This document provides an overview of health research ethics training. It begins with learning objectives around key values, theories, and principles that guide health research. It then discusses the definition and goals of ethics. Several key points are covered, including: the history of research ethics and important documents/events that shaped guidelines; principles of autonomy, beneficence, non-maleficence, and justice; roles and responsibilities of ethics committees and researchers; and issues like scientific misconduct, informed consent, and protecting participants. The document emphasizes applying fundamental ethical principles to ensure research is planned and conducted properly.

1. Training on Health Research Ethics
Introduction :
Prof Dr Sanjev Dave
Department of Community medicine,
Soban Singh Jeena Government Institute of
Medical Sciences, Almora (Uttarakhand)
India-263601

2. Learning Objectives
• To state the key values that underpin health
research
• To comprehend the ethical theories underlying
health research
• To describe the specific ethical principles that
guide health research

3. • Itis a scientific approach to answering questions,
often involving human participants to test health
care treatments or drugs.
• It can be related to
1. prevention of disease,
2. promoting health,
3. early diagnosis,
4. understanding effects of diseases on the body,
5. treatment and treatment seeking behavior,
6. access to treatment,
7. delivery systems or platforms or health programs.
Research??

6. Outcome of
research
Any intervention or product developed, or knowledge
generated from research should be made reasonably
available for the benefit of that population or
community
Availability
Acceptability
Accessibility
Affordability
Ethics Committees have to examine if the proposal clearly
describes this component

7. Understanding Research Ethics ?
•Ethics are described as
standards of conduct or social
norms that prescribe behavior.
• Goals of ethics are prescriptive
and evaluative rather than
descriptive and explanatory.
• This differentiates ethics from
social science.
Protection of Human Subjects
Prior to the twentieth century,
research ethics were primarily
governed by
physicians’conscience and
professional codes of conduct
Research Ethics
The Hipocratic oath is the oldest
expression of medical ethics
“Primum non nocere: First do no harm”

8. Research Ethics…..
 Involves the application of fundamental
ethical principles to planning,
conducting & publishing of research

9. Why should there be research ethics?
 To protect participants /patients /society
/resources /researcher?
 To ensure accuracy of scientific knowledge
 To protect intellectual and property rights

10. To protect
participants/patients/society/resources
 Protect from harm
 Show respect -privacy /confidentiality
 -Informed consent
 Refrain from Coercion and undue inducement
When do incentives amount to coersion/undue
inducement?
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2600
442
Why should there be research ethics?

11.  Refrain from exploitation of vulnerable
participants Who are the vulnerable groups?
 Refrain from indiscriminate use of resources
 Ensure Favorable Risk-Benefit Ratio: risk should
be minimized & potential benefit to society
must outweigh risks
Why should there be research ethics?

12.  Must be of social value: improvement of
health/knowledge for the benefit of
society/science
high social value: use of stem cells to improve quality of
life for Huntington's disease patients
less social value: drug studies conducted to obtain data
that allows a new drug to compete in the healthcare
marketplace even though existing effective and often
cheaper therapeutics are already available
Why should there be research ethics?

13. To ensure accuracy of scientific knowledge
 Should be methodically rigorous - Scientific validity
 Fair subject selection: with inclusion / exclusion
criteria & a valid number of subjects in order to
project results to the population
 State research method clearly so that another
person can conduct advanced study in future by
using publication
Is it ethical to copy the methodology from a
published paper?

