The document discusses ethics in medical research. It covers several key topics, including the principles of research ethics such as respect for persons, beneficence, and justice. It also discusses informed consent, guidelines for ethical research, and oversight by ethics committees. Special protections are needed for vulnerable groups participating in research. Overall, the document aims to outline important concepts in research ethics and their role in ensuring ethical and responsible medical research.

1. Ethics Issues in Medical
Research
Dr Abdulaziz F Alkaabba
MBBS, ABFM, JBFM, MSc ME, MSc Bioethics
Professor of Family Medicine , Ethicist
Dr. Ghiath Alahmad MD, PhD
KAIMRC

2. Why we need to know ethics
in Medical Research ??
What is the Answer ??
How many papers we published last year ??

3. (Our Objectives in this presentation )
To Know and to Discuss What is the :
1. Research Ethics?
2. History and importance of research ethics.
3. Principles of research ethics.
4. Guidelines of research ethics.
5. Ethics committees in research( IRB or REC).

5. UNIVERSAL ETHICAL
PRINCIPLES IN RESEARCH
 Principle of Beneficence
 Principle of Respect for Human Dignity
 Principle of Justice
 Vulnerable Groups
 Ethical code of Conduct of Health Profession
 Scientific misconduct in Research

6. Principles of Research Ethics
Re spe c t for Pe r son
Be ne fic e nc e
Ju stic e

7. Principles of Research Ethics
Re spe c t for Pe r son
Beneficence
Justice
Autonomy, self-determination
Capacity to decide, make choices
The dignity of people and individual
Respect for community and local culture

8. Principles of Research Ethics
Re spe c t for Pe r son
Be ne fic e nc e
Ju stic e
Autonomy, self-determination
Capacity to decide, make choices
The dignity of people and individual
Respect for community and local culture

9. Principles of Research Ethics
Re spe c t for Pe r son
Be ne fic e nc e
Ju stic e
Physical, mental and social well-being
Risks reduced to a minimum, non-maleficence
Protection of the participant is the primary
Responsibility of the researcher
Benefits for the communities where the
research will be conducted

10. Principles of Research Ethics
Re spe c t for Pe r son
Be ne fic e nc e
Ju stic e
Physical, mental and social well-being
Risks reduced to a minimum, non-maleficence
Protection of the participant is the primary
Responsibility of the researcher
Benefits for the communities where the
Research will be conducted

11. Principles of Research Ethics
Re spe c t for Pe r son
Be ne fic e nc e
Ju stic e
Distribution of risk and benefit
Equitable recruitment of research participants
Special protection for vulnerable groups

12. Principles of Research Ethics
Special protection for vulnerable groups
Pregnant women
Children
Prisoners
Mentally ill
Limited education
Poor
Terminally ill
Women in some
circumstances

13. Summary-Principles of Research Ethics
Re spe c t for Pe r son
Be ne fic e nc e
Ju stic e

14. 1979
1947 1964
2011
2010
1982 1996 2004
The Development of Contemporary Research Ethics

15. 1979
1947 1964
2011
2010
1982 1996 2004
The Development of Contemporary Research Ethics

16. 1996
1979
2005
2004
2005 1964
2011
2004 2010
1982
1947
The Development of Contemporary Research Ethics

17. 1996
2005
2004
2005 1964
2011
2004 2010
1982
1979
1947
The Development of Contemporary Research Ethics

18. 1996
1964
2011
2004 2010
1979
International Ethical Guidelines for
Biomedical Research Involving
Human
1947 1982
The Development of Contemporary Research Ethics

19. 1979
1964
2011
2010
1982 2004
1947 1996
The Development of Contemporary Research Ethics

20. 1979
1964
2011
2010
1982 1996 2004
1947
The Development of Contemporary Research Ethics

21. 1979
1964
2011
2010
1982 2001 2003
1947
The Development of Contemporary Research Ethics

22. 1979
1947 1964
2011
2010
1982 1996 2004
The Development of Contemporary Research Ethics

23. Informed Consent
 NOT just a signed document
 NOT a one time event
A process of shared
decision-making
between subject
and investigator.
• Consent- is An
Autonomous
authorization of
a medical
intervention
by… individual
patients-
(Beauchamp
(2004)

24. What is Ethical Review?
 It is a process by which research
proposals are reviewed for their
compliance and accordance with the
national/international ethical principles
& guidelines for research involving
human subjects.
24 Research Ethics, FOM, Mar.

