Research Ethics

Handout for Graduate Students of the College of Health

and Medical Sciences (COHMS), Haramaya University

For the protection of Human

Subjects

By Negga Baraki,
Haramaya University, COHMS,
Harar, June 2019
 OBJECTIVES

• Internalize the concepts and rationale

of research ethics.
• Equip with the knowledge of the
essential ethical principles.
• Acquaint the required formalities to
fulfill for ethical review.

2
Introduction

3
 Some Definitions

1. Research: Is a systematic investigation

including research development, testing and
evaluation designed to contribute to
generalizable knowledge.
2. Human subject (research participant): is a
living individual about whom an investigator
conducting research obtains data through
intervention or interaction with the
individual, or identifiable private
information.
4
3. Ethics: Is the branch of philosophy that deals
with distinctions between right and wrong-
with the moral consequences of human
actions.
4. Health Research Ethics: Scientifically
rationalized and substantiated codes of
moral principles and practices with respect
to design, formulation, implementation, and
dissemination of any health research
undertaking.
• It may be legally enforced or not.
5
6
 Ethics: Historical Perspectives

• Babylonian surgeons were rewarded or punished for the results

of their efforts

• Religious moral/ norms: Doing good/ not intend to harm people

• Greek philosophy and practice (Hippocratic Oath)

• Handling of Prisoners of War (POW)–Nuremberg Code and War

Crimes Trial

• UN System and the “Codes of Rights”: e.g human rights and

rights to health

• Tuskegee experience: Belmont Report

• World Medical Association: Helsinki Declaration, and others.

7
Examples:
A. Hippocratic Oath

• Primum non nocere

• Above all, do no harm.

8
B. Nuremberg War Crimes
• Court trials were made for Nazi doctors
in Nuremberg (a city in Germany)
around 1945/46 after the 2nd world war
for medical experiments conducted
among civilians and Allied forces under
the custody of the German Reich
(German empire/Nazi Germany).

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Hitler and his Nazi SS

10
Nazi Medical Experiments…

• Several inhuman experiments were

performed on people under the custody
by the Nazi brutal. These include:

– High altitude experiments: conducted in

low pressure chambers that approximate
pressure at extremely high altitudes.

12
Nazi Medical Experiments…

– Freezing experiments: subjects remained

in ice tanks for 3 hours, severely chilled
and re-warmed.

– Malaria experiments: healthy humans

were infected with malaria through
infected mosquitoes.

13
Nazi Medical Experiments…

Low pressure experiments

14
Nazi Medical Experiments…

Freezing Experiments

15
Nazi Medical Experiments…

– Gas Experiments: wounds inflicted on

subjects affected with poison gas.

– Sulfanilamide experiments: wounds

infected with bacteria like streptococcus,
tetanus aggravated by forcing wood
shavings or glass and treated with
sulfanilamide.

– Bone, nerve, muscle transplantation from

one person to another.
16
Nazi Medical Experiments…

17
Nazi Medical Experiments…

– Sea water experiment: subjects deprived

of food and given chemically treated water.

– Epidemic jaundice experiment: subjects

infected with jaundice.

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Nazi Medical Experiments…

– Sterilization of subjects by means of x ray,

surgery and drugs

– Spotted fever (typhus) germs infected

healthy subjects to develop vaccine

19
Nazi Medical Experiments…

– Poison mixed with food or subjects shot

with poison bullets to investigate effects of
various poisons.

– Incendiary (inflammable) bomb

experiments: Burns inflicted on subjects
by using phosphorous from bombs then
treated with various drug preparations

20
Nazi Medical Experiments…

• The Nuremberg tribunal (court)

condemned the experiments and
established Nuremberg Code (a code of
ethics regarding research on human
subjects).

21
 Nazi Medical War Crimes

In December 1946,
 23 physicians and administrators, were indicted
before the War Crimes Tribunal at Nuremberg for
their willing participation in the systematic torture,
mutilation, and killing of prisoners in experiments. 

 Despite arguments by the physicians that the

experiments were medically justified, the Nuremberg
Military Tribunals condemned the experiments as
"crimes against humanity“.