14.  Do not gloss research method
 Should not falsify/modify/omit data
 Use actual data for analysis/cannot include someone
else's data
 Report errors
 Be aware of conflict of interest
 Should not withhold and/or ‘vaguing up’ information
 Keep data and material for 5 years
 Data and material should be available to others
DO in research ethics

15.  Do not present/publish paper from incomplete
research or from anticipated outcomes
 Should not duplicate publications and
submissions
 Avoid piecemeal publication
 Should be reviewed Independently by
unaffiliated individuals
DO NOTs in research ethics

16. To protect intellectual and property rights
 Citation and authorship
inclusion-Writing and significant
scientific contribution
order- order of contribution
-actual researchers
-approval must be sought to
include a name

17. (Piracy vs plagiarism)
 Whenever somebody else’s work is quoted
reference should be made to the original
author (Piracy vs plagiarism)
 Acknowledgement should include the names
of person who helped

18. Breach of ethics in research would
amount to scientific misconduct

19. Scientific misconduct
 Fraud : invention/fabrication of data
 Plagiarism : copying data, ideas, text without
acknowledgement of source
 Piracy : infringement of a copyright
 Submitting/Publishing the same paper to
different journals

20. Scientific misconduct …
 Not informing a collaborator of your intent
to file a patent in order to make sure that
you are the sole inventor
 Including a colleague as an author on a paper
in return for a favor even though the
colleague did not make a serious
contribution to the paper

21.  Trimming outliers from a data set without
discussing your reasons in paper
 Using an inappropriate statistical technique in
order to enhance the significance of your research
 Bypassing the peer review process and announcing
your results through a press conference without
giving peers adequate information to review your
work

22.  Conducting a review of the literature that fails
to acknowledge contributions of others
 Stretching the truth on a grant application in
order to convince reviewers that your project
will make a significant contribution to the field
 Giving the same research project to two
graduate students in order to see who can do it
the fastest

23.  Overworking, neglecting, or exploiting
research students
 Making derogatory comments and personal
attacks in your review of author's submission
 Making significant deviations from the
research protocol approved by the Review
Board without informing the committee

24.  Not reporting an adverse event in a human
research experiment
 Wasting animals in research
 Exposing students and staff to biological risks
 Rejecting a manuscript for publication without
even reading it

25.  Sabotaging someone's work
 Rigging an experiment so you know how it will
turn out
 Deliberately overestimating the clinical
significance of a new drug in order to obtain
economic benefits

26. Ethical review committee
(Institutional Review Boards)
Convened to
 maintain ethical standards of practice in
research
 ensure protection of subjects/research
workers from harm or exploitation
 to provide reassurance to the public
 protect researchers from unjustified criticism

27. Procedure for ethical clearance
 Fill ethical clearance form and attach
proposal, questionnaires, informed consent
forms, information leaflets etc., and submit
 When ethical clearance is granted, data
collection can commence according to the
approved methodology

28. Ethical Issue : Example
 A group of undergraduate students planned a
research on family planning practices of Sri
Lankan females.
 As they were close to the deadline for
presenting their results, they started collecting
information form participants before formal
approval by the ethics review committee

29. • In the 18th century Edward Jenner was the pioneer of vaccination against
infectious diseases,
• however, his research did not respect the principal rights of humans in
research because these had not yet been defined.
• Louis Pasteur understood the need for comprehensive information
generated by research in animals before exposing a human being to an
experiment.
• Urgent patient need was the reason for his first medical administration
to humans in 1885. In the 20th century, medical research experienced
rapidly developing methodology, precision measurements, and quick
development of new scientific disciplines.
• However, unethical experiments with human beings were still being
performed in many countries, such as the Tuskegee Syphilis Study,
conducted between 1932 and 1972 by the U.S. Public Health Service.
• Some unethical studies were carried out in concentration camps during
World War II.
29
History of Ethics in medical research

30. • Beginning with the Nuremberg trials in 1947,
the principles of ethical research in human
beings were defined based on the
voluntary informed consent of research
participants.
• The United Nations (UN) and World Health
Organization (WHO) followed with a focus on
the priority of the wellbeing of the individual
over the interests of the patients at large.
30
Post-WWII definition of principles of
ethical research in humans