25. Parties of Research Ethics
REC or IRB
Researcher
Sponsor
Community representative

26. Review and Approval
of research protocols
Regulations
REC
Community
Representative
Responsible
advise

27. Protecting Research Participants

28. Respect Sensitivity
Researcher's Human Qualities

29. Researcher's Responsibilities

30. ‫وسمل‬ ‫يه‬‫عل‬ ‫هللا‬ ‫صىل‬ ‫هللا‬ ‫رسول‬ ‫قال‬

31. Privacy vs. Confidentiality
Privacy
 About people
 Sense of being in
control of access
that others have to
ourselves
 A Right to be
Protected
Confidentiality
 Extension of privacy
 About identifiable data
 an Agreement about
maintenance and who
has access to
identifiable data
 HIPAA - protects patients
from inappropriate
disclosures of "Protected
Health Information" (PHI)
‫من‬
‫العلمي‬ ‫البحث‬ ‫أخالقيات‬
v
‫المصداقية‬
(Truthfulness)
v
‫المهنية‬
)
Professionalism
(
v
‫السالمة‬
(Safety)
v
‫الثقة‬
(Trust)
v
‫الموافقة‬
Consent)
(

32. Definitions
 Privacy –
 about people and our sense of being in
control of others access to ourselves or to
information about ourselves with others.
 Confidentiality –
 treatment of identifiable, private
information that has been disclosed to
others.
‫من‬
‫العلمي‬ ‫البحث‬ ‫أخلقيات‬
v
‫المصداقية‬
(Truthfulness)
v
‫المهنية‬
)
Professionalism
(
v
‫السلمة‬
(Safety)
v
‫الثقة‬
(Trust)
v
‫الموافقة‬
Consent)
(
v
‫الدقة‬
)
Accuracy
(
v
‫المسؤولية‬
)
(Responsibility)
v
‫األمانة‬
‫العلمية‬
)
(Integrity)
v
‫التعاون‬
)
Collaboration
(
v
‫المعلومات‬ ‫سرية‬
Confidentiality
)
(
v
‫الموضوعية‬
)
Objectivity
(
‫أخالقيات‬
‫البحث‬
‫العلمي‬

34. “Misconduct in Science means fabrication, falsification,
plagiarism or other practices that seriously deviate
from commonly accepted within the scientific
community for proposing, conducting, or reporting
research.”
US federal policy, 42 CFR 50.102
Definition of Scientific Misconduct (
(
‫السلوك‬ ‫سوء‬
-
‫السرقات‬

35. It does not include honest error or
honest differences in
interpretations or judgment of data
Definition of Scientific Misconduct

36. Your Opinion ?
 Many people Have
confused Issues About
this Topic ??????

37. Scientific Misconduct Definition
• Fabrication – making it up
• (
‫التلفيق‬
-
‫أصال‬ ‫موجدة‬ ‫غير‬ ‫معلومات‬
)
• Falsification – changing the true description
‫التزييف‬
/
‫التزوير‬
-
‫الموجودة‬ ‫المعلومات‬ ‫تغيير‬
) )
• Plagiarism – taking the words and ideas of others
without citation (
‫انتحال‬
‫وسرقة‬
‫الكلمات‬ ‫أو‬ ‫اآلراء‬
)
•that seriously deviate from the Reality
•Other – self plagiarism - add my name to Research
without any participation , change in scientific
certifications , cheating in Exam )

38. DOCUMENTATION

39. Survey of College Students
(200) students assignments
 75 % admit to some cheating.
 41 % have Plagiarized through the Internet.
The Center for Academic Integrity, 2002.

40. Types of Misconduct Total %
Fabrication 18
Falsification 64
Plagiarism 8
Fabrication/Falsification 47
Other 13
*Adapted from report of Office of Research Integrity, Scientific Misconduct Investigations
(ORI,)
Type of Misconduct in other study
in 150 Cases: of student's report

42. It is making up data or results and
recording or reporting them.
( Creation of data without proper experimentation
or changing the numbers to improve the results).
Fabrication ‫التلفيق‬
-
‫معلومات‬
‫المعلومات‬ ‫موجودة‬ ‫غير‬

43. Misconduct – Examples:
Fabrication:
• Creating records/ Filling up missing data.
• Making up progress reports
• Creating records of calls and follow-up
(ORI web-site of Office of Research Integrity, )

44. 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.
Falsification -
‫التزييف‬
/
‫التزوير‬
-
‫تغيير‬
‫المعلومات‬

45. Fraud or Falsification
 Fraud means: ‫االنتحال‬ ‫أو‬ ‫التزييف‬
 Turning in someone else's writing as your
own;
 Inventing statistics or sources that do not
exist;
 Falsifying evidence.
 ‫العلمي‬ ‫السطو‬ ‫تهمة‬ ‫في‬ ‫الوقوع‬

46. Misconduct – Examples:
Falsifications:
 Subject substitution one for another.
 False reporting of data.
 Altering results of subject’s eligibility visit.
 Altering dates on screening.
 Failing to update subject’s record when it is
required.
 Altering tests on blood samples.
 Falsifying the times that blood samples were
drawn from human subjects.

