Compliance at Rowan University and Presented by University Advancement and the Office of Sponsored Programs April 19, 2012 Beyond.

Compliance at Rowan University and

Presented by University Advancement and

the Office of Sponsored Programs

April 19, 2012

Beyond

Why Comply?

• Complying with Rowan Universities policies and procedures assists in the timely completion of the proposal and proposed project

• Provides a base to act as a good steward of awarded funds• Helps enhance Rowan University’s and reputation• Complying with federal, state, agency, and industry regulations

and guidelines, as well as specific terms and conditions of the project, will help Rowan and yourself…….

your own

Stay off the front page of the newspaper or webpage!

Why Comply? - ContinuedProfessor Faces Felony Charges for Grant Fraud• Professor of Electrical Engineering and Director

of Center, Craig Grimes employed by Pennsylvania State University, received funding from multiple federal agencies – National Science Foundation, Department of Energy and National Institutes of Health – but the projects overlapped, were virtually the same and no substantive work was ever produced

Funding Freeze; Prof. Daniel Kwok’s spending has run afoul of Canada’s research council• Canada’s largest research-funding organization has slapped an extraordinary ban

on a star scientist, who is accused of plagiarism and of spending up to $150,000 in government grant money on custom car parts, televisions, home-entertainment systems and other equipment “inconsistent” with his research proposal

Sponsored Programs and Research Compliance at RU• Office of Sponsored Programs (OSP)• OSP Research Policies & Procedures• http://www.rowan.edu/open/provost/grants/policies_and_procedures

/policies_and_procedures.cfm

• Office of Research• http://www.rowan.edu/open/provost/research/index.cfm• Following subjects are available for review on the webpage:

• Institutional Animal Care and Use Committee – IACUC• Institutional Biosafety Committee – IBC• Institutional Review Board – IRB• Rowan University IRB Policy

• Intellectual Property & Technology Transfer• Rowan University Intellectual Property Policy

Office of Sponsored Programs Policy – Research Policies and ProceduresPrincipal Investigator Guidelines and Eligibilityhttp://www.rowan.edu/open/provost/grants/policies_and_procedures/documents/PI_Eligibility.pdf• Review of sponsor guidelines should be thoroughly performed prior to

submitting the Intent to Propose Form• After submitting the Intent to Propose Form, a Proposal Planning and

Submission Form needs to be completed and signed by the appropriate individuals – Dean, Chair, Assoc. Vice Provost for Research, Principal Investigator and OSP Director

• Both forms are located on the OSP Home webpage http://www.rowan.edu/open/provost/grants/index.cfm

• Submit forms to [email protected] or use interoffice mail

If possible, complete the Proposal Planning and Submission Form and submit to the Office of Sponsored Programs within 5 days of the sponsor’s deadline, but the sooner, the better.

Institutional and Animal Care and Use Committee - IACUC• Rowan University Assurance of Compliance with Public Health Service Policy

on Humane Care and Use of Laboratory Animals• Rowan will comply with all applicable provisions of the Animal Welfare Act – 7

U.S.C. 54 http://www.gpo.gov/fdsys/pkg/USCODE-2009-title7/html/USCODE-2009-title7-chap54.htm

• Regulations can be found in the Code of Federal Regulations (CFR) Title 9 – Animals and Animal Products, Chapter 1 – Animal and Plant Health Inspection Service, Dept. of Agriculture http://www.gpo.gov/fdsys/pkg/CFR-2009-title9-vol1/xml/CFR-2009-title9-vol1-chapI-subchapA.xml

• Rowan is guided by the “U.S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training http://www.nal.usda.gov/awic/pubs/IACUC/vert.htm • Principles include but not limited to:• Transportation, care and use• Research procedures• Appropriate selection of animals• Proper use and humane treatment of animals• Humane treatment of animals

Institutional Review Board (IRB)• IRB Policy• Human subject research conducted by or under the auspices of Rowan University will

be performed in accordance with Title 45 Code of Federal Regulations (CFR), Part 46• All research involving human subjects that is conducted by anyone affiliated with

Rowan must be reviewed and approved by the IRB Committee prior to such studies being undertaken

• Title 45 CFR Part 46 – Protection of Human Subjects http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&tpl=/ecfrbrowse/Title45/45cfr46_main_02.tpl • Subpart A – Basic

• Section 46.116 General Requirements for informed consent• Section 46.118 Applications and proposals lacking definite plans for involvement of human subjects• Section 46.119 Research undertaken without the intention of involving human subjects

• Subpart B – Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research

• Subpart C – Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects

• Subpart D – Additional Protections for Children Involved as Subjects in Research

• Oral History Policy• Faculty should consult the Department Chair or Dean to determine whether a project

must be submitted to the IRB for approval

Institutional Review Board – Q & AQuestion #1: Do I need to provide a statement on the consent form describing the extent,

if any, to which confidentiality of records identifying the subject will be maintained?

