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Compliance and Presented by University Advancement, Office of Sponsored Programs, And Research Office February 13, 2013 Beyond

Compliance and Presented by University Advancement, Office of Sponsored Programs, And Research Office February 13, 2013 Beyond

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Page 1: Compliance and Presented by University Advancement, Office of Sponsored Programs, And Research Office February 13, 2013 Beyond

Compliance andPresented by University Advancement,

Office of Sponsored Programs,And Research Office

February 13, 2013

Beyond

Page 2: Compliance and Presented by University Advancement, Office of Sponsored Programs, And Research Office February 13, 2013 Beyond

Why Comply?• 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 award, will help Rowan University and yourself…….

your own

Stay off the front page of the newspaper or webpage!

Page 3: Compliance and Presented by University Advancement, Office of Sponsored Programs, And Research Office February 13, 2013 Beyond

Principal Investigator (PI) and Sponsor GuidelinesPrincipal Investigator Guidelines and Eligibilityhttp://www.rowan.edu/open/provost/grants/policies_and_procedures/documents/PI_Eligibility.pdf• Permanent employee at the time of submitting proposal• Regular full-time faculty and staff• If personnel do not meet the criteria above, there is a petition

process to become a PI

Sponsor GuidelinesA thorough review of sponsor guidelines will:• contribute to a quick, expeditious review and processing of

proposals• provide an underlying understanding of the possible compliance

issues Submit forms to [email protected]

Page 4: Compliance and Presented by University Advancement, Office of Sponsored Programs, And Research Office February 13, 2013 Beyond

What is Research Compliance?• Application of ethics and ethical behavior• Following institutional policies and procedures that govern ethical

behavior and compliance• Complying with federal, state, and local laws and regulations• Circulars A-110, A-21, and A-133• State Laws that may impact research:

• Tort Claims Act• Open Public Records Act

• Implementation and use of best practices

• Use the resources available at Rowan University when in doubt• Office of Sponsored Programs / Research Office

• Review Rowan University Policy titled: Ethical Principles and Policies for Conducting Research at Rowan

• Use the link on the OSP Research & Integrity webpage to take online modules associated with ethics in specific fields of study

• University Advancement

Page 5: Compliance and Presented by University Advancement, Office of Sponsored Programs, And Research Office February 13, 2013 Beyond

Ethics – General and ResearchWhat is and how are ethics determined?• Rules for distinguishing between right and wrong• Professional codes of conduct• Religious Creeds• Wise Aphorisms• Ethical behavior is based on a number of things• Childhood experiences, parental values, social norms and values, religion,

and ethnicity and culture

Where did the concept of research ethics come from?• For the most part, developed as a concept in medical research• Key agreements are the Nuremberg Code and 1974 Declaration of

Helsinki• Belmont Report of 1979 established additional set of principles• The Animal Welfare Act and Title 45, Part 46 from Code of Federal

Regulations (CFR): The Protection of Human Subjects Regulations established additional guidance related to research ethics

Page 6: Compliance and Presented by University Advancement, Office of Sponsored Programs, And Research Office February 13, 2013 Beyond

Research Ethics - Defined• Research Ethics is defined as:• The application of fundamental ethical principles in the

planning, development, conducting, managing, and reporting of scientific research.

• An alternative definition of ethics can be:• Method, procedure, or perspective for deciding how to act

and for analyzing complex problems and issues

Page 7: Compliance and Presented by University Advancement, Office of Sponsored Programs, And Research Office February 13, 2013 Beyond

Ethical Principles and NSF MisconductEthical Principles• Honesty, Integrity, Carefulness, Openness, Respect for Intellectual

Property and Colleagues• Confidentiality, Responsible Publication and Mentoring, Social

Responsibility, Non-Discrimination, Competence• Legality, Animal Care, Human Subject Protection

NSF Misconduct• National Science Foundation defines misconduct of research as

fabrication, falsification, or plagiarism in proposing, performing, or reviewing research or in reporting research results• Fabrication is making up results and recording or reporting them• Falsification is manipulating research materials, equipment, or processes

or changing or omitting data or results such that the research is not accurately represented in the research record

• Plagiarism is the use of another person’s ideas, processes, results, or words without giving credit to that person

Page 8: Compliance and Presented by University Advancement, Office of Sponsored Programs, And Research Office February 13, 2013 Beyond

Research Ethics – Case Review

Is there any violation of ethical behavior?

