHS

Work must be overseen

University of Michigan – $105K personal fine, 1 year probation for Conflict of Interest violations

U of Vermont Scientist sentenced to 1 year and 1 day in jail and paid $180,000 fine for fabricating more than a decade’s worth of scientific data, and using it to obtain millions of dollars of NIH grants

Recent Criminal Case DOJ/U of Tennessee

Export Control laws in the U.S. prohibit the export of certain technologies to certain countries

Sharing knowledge of those technologies with certain foreign nationals qualifies as a “deemed export”

Timeline May 2004 - UT professor of Physics and Atmospheric Glow Technologies (AGT) discuss

work for a Small Business Contract with the Air Force, including involvement of Chinese graduate student (written notes reference possible export control issues)

Oct. 2004 – AGT tells Air Force no foreign nationals on contract Jan 2005 – AGT gets the contract May 2005 UT signs subcontract with AGT; contract contains a clause regarding export

controlled technical data. Prof. signs statement acknowledging that he has read the agreement and understands his obligations as a University employee

2006 – Roth goes on lecture tour outside of U.S., taking his laptop with him and has a report e-mailed to him through a Chinese colleague’s internet connection

May 2006 – Prof. reveals to new UT Export Control Coordinator that Chinese student is working on the project

UT’s actions Consulted with Legal Counsel and Vice Chancellor

for Research

Advised Prof. foreign national must be taken off project immediately

Made AGT remove their export-controlled equipment from UT’s lab

UT self-disclosed to FBI and Dept. of State

Export Control Office cooperated with investigation and trial

Institutional Responsibilities Faculty Awareness – must be trained in rules and

regulations

Sponsored Programs – performs a pre-award review through checklist

Travel Office – alerts for travel requests to restricted countries

Financial System - tags restricted research accounts

Notifies Government agencies in case of infraction

Faculty Responsibilities in this Case Researcher is responsible for complying with the law

Determine through the checklist on OSP website whether or not you are involved with an export-controlled technology

Researcher must understand what he/she signs

Ask questions when in doubt

What’s scary about this case Prof. was sentenced to 4 years in prison for:

Sharing lab reports and draft publications with graduate students

Teaching a foreign graduate student to use of piece of equipment

Taking a Small Business proposal outside the U.S.

Having his graduate student send research materials while abroad

Despite the fact that: National security was not harmed

Prof. never accessed or allowed access to any restricted technical data he took out of US on his laptop

Research results were not significantly linked to defense articles

DoD would likely have approved the results for public release

Other than the contract clause, no materials were marked as export controlled

What Are My Responsibilities?

Brief History of Act Passed in 1980

Federal laws governing all federally funded inventions

Built into virtually all federal grants and contracts

Gives universities broad rights to commercialize and to “own” inventions

Why Should I Care? IP can help secure future funding for a laboratory

Additional federal or industrial funding

IP can create economic growth for a community –

Silicon valley; jobs, sustainable future

You have economic rights to patents under University Policy (your share of 42.5% inventor share)

Failure to follow law can compromise your rights

But Don’t We Just Own IP Anyway? A common misconception:

University ownership is automatic with fed. funding

No! University must take affirmative steps to “elect to retain title”

Election requires filing of forms with government

Failure to file can block University ownership

Why is it My Problem?? The University needs you to disclose inventions so that

it can comply with the Act

Must disclose invention within two (2) months of receipt of disclosure

Must “elect to retain title” within two (2) years, or statutory bar, whichever is shorter

Must file a patent application within one (1) year of electing to retain title, or statutory bar, whichever is shorter

The process starts with you

What Other Obligations Are There? “Title” with University does not mean “free and clear”

from government rights

Government still retains important rights

Government imposes important obligations and responsibilities on University

These responsibilities can impact the researchers

Government Rights Retained Non-exclusive royalty-free right to use for government

purposes

This can limit commercial value

Especially with technologies where government is a heavy user

“March-in” rights (rights revert to government)