Answer: Yes, a human subject should have knowledge that their participation will be confidential and how confidentiality will be maintained – Title 45: Part 46; Subpart A – Section 46.116(a)(5).

Question #2: Do I need to send an application to the IRB Committee when submitting a research training proposal (institutional type of grants and contracts), which it is known that future activities will involve human subjects yet the extent of human research is unknown, to the sponsor for approval?

Answer: No, the proposal can be awarded without submitting an IRB application – Title 45: Part 46; Subpart A – Section 46.118

Note: Prior to starting any human subject research on the proposal discussed in question #2, IRB Review Committee review and approval is required.

Question: Do I need to submit an IRB application for human subject research for my grant or contract that has already been awarded even though the research awarded was not intended to involve human subjects?

Answer: Yes, at any time during an awarded research project if it is determined that human subject research needs to occur, then prior to conducting the human subject research, and IRB application needs to be filed and approved by the IRB Committee – Title 45: Part 46; Subpart A – Section 46.119

Intellectual Property – Overview and Ownership of Copyrights• Rowan University Intellectual Property Policy• Applies to all University employees, graduate students and non-

University employees using University facilities and resources• Includes Camden Campus, South Jersey Technology Park and any other entity

owned and operated by Rowan University

• Ownership of Copyright Rights apply to the following works that are commissioned and created:• Signed contract commissioned by Rowan• By Rowan faculty, staff or other employee within the scope of employment• Excludes works traditionally belonging to faculty such as books, articles, artistic

works, lectures and performances• By Rowan facilities or financial support that is more than incidental• As a result of external funding

• Copyright Ownership Rights Committee at Rowan• Will resolve any disputes of ownership, if applicable

Intellectual Property – Ownership of Patents and Royalties• Ownership of Patents• Rowan is the sole proprietor of all inventions and improvements, whether

or not patentable, that are conceived or reduced to practice using the facilities, equipment or funds of Rowan by employees of Rowan or others authorized to use the facilities, equipment or funds of Rowan

• Need to file an invention disclosure form when intellectual property has been developed and protection may be warranted

• Industry-sponsored projects need to clarify ownership of intellectual property in the agreement / contract negotiation phase of the project

• Royalties• Royalties and other income from intellectual property is shared after the

direct costs related to processing the patent or copyright application and costs of commercializing the property are recovered

• If multiple authors or inventors, then revenue distribution to the authors/inventors can be different if all inventors and authors unanimously agree in writing

Conflict of Interest – Office of Research

• Rowan University Conflict of Interest is based on NJ Conflict of Interest Law (N.J.S.A. 52:13D-12, et seq.) http://www.state.nj.us/ethics/statutes/conflicts/ • Policy intent is to identify, eliminate or manage any possible threat to

grants and sponsored project objectivity• Main components are disclosures of investigator’s financial interests

and application of methods to minimize or eliminate the risks associated with such connections

• What is the definition of Conflict of Interest?• Reasonable determination that an investigator’s personal financial

and other concerns could directly and significantly influence the design, implementation, or reporting of grants and sponsored project activities http://www.rowan.edu/open/provost/research/Integrity_and_compliance/Conflict_of_Interest/Conflict_Int_Pol_Rev.pdf

Conflicts of Interest - Types• Financial Conflict• Very important and typically the greatest concern• Investigator’s financial interest may create bias in the performance of the

investigator’s work related to grants and sponsored project activities• National Institutes of Health (NIH) will soon implement new Financial Conflict of

Interest regulations and rules – Expected implementation date is August 2012• Significant Financial Conflict includes the Investigator’s spouse and immediate

children• Conflicts of Conscience• Personal, moral principle or perspective conflicts with professional responsibilities

• Conflicts of Commitment• Amount of time committed to conduct and perform one’s responsibilities conflicts

Example – Conflict of Commitment:A commitment was made by an investigator to work on a project 50% of their time, but due to other responsibilities, time spent on the research is 25%, not 50%

Effort Reporting - Information at RU and Where effort reporting came from• The following information is available for you in the Office of

