This document provides an overview of ethics in scientific research. It discusses key topics like the importance of research ethics, principles of autonomy, beneficence, and non-maleficence. The document outlines ethical review processes, including obtaining informed consent and review by institutional review boards and animal care committees. Examples of ethical misconduct like fabrication and plagiarism are also presented. The goal is to establish practical moral standards to ensure research involves no harm and respects participants.

1. «‫العلمي‬ ‫البحث‬ ‫مهارات‬ ‫برنامج‬8»

2. King Saud University
30th November 2015
Ethics in Scientific
Research
Dana Bakheet, PhD
Scientist @ KFSH&RC
Vice Dean @ Alfaisal University
dbakheet@Kfshrc.edu.sa
11/30/2015 Dana Bakheet 1

3. Presentation Outline
 Research
 Ethics
 Ethical Misconduct and Case
 Consenting
 Research Review Committees
 IRB/ Ethics and ACUC
 Ethics Towards Information and Case
 Authorship & Publication and Case
 Wrap Up 2

4. 1- Research
 ReSearch
 Re: once more..
 Search: investigation and examination
to find unknowns
11/30/2015 3
- Systematic investigation into
Study of materials & sources
In order
- to establish facts
and
- Reach new conclusions

5. Research Ethics
 It aims to establish practical moral norms
and standards for the conduct of
research” (Acceptable and Unacceptable)
 Four basic guidelines:
– Honesty in conveying information
– Accuracy in reporting findings
– Efficiency by using resources wisely
– Objectivity by letting facts speak
11/30/2015 Dana Bakheet 4

6. Ctnd…
 Areas of focus:
 Harm
 Informed consent
 Confidentiality
 Reporting results and plagiarism
 Deception (mislead , hide )
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7. 11/30/2015 Dana Bakheet 6
Introduc on
A review by Knechtle SJ, published in the PhilosTrans R Soc
Lond B Biol Sci, 2001, May 29;356(1409):681-9, entitled
‘Treatment with immunotoxin,’ cites 4 publications from the
Thomas Laboratory.
Not only were these papers cited, but the reviewer seemed
impressed by the Thomas work.
All 4 papers were later retracted because of false claims.
What does this do to the credibility of other papers from this
research lab?
What does this do to the credibility of Knechtle & his paper?
What does this do to the field of immunotoxicology?

8. 11/30/2015 Dana Bakheet 7
Ten most important things to
know about Research Ethics
• Be Honest
• Be Fair
• Do no harm
• Know and Follow the Rules
• Bad rules should be changed, not broken
• Be a good ci zen
• When in doubt, ask ques ons
• Listen to the s ll small voice of your conscience, especially
when it’s being overwhelmed by the cacophony of stress
• If you suspect unethical behavior, proceed cau ously

9. 11/30/2015 Dana Bakheet 8
Your Responsibili es
In order to function effectively and make appropriate ethical
decisions, faculty and administrative staff need to develop
the skills to:
1. identify when situations present ethical conflicts,
2. reason among possible courses of action, and
3. effectively implement their best solution to the problem.
We all function in an environment governed by regulations
and policies, which we must abide by within a core of
ethical principles.

10. Research Projects
 Knowing “Rules of Research” is good
for everyone
 Ethical & Scientific review Path of
proposal once submitted
 Office of Research Affairs (ORA)
– Basic & or Clinical & or Animal & or Ethics
– Any proposal can go to any combination of
above depending Research subject &
sample types11/30/2015 9

11. Q: If both sample and subject are
Animal and Human ??? 10
Basic Clinical Ethics ACUC
Subject
Type
Human
(even Chart)
+ + + -
Animal + - - +
Chemical
Physical
+ - - -
Sample
Types
Human
(even chart)
+ + + -
Animal + - - +

12. Types of Research
Benefiting Human
 Basic: (No clinical applications)- Bench work
Lays foundation for advancements in
knowledge
 Clinical: (including clinical trials) determines
safety and effectiveness of medication,
diagnostic products and treatment regimens
 Animal: Understanding of diseases &
development of effective medical treatments
11/30/2015 Dana Bakheet 11

