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RESEARCH
ETHICAL ISSUES
D E F I N I T I O N , I M P O R TA N C E A N D G U I D E L I N E S
https://www.ahc.umn.edu/img/assets/26104/Research_Et
hics.pdf
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GROUP SEATWORK
RECALL:
Nuremberg Code
Helsinki Declaration
Belmont Report
..Seatwork 6.-ETHICS Belmont Report.docx
ETHICAL ISSUES
•Authorship
•Plagiarism
•Peer review
•Conflict of
interest
•Data
•Research
Misconduct
•Research with
Animals
•Research with
Human Subjects
AUTHORSHIP: DEFINITION AND
IMPORTANCE
• process of deciding whose names belong on a
research paper
• research evolves from collaboration and
assistance between experts and colleagues
• assistance will require acknowledgement and
some will require joint authorship
• proper authorship practices in order to protect
their work and ideas while also preventing
research fraud.
AUTHORSHIP: GUIDELINES
• Each person listed as an author on an article
should have significantly contributed to both
the research and writing
• all listed authors must be prepared to accept
full responsibility for the content of the research
article
AUTHORSHIP: GUIDELINES
• The International Committee of Medical
Journal Editors (ICMJE) is the recognized
international expert organization when it comes
to guidelines regarding biomedical research
authorship
AUTHORSHIP: GUIDELINES
Authorship credit should be based only on:
substantial contributions to conception
and design, or acquisition of data, or
analysis and interpretation of data
drafting the article or revising it critically
for important intellectual content;
final approval of the version to be
EXAMPLE CASE STUDY
Query
Jamal is a graduate student working under the supervision of
professor, Dr. Kerry. Dr. Kerry is conducting research on tooth
decay and has gathered data from hundreds of dental
patients. Jamal uses Dr. Kerry’s data to analyze a research
question that he came up with on his own about tooth
erosion. His question is his own idea, but is still based on
he learned about tooth and enamel decay under Dr. Kerry.
Jamal’s friend, Darcie, helped Jamal design a statistical
computer program for data analysis, but did not contribute
any other way to the research. When writing up his results,
Kerry helped Jamal write the methods section of his
manuscript and reviewed his final results and conclusions, as
well as the final draft of the entire manuscript.
How should authorship be decided in this case?
EXAMPLE CASE STUDY
Answer
Jamal should be listed first as the primary
author because he is most closely involved in
research project.
Dr. Kerry should be listed second as co-author
because she meets the ICJME requirements of
authorship.
Darcie does not meet the criteria for authorship,
but she should be acknowledged for her
contribution if she so consents.
PLAGIARISM: DEFINITION AND IMPORTANCE
• the act of passing off somebody else’s ideas, thoughts,
pictures, theories, words, or stories as your own
• both an illegal act and punishable, considered to be on the
same level as stealing from the author that which he or she
originally created
• people who intentionally take a passage word-for-word, put it
in their own work, and do not properly credit the original
author
• unintentional (or simply lazy) paraphrased and fragmented
texts the author has pieced together from several works
without properly citing the original sources
PLAGIARISM AND SELF PLAGIARISM
• Plagiarism: using the ideas
or words of another person
without giving appropriate
credit
• Self-Plagiarism: The
verbatim copying or reuse
of one’s own research
FABRICATION OR FALSIFICATION
• Fabrication is making up data or 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: GUIDELINES
Cite the original source if:
• “Quotes another person’s actual words, either
oral or written;
• Paraphrases another person’s words, either oral
or written;
• Uses another person’s idea, opinion, or theory;
or
• Borrows facts, statistics, or other illustrative
material, unless the information is common
PLAGIARISM: GUIDELINES
• “Redundant or duplicate publication is
publication of a paper that overlaps
substantially with one already published.”
• Violation: “international copyright laws,
ethical conduct, and cost-effective use of
resources.”
• Articles that have been published already
should not be either resubmitted under
another title, or resubmitted with only minor
changes to the text unless it is clearly stated
that it is a resubmitted article
EXAMPLE CASE STUDY
Query
Belinda is publishing her first article that builds on
the research of a similar project she did three years
prior with her colleague, Isaiah. In Belinda’s current
article she has placed a graph from the article she
and Isaiah co-authored about their previous
research. Isaiah created the original graph.
Does Belinda have to cite the previous article?