31. • In 1961, public opinion around the world was
shocked by the Thalidomide scandal. 2,000
children died and 10,000 children were seriously
disabled.
• Government Authorities were then required to
take action and make regulatory arrangements to
oversee the testing of new medicines.
• In 1964, the World Medical Association (WMA)
developed and indeed continues to review and
adapt the Declaration of Helsinki as a guide for
performing research in human beings.
31
Declaration of Helsinki

32. • During the last sixty years, there has been rapid
emergence of different codes, regulations, and
Acts to govern ethical research in humans.
• As medical experimentation moved into the
public domain, decisions previously left to the
conscience of individual doctors came under
collective surveillance.
• A new balance of authority and an increase in
autonomy began to be observed between
researcher and research participant.
Regulation and Autonomy

33. The progress of science and technology has led
to continued development of ethical principles
and guidelines as a variety of different new
research topics continues to expand, for
example,
• ASSISTED REPRODUCTION,
• STEM-CELL RESEARCH,
• PRENATAL DIAGNOSTICS.
33
New Research Topics

34. Medical research Ethics?
• Conflicts of interests between the government,
medical institutions, medical personnel and
patients are being increasingly addressed.
• Individual good versus public good
• Prevention versus treatment – relative focus
• Rationale for use of genetically engineered products like
vaccines
• Research on newer technologies bring hopes of
cure but often create a heavy economic burden
and equity, access and affordability pose serious
challenges.
Drugs
Medical Devices
Newer public health
interventions Vaccines

35. Research ethics
[Researchers’ responsibility]
•Research ethics should guide research
conducted at the health care facility level or
community level to ensure that international
and national expectations and standards are
followed.
•One of the primary goals of research is the
protection of research volunteers by addressing
ethical considerations into the research study
design and implementation.
•It is important to adhere to ethical principles
during research.
•This enables protection of dignity, safety,
rights and welfare of research participants
Source: Research Ethics Training Curriculum for Community Representatives, FHI, 2004

36. Health research ethics ..
Responsibility of ECs and Members
•Research involving human participants should be
reviewed by Ethics Committees to ensure
provisions to keep the research within ethical
framework and standards
•Researchers must ensure protection of rights, safety
and welfare of research participants
•This is one of the most important expectations
from ethics committee members while reviewing
and approving research studies

37. Research & Engagement of
communities
• It is not always possible to know what will happen to the
participants;
sometimes unexpected or undesirable results happen.
• The participation of local community representatives in planning
and conducting research is, therefore, important.
• Communities should be informed of the research, possible
outcomes (positive and negative), and the results of the research.
• Community representatives and researchers can work together to
make sure that research is conducted in the most appropriate way.
Research Ethics Training Curriculum for Community Representatives, FHI, 2004

38. Hippocrates was the first physician to define
the ethical principles of research in humans.
These principles are still valid today:
• Autonomy – to respect the autonomy of the
participant or of their representative;
• Beneficence – to act always in the best interest of
the participant;
• Non-maleficence – to do as little harm as possible
to the participant;
• Justice – to act fairly to all.
38
Ethical Principles of Research

39. Cardinal principles of ethics
every researcher must practice …..
• Autonomy: Ability to decide to participate in research at
one’s own free will
• Beneficence and non-maleficence: Do good, do no harm
• Justice: Researchers must always be fair to participants
and their needs and safety should always gain priority to
pursuit of research objectives.
• All should have an opportunity to participate in
research except when there is a known risk.

40. How to ensure Autonomy?
• Documentation of ethics committee approval for the study
• Description of informed consent process
• Appropriateness of informed consent form and patient
education material
• Correct documentation of the informed consent through
effective monitoring and supervision
• Ability to give consent

41. How to assess
Beneficence and Non- Maleficence?
• Inclusion and exclusion criteria
• Benefits and risks of participation: Benefit-risk analysis
• Measures to maintain confidentiality
• Follow-up care and standard of care
• Compensation

42. How to ensure compliance to the
principle of justice?
• Rationale of the study should be sound.
• Potential public health benefit must outweigh risks to
participants
• Provision for effective third party monitoring
• Judiciously described inclusion and exclusion criteria

43. Shared responsibility ........
Research should be responsive to the health
needs and the priorities of the population or
community in which it is to be carried out
Who decides what is good for the people and
the community?
Many stakeholders do:
Investigators
Research participants
Regulatory
committees
Sponsors
Policy makers
Program managers
Ethics committees and members of ECs have a
role and responsibility in this regard.