Dr. Rowan reviewed his recent submission of a paper that was accepted for publication in a high profile journal. During the review, an error was discovered, and upon careful scrutiny, the good doctor realizes the error does not affect overall results and conclusions. However, the error may be misleading. The journal has gone to press, so a revision or resubmission cannot occur and the paper has to go out without the correction. In order to avoid embarrassment, Dr. Rowan does nothing and lets the error go to press.

Page 9: Compliance and Presented by University Advancement, Office of Sponsored Programs, And Research Office February 13, 2013 Beyond

Research Ethics – Case Review

• Dr. Rowan’s error in the research is not:• a violation of ethical principles; and• misconduct

• Dr. Rowan’s decision to take no action and not inform the editors of the error before the paper is published is not:• a violation of ethical principles; and• misconduct

• However, failing to publish a correction or errata is considered a violation of ethical principles and is considered to be misconduct – Why?

Failure to publish an errata or correction violates the principles of honesty and objectivity in research

Page 10: Compliance and Presented by University Advancement, Office of Sponsored Programs, And Research Office February 13, 2013 Beyond

Research Ethics - Responsibilities• Integrity of science, legitimacy of scientific practices, and the

investigation and responses to alleged scientific misconduct is primarily shared by and the responsibility of:• Individual scientists• Institutions• Professional societies

• Investigator and Institution primary responsibilities:• Ensure integrity of the science• Protect the public trust

• The number question to always ask yourself is:

Is this the right thing to do?

Page 11: Compliance and Presented by University Advancement, Office of Sponsored Programs, And Research Office February 13, 2013 Beyond

Research Compliance – Who owns it? When does it begin?

Responsibility at the Institution• Authorized Organizational Representative / Official• Principal Investigator• Compliance is an institutional commitment• As employees, we can facilitate research compliance by:

• Complying with internal policies, state and federal laws and regulations, and sponsor guidelines and administration policies

• Understanding ethics and compliance• Championing ethical behavior• Incorporating ethical concepts and behaviors in our daily interactions

• Compliance begins with you and your institution• If you have a concern, contact the Office of Sponsored

Programs, Research Office, or University Advancement

Page 12: Compliance and Presented by University Advancement, Office of Sponsored Programs, And Research Office February 13, 2013 Beyond

Research Compliance – Where can things go wrong?• Inadequate resources and management systems• Misunderstanding of institutional staff roles and responsibilities• Inadequate training and education• Outdated or nonexistent institutional policies and procedures• One’s own misconceptions• Internal control systems are not necessary• Internal control systems are restrictive and hinder my work• Reviewing compliance issues is a waste of my time

Scientists’ Small Errors in Research Grants Can Mean Big PenaltiesErrors in effort reporting, clearly identifying costs as administration, and unallowable costs may result in the federal government demanding repayment of federal funds awarded to an institution. The recover / repayment amounts can be in the millions. This is due to the federal government’s fairly recent use of extrapolation.

