for researchers basic knowledge

2. ETHICAL CONSIDERATIONS
IN RESEARCH

3. CONTENTS :
• Introduction
• Historical background
• Code of ethics in world war
• Ethical Violations in Research
• Oral health clinical research
• DSMB
• Biomedical Research in India
• Key Ethical Principles in Public Health Research
• Code of ethics for in public health research
• Ethics of screening

4. • Ethical principles in Epidemiological Studies
• CIOMS/WHO guidelines
• Institutional review board
• Informed consent
• Vulnerable populations
• Conclusion
• References
• Previous year questions

5. Introduction
• Nations, communities, professional organizations, and their
leaders aspire to uphold values that are respected by group as a
whole.
• This is often concern about questions of right and wrong with
moral values, human rights, and duties pertaining to behaviour
as a member of the group. Norms for ethical conduct are
sought for the group, anchored in its core values.
• In this way, professional organizations, like society at large,
distinguish between acceptable and unacceptable conduct.

6. Historical background
• 1700 -Edward Jenner vaccination trials and tested small pox vaccines
on his own son and on neighbour hood children.
• 1865 - Claude Bernard, justified experiments on condemned criminals
in Egypt. He said that it is not cruel to inflict on a few criminals who
suffer which may benefit multitudes of people through all centuries.

7. WORLD WAR I AND WORLD WAR II:
Developing a CODE of ETHICS for Research-
1) Nuremberg code
2) Declaration of Helsinki
3) National Research act
4) Belmont Report
5) The Common Rule
6) Health insurance portability and accountability act.

8. THE NUREMBERG CODE:
History:
• The U.S. Government believes it has an ethical and legal
responsibility to protect the right of citizens who agree to participate
in research studies.
• The principles underlying the protection of human subjects have
their seeds in events following World War II.
• In 1947, the Nuremberg (American) Military Tribunal developed a
code of standards to use in judging Nazi physicians, scientists and
administrators who were accused of conducting research atrocities
in Nazi concentration camps

9. •The deeds carried out by defendants, although referred to as
experimentation, were infamous atrocities that amounted to nothing
more than torture and killing.
•They received a great deal of attention in trials for World War II
criminals.
•This resulted from prosecution of 23 German physicians and
administration for allowing and performing experience like injecting
prisoners with gasoline.

10. • The original code was submitted by American doctors to provide
standards with which to judge those who had committed the
atrocities in the name of research.
•The first iteration of the code contained 6 points but these
ultimately evolved into 10 principles intended to guide human
experimentation.

11. Nuremberg Code, 1949 – A legal judgement:
First internationally recognized code
Focus on ethical treatment of humans even in non therapeutic
research.
It has become the corner stone for all the guidance, regulations
required in human research.
It helped shape and define the ethically appropriate use of human
subjects in medical and behavioural research.

12. Nuremberg Code:
1) Consent must be voluntary
2) Experiments should yield fruitful or beneficial results for the
good of the society that cannot be obtained by any other means
3)Should be based on results of previous animal studies .
4) Avoid all unnecessary physical and mental harm.
5) No experiment should be conducted where if death or disabling
injury is expected .

13. 6) Degree of risk should not exceed anticipated benefits
7) Experiments should be conducted under conditions and
facilities that protect against the possibilities of injury, disability
or death.

14. 8) Should be conducted by scientifically qualified persons.
9) Human subject should be at liberty to withdraw from study
10)Scientist in charge of the study should stop the experiment if its
continuation is likely to result in injury ,disability,or death of the
subject

15. THE DECLARATION OF HELSINKI:
•Specially differentiated therapeutic and non-therapeutic research.
•Adopted by 18th WMA General Assembly,Finland in June 1964.
•Its updated at least once during every decade since its inception.
• 7TH update of the declaration 64th WMA OCT 2013 Fortaleza

16. 3 sections-
i) Introduction - i.e. general statements regarding research
ii) Basic principles for all medical research.
covering areas from study design to publication with strong
emphasis on risk assessment and informed consent.
iii) 5 additional principles
Conducts in medical research when combined with medical care.