13. 2- Ethics
 Is a way understanding and examining
What's RIGHT (Good)
AND
What's WRONG (Evil)
Dealing with Human Morality
11/30/2015 Dana Bakheet 12

14. Ctnd…
 Involves application of fundamental ethical
principles
 These include design and implementation of
medical and biological research involving:
– Human experimentation
– Animal experimentation
– Various aspects of academic misconduct,
including scientific fraud, fabrication,
plagiarism
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15. Historical Background
1) After misuse of Human in Research in West
- 1947 lead Nuremberg Code (First modern code1948)
- 1979 lead Belmont Report (Tuskegee Syphilis Study)
2) International guidelines
- 1990 WHO International Guidelines on ethics
- 1993 WHO International ethics guidelines for
biomedical research involving human subjects
3) Local ethical guidelines (KACST, KFSHRC,
KSU)
 Q: Multi center study ? Multi national study?
14

16. 11/30/2015 Dana Bakheet 15

17. Importance
 Planning for Research
– Original, continuation, duplication
 Conducting project
– Fabrication, falsification of data
– Proper consenting of patient
 Publishing its results
– Authorship, fabrication of outcome
11/30/2015 Dana Bakheet 16

18. Requirements
 HUMAN
– Justification of the research project
– Access to participants
– Protecting privacy
– Informed Consent (form, process)
– Clarify potential harm
 Q: any sharing experience in process /
difficulty
11/30/2015 Dana Bakheet 17

19. Principles
 The Belmont Report is for the protection
of research participants
 http://www.hhs.gov/ohrp/humansubjects/guid
ance/belmont.html
 Pillars:
– Autonomy
– Beneficence & Non-Maleficence
 Risks Vs. Benefits
– Justice11/30/2015 Dana Bakheet 18

20. Vulnerable Participants
 Children
 Mentally ill
 Prisoners, poor
 Elderly
 Others as in military, peer pressure,
pregnant & lactating women
– Extra care is needed to protect them
11/30/2015 Dana Bakheet 19

21. Autonomy
 Each participant should be given
Respect, Time and Opportunity
necessary to make their own decisions
 Must be given sufficient information
that they will need to decide to enter a
study or refuse
 No PRESSURE
11/30/2015 Dana Bakheet 20

22. Beneficence
 Do not Harm, prevent it , prevent evil
 Promote good
 So the most important responsibility of
the researcher
– Protect physical, mental, social well being
of each participant
– Maximize benefits
– Minimize risks
11/30/2015 Dana Bakheet 21

23. Non Maleficence
 On Balance
 Generation of more good than harm
 Risks of research should be reasonable
in light of expected benefits to
individual and society
11/30/2015 Dana Bakheet 22

24. Risks vs. Benefits
 Physical, social and
emotional
 Stigma
 Improved access to
health care
 Better prevention,
diagnosis and
treatment
 Social contribution
11/30/2015 Dana Bakheet 23

25. Justice
 Select participants who will benefit
from Research
 Provide protection for vulnerable
groups
 Share Risks & Benefits
11/30/2015 Dana Bakheet 24

26. Key Concerns
Before-During-After
 Data fabrication & falsification, plagiarism
 Consent
– Voluntary & Provide fully details
 Not be used for unrelated purposes
– Unless with prior agreement
 Confidentiality and Anonymity
 Q: what is the difference between last 2
items Dana Bakheet 25

27. 3- Ethical Misconduct
 Fabrication: making up data, results
 To record / report them
 Falsification: manipulating research materials,
equipment, processes, changing, omitting data
 Research not accurately represented
 Plagiarism is appropriation of another person’s
ideas, processes, results without giving
appropriate credit
 Research misconduct does not include
differences of opinion 26

28. Case
11/30/2015 Dana Bakheet 27

29. Ruling
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30. Ethical Misconduct
(what else?)
 Plagiarism, Fabrication, falsification, dishonesty of
research
 Publishing the same paper in two different
journals without telling the editors
 Publication authorship (not giving credit to
all authors for their roles in research)
11/30/2015 Dana Bakheet 29