Research webpage http://www.rowan.edu/open/provost/research/Integrity_and_compliance/Percentage_of_effort/Percentage_of_effort.cfm• Percentage of Effort Form• Percentage of Effort Policy• Percentage of Effort Frequently Asked Questions• Percentage of Effort Semester Examples• OMB Circular A-21; Cost Principles for Educational Institutions• Requires Rowan University to have an effort reporting system that

addresses the following:• Reasonable amounts for activities contributing and intimately related to

work under the agreement• On an annual basis, Principal Investigator’s need to verify that the proposed

work was performed• Charge government sponsors only for those portions of employee effort that

are devoted to their projects

Effort Reporting – Key Elements: Total Effort, Effort Report Form and NIH Salary Cap• Effort Report form must account for all effort for which the University

compensates the individual – Total Effort• Total effort cannot exceed 100% - Neither more or less• Total effort encompasses all effort expended on University-compensated activities• Total effort does not include effort for which compensation is received directly from

another entity – for example, outside consulting work• Reasonable estimates of university compensated effort for the period

• Effort Report Form• Must be completed by the individual whose effort is being reported or by a

responsible person with access to reliable information on how the individual’s effort has been expended (generally, the college dean)

• Individuals subject to the NIH Salary Cap• If an individual’s University compensation for the effort being reported exceeds the

NIH compensation cap of $161,200, effort percentages for all NIH sponsored research must reflect the total effort on such research, rather than just the percentage of salary reimbursed by NIH

Effort Reporting – Key Elements: AFT Faculty Contract and Unfunded Activity

• AFT Faculty Contract• Employees can receive compensation up to 30% of his or her base salary

or $18,000, whichever is greater – “Compensation from Outside Funded Activities” e.g. grants

• Unfunded Activity (Cost Sharing)• Effort that is expended on a project, but the effort is not charged to the

project• Reported on the Effort Report Form as “Unfunded Activity” (Cost

Sharing)• Only applies to effort specifically expended on the project• General research unfunded and not budgeted and accounted for is

categorized as unsponsored scholarly activity and reported as “Instruction and Unsponsored Scholarly Activity” on the Effort Report Form

Effort Reporting – Key Elements: Responsibility of Accurate ReportingResponsibility for Accurate Reporting• Whoever completes an Effort Report Form must be a responsible

person who knows how the work in question was actually performed

• If someone, other than the individual whose effort is reported on the form, is reviewing the effort, then the effort must be reviewed carefully• If possible, have in writing a statement from the individual whose effort is

being reported that clearly shows his or her agreement with the effort reported on the Effort Report Form

Effort Reporting Procedures• After-the-fact certification of effort of all individuals when all or a

portion of their salaries is charged to a sponsored project• Effort reporting is based on the calendar year• Submission dates are:• February 28 – Fall Term• July 31 – Spring Term• September 30 – Summer Term

• Effort Report Forms are distributed to appropriate faculty 30 days before submission dates

• Effort Report Forms must be reviewed, signed and returned• For instances where individuals sign Effort Report Forms for other

employees, the effort of individuals whose salary charges are distributed to sponsored projects must be confirmed with the Principal Investigator

Ethics in Research and Responsible Conduct of ResearchEthical Principles and Policies for Conducting Research• Approved by Dean’s Council in 2000

http://www.rowan.edu/open/provost/research/Integrity_and_compliance/Ethics/documents/Ethical_principles.pdf

• Lists Ethical Principles where Researchers at Rowan University have a responsibility to:• Inform subjects of all features of the research that may have an effect on their

willingness to participate• Respect the freedom of subjects to decline or withdraw from participation at any

time• Honor all commitments and responsibilities that they make to subjects• Protect subjects from physical or mental discomfort, distress, harm or danger• Protect anonymity and/or confidentiality of subjects to the extent possible and

practical• Research is methodologically sound, capable of answering the questions it is

intended to answer, and to deal honestly with data collected• If concealment and/or deception is necessary, then subjects must be informed, at

the conclusion of the research project, that they have been deceived, and an explanation as to why concealment and/or deception was necessary to ensure the validity of the research project

Ethics in Research and Responsible Conduct of ResearchEthics in Research – Rowan University Webpage• http://

www.rowan.edu/open/provost/research/Integrity_and_compliance/Ethics/Ethics.cfm• Ethical Principles and Policies for Conducting Research at Rowan• Federal Policies• Online Ethics Instructional module

• Federal definitions and regulations are provided on the Rowan University Office of Research webpage• http://www.rowan.edu/open/provost/research/Integrity_and_compliance/R

esponsible_conduct/Federal_definitions/Federal_definitions.cfm

Responsible Conduct of Research at RU

• RCR training is mandatory for any faculty, staff, or student (both graduate and undergraduate) who engages in research and salary is being paid from a grant fund• Currently funded researchers, including students, must complete RCR

by April 30, 2012

• When submitting proposals to the Office of Sponsored Programs, Principal Investigator, Co-PI and any other named researcher(s) have to take the RCR online, web-based training through CITI if not done already

