Compliance and Beyond
Presented by University Advancement
and
the Office of Sponsored Programs
September 27, 2012
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
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
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
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
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
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
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
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
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?
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
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)
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
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?
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
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.
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
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
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
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?
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
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?
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
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 A110 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 A21
• 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
Webpage links
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
Citations and Sources
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