31. 4- Consenting
 Give permission for something to happen
 Informed consent is process for
getting permission before conducting
healthcare intervention on person
 Health care provider may ask patient to
consent to receive therapy before
providing it OR clinical researcher may
ask research participant before enrolling
that person into clinical trial

32. Basic Elements
 Explanation of purpose and duration
 Description of risks and benefits
 Explanation of confidentiality
 Signatures
 Q: what does the word Basic refers to ?
11/30/2015 Dana Bakheet 31

33. Contents
 Name and contact of researcher
 Name and contact of participant
 Aims & objectives of research project
 Role of participant
 Treatment of material/information
collected
 Potential risks
11/30/2015 Dana Bakheet 32

34. Ctnd…
 Sources of advices/ help
support/treatment
 Freedom of withdrawal
 Option of receiving of summary findings
 Confirmation project has ethical approval
 Signature of and date of researcher and
participant
11/30/2015 Dana Bakheet 33

35. Validity
 Must
–Signed by:
① Subject
② Legal representative
③ Investigator
–Give copy to subject
11/30/2015 Dana Bakheet 34

36. Process
 Identify participant population
 Produce information sheet & Consent form
 Submit & Obtain permission of Ethics
Committee
 Distribute Inf. sheet &perform consenting
– Discuss content, research, its implications
– Allow time for withdrawal and decision
– Obtain signature - Not the main aim
 START RESEARCH
35

37. Minors
 Consenting:
Must be obtained from parents
Since they are vulnerable population
11/30/2015 Dana Bakheet 36

38. 11/30/2015 Dana Bakheet 37
I have read the Information Sheet and have had the
details of the study explained to me. My questions
have been answered to my satisfaction, and I may ask
further questions at any time.
I understand I have the right to withdraw from the
study at any time and decline to answer any particular
questions.
I agree to provide information to the researcher(s) on
the understanding that my name will not be used
without my permission.
I agree/do not agree to the interview being recorded
electronically.
I understand that I have the right to ask for the tape to
be turned off at any time during the interview
I agree to participate in this study under the conditions
set out in the information sheet
Signature – Name - Date

39. 5- Research Review
Committees
 Institutional Review Board IRB/ (Ethics)
 Animal Care and Use Committee ACUC
11/30/2015 38

40. Review from Ethical
Perspectives
 Full Review: Investigational drugs
(clinical trials), devices, invasive
techniques etc… even for Basic Research
 Expedited: Non invasive collection
(sweat), hair, teeth and Adult blood
(not more than 2 times / week), ECG,
weighing
Dana Bakheet 39

41. Exempted From review
 Proposal:
 Comparison of techniques, survey
without identifiers, Public data
 Consent form:
 May be waived by IRB for some
research types (as studying patients
discarded materials)
11/30/2015 Dana Bakheet 40

42. Ethics Committee
Members / IRB
 Chairperson
 3-4 members
 One member from general public
11/30/2015 Dana Bakheet 41

43. Role of Ethics Committee
 Review and approval
 Investigate / resolve conflict in ownership
(patent/ software)
 Protect Rights of participants by assuring:
1. Risks to be minimized
2. Reasonable balance b/w Risks & Benefits
3. Selection of participants is fair
4. Approve CONSENT FORM and document it
5. Assure Privacy & Confidentiality 42

44. Animal Care & Use Committee
 ACUC Functions & Procedures
– Inspection of facilities
– Evaluation & reporting (once/ 6 months
minimum)
– Review of proposed uses of animals in
research, testing, or education (ie.,
protocols).
11/30/2015 Dana Bakheet 43

45. Members
 A doctor of veterinary medicine
 At least 3 practicing scientists
 At least 1 technician from Animal Facility
 At least 1 member from Management
 At least 3 members from Hospital’s
Physicians
 An unaffiliated member from Community
11/30/2015 Dana Bakheet 44

46. Protocols
 Rational & purpose of animal use
 Justification of species & number
 Use of less-invasive procedures
 Appropriateness of
– Species
– Organ preparation, Cell or tissue culture
– Computer simulation
– Q: what is the best preference ?11/30/2015 Dana Bakheet 45