Page 13: Compliance and Presented by University Advancement, Office of Sponsored Programs, And Research Office February 13, 2013 Beyond

Research Compliance – Managing before and during the award

• Create list of responsibilities and include oversight responsibilities for each role in the research• Communication is essential• Conduct focus groups• With personnel contributing/working on the project• With Department personnel and administration

Establish Roles and Responsibilities

Communication is Key• If no one knows of your concern, than no one can help you• Keep lines of communication open amongst all groups – project

personnel, department, and Office of Sponsored Programs, Research Office and University Advancement

• Consult with experienced researchers and Principal Investigators

Page 14: Compliance and Presented by University Advancement, Office of Sponsored Programs, And Research Office February 13, 2013 Beyond

Research Compliance – Managing before and during the award (Cont’d)

• Rowan University, as an institution of higher education, is subject to federal regulations

• Review state laws and regulations and have an understanding of those laws and regulations• Hint: Review your research project, identify potential areas of error and

concern, then tailor your search of federal and state laws and regulations to those specific errors and concerns

• Have an understanding of the sponsor’s policies by reviewing their website

• Review the terms and conditions of your award• Create favorites in your web browser for easy reference• Use Rowan University Office of Sponsored Programs, Research

Office, and University Advancement website and personnel• Contact Chairs of respective committees – IRB, IBC, and IACUC

Know the policies, procedures, regulations, laws, and rules

Page 15: Compliance and Presented by University Advancement, Office of Sponsored Programs, And Research Office February 13, 2013 Beyond

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

grant/contract to follow federal regulations specific to the federal agency (DHHS/NIH, DOJ, DOE, etc.)

• 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

• Legislature statute: Title 18A: Education• Legislature webpage http://www.njleg.state.nj.us/• Click on statutes link on left-hand side of webpage• Then search and click on Title 18A: Education

Page 16: Compliance and Presented by University Advancement, Office of Sponsored Programs, And Research Office February 13, 2013 Beyond

Research Compliance – Training

• Training and continuing education is critical• Policies, regulations, and laws can change

• Attend and complete training courses and workshops offered by sponsors, professional organizations, and Rowan University

• Review sponsor websites for links to webinars, presentations, workshops, and discussions regarding compliance and/or a compliance issue

• Be mindful of staffs’ role and which training will be the most effective and relevant to their responsibilities

Page 17: Compliance and Presented by University Advancement, Office of Sponsored Programs, And Research Office February 13, 2013 Beyond

Research Compliance – Case Study 1University employee transfers expenses from one federally sponsored project account to another federally sponsored project account and annotates the cost transfer as “to correct an accounting error”. This entry is made 100 days after initially discovering the error, and the original supporting documentation is not available.

An internal auditor takes exception. Why?

Page 18: Compliance and Presented by University Advancement, Office of Sponsored Programs, And Research Office February 13, 2013 Beyond

Research Compliance – Case Study 1: Explanation• Errors should be corrected 90 days upon discovery of the error• Transfers must be supported by:• Documentation fully explaining how the error occurred• Certification of the correctness of the transfer by the Principal

Investigator (PI) – Always make an effort to obtain PI signature to ensure the cost is related to the sponsored projects purpose

• All charges to federally funded projects must adhere to the core cost principles of:• Reasonable• Allowable• Allocable• Consistent

Page 19: Compliance and Presented by University Advancement, Office of Sponsored Programs, And Research Office February 13, 2013 Beyond

Research Compliance – Case Study 2Professor Rowan asks an administrative assistant in her department to pick up some office supplies (pens, paper, and envelopes), stop by a donut shop to pick-up donuts for a general lab meeting, and pick-up a cake for a farewell office celebration for a lab research assistant accepting another position in another institution. When the administrative assistant enters the office, Professor Rowan tells him to charge the costs to her grant.

However, the department administrator overhears the conversation, and she informs the administrative assistant to charge the costs to the departmental funds. Why?