47. ‫الخاطئة‬ ‫السلوكية‬ ‫الممارسات‬ ‫بعض‬
1
-
‫االمتحانات‬ ‫في‬ ‫الغش‬
2
-
‫والمؤلفات‬ ‫الشهادات‬ ‫في‬ ‫التزوير‬
3
-
‫العلمية‬ ‫السرقات‬
4
-
‫العلمية‬ ‫لألبحاث‬ ‫النتائج‬ ‫أو‬ ‫البيانات‬ ‫أو‬ ‫أألبحاث‬ ‫في‬ ‫تغيير‬
5
-
‫حقيقي‬ ‫عمل‬ ‫غير‬ ‫من‬ ‫البحوث‬ ‫في‬ ‫أألسماء‬ ‫وضع‬
6
-
‫األبحاث‬ ‫عمل‬ ‫في‬ ‫والطالب‬ ‫األخرين‬ ‫إستغالل‬
7
-
‫نفسه‬ ‫للشخص‬ ‫سابق‬ ‫عمل‬ ‫ومن‬ ‫النفس‬ ‫من‬ ‫السرقة‬
‫؟‬ ‫وغيرها‬ ‫وغيرها‬ ‫وغيرها‬

48. “the appropriation of another person’s
ideas, processes, results, or words
without giving appropriate credit.”
Plagiarism ‫الكلمات‬ ‫أو‬ ‫اآلراء‬ ‫انتحال‬

49. Plagiarism
Plagiarism
Is the presentation of words, ideas, images, or
creative works without
giving proper credit to their originators.
It is an academic crime—even when
plagiarism is unintentional.

‫العلمي‬ ‫للسطو‬ ‫مبسط‬ ‫تعريف‬

50. Misconduct – Examples:
Plagiarism:
 Copycat (verbatim) of large portions of
another publication without attribution.
 Rephrasing of an original idea as one’s own
original idea without attribution.
 Lack of acknowledgement of previous work.
 ‫نفسه‬ ‫الشخص‬ ‫عمل‬ ‫من‬ ‫السرقة‬
- ( self plagiarism).

51. Duplication of publication
Repeat publication or
publication of the same work
in a different journal or forum.
Occasionally, an article may be a
chapter in another book or
symposium.

53. • Money
• Reputation
• Fame (International recognition/Nobel Prize .
• Conflict of Interest
• Promotion
• Pressure to produce
• Poor Training
• Complex research environment/competition
Factors Contributing and
supporting Scientific Misconduct

54. ‫العلمية‬ ‫السرقات‬ ‫في‬ ‫الوقوع‬ ‫أسباب‬ - 10
1
-
‫العلمي‬ ‫بالبحث‬ ‫والمعرفة‬ ‫البحثية‬ ‫المهارات‬ ‫تدني‬
2
-
‫االنجليزية‬ ‫واللغة‬ ‫اللغوية‬ ‫المهارات‬ ‫تدني‬
3
-
‫العلمي‬ ‫السطو‬ ‫بخطورة‬ ‫الوعي‬ ‫انخفاض‬
4
-
‫الخبرة‬ ‫وقلة‬ ‫العلمية‬ ‫النزاهة‬ ‫ثقافة‬ ‫نضج‬ ‫عدم‬
5
-
‫علي‬ ‫ذلك‬ ‫وتفضيل‬ ‫النجاح‬ ‫و‬ ‫العلمية‬ ‫الدرجة‬ ‫علي‬ ‫للحصول‬ ‫السعى‬
‫ذلك‬ ‫في‬ ‫والجهد‬ ‫والمعرفة‬ ‫التعلم‬
6
-
‫العامة‬ ‫المعلومات‬ ‫بخصوص‬ ‫المفاهيم‬ ‫بين‬ ‫الخلط‬
7
-
‫السريع‬ ‫المادي‬ ‫الربح‬
8
-
‫والمشرفين‬ ‫الجامعات‬ ‫من‬ ‫الرقابة‬ ‫وقلة‬ ‫األنظمة‬ ‫ضعف‬
9
-
‫المصادر‬ ‫ثبت‬ ‫و‬ ‫االسناد‬ ‫بتقنيات‬ ‫الوعي‬ ‫قلة‬
10
-
‫ومراقبته‬ ‫هللا‬ ‫من‬ ‫الخوف‬ ‫قلة‬
.