EXAMPLE CASE STUDY
Answer
Yes. Belinda is using the ideas of another
person(s). Even though the graph came from an
article she herself worked on, she should
appropriately cite the prior publication to show
that: a) the data and results depicted in the
graph are not new and have been previously
published; and, b) the idea originated with
another entity (in this instance the other entity is
the research team of Belinda and Isaiah).
PEER REVIEW: DEFINITION AND IMPORTANCE
• the process in which an author (or
authors) submits a written manuscript
or article to a journal for publication
and the journal editor distributes the
article to experts working in the same,
or similar, scientific discipline
• the reviewers, and the editor then enter
the peer review process
PEER REVIEW PROCESS
1. Reviewers and editors read and
evaluate the article
2. Reviewers submit their reviews back
to the journal editor
3. The journal editor takes all comments,
including their own, and communicates
this feedback to the original author (or
authors)
HIGH QUALITY PEER REVIEW
Importance – Does the research impact health and health care?
Usefulness – Does the study provide useful scientific information?
Relevance – Does the research apply to the journal’s readers and
content area of interest?
Sound methods – Was the research conducted with sound scientific
methods that allowed the researchers to answer their research
question?
Sound ethics – Was the study conducted ethically ensuring proper
protection for human subjects? Were results reported accurately and
honestly?
Completeness – Is all information relevant to the study included in the
article?
Accuracy – Is the written product a true reflection of the conduct and
results of the research?
PEER REVIEW GUIDELINES
• confidentiality and protection of intellectual
property
• Reviewers should not know the author (or
• the author (or authors) should not be told the
names of the reviewers
• Neither conflicted nor political
• include articles that they believe to be honest,
accurate, ethical, and scientifically responsible
EXAMPLE CASE STUDY
Query
Dr. Connelly is a faculty member at Springer
University. He has been asked to review a
publication for a biomedical journal. After
the article, he realizes the author is a student
working under the guidance of a fellow faculty
member in a neighboring department. The faculty
member happened to mention the merits of the
student at a recent social gathering.
Does Dr. Connelly have a reportable conflict of
Answer
The peer review process relies on a
foundation of confidentiality. Dr. Connelly
should contact the journal editor and
report his belief that the manuscript
originated from the university where he is
employed. He and the editor should then
open a dialogue about how this could
potentially effect his participation in the
peer review process and how to proceed.
CONFLICTS OF INTEREST: DEFINITION
AND IMPORTANCE
• arise when a person’s (or an organization’s)
obligations to a particular research project conflict
with their personal interests or obligations
• EX: a university researcher who owns stock in XYZ
Pharmaceuticals is obligated to report truthful and
accurate data, but he might be conflicted if faced
with data that would hurt stock prices for XYZ
pharmaceuticals
• identify potential conflicts of interest in order to
confront those issues before they have a chance to
do harm or damage
CONFLICTS OF INTEREST: GUIDELINES
• “Objectivity in Research NIH Guide,” provides
guidelines on how investigators receiving grants
from the National Institutes of Health (NIH)
handle conflicts of interest
• Investigators should:
Disclose to their institution any major or
significant financial conflicts of interest that might
might interfere with their ability to conduct a
research project objectively
Disclose any such financial conflicts of interest of
their spouses or dependent children
Physician and other health care
professional researchers may
find themselves facing conflicts
of interest in their duties
towards research versus their
duties towards the health and
welfare of their patients.
EXAMPLE CASE STUDY
Query
Dr. Garrath is a dermatological physician and an
investigator on a research project for a
pharmaceutical company testing a new
for a skin disease that must be administered
frequently and can cause itching and irritation.
The company is paying her a rate of P20,000 per
person enrolled.
Does she have a conflict of interest?