Project Reporting - Overview and Types• Reporting is determined during negotiations with sponsors and in

some instances, required by regulations and administrative guidelines

• Types of Reporting• Technical• Assessment• Financial• Conflict of Interest• Final / Cost Cumulative• Various others may exist or are required depending on the situation –

for example, change of key personnel during project performance period

Project Reporting – Progress Reports• Progress Reports• Performance reporting requirements are/as specified in 2 CFR part 215

(OMB Circular A-110) and the Common Rule implementing OMB Circular A-102 – Grants and Cooperative Agreements with State and Local Governments

• Some government agency websites’ allow users to submit progress reports online• eRA Commons (NIH/DHHS)• Fastlane

• NIH and DHHS require end of year progress reporting for non-competing grants

• NSF uses a Research Performance Progress Report (RPPR)• Agencies will direct recipients to report on the one mandatory component

(“Accomplishments”) while other agencies may make other components of the report optional to complete

• Link to NSF website with RPPR implementation plans: http://www.nsf.gov/bfa/dias/policy/rppr/

Project Reporting –Final Reports• Final Reports• Government agencies, and other sponsors, may have their own format

for final reports and method for submission of final reports• NSF requires final reporting and provides awardees' a final report format to

use

• Agency for Healthcare Research and Quality uses a Final Federal Financial Report (FFR) and Final Progress Report, but the agency does not use an online, web-based tool

• NIH/DHHS allows users to complete a Final Financial Status Report (FSR) through the eRA Commons Closeout feature – online, web-based system

Project Reporting – NSF• As a result of the America COMPETES Act (Section 7010: Reporting

of Research Results), NSF is required to make available to the public, in a timely manner and electronically via NSF’s website, all final project reports and citations of published research documents resulting from research funded, in whole or in part by NSF• Requirement went into effect on January 4, 2010

• NSF accomplished and met the requirements of the act when the foundation implemented the use of the Project Outcomes Report• Project Outcomes Report does not replace or take the place of the Final

Project Report

• NSF final reports can be thought of like this:• Project Outcomes Report is meant for general public• Final Project Report is the communication between the Principal

Investigator and the NSF Program Officer

New Jersey State Regulations and Agencies• State of New Jersey will look for institutions that are awarded the

grant to follow federal regulations related to the state agency (DHHS/NIH, DOJ, DOE, etc.), state regulations and in some cases, state agency regulations• OMB Circular A-21 – Cost Principles for Educational Institutions• OMB Circular A-110 – Uniform Administrative Requirements for Grants

and Other Agreements with Institutions of Higher Education, Hospitals and Other Non-Profit Organizations

• Some New Jersey agencies/affiliates/councils, such as but not limited to NJ Council for Humanities, have their own guidelines and requirements related to proposal development and award management

Award Management – Federal GuidelinesOMB Circular A-110• OMB Circular A-110: Uniform Administrative Requirements for Grants

and Other Agreements with Institutions of Higher Education, Hospitals and Other Non-Profit Organizations – 2 CFR Part 215• Section 11 – Pre-award Policies

• A grant or cooperative agreement shall be used only when the principal purpose of a transaction is to accomplish a public purpose of support or stimulation authorized by Federal statute

• Contracts shall be used when the principal purpose is acquisition of property or services for the direct benefit or use of the Federal Government

• Section 23 – Cost-sharing• Section 25 – Revision of Budget and Program Plans• Section 27 – Allowable Costs

• OMB Circular A-21: Cost Principles for Educational Institutions

Award Management – Federal GuidelinesOMB Circular A-21• OMB Circular A-21: Cost Principles for Educational Institutions – 2

CFR Part 220• Section C – Basic Considerations – Reasonable, Allocable and

Unallowable Costs• Section D – Direct Costs• Section E – F&A Costs• Section J – General Provisions for Selected Items of Cost

• Subsection 10 – Compensation for Personal Services• Subsection 17 – Entertainment Costs• Subsection 18 – Equipment and Other Capital Expenditures• Subsection 31 – Materials and Supplies Costs• Subsection 32 – Meetings and Conferences• Subsection 37 – Professional Services Costs• Subsection 39 – Publication and Printing Costs• Subsection 53 – Travel Costs

Help!For help with pre-award and post-award compliance issues, contact:Eric Gregory, Compliance & Contracts SpecialistOffice of Sponsored [email protected] x4058

For post-award questions, contact:Maria McCall, Associate DirectorAccounting [email protected] x4121

For pre-award issues, contact:

Stephanie Lezotte, Assistant DirectorOffice of Sponsored [email protected] x4124

(state, federal grant applications)

Deanne Farrell, DirectorCorporate and Foundation [email protected] x5418

(industry, foundation grant applications)