22
Nazi Medical War Crimes …

August 1947 Verdict:

– 16 out of 23 physicians were found guilty and
imprisoned,

– 7 were sentenced to death. 

– The judges included a section called "Permissible

Medical Experiments“. 

– This describe allowable researches on human subjects,

and the necessary indications.

– This section became known as the Nuremberg Code and

has formed the basis for ethics codes internationally.
23
Nazi Medical War Crimes …

24
C. The Tuskegee Syphilis Study on
blacks : The Belmont Report

• The most notorious example in the US of prolonged

and known violations of the rights of vulnerable
people (which occurred after the 2nd world war).

• Long-term study on black males conducted at

Tuskegee [Alabama] by the United States Public
Health Service. 

• Study initiated in 1932 as an examination of the

natural history of untreated syphilis; it continued
until 1972.
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The Tuskegee Syphilis Study on blacks…

• More than 400 black men with syphilis

participated, and about 200 men without
syphilis served as controls. 

• The men were recruited without informed

consent and, in fact, were misinformed
that some of the procedures done in the
interest of research (e.g., spinal saps)
were actually "special free treatment."

26
The Tuskegee Syphilis Study on blacks…

27
The Tuskegee Syphilis Study on blacks…

• By 1936, it was apparent that many more infected

men than controls had developed complications,
and

• 10 years later, a report of the study indicated that the

death rate among those with syphilis was about
twice as high as it was among the controls. 

• In the 1940s, penicillin was found to be effective in

the treatment of syphilis. 

• The study continued, however, and the men were

neither informed nor treated with the antibiotic. 28
The Tuskegee Syphilis Study on blacks…

• The first accounts of this study appeared in

the national press in 1972.

• The resulting public outrage led to the

appointment of an ad hoc advisory panel by
the Department of Health, Education and
Welfare (DHEW) to review the study and
advise on how to ensure that such
experiments would never again be conducted. 

• The ad hoc advisory panel produced a report

which is cited as the Belmont Report.
29
Belmont Report

• Among the recommendations of the ad hoc

advisory panel was the request that
Congress establish a "permanent body
(Federal Wide Assurance/Ethical Boards)
with the authority to regulate, at least, all
Federally supported researches involving
human subjects.“

• Government continues to compensate

surviving participants and the families of
deceased participants.
30
The Belmont Report…

• In the 1950s and 1960s, Federal funding for biomedical

research increased dramatically. 

• Along with increased interest and funding, there was

heightened public concern about research abuses such as
the Tuskegee Study and other reported biomedical abuses.

• Following the ad hoc committees’ recommendation (belmont

Report) the US has organized a Federal Wide Assurance
(FDA) system to ensure all US Government funded
researches should be approved for ethical considerations.

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 AIM OF RESEARCH ETHICS
• The cardinal aim of research ethics is the
protection of human subjects from
any form of harm/risk.

• This will be ensured through the role ethical

committees play at different levels and the
trust endowed to researchers.

32
Implications of not adhering to ethical principles in research
“A Serious Matter”
• Breaches of ethical guidance and codes, or significant
deviations from the research proposal originally approved,
may cause harm to your participant(s).

• In addition, these may be taken as serious matters within the

University and the wider community and the government.

• Typical repercussions could be:

– failure at examination (academic dishonesty);
– removal of professional accreditation;
– refusal to publish results of the study;
– removal of funding for research;
– damage to the academic and ethical reputation of yourself and the
University/your institution.
33
 The Three Basic Ethical Principles

1. Respect for autonomy

• a norm of respecting the decision-making
capacities of autonomous persons.
2. Beneficence and Non-malificence:
• Beneficence: a group of norms for providing
benefits and balancing benefits against risks and
costs.
• Non-maleficence: a norm of avoiding the
causation of harm (do no harm).
3. Justice
• a group of norms for distributing benefits, risks,
and costs fairly.
34
 Basic Ethical Principles:
A. Respect for Autonomy

Voluntary participation:
• Free, adequately informed and consented
decision for participation or decline.
• It has to be free of any forms of coercion
and, undue and unjustifiable influences.

