Research Integrity and Ethics
Wilna Venter, M.A., M.Ed.
Cluster Manager: Strategic Support
University of Cape Town Research Office
Content
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Historical background
Definition of research integrity and ethics
Responsible conduct of research
NIH compliance requirements
Historical Background
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Nuremberg Code—1946
Declaration of Helsinki—1964
The Belmont Report—1979
Singapore Statement on Research Integrity—2010
Definition of Research Integrity and
Ethics
Research integrity could be defined as (i) active adherence to the
(ii) ethical principles and (iii) professional standards essential for
the (iv) responsible conduct of research.
Integrity in Research
Research integrity is an integral part of all of the following stages
in research process:
• Planning of research
• Conducting the research
• Disseminating results
Sources Guiding Responsible Conduct
of Research
• Professional codes
• Government legislation
• Institutional policies governing
– Human subjects
– Animal subjects
– Research misconduct
– Conflicts of interest
• Personal values/responsibility
Ethical Principles Underlying Codes
and Policies
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Honesty
Objectivity
Integrity
Carefulness
Openness
Respect for intellectual property
Confidentiality
Responsible publication
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Responsible mentoring
Respect for colleagues
Social responsibility
Nondiscrimination
Competence
Legality
Animal care
Human subjects protection
Human Subjects
Guiding principles in the Belmont Report (1979):
a. Respect for persons
(i) Individuals should be treated as autonomous agents; (ii)
persons with diminished autonomy are entitled to protection
b. Beneficence
(i) Do not harm; (ii) maximize possible benefits and minimize
possible harms
c. Justice
“An injustice occurs when some benefit to which a person is
entitled is denied without good reason or when some burden
is imposed unduly...”
Human Subjects (cont.)
Issues to consider:
• Critically evaluate the decision to conduct research involving
human beings
• Comply with regulations (e.g., protocol)
• Protect individual rights to self-determination
• Promote responsible use of human subjects
Animal Subjects
Cruelty to Animals Act—1876
The central problem is determining what is and what is not
humane treatment of animals, and how humane treatment can
be promoted without prejudice to scientific and medical aims
Resource: Russell, W.M.S., & Burch ,R.L. (1959): Principles of Humane Animal
Experimentation. Charles C. Thomas, Springfield, IL. Excerpts available at
http://altweb.jhsph.edu/pubs/books/humane_exp/het-toc
Publications and Authorship
• Research is incomplete until published
• Publication is not merely a matter of credit
• There are significant responsibilities in publishing, including
accurate, complete, clear, and unbiased representation of the
research
• Authorship:
– Credit
– Responsibility for any deficits
– Transparency
– Who should be an author?
Publications and Authorship (cont.)
• According to the International Committee of Medical Journal
Editors (2006), someone should be listed as an author if and
only if they have done all of the following:
– Made substantial contributions to conception and design,
acquisition of data, or analysis and interpretation of data;
– Drafted the article or revised it critically for important
intellectual content; and
– Approved of the final version to be published.
Biosecurity
Biosecurity: efforts designed to minimize the likelihood that
biological research will be misused for malicious purposes, such
as bioweapons.
Dual-use research: any type of legitimate life sciences research
that has the potential to be misused for malicious purposes.
Resource: National Science Advisory Board for Biosecurity . (2007). Proposed
Framework for the Oversight of Dual Use Life Sciences Research: Strategies for
Minimizing the Potential Misuse of Research Information. http://oba.od.nih.gov/
biosecurity/pdf/Framework%20for%20transmittal%200807_Sept07.pdf
Collaboration
CHALLENGE: communication about what is to be achieved,
methodology, and data sharing
• Collective skills, knowledge, and resources
• Funding favours program in which each key area is tied to a
recognised expert in that field
• Interdisciplinarity gives rise to significant breakthroughs
• Private-sector and academic partnerships
Conflict of Interest
“A conflict of interest in research exists when the individual has
interests in the outcome of the research that may lead to a personal
advantage and that might therefore, in actuality or appearance,
compromise the integrity of the research.” National Academy of
Science, Integrity in Scientific Research
Resource: Brainard, J. (2000). The Ties that blind? (Financing that might influence
medical research). Chronicle of Higher Education ,47, A31.
Data Management
Data acquisition, management, sharing, and ownership
Responsible conduct of research, therefore,
• Begins with experimental design and protocol approval;
• Involves recordkeeping in a way that ensures accuracy and
avoids bias;
• Guides criteria for including and excluding data from statistical
analyses; and
• Entails responsibility for collection, use, and sharing of data.
Resource: Department of Health and Human Services .(1990). Workshop on Data
Management in Biomedical Research.
Mentoring
a. Promoting responsible conduct of research
b. Reducing the risk of research misconduct
Resource: Eastwood, S., Derish, P., Leash, E., & Ordway, S. (1996). Ethical issues in
biomedical research: Perceptions and practices of postdoctoral research fellows
responding to a survey. Science and Engineering Ethics, 2, 89-114.
Stem Cell Research
Derivation of human cell lines capable of differentiation into any of the cells of the human
body (1998-2008)
International Society for Stem Cell Research:
• “All experiments pertinent to human embryonic stem cell research…shall be subject to
review, approval and ongoing monitoring by a special oversight mechanism or body
equipped to evaluate the unique aspects of the science.”
• “Given current scientific and medical safety concerns, attempts at human reproductive
cloning should be prohibited.”
• “…privacy and confidentiality of personal information should be protected with the
utmost care. Caution must also be taken to ensure that persons are not exploited
during the procurement process, especially individuals who are vulnerable due to their
dependent status or their compromised ability to offer fully voluntary consent.”
RESOURCE: International Society for Stem Cell Research. (2006). Guidelines for the conduct of human
embryonic stem cell research. http://www.isscr.org/docs/default-source/hescguidelines/isscrhescguidelines2006.pdf.
Research Misconduct
Violation of the standard codes of scholarly conduct and ethical behavior in
professional scientific research
• Fabrication
• Falsification
• Plagiarism
– Plagiarism-fabrication
– Self-plagiarism (salami)
• Ghostwriting
• Photo manipulation
• Suppression/nonpublication of data
Resource: National Academy of Sciences, National Academy of Engineering, &
Institute of Medicine. (1995). On Being a Scientist: Responsible Conduct in Research.
http://www.nap.edu/readingroom/books/obas
Whistleblowing
Institutions have obligation to address allegations of research
misconduct.
“…someone who has witnessed misconduct has an
unmistakable obligation to act.”
Institutions should have processes and procedures to
investigate misconduct and mete out justice as is appropriate
Resource: Department of Health and Human Services. (2000). Public Health Service
Standards for the Protection of Research Misconduct Whistleblowers: Notice of
proposed rulemaking. Federal Register, 65, 70830-70841. http://ori.hhs.gov/nprmregulation
NIH Compliance Requirements
Institutional policies
• Human subjects
– Institutional Review Board: must be registered with Office for Human
Research Protection (OHRP)
– Federalwide Assurance for the Protection of Human Subjects (HHS)
• Animal subjects
– Institutional Animal Care and Use Committee (IACUC)
– Animal Welfare Assurance: Office of Laboratory Animal Welfare
(OLAW)
• Research misconduct policies
• Conflict of interest policies