Compliance and

1. Beyond Compliance and Presented by University Advancement and the Office of Sponsored Programs September 27, 2012

2. Research Ethics • Regulation of research, Research Ethics, is most developed as a concept in medical research • Key agreements are the Nuremberg Code and 1974 Declaration of Helsinki • Nuremberg Code established 10 Basic Principles • 1974 Helsinki Declaration established 7 unique principles • Belmont Report of 1979 established the next set of principles • Focus was the protection of human subjects of biomedical and behavioral research • 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 • Research in social sciences presents a different set of issues than those in medical research

3. Ethics • Rules for distinguishing between right and wrong • Golden Rule - Do unto others as you would have them do to you • Professional codes of conduct • Hippocratic Oath • Religious Creeds • Thou Shall not Steal • Wise Aphorisms • Sayings of Confucius • Ethics definition made simple: • Principles for conduct that distinguish between acceptable and unacceptable behavior

4. Ethics • If ethics are as simple as commonsense, as some people say, then why are there dilemmas and differences in ethical behavior? • Ethical behavior is based on a number of things: • Childhood experiences • Parental values • Social norms and values • Religion • Ethnicity and culture

5. Research Ethics • Research Ethics 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

6. Ethical Principles • Honesty • Honestly report data, results, methods and procedures, and publication status • Objectivity • Avoid bias in experimental design, data analysis, data interpretation, peer review, personnel decisions, grant writing, expert testimony, and other aspects of research where objectivity is expected or required • Disclose institutional, commitment, personal, and financial interests • Integrity • Keep to your promises and agreements • Carefulness • Critically examine your own work and the work done of your peers • Keep good records of research activities • Openness • Share data, results, ideas, etc. • Be open to other and new ideas

7. Ethical Principles • Respect for Intellectual Property • Honor all forms of intellectual property • Do not use unpublished data without permission • Never plagiarize • Confidentiality • Protect classified and confidential material and communications • Responsible Publication • Publish to advance research and scholarship • Do not publish to further one’s own career • Avoid wasteful publication • Responsible Mentoring • Educate, mentor, and advise students • Respect for Colleagues

8. Ethical Principles • Social Responsibility • Seek to and promote social good and mitigate or prevent social harms • Non-Discrimination • Competence • Maintain and improve one’s own professional competence through lifelong education and learning • Promote science as a whole and promote continued education amongst lab and research personnel • Legality • Know and obey relevant laws and institutional and governmental policies • Animal Care • Show proper respect and care for animals when used in research • Do not conduct poorly designed or unnecessary animal experiments • Human Subject Protection • Minimize harm and risk to patients while maximizing benefits • Respect human beings and their dignity, privacy, and autonomy

9. Research Ethics – 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 appropriation of another person’s ideas, processes, results, or words without giving appropriate credit

10. 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 maybe 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?

11. Research Ethics – Case Review • Dr. Rowan’s error in the research is not a violation of ethical principles and is not considered to be 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 is not considered to be 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

12. Research Compliance • 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 • A-110 Uniform Administrative Requirements for Grants and Cooperative Agreements Awarded to Universities, Hospitals, and Other Non-profit Institutions • A-21 Cost Principles for Educational Institutions • Implementation and use of best practices • Use the resources available at Rowan University when in doubt or want a refresher in responsible conduct of research • Office of Sponsored Programs • Office of Research • CITI – online, web-based training module for Responsible Conduct of Research (RCR)

13. Research Compliance - Robustness • Concept of the Ying and Yang • Complementary relationship between ethics and compliance is necessary for wholeness • Research Ethics and Compliance • Complementary relationship creates a wholeness • Promotes Integrity • Contributes to good science

14. Research Ethics - Responsibilities • Responsibility of integrity of science, legitimacy of scientific practices, and the investigation and responses to alleged scientific misconduct is primarily shared by: • 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?

