Compliance and

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

2. 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!

3. Principal Investigator (PI) and Sponsor Guidelines Principal Investigator Guidelines and Eligibility http://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 Guidelines A 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 Sponsoredprograms@rowan.edu

4. 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

5. Ethics – General and Research What 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

6. 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

7. Ethical Principles and NSF Misconduct Ethical 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

8. Research Ethics – Case Review 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. Is there any violation of ethical behavior?

9. 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

10. 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?

11. Research Compliance – Who owns it? When does it begin? • Compliance begins with you and your institution • If you have a concern, contact the Office of Sponsored Programs, Research Office, or University Advancement 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

12. 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 Penalties Errors 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.

13. Research Compliance – Managing before and during the award Establish Roles and Responsibilities • 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 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

14. Research Compliance – Managing before and during the award (Cont’d) Know the policies, procedures, regulations, laws, and rules • 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

15. 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

16. 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

17. Research Compliance – Case Study 1 University 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?

18. 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 effortto 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

19. Research Compliance – Case Study 2 Professor 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?

20. 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

21. 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

22. Rowan University Conflict of Interest Conflict 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

23. Conflicts of Interest - Types Financial 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

24. 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

25. 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

26. 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

27. 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 sponsoredprograms@rowan.edu email account

28. Effort Reporting • OMB Circular A-21; Cost Principles for Educational Institutions • Requires institutionsto 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

29. 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

30. 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

32. Webpage links Citations and Sources Rowan University Foundation / University Advancement Office http://rufoundation.org/ Rowan University: Office of Sponsored Programs http://www.rowan.edu/provost/grants/index.cfm Rowan University: Office of Research http://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 Manual http://www.nsf.gov/pubs/manuals/gpm05_131/index.jsp Collaborative Institutional Training Initiative https://www.citiprogram.org Dean, 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