17. ■ Duty of the physician to protect the life, health, privacy and
dignity of the subject.
■ Research should conform to accepted scientific principles, be
based on thorough knowledge of scientific literature and
adequate lab and animal experiments

18. ▪ Research protocols should be reviewed by an independent
committee
■ Research protocols should be conducted
bymedically/scientifically qualified individuals
■ Risks and burden to the participant should not outweigh
benefits
■ Researcher should stop study if risks are found to outweigh
potential benefits

19. ▪ Research is justified only if there is a reasonable likelihood
that the population under study will benefit from the results
■ Participants must be volunteers and informed in research
project
■ Every precaution must be taken to respect privacy,
confidentiality, and participant’s physical and mental integrity

20. – Assent must be obtained from minors, if child able to do so
■ Investigators are obliged to preserve the accuracy of results;
negative and positive results should be publicly available
■ Appropriate caution must be exercised in the conduct of
research

21. National Research Act, 1974 (Public Law 93-348)
•The U.S Congress passed the National Research Act on May 1974.
•The driving force was , Tuskegee Studies (1932-1973).
• It mandated the establishment of the IRB to review research and it
also included requirement for informed consent to approve human
subject’s research.
•It established National Commission for the Protection of Human
subjects of Biomedical and Behavioural Research.
• This culminated in Belmont Report published in 1979.

22. Belmont report
•The report was issued on 30th September 1978 and published in
the Federal Register on 18th April 1979.
•Three basic principles, among those generally accepted in our
cultural tradition, are particularly relevant to the ethics of
research involving human subjects:
•The principles of respect for persons,
•Beneficence and
•Justice

23. The Common Rule :
As governmental oversight of federally funded clinical research
continued to grow, the Office for Human Research Protections
(OHRP) under the Department of Health and Human Services
(DHHS) was formed in 1991.
The OHRP is organised into 3 major divisions-
i) Compliance oversight
ii) Education and Development
iii) Policy and Assurances

24. Health Insurance Portability and Accountability
Act (HIPAA), 1996 :
• The right of the patients to have their private health information
protected have been legally established in this act (HIPAA), 1996.
•This law covers medical information (diagnosis and test results),
personal information (DOB, social security number, address, pin
code/ zip code and phone number).
•Investigators working under the HIPAA covered entity must follow
these rules.

25. • Data of individual participants can be disclosed under the
following circumstances :
• Only in a court of law under the orders of the presiding judge
• There is threat to a person’s life
• In cases of severe adverse reaction may be required to
communicate to drug registration authority
• If there is risk to public health it takes precedence over
personal right to privacy and may have to be communicated to
health authority.

26. Ethics Violation in Research:
•Dr. Henry K. Beecher wrote an article "Ethics and clinical research"
in New England Journal of Medicine in June 16, 1966 describing 22
examples of published Research studies on human subjects that have
considered to have violated ethical standards.
•The studies ranged in scope from failure to obtain informed consent
to inappropriate use of vulnerable research populations.

27. Examples of Unethical Research:
Soldiers unknowingly being given placebo instead of penicillin
for rheumatic fever.
Hospital patients randomly given placebos instead of penicillin
for acute streptococcal infection.
A group of children including mental and juvenile delinquents
who were inmates of children’s centre were given a drug that had
shown effects of hepatotoxicity to see if it was hepatotoxic.

28. Other Studies of Ethics Violation in Research:
• Nazi human experiments
Tuskegee Syphilis Study (1932-1972)
Vipeholm Dental Caries Study 1954
Willow Brook Mental Hospital (1956)
Jewish Chronic Disease Hospital (1965)

29. Nazi human experimentation
• Series of controversial medical experiments on large numbers
of prisoners by the German Nazi regime in its concentration
camps during World War II.
• Prisoners were coerced into participating:
• Ethical issues - no volunteer and there was never informed
consent.
• The experiments resulted in death, disfigurement or permanent
disability

30. Twins :(1943 to 1944 )
• AIM :
• To show the similarities and differences in the genetics of
twins, as well as to see if the human body can be unnaturally
manipulated.
• The central leader - Josef Mengele
• Study population -1,500 sets of imprisoned twins ,Auschwitz.

31. • Twins were arranged by age and sex and kept in barracks between
experiments, which ranged from injection of different dyes into the
eyes of twins to see whether it would change their color to sewing
twins together in attempts to create conjoined twins
• Often times, one twin would be forced to undergo experimentation,
while the other was kept as a control.
• If the experimentation reached the point of death, the second twin
would be brought in to be killed at the same time. Doctors would
then look at the effects of experimentation and compare both bodies.