Page 20: Compliance and Presented by University Advancement, Office of Sponsored Programs, And Research Office February 13, 2013 Beyond

Research Compliance – Case Study 2: Explanation• If office supplies are not specifically allocable to the grant, they are

considered general office supplies that fall under Facilities and Administration (F&A) costs and cannot be directly charged to the fund

• Entertainment costs, such as food, are generally unallowable• Alcohol is generally considered unallowable in most, if not all,

circumstances

• Meals may be allowable on a research grant if:• The Notice of Award explicitly states that meals are allowable• The purpose of the meeting is to disseminate technical information• NOTE: Recurring business meetings, for example staff or lab meetings, are

generally not considered meetings to disseminate technical information

Page 21: Compliance and Presented by University Advancement, Office of Sponsored Programs, And Research Office February 13, 2013 Beyond

Research Compliance – Case Study 2: National Science Foundation (NSF)• NSF is a federal agency, and guidance related to administration and

cost principles can be found in NSF’s Award and Administration Guide and OMB circulars A-110 and A-21

• NSF Award and Administration Guide, Chapter V: Allowability of Costs• General office supplies are considered F&A, and not direct costs• Materials and supplies that are necessary to carry out the project are

allowable as prescribed in the governing cost principles – OMB Circular A-21

• Section 5: Paraphrased “NSF funds are not otherwise to be spent for meals or coffee breaks for intramural meetings of an organization or any of its components, including, but not limited to, laboratories, departments and centers.”

• General staff and lab meetings are not considered conferences

Page 22: Compliance and Presented by University Advancement, Office of Sponsored Programs, And Research Office February 13, 2013 Beyond

Rowan University Conflict of InterestConflict of Interest Policy• Identify, eliminate or manage any possible threat to grants and

sponsored project objectivity• Main components are disclosures of investigator’s conflicts, financial

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

• Rowan University Research Conflict of Interest policy has two (2) main components:• General (NSF Conflict of Interest)• Revised 2011 PHS Regulations (Financial Conflict of Interest)

What is a Conflict of Interest?• In general, a reasonable determination that a conflict could directly

and significantly influence the design, implementation, or reporting of grants and sponsored project activities of investigators and key personnel

Page 23: Compliance and Presented by University Advancement, Office of Sponsored Programs, And Research Office February 13, 2013 Beyond

Conflicts of Interest - TypesFinancial Conflict• Very important and typically the greatest concern• Financial conflict procedures and policy varies significantly between

two (2) major sponsors – the National Science Foundation (NSF) and DHHS/PHS National Institutes of Health (NIH)\

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

professional responsibilities

Page 24: Compliance and Presented by University Advancement, Office of Sponsored Programs, And Research Office February 13, 2013 Beyond

Conflict of Interest Procedures

Proposal Planning Stage• Identify conflicts on the Proposal Planning Form• Inform Office of Sponsored Programs and University Advancement of

conflicts using Conflict of Interest Form (General) and financial interests using Significant Financial Interest Form (PHS Funding) during the Proposal Planning Stage• HINT: If a conflict of interest exists, make sure to check the box on the

Proposal Planning form

• If NIH or other PHS operating agency is funding applicable research, then:• Take and complete Conflict of Interest training in the CITI training

program/website

Page 25: Compliance and Presented by University Advancement, Office of Sponsored Programs, And Research Office February 13, 2013 Beyond

Conflict of Interest Procedures (Cont’d)

During and After the Award• Complete training as required

• PHS and PHS operational agencies require annual training

• If applicable, manage conflicts as agreed upon in Management Plan

• Inform Office of Sponsored Programs, Office of Research and University Advancement of any new significant financial interest and conflict; AND

• Any significant financial interest or conflict that once existed but now does not exist

Page 26: Compliance and Presented by University Advancement, Office of Sponsored Programs, And Research Office February 13, 2013 Beyond

Responsible Conduct of Research (RCR)Rowan University Policy• RCR training is mandatory for any faculty, staff, or student (both

graduate and undergraduate) who engages in research and receives compensation from a research project

• When submitting proposals, the following individuals are expected to complete RCR training:• Principal Investigator• Co-Principal Investigator(s)• Any other named/key researcher(s)

• RCR training is administered through the Collaborative Institutional Training Initiative (CITI) program• Online, web-based• Can be done anywhere with a device that has access to the internet• As one progresses through the training program, the modules completed

are saved, allowing users to return at a later time and not lose training already completed