44. • The assessment of trial applications by research
ethics committees and National Competent
Authorities helps to ensure the well-being, safety,
and protection of persons who participate in
clinical trials.
• It is in the best interest of all stakeholders
(including patient representatives) to cooperate
to improve the ethical conduct of clinical trials.
44
Safety and Protection of Clinical Trial
Participants

45. Good Clinical Practice GCP)
Ethical and scientific
quality standards for ---
designing,
--conducting,
--recording and reporting
trials that ----involve
participation of human
subjects

46. Why is GCP Important?
Why is it needed?
•To ensure for the trial
subjects:
RIGHT
S
SAFET
Y
WELL
BING
•Ensure the CREDIBILITY of
clinical trial data
•To streamline clinical

47. Participants activity
Identify ethical issues in the
following scenarios

48. Group 1
Two graduate students have made some
measurements on a new material. The data points
are as shown. To prove their hypothesis the
results should lie on the curve shown. The two
students considered omitting the two data points
which were off the theoretical curve.

49. • Unethical as it would amount to falsification
of data
• Should include outliers and give probable
reasons or find out statistically acceptable
ways of trimming outliers

50. Group 2
A group of medical students conducted a research
on the awareness of diabetic diet in medical clinic
participants.
Their research was recognized as the best
undergraduate research and later they submitted
the same research paper to two different journals
to see which journal publishes it first.

51. • Unethical as it would result in "inadvertent
double-counting or inappropriate weighting of
the results of a single study, which distorts
the available evidence
-it would give a false idea of the number of
publications in a given area
-wasting of resources on the review and
publication process
• Should submit to one journal and wait for
response prior to submitting to another

52. Group 3
Students are required to prepare a research
proposal during their undergraduate program.
Nimal developed the idea for his project and
discussed with a friend.
Several months later, he found that his idea had
been submitted as a research proposal by his
friend without his knowledge.

53. • Unethical as failure to give credit to the person
whose idea it is (intellectual property) amounts
to plagiarism
• Should discuss and include as co-author

54. Group 4
Four friends decide to work together on a research project
during the vacation.
One of them went abroad during the vacation and did not
contribute to the research.
The friends include all 4 names in a presentation made at a
scientific congress.

55. • Unethical as only those who contributed
intellectually should be cited as authors
• Those who contribute in other ways may be
acknowledged

56. Group 5
A group of undergraduate students planned a
research project on the detection of fetal
abnormalities in the second trimester, by
ultrasound scanning. They collected data from
the scan room without informing the mothers

57. • Unethical as informed consent was not taken
• Should have informed mothers of their intent
even though there is no particular
advantage/disadvantage to the mother in
doing so

58. Group 6
A group of undergraduate students collected data from a
group of bank officers, with their consent, regarding their
working hours and salary with regards to the prevalence
of high blood pressure.
Subsequently the researchers gave the same data to
another group who were in need of same data variables.

59. • Unethical as violating principles of consent and
confidentiality
• Data can be used for a secondary purpose which
was not first considered as long as
- informed consent for sharing has been given
- identities anonymised
- due consideration to access restrictions
• Develop ethical guidelines for data sharing?

60. • What should members of ethics review
committees consider in evaluating a
proposal for ethical clearance?
• Elements of a review
• Send to:
• Communitymedicine.gmcalmora
@gmail.com

61. Take Home Messages ................................................

62. THANK YOU