Answer
Yes. Dr. Garrath’s obligation to her patients has the potential to
compromised by her personal interests. While her job is to
and promote her patients’ welfare and health, at P20,000 per
person enrolled, she might be tempted to recruit more people
the study for her personal financial benefit by encouraging her
patients to participate and downplaying the side-effects and
burdens of participation. Dr. Garrath should carefully evaluate
whether this conflict of interest might impact her patients’ health
and welfare and how to solve this potential conflict before
agreeing to be an investigator. She should also report this
potential conflict to the proper administration authority at the
clinical site where she is practicing
DATA MANAGEMENT: DEFINITION AND IMPORTANCE
Three issues:
1. the ethical and truthful collection of reliable data;
2. the ownership and responsibility of collected data; and,
3. retaining data and sharing access to collected data with
colleagues and the public
• Ethical data collection refers to collecting data in a way that
does not harm or injure someone
• Assigning and ensuring responsibility for collecting and
maintaining data is one of the most important ethical
considerations when conducting a research project
RESPONSIBILITIES FOR COLLECTING AND
MAINTAINING DATA
Oversight of the design of the method of data collection
Protecting research subjects from harm
Securing and storing data safely to preserve the
integrity and privacy of data
Delegating work with data to others and responsibility over
the work of others
Responsible use of data and truthful portrayal of data results
DATA MANAGEMENT: GUIDELINES
• The three issues for data management (ethical
and truthful data collection, responsibility of
collected data, and data sharing) can be
addressed by researchers before and during
the establishment of a new research project
• Accurately identify answers to the following
questions to resolve and address all data
management issues in a timely manner
QUESTIONS:
• Who is in charge of the data? (This person is usually the principal
investigator of
the research project and is responsible for data collection design and
physical data
collection.)
• How will data be collected? Will data be collected via phone, mail,
personal interview, existing records, secondary sources, etc.?)
• Will there be identifying information within the data? If yes, why? How will
this be rectified?
• How will data be stored and what privacy and protection issues will result
from the method of storage? (Will it be stored electronically, on paper, as
raw tissue samples, etc.?)
• Who will ensure that no data were excluded from the final results and
ensure accuracy of result interpretation?
• How long after the project is over will data be kept? (This will depend on
the source of funding and organizational policies.)
• Protecting intellectual property while at the same time encouraging data
sharing is highly important in order to ensure valid and reliable research.
“Intellectual Property’ means any invention, discovery, improvement,
copyrightable work, integrated circuit mask work, trademark, trade secret, and
licensable know-how and related rights.
Intellectual property includes, but is not limited to, individual or multimedia
works of art or music, records of confidential information generated or
maintained by the University, data, texts, instructional materials, tests,
bibliographies, research findings, organisms, cells, viruses, DNA sequences,
other biological materials, probes, crystallographic coordinates, plant lines,
chemical compounds, and theses.
Intellectual property may exist in a written or electronic form, may be raw or
derived, and may be in the form of text, multimedia, computer programs,
spreadsheets, formatted fields in records or forms within files, databases,
graphics, digital images, video and audio recordings, live video or audio
broadcasts, performances, two or three-dimensional works of art, musical
compositions, executions of processes, film, film strips, slides, charts,
transparencies, other visual/aural aids or CD-ROMS.35 ” (University of Minnesota’s
EXAMPLE CASE STUDY
Query
Joanne is a researcher at George Kent College. She
collected data on rural mental health patients and just
published an article on her research in a scholarly
Joanne plans to independently write a book about her
research and develop educational tools that she can sell
professionals. Joanne is partly funded through her
but most of her research was paid for with a private
stipend from a charitable foundation. Joanne is reluctant
to publicly disclose her data before her book is finished.
Can she hold off on sharing her data until she completes
her book?
Answer
Joanne has published an article on her data and
according to NIH policies, she should be
to disclose her data at the time of publication.
However, Joanne is not funded with NIH dollars.
She would have to use her judgment about
publishing her data and be prepared to give a
strong reason to the editor of the journal (i.e. she
is writing a book) as to why she isn’t sharing her
data at this time.
RESEARCH MISCONDUCT: DEFINITION
AND IMPORTANCE
•the process of identifying and
reporting unethical or unsound
research.
•defined as fabrication,
falsification, or plagiarism in
proposing, performing, or
reviewing research, or in reporting
research results
RESEARCH MISCONDUCT:GUIDELINES
• The United States’ Office of Scientific and Technology Policy
(OSTP) released a new definition of research misconduct that went
went into effect in December of 2000.
A finding of research misconduct requires that:
There be a significant departure from accepted practices of the
relevant research community;
The misconduct be committed intentionally, or knowingly, or
recklessly; and
The allegation be proven by a preponderance of evidence
RESEARCH MISCONDUCT:GUIDELINES
• ..Research_Ethics.-NOTES.pdf
EXAMPLE CASE STUDY
Query
Marcus and Clay have been working on a
research project studying the prevalence of
pneumonia in nursing home residents. Marcus
learns that while Clay is interviewing research
participants, if he does not elicit an answer, he
invents one and passes it off as truthful data
collection. Marcus questions Clay and he denies
the allegation.