Page 27: Compliance and Presented by University Advancement, Office of Sponsored Programs, And Research Office February 13, 2013 Beyond

Responsible Conduct of Research (RCR)Rowan University Policy (Cont’d)• RCR Training Exemption policy is located on the OSP RCR webpage• RCR exemptions are associated with four (4) types of employee

assignments:• Tutoring• Professional Development Workshops• Academic Advising• Routine Administrative/Office Support

• Exemptions have to be reviewed and approved by the Research Office

• HINT:• When completing HR paperwork associated with a position that will be

paid from a sponsored project, then do the following:• Complete the necessary HR paperwork and forward to the appropriate

department• At the same time, complete the RCR Exemption Form and submit to the

[email protected] email account

Page 28: Compliance and Presented by University Advancement, Office of Sponsored Programs, And Research Office February 13, 2013 Beyond

Effort ReportingOMB Circular A-21; Cost Principles for Educational Institutions

Requires institutions to have an effort reporting system that:• Provides reasonable amounts of estimated effort for activities

contributing and intimately related to work under an 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

Page 29: Compliance and Presented by University Advancement, Office of Sponsored Programs, And Research Office February 13, 2013 Beyond

Effort Reporting (Cont’d)Key Elements of Effort Reporting• Total effort cannot exceed 100% (Neither more or less)• Encompasses all effort expended on University-compensated activities• Represents reasonable estimates of university compensated effort for the

period• Does not include effort for which compensation is received directly from

another entity (e.g. outside consulting work)• Must be signed by the Principal Investigator (PI) OR:

• Personnel with direct knowledge of the individual’s work on the project OR:

• Dated email, fax, or letter from Principal Investigator, either confirming effort percentage reported or providing revised percentages of effort

• NOTE: Direct knowledge means that the individual can account for the daily work performed, has an understanding of how the work should be conducted, and is in close proximity to the personnel named on the effort report

Page 30: Compliance and Presented by University Advancement, Office of Sponsored Programs, And Research Office February 13, 2013 Beyond

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

a portion of their salary is charged to a sponsored project, except for non-exempt hourly employees paid via timecard / timesheet

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

• Effort Report Forms must be reviewed, signed and returned• If percentages documented on the effort report form are incorrect,

then the Principal Investigator signing the form must cross out the recorded percentages and provide the percentages that are reasonable estimates of the individual’s time and effort

Page 31: Compliance and Presented by University Advancement, Office of Sponsored Programs, And Research Office February 13, 2013 Beyond
Page 32: Compliance and Presented by University Advancement, Office of Sponsored Programs, And Research Office February 13, 2013 Beyond

Citations and SourcesDean, D. (2003). A Federal Perspective on Compliance. Compliance workshop presented during NIH Regional Seminar Series

Dean D.; Hancock, K.; Snyderman, J. (2012, April). Common Compliance Pitfalls and Strategies for Success. Compliance workshop presented during NIH Regional Seminar in Indianapolis, IN

Resnik, David B. (2011, October). What is Research Ethics and Why is it Important. Provided on National Institutes of Environmental Health Sciences

Kelderman, E. (September 2010). Scientists’ Small Errors in Managing Research Grants Can Mean Big Penalties. Chronicle of Higher Education

Webpage linksRowan University Foundation / University Advancement Officehttp://rufoundation.org/

Rowan University: Office of Sponsored Programshttp://www.rowan.edu/provost/grants/index.cfm

Rowan University: Office of Researchhttp://www.rowan.edu/provost/research/index.cfm

Office of Management & Budget (OMB) Circulars – A-110 and A-21 http://www.whitehouse.gov/omb/grants_circulars/

National Science Foundation Grants Policy Manualhttp://www.nsf.gov/pubs/manuals/gpm05_131/index.jsp

Collaborative Institutional Training Initiativehttps://www.citiprogram.org