47. Ctnd …
 Housing & husbandry requirements
 Appropriate sedation, analgesia &
anesthesia
 Euthanasia if painful or stressful
outcomes are anticipated
 Disposition of animal
 Method of euthanasia or Safety of
working environment for personnel11/30/2015 Dana Bakheet 46

48. 6- Ethics Towards
Information
 Confidentiality
– Related to researchers’ conduct
 Data protection
– Related to work sheets and materials
 Who accesses the data ?
– Physician, PI and project coordinator
 Who owns information: Institution
11/30/2015 Dana Bakheet 47

49. Can you Think of examples
where confidentiality would
be of important ?
11/30/2015 Dana Bakheet 48

50.  Name
 Genetic condition
 Diseases
 Treatment of drugs (fertility)
11/30/2015 Dana Bakheet 49

51. 11/30/2015 Dana Bakheet 50
Case Study
Case Study: Data Ownership
Betty. came to Dr. T’s lab as a post-doc after completing
her Ph.D. at a leading university. Dr. T accepted her
because of her ability in isolating and manipulating
proteins in complex structures. Dr. T. has some grant
support that will cover much of Betty’s stipend for three
years. Under Dr. T’s intellectual leadership they
complete some basic research that promises intellectual
property development. They file a patent application.
Question: Who has the intellectual ownership?

52. 11/30/2015 Dana Bakheet 51
Case Study – answer
Both have intellectual ownership, but Dr. T. retains
primary project management and supervisory role.
The university has legal ownership based on access
to and retention of research data.
Ruling

53. 7- Authorship &
Publication
 Names that appear at beginning of
paper serve one important purpose
– Let others know who conducted research
and should get credit for it
– Authors listed on papers should accurately
represent person/s responsible for work
 Contribution
 Importance
 Corresponding/primary author
11/30/2015 Dana Bakheet 52

54. Contribution
 Authorship: limited to individuals who
make significant contributions this
includes:
– Instrumental in obtaining funding for
project
– Involved in conception & design of research
– Data collection, analysis and interpretation
– Participated in drafting publication and
approved final version of publication 53

55. Importance
 Authors usually listed in their order of
importance, with designation first or
last author carrying special weight
 Some journals have specific rules for
listing authors
 Others do not
– again placing most of responsibility for
this decision on authors themselves
11/30/2015 Dana Bakheet 54

56. 11/30/2015 Dana Bakheet 55

57. 11/30/2015 Dana Bakheet 56
Even though the reviewer, Mary, did not or will not claim
the author’s technique as her own, by writing it in a paper
or presenting it at a conference, she nevertheless
appropriated to herself someone else’s intellectual
property and used it to her own advantage without the
permission of the true owner.
Mary abused one of the important tenets of the review
process, namely that reviewers will keep the contents of
the manuscripts confidential and will not use that
information to give them an unfair advantage.
Ruling
Question 2: What should Mary have done?

58. 11/30/2015 Dana Bakheet 57

59. 8- Policies must…
 Establish definitions of “misconduct”
 Outline procedures for reporting and
investigation misconduct
 Provide protection for whistle-blowers
 Without these, studies can get out of
hand
11/30/2015 Dana Bakheet 58

60. Other Ethical Matters
 Conflict of interest
– Researcher Conflicts: Financial, work
commitments, personal & intellectual matters
 Data management
 Mentor-Trainee relationship (agreement)
– Mentoring Ethics
 Peer Review
11/30/2015 Dana Bakheet 59

61. Conclusion
 All research projects should be
conceived, designed and implemented
according to highest standards
 Experiments should be conducted in
accordance with health & safety
regulations
 No harm in research
– Codes and policies are in place
11/30/2015 Dana Bakheet 60

62. Thank you
11/30/2015 Dana Bakheet 61

63. Presentation Outline
1) Research
2) Ethics
3) Ethical Misconduct
4) Consenting
5) Research Review Committees
 IRB/ Ethics and ACUC
6) Ethics Towards Information and Case
7) Authorship & Publication and Case
8) Wrap Up 62