32. Sulfonamide Experiments :
■ July 1942 to September 1943
■ To investigate the effectiveness of sulfonamide
■ Wounds deliberately inflicted on the subjects were infected with
with bacteria such as streptococcus, gas gangrene, and tetanus.
■ Circulation of blood was interrupted by tying off blood vessels
at both ends of the wound

33. High Altitude experiments
A prisoner in a compression
chamber loses consciousness (and
later dies) during an experiment to
determine altitudes at which aircraft
crews could survive without oxygen.
Dachau, Germany, 1942. NARA
Taken from www.myclinicalresearchbook.blogspot.com/

34. MUSTARD GAS
EXPERIMENTS :
■ At various times between September 1939 and April 1945,
experiments were conducted at Sachsenhausen, Natzweiler, and
other camps to investigate the most effective treatment of wounds
caused by mustard gas.
■ Test subjects were deliberately exposed to mustard gas and other
vesicants, which inflicted severe chemical burns.
■ The victims’ wounds were then tested to find the most effective
treatment for the mustard gas burns.
Taken from:-
www.wikipedia.org/wiki/Nazi_human_experiment
ation

35. TUSKEGEE SYPHILIS STUDY (1932 – 1972)
•The 40 year project begun in 1932 and it was funded by the U.S.
Public Health Service.
•It offered free medical care in exchange for participating in the
study.
AIM:
•Determine the natural history of syphilis to death or the
untreated course of syphilis in African American males.

36. Study Design:
- 1932: Followed 399 black syphilitic males.
- 1933 : 201 controls added
- 1940: Even after the discovery of penicillin, research subjects
were not informed about this therapy even though it could have
been used to cure their infection no and no connection made to
Nuremberg code in 1947. Study allowed to continue for almost 3
decades
-1973: U.S Dept of Health Education and Welfare took steps to
provide treatment to the surviving research subjects
-1997 -Bill Clinton apologized to subjects and families.

37. Results: Disability: 100
Death : 28
Congenital Syphilis: 19
Ethical Issues :
•no informed consent,
• it caused harm and
• it lacked moral responsibility. In short they were betrayed.

38. VIPEHOLM STUDY (1954):
• The study was done at Vipeholm Hospital, Lund, in Sweden
1954 by Gustafson et al.
• More than 400 adult mental patients were placed on controlled
diet and observed for 5 years.
•The subjects were divided into - control ,sucrose ,bread ,chocolate
,caramel ,8 toffee and 24 toffee group

39. . Conclusions :
• sucrose consumption could increase caries activity.
•The risk increased if the sucrose was consumed in a sticky form that
adhered to the tooth's surface.
•The greatest damage was inflicted by foods in sticky form, eaten
between meals.
Ethical issues :
•were mentally retarded children,
• no informed consent and
• hazards not informed.

40. WILLOW BROOK HOME STATE HOSPITAL
HEPATITIS STUDY NEW YORK 1956:
Study population-
• 320 mentally retarded institutionalised children on Staten Island.
Objectives:
- To follow the natural history of viral hepatitis.
-To test the effectiveness of globulin against hepatitis.
-The ethical issue are vulnerable group ,informed consent not taken
and hazards not informed.

41. BROOKLYN JEWISH CHRONIC
DISEASE HOSPITAL STUDY (1965):
•The aged and senile patients ,injected with live cancer cells to
determine if the cells would be immunologically rejected.
• Patients had been told that they were receiving a skin test.
•Physicians stated they did not wish to evoke emotional response by
informing patients.
The ethical issue are informed consent not taken and hazards not
informed.

42. Oral Health Clinical Research:
•In 1979, the Council on Dental Research articulated guidance with
special relevance to research populations involved in dental research.
•These “Guidelines for the Use of Human Subjects in Dental
Research” were published as approved by the ADA, for Dental
Research, and the American Association of Dental Schools.

43. i) Aimed at diagnosis, control, or treatment of a disease or condition
ii)Aimed at prevention of a disease or condition
iii) Not directly concerned with either of the first 2 categories
Eg: Behavioural studies, Plaque and saliva sampling
The guidelines present 3 categories-

44. Data and Safety Monitoring Board (DSMB) Guidelines:
National Institutes of Health (NIH), National Institute of Dental
and Craniofacial Research (NIDCR)
Roles and Responsibilities -
DSMB is an independent group of experts that advises NIDCR and
the study investigators. The members of the DSMB serve in an
individual capacity and provide their expertise and
recommendations.