What should Marcus do?
Answer
Marcus is obligated to report Clay’s activity to the person in
charge of the research project. If this person does not respond
and the behavior continues, Marcus should then go to his
institution’s officer research integrity. Marcus should not
embellish any information or make assumptions, but merely
report his observations. If Marcus is worried about his working
relationship with Clay and the project’s leadership, he should
also report that concern to the research integrity office.
RESEARCH WITH ANIMALS
• In order to prevent the mistreatment of animals the
United States government first passed the Animal
Welfare Act in 1966 (last revised in 1990).
• Other agencies
EXAMPLE CASE STUDY
Query
Dr. Xiang conducts research studying antibacterial treatment
for infected skin wounds. He wants to study the infection rate
of a particular bacteria and see if it responds to a new antibiotic
drug he has developed. In order to test the drug, Dr. Xiang
must first inflict shallow wounds on animals, then infect the
wounds with the bacteria, and finally apply the antibiotic drug
to test its effectiveness. Dr. Xiang has two options:
a) inflict multiple wounds on a few animals; or, b) inflict
wounds on several
animals.
Which option is more attractive and the least harmful?
Answer
Is it better to minimize the number of animal subjects?
How much suffering can be born by one animal? Can
the data provide enough information for appropriate
analyses?
The Institutional Animal Care and Use Committees
(IACUC) at Dr. Xiang’s institution must answer these
questions to its satisfaction before approving the
research proposal.
RESEARCH WITH HUMANS
• Refer to the other file
EXAMPLE CASE STUDY
Query
Mike’s physician has asked him to
participate in a research project.
What should Mike know before he
consents?
Answer
Mike should be asked first to consent to participate in the
research
project. The consent process should tell him everything he
to know about the project including: possible risks, expected
benefits (when applicable), and protections for his privacy and
confidentiality. If Mike’s physician doesn’t explain these things
thoroughly to Mike, he should request more information or
reconsider his participating.
Mike should only consent to participate if he: a) understands all
the information as presented to him; b) feels that he is
voluntarily consenting to participate of his own free will; and, c)

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Research Ethical Issues

  • 1. RESEARCH ETHICAL ISSUES D E F I N I T I O N , I M P O R TA N C E A N D G U I D E L I N E S https://www.ahc.umn.edu/img/assets/26104/Research_Et hics.pdf clipart.com
  • 2. GROUP SEATWORK RECALL: Nuremberg Code Helsinki Declaration Belmont Report ..Seatwork 6.-ETHICS Belmont Report.docx
  • 3. ETHICAL ISSUES •Authorship •Plagiarism •Peer review •Conflict of interest •Data •Research Misconduct •Research with Animals •Research with Human Subjects
  • 4. AUTHORSHIP: DEFINITION AND IMPORTANCE • process of deciding whose names belong on a research paper • research evolves from collaboration and assistance between experts and colleagues • assistance will require acknowledgement and some will require joint authorship • proper authorship practices in order to protect their work and ideas while also preventing research fraud.
  • 5. AUTHORSHIP: GUIDELINES • Each person listed as an author on an article should have significantly contributed to both the research and writing • all listed authors must be prepared to accept full responsibility for the content of the research article
  • 6. AUTHORSHIP: GUIDELINES • The International Committee of Medical Journal Editors (ICMJE) is the recognized international expert organization when it comes to guidelines regarding biomedical research authorship
  • 7. AUTHORSHIP: GUIDELINES Authorship credit should be based only on: substantial contributions to conception and design, or acquisition of data, or analysis and interpretation of data drafting the article or revising it critically for important intellectual content; final approval of the version to be
  • 8. EXAMPLE CASE STUDY Query Jamal is a graduate student working under the supervision of professor, Dr. Kerry. Dr. Kerry is conducting research on tooth decay and has gathered data from hundreds of dental patients. Jamal uses Dr. Kerry’s data to analyze a research question that he came up with on his own about tooth erosion. His question is his own idea, but is still based on he learned about tooth and enamel decay under Dr. Kerry. Jamal’s friend, Darcie, helped Jamal design a statistical computer program for data analysis, but did not contribute any other way to the research. When writing up his results, Kerry helped Jamal write the methods section of his manuscript and reviewed his final results and conclusions, as well as the final draft of the entire manuscript. How should authorship be decided in this case?