In the event University is not successful in commercializing

Or does so in a way where public does not benefit

Obligations of University Manufacture in USA

Waivers, if university can prove no ability to do so if the US

Small business preference

Must use reasonable efforts to commercialize

“Reporting” obligations

Federal funding must be noted in patent application

Right at the beginning

Prohibited Actions University can not to allow patents to go abandoned

without notice to the federal government

University cannot “assign” to other companies or entities

For example, start-up company, etc. run by researchers

Where does Bayh-Dole apply? To any of your inventions that use federal funds to

either:

Conceive; or

Reduced to practice

Even if funding is only partially responsible for generation of invention

Casts a broader net than one might think

Case Scenario #1: Stanford v. Roche Case currently in Supreme Court

Includes issues of who owns patent

Bayh Dole compliance

Importance of faculty consulting and “extramural” activities

Basic facts of case Stanford researchers signed agreement with Roche

“Visiting Scientist Agreement”

Included department head and several other researchers

Ongoing collaboration between Stanford and Roche

Included weekly meetings, joint publications, etc.

Roche Patents Roche filed a number of patent applications covering

work arising out of collaboration

These issued as valid patents

Quite valuable – hundreds of millions in revenue

No participation in revenue stream by Stanford

No sharing with researchers

Stanford reaction Stanford sued Roche alleging ownership

Said their faculty already signed an agreement with University for patent rights

But Stanford’s researchers never disclosed inventions pursuant to University patent policy

Stanford never elected to retain title

Stanford never elected to file patent applications

Results in Court Stanford lost at the federal trial and appellate court

levels

Appealed to the United States Supreme Court

Stanford looking for support from US government and from industry to support its position

Lesson Learned for Researchers Underscores the importance of compliance with Bayh-

Dole obligations

Consider whether there have been inventions, or novel developments that could be valuable

Coordinate with your faculty about preparing a disclosure

Case scenario #2; Medical Device Post Doc works for two years at University

Helps develop and write code for medical device

Code is developmental, but functional

Utilizes 5 million in government funding

Post Doc then leaves University

Subsequent University Activities University continues to develop software

Licenses software to faculty startup company

Consistent with Bayh Dole obligations

US company

Successful technology transfer efforts

Company obtains FDA approvals and prepares to launch product

Win–Win–Win situation! . . . . . .

Subsequent Post Doc Activities Accepts employment with major European company

Within three weeks of hire, company files 4 patent applications covering medical device

Within six months, company has filed over 12 patent applications

Applications cover algorithms and other concepts embodied within software code

Question arises as to whether copy of code “accompanied” Post Doc to company

Impact of Company Patent Applications Company’s patent position blocks start up company’s

commercial progress

Potentially bypasses government rights

Post Doc and Company could be subject to claims of misappropriation of IP

Government may have a claim against University for failure to report inventions, and may have a claim against company

Ability to enforce “March-in”rights

Lessons Learned for Researchers: Understand whether code, data and other materials

are proprietary

Respect government rights to these items

Seek advice from faculty and/or OIL regarding access to such materials

Be aware that contracts with companies, through consulting, etc., can compromise patent protection for federally funding inventions

To be informed about the University’s policies and procedures

Restaurant Study

Was the chair correct?

Is ignorance bliss?

What are the consequences?

What are the Researcher’s Responsibilities?

To act in an ethical manner

Collaborative Study

Who is responsible for human subjects compliance?

Who is responsible for documenting compliance?

Who should be first author?

What should ORI do?

What are the Researcher’s Responsibilities?

To follow your discipline’s code of conduct and its conventions regarding such things as authorship; good laboratory practices; data management, etc.

What are the Researcher’s Responsibilities?

To report any suspected non-compliance to your mentor, another faculty member, the Chair of your department, SVPR, or Compliance Hotline

What are the Researcher’s Responsibilities?

Mentors’ Responsibilities Provide training and supervision

Give feedback

Provide appropriate educational experiences

Provide opportunities to become integrated scientific societies.

Not Mentor’s Responsibilities To provide compliance training

To document compliance

Things I wish I had known Accounting

Policy implementation

Policy support