15. Research Compliance – Who owns it and when does it begin? • At the Institution • Authorized Organizational Representative / Official • Principal Investigator • Compliance is an institutional commitment • As employees, we can facilitate and ensure the institution is committed 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 • Comply with institutional and federal requirements • If you have a concern, contact the Office of Sponsored Programs or University Advancement • Institutional policies may be more restrictive than federal and state policies • Read the Notice of Award and/or terms and conditions of agreement

16. Research Compliance – Where can things go wrong? • Inadequate resources • Misunderstanding of institutional staff roles and responsibilities • Inadequate training and education • Outdated or nonexistent institutional policies and procedures • Inadequate management systems – for example, lack of effort reporting system • One’s own misconceptions and imperceptions • 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 resulted in the federal government demanding repayment of federal funds awarded to the institution. The recover / repayment amounts can be in the millions. This is due to the federal government’s fairly recent use of extrapolation.

17. 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 • With the Office of Sponsored Programs and Advancement Communication is Key • If no one knows of your concern/situation, than no one can help you solve your concern/situation • Keep lines of communication open amongst all groups – project personnel, department, and Office of Sponsored Programs and University Advancement • Consult with experienced researchers and Principal Investigators

18. Research Compliance – Managing before and during the award Know the policies, procedures, regulations, laws, and rules • Rowan University, as a state funded institution of higher education is subject to the federal regulations as identified in: • OMB Circular A-110 Uniform Administrative Requirements for Grants and Cooperative Agreements Awarded to Universities, Hospitals, and Other Non-profit Institutions • OMB Circular A-21 Cost Principles for Educational Institutions • 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 and Office of Research website links and information • Contact Compliance and Contracts Specialist in the Office of Sponsored Programs

19. Research Compliance – Training • Training and continuing education is critical • Policies, regulations, and laws can change • Attend and complete training courses and workshops offered by Rowan University • Keep training current • Review sponsor websites for links to webinars, presentations, workshops, and discussions regarding compliance and/or a compliance issue • Be mindful of staffs’ role and what or which training will be the most effective and relevant • Office of Sponsored Programs, Office of Research, and University Advancement are central resources to receive information related to compliance and training

20. 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. An internal auditor takes exception. Why?

21. 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 a responsible organizational official or Principal Investigator (PI) – Always make an effort to obtain PI signature to ensure the cost is related to the sponsored projects purpose • Transfer of costs from one project fund to another project fund to cover overrun costs is unallowable • All charges to federally funded projects must adhere to the core cost principles of: • Reasonable • Allowable • Allocable • Consistent

22. Research Compliance – Case Study 2 Professor Rowan asks an administrative assistant in her department to pick up some office supplies (pens, paper, and envelopes) and to stop by a donut shop to pick-up donuts for a lab meeting in the morning. 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 department funds. Why?

23. 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 • Entertainment costs such as food are unallowable • 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 Electronic Devices • Computers, smartphones, and other electronic devices are generally unallowable costs and treated as part of F&A • General use is considered when submitting electronic equipment as direct costs. HOWEVER, electronic equipment is not justifiable using the General Office use justification. Electronic equipment need to have a direct, sole benefit to the research purpose to be a direct cost

24. Research Compliance – Case Study 2: National Science Foundation (NSF) • National Science Foundation is a federal agency, and when NSF is the sponsor administrative and cost principle requirements applicable are A-110 and A-21 • National Science Foundation Grants Policy Manual Chapter VI of Allowability of Costs: • Materials and supplies are defined as tangible personal property other than equipment, costing less than $5,000, or other lower threshold consistent with grantee policy • Materials and supplies that are necessary to carry out the project are allowable as prescribed in the governing cost principles – OMB Circular A-21 • When certain meals are an integral and necessary part of a conference (e.g., working meals where business is transacted), grant funds may be used for such meals • Grant funds may also be used for furnishing a reasonable amount of hot beverages or soft drinks to conference participants and attendees during periodic coffee breaks • General staff and lab meetings are not considered conferences

25. Webpage links Citations and Sources Rowan University Foundation / University Advancement Office http://rufoundation.org/ Rowan University: Office of Sponsored Programs http://www.rowan.edu/open/provost/grants/index.cfm Rowan University: Office of Research http://www.rowan.edu/open/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