55. ‫العلمي‬ ‫السطو‬ ‫أنواع‬

57. ‫العلمي‬ ‫السطو‬ ‫تهمة‬ ‫لتجنب‬ ‫األساسية‬ ‫الطرق‬

58. Who Can Be Cited For
Misconduct
 Primary Investigator
(He-She is responsible for all study activities)
 Sub Investigators
 Research Staff

59. Who might suspect and report
misconduct?
 Study monitors
 Supervisors – committees
 Editors
 Study staff or other contributors
 Peer reviewers/journal readers
 Subjects and their families

60. • Inquiry ( ‫واستعالم‬ ‫)استفسار‬
• Investigation ‫والتحقيق‬ ‫الفحص‬
) )
• Adjudication ) ‫)المقاضاة‬
Three Phases of Handling
Misconduct Issues

61. Plagiarism Detection Tools
 During the 20 years that OSI/ORI have existed,
investigators have developed a number of computer-
assisted tools and approaches to help strengthen
institutional findings. As
 grammerly programmer
 Research by ORI (office of Research Integrity)

62. Many FREE Plagiarism Detection Tools
Anti-Plagiarism
Anti-Plagiarism is a software designed to effectively detect and thereby prevent
plagiarism.
DupliChecker
PaperRater
Paper Rater offers three tools: Grammar Checking, Plagiarism Detection and Writing
Suggestions.
Plagiarisma.net
PlagiarismChecker
PlagiarismChecker.com makes it simple for educators to check whether a student's
paper has been copied from the Internet.
Plagium
PlagTracker

63. How to Prevent It
Training, training, and
more
‫والتدريب‬ ‫المعرفة‬
‫للجميع‬ ‫والتعليم‬

65. Researcher's Responsibilities

66. Guidelines on Authorship
Co-author must participate in:
1. Conception or design, or analysis and
interpretation
2. Drafting or editing portion (s) or revision of the
article
3. Intellectual input to the proposal for funding
 Order of authorship commensurate to
contributions
 Graduate student’s thesis should have the
student’s name as first author

67. Guidelines on Authorship
The following conditions does NOT justify
authorship:
• Participation solely in the acquisition of funding
or the collection of data.
• Peer reviewing of the article.
• General supervision of the research group.

68. Unethical forms of authorship
Authorship
misconduct
Definition
Ghost-‫ا‬ ‫الشبح‬
‫وال‬ ‫البحث‬ ‫يكتب‬ ‫لذي‬
‫بالبحث‬ ‫اسمه‬ ‫يضع‬
‫له‬ ‫ويدفع‬
Authors who contributed to the work but are not listed, generally to hide a conflict of interest from editors,
reviewers, and readers.
An author is paid to write an article but does not contribute to the article in any other way.
Guest -
‫الضيف‬
-
‫اسمه‬ ‫يضع‬ ‫زائرالذي‬
‫منصبه‬ ‫علشان‬ ‫بالبحث‬
Individuals given authorship credit who have not contributed in any substantive way to the research but are
added to the author list by virtue of their stature in the organization.
Orphan ‫الذي‬ ‫هو‬
‫ولم‬ ‫البحث‬ ‫في‬ ‫عمل‬
‫اسمه‬ ‫يضاف‬
Authors who contributed materially to the work but are omitted from the author list unfairly by the drafting
team.
Forged/Gift ‫تم‬ ‫هو‬
‫ولم‬ ‫بالبحث‬ ‫اسمة‬ ‫وضع‬
‫النشر‬ ‫لزيادة‬ ‫يعلم‬
Unwitting authors who had no part in the work but whose names are appended to the paper without their
knowledge to increase the likelihood of publication.

69. -Legal-Law ‫النظامية‬ ‫الناحية‬
‫والقانونية‬

70. Scientific Misconduct Definition
• Fabrication – making it up
• (
‫التلفيق‬
-
‫أصال‬ ‫موجدة‬ ‫غير‬ ‫معلومات‬
)
• Falsification – changing the true description
‫التزييف‬
/
‫التزوير‬
-
‫الموجودة‬ ‫المعلومات‬ ‫تغيير‬
) )
• Plagiarism – taking the words and ideas of others
without citation (
‫انتحال‬
‫وسرقة‬
‫الكلمات‬ ‫أو‬ ‫اآلراء‬
)
•that seriously deviate from the Reality
•Other – self plagiarism - add may name to Research
without any participation , change in scientific
certifications , cheating in Exam )

71. DISCUSSION…
Q & A
F
Research Ethics, FOM, Mar.
2011