45. Primary responsibilities :
1) Periodically review and evaluate the accumulated study data for
participant safety, study conduct and progress, and, when
appropriate, efficacy
2) Make recommendations to NIDCR concerning the continuation,
modification, or termination of the trial. The DSMB considers
study-specific data as well as relevant background knowledge about
the disease, test agent, or patient population under study.

46. •The DSMB is responsible for defining its deliberative processes,
including event triggers that would call for an unscheduled review,
stopping guidelines, unmasking (unblinding) and voting procedures
prior to initiating any data review.
• The DSMB is also responsible for maintaining the confidentiality
of its internal discussions and activities as well as the contents of
reports provided to it.

47. •The DSMB should review each protocol for any major concern prior to
implementation.
•During the trial, the DSMB should review cumulative study data to
evaluate safety, study conduct, and scientific validity and integrity of
the trial.
•As part of this responsibility, DSMB members must be satisfied that
the timeliness, completeness, and accuracy of the data submitted to
them for review are sufficient for evaluation of the safety and welfare of
study participants. DSMB should also assess the performance of overall
study operations and any other relevant issues, as necessary

48. BIOMEDICAL RESEARCH IN INDIA :
• Is governed by set principles formulated and released by ICMR.
• The ICMR published the “policy statement on ethical
considerations involved in research on human subjects” in
February 1980 for the benefit of those involved in clinical
research in India.
• This was revised in the year 2017

49. 10.PUBLIC DOMAIN
9.INSTITUTIONAL
ARRANGEMENTS
3.NON
EXPLOITATION
7.ACCOUNTABILITY
&TRANSPARENCY
and transparency
6.PROFESSIONAL
COMPETANCE
5.PRECAUTION &
RISK MINIMIZATION
4.PRIVACY
&CONFIDENTIALITY
11.RESPONSIBILTY
12.COMPLIANCE
1 ESSENTIALITY 2.VOLUNTEER
8.MAXIMIZATION
OF PUBLIC
INTEREST
&DISTRIBUTIVE
JUSTICE
GENERAL
PRINCIPLES
ICMR

50. Key Ethical Issues in Public Health Research:
3 possible duties to communities that need to be considered-
a) Duty to respect the community
b) Duty to leave community no worse off
c) Duty to leave community better off

51. Code of Ethics in Public Health Research:
• Public health has traditionally focused more on practice and
cases than on developing theories of professional ethics.
•Values such as social justice and prevention have animated the
day-to-day activities and the practice of public health over time.
• The current interest in naming ethical values demonstrates the
field’s need for guidance in analysing, making, and justifying
decisions that are becoming increasingly complex and publicly
contentious.

52. Functions of Code of Ethics:
A code of ethics is an important way for a profession to create,
support, and preserve its moral foundations, its professional
integrity, and its relationship of trust with clients and society.

53. Frankel (1989) believes a code expresses the collective
conscience and norms of the profession, identifies 3 types
of codes-
a) Aspirational code – Sets ideals to strive for
b) Educational code – Provides commentary and interpretation to
help identify and address ethical problems in professional practice
c) Regulatory code – Sets rules and provide mechanisms for
adjudication and enforcement

54. Frankel (1989) catalogues 8 functions that a code
may perform-
• Enabling document
• Source of public evaluation
•. Professional socialization
•Enhance profession’s reputation and public trust
• Preserve entrenched professional biases
•Deterrent to unethical behaviour
•. Support system
• Adjudication

55. Screening:
U.S. Commission on Chronic Illness (1951)as, “the presumptive
identification of unrecognized disease or defect by the application of
tests, examinations or other procedures which can be applied rapidly to
sort out apparently well persons who probably have a disease from
those who probably do not.”

56. Ethical considerations in screening-
Provisions for obtaining informed consent
Protecting privacy and confidentiality
Balancing risks and potential benefits
Issues pertaining to targeted screening of higher-risk persons
How best to allocate finite public resources for screening

57. Informed decision making-
•Informed consent prior to screening is a principle of respect
for the autonomy.i.e .Individuals must be given information
about the procedure, the meaning of positive and negative test
result, and any appreciable risks or potential harm and benefits
before undergoing screening.
• Shared decision making occurs when a patient and his or her
health care provider. In a clinical setting, both express
preferences and participate in making treatment decisions
(Briss et al, 2004; Sheridan et al, 2004).