  • 9. EXAMPLE CASE STUDY Answer Jamal should be listed first as the primary author because he is most closely involved in research project. Dr. Kerry should be listed second as co-author because she meets the ICJME requirements of authorship. Darcie does not meet the criteria for authorship, but she should be acknowledged for her contribution if she so consents.
  • 10. PLAGIARISM: DEFINITION AND IMPORTANCE • the act of passing off somebody else’s ideas, thoughts, pictures, theories, words, or stories as your own • both an illegal act and punishable, considered to be on the same level as stealing from the author that which he or she originally created • people who intentionally take a passage word-for-word, put it in their own work, and do not properly credit the original author • unintentional (or simply lazy) paraphrased and fragmented texts the author has pieced together from several works without properly citing the original sources
  • 11. PLAGIARISM AND SELF PLAGIARISM • Plagiarism: using the ideas or words of another person without giving appropriate credit • Self-Plagiarism: The verbatim copying or reuse of one’s own research
  • 12. FABRICATION OR FALSIFICATION • Fabrication is making up data or 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.
  • 13. PLAGIARISM: GUIDELINES Cite the original source if: • “Quotes another person’s actual words, either oral or written; • Paraphrases another person’s words, either oral or written; • Uses another person’s idea, opinion, or theory; or • Borrows facts, statistics, or other illustrative material, unless the information is common
  • 14. PLAGIARISM: GUIDELINES • “Redundant or duplicate publication is publication of a paper that overlaps substantially with one already published.” • Violation: “international copyright laws, ethical conduct, and cost-effective use of resources.” • Articles that have been published already should not be either resubmitted under another title, or resubmitted with only minor changes to the text unless it is clearly stated that it is a resubmitted article
  • 15.
  • 16. EXAMPLE CASE STUDY Query Belinda is publishing her first article that builds on the research of a similar project she did three years prior with her colleague, Isaiah. In Belinda’s current article she has placed a graph from the article she and Isaiah co-authored about their previous research. Isaiah created the original graph. Does Belinda have to cite the previous article?
  • 17. EXAMPLE CASE STUDY Answer Yes. Belinda is using the ideas of another person(s). Even though the graph came from an article she herself worked on, she should appropriately cite the prior publication to show that: a) the data and results depicted in the graph are not new and have been previously published; and, b) the idea originated with another entity (in this instance the other entity is the research team of Belinda and Isaiah).
  • 18. PEER REVIEW: DEFINITION AND IMPORTANCE • the process in which an author (or authors) submits a written manuscript or article to a journal for publication and the journal editor distributes the article to experts working in the same, or similar, scientific discipline • the reviewers, and the editor then enter the peer review process
  • 19. PEER REVIEW PROCESS 1. Reviewers and editors read and evaluate the article 2. Reviewers submit their reviews back to the journal editor 3. The journal editor takes all comments, including their own, and communicates this feedback to the original author (or authors)
  • 20. HIGH QUALITY PEER REVIEW Importance – Does the research impact health and health care? Usefulness – Does the study provide useful scientific information? Relevance – Does the research apply to the journal’s readers and content area of interest? Sound methods – Was the research conducted with sound scientific methods that allowed the researchers to answer their research question? Sound ethics – Was the study conducted ethically ensuring proper protection for human subjects? Were results reported accurately and honestly? Completeness – Is all information relevant to the study included in the article? Accuracy – Is the written product a true reflection of the conduct and results of the research?
  • 21. PEER REVIEW GUIDELINES • confidentiality and protection of intellectual property • Reviewers should not know the author (or • the author (or authors) should not be told the names of the reviewers • Neither conflicted nor political • include articles that they believe to be honest, accurate, ethical, and scientifically responsible
  • 22. EXAMPLE CASE STUDY Query Dr. Connelly is a faculty member at Springer University. He has been asked to review a publication for a biomedical journal. After the article, he realizes the author is a student working under the guidance of a fellow faculty member in a neighboring department. The faculty member happened to mention the merits of the student at a recent social gathering. Does Dr. Connelly have a reportable conflict of
  • 23. Answer The peer review process relies on a foundation of confidentiality. Dr. Connelly should contact the journal editor and report his belief that the manuscript originated from the university where he is employed. He and the editor should then open a dialogue about how this could potentially effect his participation in the peer review process and how to proceed.