58. Characteristics:
The patient must:
Understand the risk or seriousness of the disease or condition
Understand the preventive service, including the risks, benefits,
alternatives, and uncertainties
Have weighed his or her values regarding the potential harms and
benefits associated with the service
Have engaged in decision making at a level he or she desires and
feels comfortable with the decision

59. PRINCIPLES OF ETHICS IN
EPIDEMIOLOGICAL STUDIES
1. Informed consent -The study must be explained to participants and
privacy must be maintained. There is no alternative to obtaining
individual’s informed consent.
2. Consent of community can be obtained through the Village
Leaders, the Panchayat head, the tribal leaders etc. who are
considered to be gate keepers of the society/ Community
3. Avoid societal pressures to participants to give consent

60. 4. Financial inducements, to get individuals and communities to give
consent are not permissible. It is necessary to provide adequate
compensation for loss of wages and travel / other expenses incurred
for participating in the study.
5. All risks involved must be explained
6. Maintain confidentiality

61. 7. Minimise harm to the individuals and society at large and
prevent any disturbance to cultural sensitivities
8. Benefits of the study are maximised for the individuals and
communities taking part in the study. Beneficial results of
epidemiological studies are fed into the health system and necessary
training modules should be developed as part of the epidemiological
project.

62. 9. Conflicts of interest – ensure that the interest of the individuals
involved in the study are protected at all cost
10. Scientific objectivity should be maintained with honesty and
impartiality
11. Ethical Review Procedures
12. Programme evaluation and surveillance is launched -
monitoring and evaluating mechanisms should clearly be planned
and cleared by IEC before initiation as is done in all
epidemiological studies

63. CIOMS (Council for International Organizations of
Medical Sciences) + WHO (International Ethical
Guidelines for Epidemiological Studies):
• In the late 1970s, CIOMS began working in collaboration with
WHO on ethics in relation to research.
•The initial objective was to prepare guidelines to indicate how the
ethical principles that should govern the conduct of biomedical
research involving human subjects, as set forth in the Declaration of
Helsinki ,could be effectively applied, particularly in developing
countries, given their socioeconomic circumstances, laws and
regulations, and executive and administrative arrangements.

64. •The first product of this CIOMS/WHO undertaking was the
publication in 1982 of Proposed International Ethical Guidelines
for Biomedical Research Involving Human Subjects.
•There was timely to revise and update the of the 1982 guidelines,
and CIOMS, with the cooperation of WHO and its Global
Programme on AIDS, in 1993 issued International Ethical
Guidelines for Biomedical Research Involving Human Subjects.

65. •During this period, CIOMS and its collaborators also recognized
that ethical guidance was also needed for public health research.
•Therefore, even before the revision of the biomedical research
guidelines was completed, International Guidelines for Ethical
Review of Epidemiological Studies were published in 1991.
•In the years that followed, it became apparent that the biomedical
guidelines would need to be revised again to address additional
issues, especially those arising in controlled clinical trials carried
out in low-resource countries by sponsors from richer countries.

66. Institutional Review Board (IRB) :
Synonyms : Institutional Ethics Committee (IEC),
Ethics Review Board (ERB)
Research Ethics Board (REB).
It is an administrative body established to protect the right and
welfare of human research subjects.It has the authority to
approve, modify or disapprove all research activities that fall
within its jurisdiction.

67. IRB Mission:
Review protocols and consent forms
Assuring that there is a valid scientific basis and that the methods
adequate to answer the scientific question
Providing approvals
Not recommend altering the science unless to minimize
participant risk
Assessing the risks and evaluating the risk-benefit ratio
Benefits from study considered for both participant and society
Monitoring the progress of studies
All studies must have IRB approved prior to initiation of the
protocol.

68. The IRB shall consist of at least five members, including both men
and women, of whom.
- At least two members have broad expertise in the methods or in the
areas of research that are covered by IRB.
- At least one member is knowledgeable in ethics.
- For biomedical research, at least one member is knowledgeable in
the relevant law.
- At least one member has no affiliation from the community and
may also be non-scientist.
Irb membership

69. Items Required For Submission:
- Protocol
- Review of science
- Questionnaires, survey
- Informed consent
- Human subjects protection issues
- Any ads, radio announcement etc
- Outside approvals, letters of permission.

70. Criteria for Approval of Research:
- Appropriate study design
- Risk minimized
- Equitable selection of subjects
- Informed consent
- Privacy and confidentiality assured
- Voluntary participation

71. Informed Consent:
• Informed consent is the first stated and the largest principle of the
Nuremberg code.
• The Nuremberg code identified four attributes of content without
which content cannot be valid.Consent must be voluntary, legally
competent, informed and comprehending.
• Although Nuremberg code calls for ‘voluntary consent’, it has been
customary, since 1950 to refer it as ‘informed consent’. Consent should
not be obtained without bribery, coercion or misinformation.

72. •If a person cannot give informed consent it is desirable to obtain
proxy consent (Perhaps better to be called "permission") of a
community leader.
•Although IRB approves an informed consent document as a part
of the protocol, in reality, informed consent is an ongoing
interaction and process between investigator and research
participant.
•It provides an individual, or their legally authorized
representative (LAR), the necessary information to make an
informed thoughtful, and voluntary decision to participate.

73. INFORMED CONSENT REGULATION
FOR BIOMEDICAL RESEARCH IN INDIA
•As per DCI regulations, dentists shall maintain patient records
as well as a register of certificates, money receipts and official
notifications issued by them for a period of at least 3 years.
•The DCI in its regulation mentions that ethical guidelines
prescribed by ICMR must be stringently followed in research
involving human subjects.

74. •As per ICMR regulations, for all biomedical research
involving human subjects, the investigator must obtain the
informed consent of the prospective participant or in the
case of an individual, who is not capable of giving informed
consent, obtain the consent of the legal guardian.
• In cases of research involving children, a parent or legal
guardian of the child should give proxy consent. In these
cases, the assent of the child should be obtained to the extent
of the child’s capabilities such as in the case of mature
minors from the age of 7-18 years of age.

75. Informed consent holds a central place in the ethical justification
of ethical research involving human subjects. The informed
consent has a two step process.
1. Information is presented to the subject by the investigator.
2. The subject satisfies himself or herself that he or she
understands and based upon this understanding either agrees or
refuses to participate in the research projects.

76. Purpose of Informed Consent-
Provide information on
•study’s purpose
• duration
•experimental procedures
• alternatives, risks
• and benefits to the participants.

77. Characteristics of an Informed Consent-
- Information to be provided in a language that a human subjects can
understand and in terms they can comprehend
- Participants should be given sufficient opportunity to consider
whether or not to participate, and coercion and undue influence must
be minimised
- It must not include exculpatory language that would require
participant to waive (surrender) any of their legal rights, or release the
investigator, sponsor or institution from liability for negligence
- It should delineate (describe) any costs of participation, and if
portions of study are gathering data from standard clinical care, which
will be charged to the participant or their insurance

78. Informed consent to people with low literacy:
- Written consent may need to be read out
- These individuals to be provided the same information and be
able to ask questions so that they can understand the procedures,
risks and benefits
- Participants with low English proficiency must be provided the
information in a language they can understand
- These individuals be included in appropriate research and not
excluded out of convenience

79. - If inclusion is anticipated, consent should be translated in
appropriate language
- When unanticipated participant is eligible for enrolment, then a
translator should be found that can translate the consent and
assist with the participant’s understanding
- The ability of participant to communicate with the research
team is maintained throughout the study
- For more than minimal risk studies, the ability of the participant
to be able to reach and communicate with the researcher must be
24 hrs a day

80. Types of consent :
• According to BDA it is of 4 types :
• A)implied consent
• B)informed consent
• C)valid consent
• D)written consent

81. a) Implied consent:
It is a type of consent where the patient indicates agreement
to examination by lying in the dental chair and opening the mouth.
b) Informed consent:
It requires a full explanation of the nature, purpose and
material risks of the proposed procedures in a language that the
patient understands. The patient should have opportunity to
consider information and ask questions in order to arrive at a
balanced judgement of whether to proceed with the proposed
treatment.

82. c) Valid Consent:
For consent to be valid it must be specific, informed and
normally be given by a patient or a parent or a guardian.
d) Written consent:
Most countries in which dental law is an evolved concept
require written consent to be taken for major procedures.
Eg: In Implantology, wisdom teeth removals, sedation etc.
Written consent is all the above with a signature of the patient
essential. Written consent is important but cannot be
considered a substitute for obtaining valid consent.