  • 24. CONFLICTS OF INTEREST: DEFINITION AND IMPORTANCE • arise when a person’s (or an organization’s) obligations to a particular research project conflict with their personal interests or obligations • EX: a university researcher who owns stock in XYZ Pharmaceuticals is obligated to report truthful and accurate data, but he might be conflicted if faced with data that would hurt stock prices for XYZ pharmaceuticals • identify potential conflicts of interest in order to confront those issues before they have a chance to do harm or damage
  • 25. CONFLICTS OF INTEREST: GUIDELINES • “Objectivity in Research NIH Guide,” provides guidelines on how investigators receiving grants from the National Institutes of Health (NIH) handle conflicts of interest • Investigators should: Disclose to their institution any major or significant financial conflicts of interest that might might interfere with their ability to conduct a research project objectively Disclose any such financial conflicts of interest of their spouses or dependent children Physician and other health care professional researchers may find themselves facing conflicts of interest in their duties towards research versus their duties towards the health and welfare of their patients.
  • 26. EXAMPLE CASE STUDY Query Dr. Garrath is a dermatological physician and an investigator on a research project for a pharmaceutical company testing a new for a skin disease that must be administered frequently and can cause itching and irritation. The company is paying her a rate of P20,000 per person enrolled. Does she have a conflict of interest?
  • 27. Answer Yes. Dr. Garrath’s obligation to her patients has the potential to compromised by her personal interests. While her job is to and promote her patients’ welfare and health, at P20,000 per person enrolled, she might be tempted to recruit more people the study for her personal financial benefit by encouraging her patients to participate and downplaying the side-effects and burdens of participation. Dr. Garrath should carefully evaluate whether this conflict of interest might impact her patients’ health and welfare and how to solve this potential conflict before agreeing to be an investigator. She should also report this potential conflict to the proper administration authority at the clinical site where she is practicing
  • 28. DATA MANAGEMENT: DEFINITION AND IMPORTANCE Three issues: 1. the ethical and truthful collection of reliable data; 2. the ownership and responsibility of collected data; and, 3. retaining data and sharing access to collected data with colleagues and the public • Ethical data collection refers to collecting data in a way that does not harm or injure someone • Assigning and ensuring responsibility for collecting and maintaining data is one of the most important ethical considerations when conducting a research project
  • 29. RESPONSIBILITIES FOR COLLECTING AND MAINTAINING DATA Oversight of the design of the method of data collection Protecting research subjects from harm Securing and storing data safely to preserve the integrity and privacy of data Delegating work with data to others and responsibility over the work of others Responsible use of data and truthful portrayal of data results
  • 30. DATA MANAGEMENT: GUIDELINES • The three issues for data management (ethical and truthful data collection, responsibility of collected data, and data sharing) can be addressed by researchers before and during the establishment of a new research project • Accurately identify answers to the following questions to resolve and address all data management issues in a timely manner
  • 31. QUESTIONS: • Who is in charge of the data? (This person is usually the principal investigator of the research project and is responsible for data collection design and physical data collection.) • How will data be collected? Will data be collected via phone, mail, personal interview, existing records, secondary sources, etc.?) • Will there be identifying information within the data? If yes, why? How will this be rectified? • How will data be stored and what privacy and protection issues will result from the method of storage? (Will it be stored electronically, on paper, as raw tissue samples, etc.?) • Who will ensure that no data were excluded from the final results and ensure accuracy of result interpretation? • How long after the project is over will data be kept? (This will depend on the source of funding and organizational policies.)
  • 32. • Protecting intellectual property while at the same time encouraging data sharing is highly important in order to ensure valid and reliable research. “Intellectual Property’ means any invention, discovery, improvement, copyrightable work, integrated circuit mask work, trademark, trade secret, and licensable know-how and related rights. Intellectual property includes, but is not limited to, individual or multimedia works of art or music, records of confidential information generated or maintained by the University, data, texts, instructional materials, tests, bibliographies, research findings, organisms, cells, viruses, DNA sequences, other biological materials, probes, crystallographic coordinates, plant lines, chemical compounds, and theses. Intellectual property may exist in a written or electronic form, may be raw or derived, and may be in the form of text, multimedia, computer programs, spreadsheets, formatted fields in records or forms within files, databases, graphics, digital images, video and audio recordings, live video or audio broadcasts, performances, two or three-dimensional works of art, musical compositions, executions of processes, film, film strips, slides, charts, transparencies, other visual/aural aids or CD-ROMS.35 ” (University of Minnesota’s
  • 33. EXAMPLE CASE STUDY Query Joanne is a researcher at George Kent College. She collected data on rural mental health patients and just published an article on her research in a scholarly Joanne plans to independently write a book about her research and develop educational tools that she can sell professionals. Joanne is partly funded through her but most of her research was paid for with a private stipend from a charitable foundation. Joanne is reluctant to publicly disclose her data before her book is finished. Can she hold off on sharing her data until she completes her book?