83. The Health Care Consent Act, 1996 Ontario included obtaining
the following salient features for informed consent:
Nature of proposed treatment
Expected benefits
Material risks and side effects
Alternative courses of action
Consequences of not having the proposed treatment
Answers to any questions the patient has regarding the
proposed treatment
Cost of the treatment

84. Vulnerable Populations-
‘Any participant who cannot make voluntary decision to
participate or is unable to understand the research, especially the
procedures and risks, may be vulnerable.’

85. Vulnerable populations :
• Research on genetics should not lead to racial inequalities.
• Persons who are economically or socially disadvantaged should not
be used to benefit those who are better off than them .
• Rights and welfare of mentally challenged and mentally differently
able persons who are incapable of giving informed consent or those
with behavioral disorders must be protected .
• Adequate justification is required for the involvement of participants
such as prisoners, students, subordinates, employees, service
personnel etc. who have reduced autonomy as research participants .

86. 1) Children-
• The definition of minor varies from state to state. In order for
children to participate, the LAR must give informed permission
for the child to participate.
•For a minimal risk research or for greater than minimal risk
research with the potential for direct benefit to the child, the IRB
may determine if one/two parents / guardians signature is required

87. •. For greater than minimal risk research with no benefit, two
signatures are required unless 1 parent is deceased, unknown,
incompetent, not reasonably available, or not a custodial parent.
While parents or LAR’s give parental permission, children are
not able to give legal consent.
•When possible it is the best to obtain the agreement of the child
to participate. This agreement is called Assent and contains
information in terms and details that the child can understand.

88. 2) Pregnant and nursing women, human foetus,
and neonates
• Each of these groups has specific requirements.
• The regulations require both preclinical trials and specific
assessment of risks and benefits to both the mother and the foetus.
• women should not be encouraged to discontinue nursing for the sake
of participation in research and in case she decides to do so, harm of
cessation of breast-feeding to the nursing child should be properly
assessed. Compensation in terms of supplying supplementary food
such as milk formula should be considered

89. Examples:
• To test the efficacy and safety of a drug for reducing perinatal
transmission of HIV infection from mother to child, trials for
detecting foetal abnormalities and for conditions associated
with or aggravated by pregnancy etc.
• Research related to termination of pregnancy : Pregnant
women who desire to undergo Medical Termination of
Pregnancy (MTP)
• Research related to pre-natal diagnostic techniques :should be
limited to detect the foetal abnormalities or genetic disorders
as per the Prenatal Diagnostic Techniques

90. Prisoners
• They require additional protections because they have
decreased autonomy and are subject to much potential
coercion. IRB review for these protocols must include a
prisoner representative on the panel.
• IRB must be notified and unless there is a direct benefit to the
participant all research activities must stop until the IRB can
review the protocol with the prisoner guidelines and must not
resume until all requirements are met.

91. 4) Individuals with impaired decision making capacity :
• Limited decision making capacity covers a broad spectrum. It may be
temporary such as after a shock or trauma or permanent and may be
variable in an individual.
• In such cases, investigators must plan for their participation, especially
how competence and understanding will be assessed; the method for
enrolment and retention and the IRB should give careful scrutiny to
plans.
• LARs will need to consent for individuals unable to give their own
consent.

92. • Because of chance or element of the unknown that ethics
become a paramount issue in those experiments that involve
human subjects.
• Medical professionals increasingly find themselves confronted
with moral questions and ethical dilemmas.
• New scopes of understanding and application of research
ethics may be needed to promote the medical profession

93. References:
1) Soben Peter. Preventive and Community Dentistry. 4th edi. New
Delhi: Arya Medi Publishing House. 2010.
2) James T Rule, Robert M Veatch. Ethical Questions in Dentistry.
2nd edi. Quintessence Publishing. 2004.
3) British Dental Association “Ethics in Dentistry” BDA 2000.
4) Anil Sharma et al. Patient Consent in Dentistry: Are we Legally
Safe? JOHCD May 2011;5(2)
5)William V Giannobile –Clinical research in oral health –john
willey and sons -2010.
6)Web references and images

94. Previous year questions
Long essay :
• Ethical considerations in medical and dental research(2006)
Short essays :
• Ethical considerations in clinical research

95. • Thank you