  • 34. Answer Joanne has published an article on her data and according to NIH policies, she should be to disclose her data at the time of publication. However, Joanne is not funded with NIH dollars. She would have to use her judgment about publishing her data and be prepared to give a strong reason to the editor of the journal (i.e. she is writing a book) as to why she isn’t sharing her data at this time.
  • 35. RESEARCH MISCONDUCT: DEFINITION AND IMPORTANCE •the process of identifying and reporting unethical or unsound research. •defined as fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results
  • 36. RESEARCH MISCONDUCT:GUIDELINES • The United States’ Office of Scientific and Technology Policy (OSTP) released a new definition of research misconduct that went went into effect in December of 2000. A finding of research misconduct requires that: There be a significant departure from accepted practices of the relevant research community; The misconduct be committed intentionally, or knowingly, or recklessly; and The allegation be proven by a preponderance of evidence
  • 38. EXAMPLE CASE STUDY Query Marcus and Clay have been working on a research project studying the prevalence of pneumonia in nursing home residents. Marcus learns that while Clay is interviewing research participants, if he does not elicit an answer, he invents one and passes it off as truthful data collection. Marcus questions Clay and he denies the allegation. What should Marcus do?
  • 39. Answer Marcus is obligated to report Clay’s activity to the person in charge of the research project. If this person does not respond and the behavior continues, Marcus should then go to his institution’s officer research integrity. Marcus should not embellish any information or make assumptions, but merely report his observations. If Marcus is worried about his working relationship with Clay and the project’s leadership, he should also report that concern to the research integrity office.
  • 40. RESEARCH WITH ANIMALS • In order to prevent the mistreatment of animals the United States government first passed the Animal Welfare Act in 1966 (last revised in 1990). • Other agencies
  • 41. EXAMPLE CASE STUDY Query Dr. Xiang conducts research studying antibacterial treatment for infected skin wounds. He wants to study the infection rate of a particular bacteria and see if it responds to a new antibiotic drug he has developed. In order to test the drug, Dr. Xiang must first inflict shallow wounds on animals, then infect the wounds with the bacteria, and finally apply the antibiotic drug to test its effectiveness. Dr. Xiang has two options: a) inflict multiple wounds on a few animals; or, b) inflict wounds on several animals. Which option is more attractive and the least harmful?
  • 42. Answer Is it better to minimize the number of animal subjects? How much suffering can be born by one animal? Can the data provide enough information for appropriate analyses? The Institutional Animal Care and Use Committees (IACUC) at Dr. Xiang’s institution must answer these questions to its satisfaction before approving the research proposal.
  • 43. RESEARCH WITH HUMANS • Refer to the other file
  • 44. EXAMPLE CASE STUDY Query Mike’s physician has asked him to participate in a research project. What should Mike know before he consents?
  • 45. Answer Mike should be asked first to consent to participate in the research project. The consent process should tell him everything he to know about the project including: possible risks, expected benefits (when applicable), and protections for his privacy and confidentiality. If Mike’s physician doesn’t explain these things thoroughly to Mike, he should request more information or reconsider his participating. Mike should only consent to participate if he: a) understands all the information as presented to him; b) feels that he is voluntarily consenting to participate of his own free will; and, c)

Editor's Notes

  1. authorship remains a murky and vague area for many scientists who frequently run into difficulty when deciding which colleagues should be listed as authors or coauthors, and which colleagues should instead receive acknowledgement.
  2. authorship remains a murky and vague area for many scientists who frequently run into difficulty when deciding which colleagues should be listed as authors or coauthors, and which colleagues should instead receive acknowledgement.
  3. authorship remains a murky and vague area for many scientists who frequently run into difficulty when deciding which colleagues should be listed as authors or coauthors, and which colleagues should instead receive acknowledgement.
  4. If such duplicates have different authors, then they may be guilty of plagiarism, whereas papers with overlapping authors may represent self-plagiarism.