Confidentiality (and privacy):

• Protecting and safeguarding consented
data or details, information, interest, etc.
35
Respect for autonomy…

Autonomy has diverse meanings:

• Self governance
• Privacy
• Individual choice
• Freedom of the will
• Causing one’s own behavior
• Being one’s own person

36
 Respect for Autonomy…

Protection of persons with diminished and

impaired abilities:
• Non matured or minors (children and
adolescents);

• Persons with disability (mental impairments);

- Persons in confinement (e.g. prisoners).

Special protection to avert undue subjection as

well as having lawful guardians on the behalf.

37
Respect for autonomy…

• A person of diminished autonomy is in some

respect controlled by others or incapable of
deliberating or acting on the basis of his/her
desires and plans.
E.g. prisoners and mentally retarded
individuals, students

– Mental incapacitation limits the autonomy

of the retarded person

– Coercive institutionalization constrains

the autonomy of prisoners

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Respect for autonomy

Moral rules
1. Tell the truth
2. Respect the privacy of others
3. Protect confidential information
4. Obtain consent
5. When asked, help others make
important decisions

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 Informed Consent Process

• Recruitment (identification of research

participants)

• Explanation of research (give adequate

information in the language the person
understands)

• Confirmation of understanding

• Documentation of agreement (written and

signed)
40
 Requirements for Informed Consent
1. Competence
– One gives an informed consent if (and perhaps only

if) one is competent to act

2. Disclosure
– receives a thorough disclosure and comprehends
it (nothing has to be concealed to the participant)
3. Understanding
– is able to understand the situation well
4. Voluntariness
– acts voluntarily, and
5. Consent
– consents to take part in the research 41
 Disclosure

In research disclosures should generally

cover:
• the aims and methods of the research,
• anticipated benefits and risks,
• any anticipated inconvenience, risk or
discomfort, and
• the subject’s right to withdraw, without
penalty from the research

42
 Consent by Surrogates

• Parents are considered surrogates for

their minor children

• Spouses for one another

• Adult children for parents when parents

are lacking

• Adult grand children for grand parents

43
 Contents of the Consent Form

The participant information sheet and voluntary

consent form need to include the following:
• Identification of the researcher and the
research title

• Identification of the sponsoring institution

• Indication of how the participants were

selected

• Identification of the purpose of the

research
44
 Contents of the Consent Form
• Identification of the benefits for participating
• Identification of the level and type of participant
involvement
• Notation of risks/benefits to the participant
• Steps to ensure privacy and confidentiality
• Guarantee of confidentiality to the participant
• Assurance that the participant can withdraw at
any time
• Provision of names of persons to contact if
questions/concerns arise (contact address)
• Verification of informed voluntary consent
(signed)
45
 The participant information sheet and
consent form template
Please read the provided template and comprehend
its:
• Title
• The contents
• The general aim
• Flow
• Who should be addressed
• How it is addressed and
• The need of translating it to local languages
46
 Privacy and Confidentiality

• Privacy—limited access to an
individual and to information about that
person

• Confidentiality—how access to and use

of private information is structured

47
 Confidentiality

• Confidentiality is necessary in diagnostic,

therapeutic and research context

• Confidential information is both private and

voluntarily imparted in confidence and trust

• If research subject authorizes release of the

information to others, then there is no
violation of rights or confidentiality

48
 Confidentiality…

• Personal/group data, if disclosed to third

parties, may cause harm or distress.
• Investigators should make arrangements for
protecting the confidentiality of such data by:
– Omitting information that might lead to
identification of individual subjects
– Limiting access to the data by any means.
• When personal identifiers remain on records
used for a study, investigators should explain
why this is necessary and how confidentiality
will be protected
49
 Potential Breaches of Confidentiality

• During data collection

– Knowledge of participation
– Overhearing interviews
– Access to names, identifiers
• Data protection during and after
analysis
– Identifying information
– Paper storage
– Computer security
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 B. Principle of Non-Maleficence and Beneficence

i. Non-Maleficence:
Minimizing harm-considerations
• Respect for local priorities and resource use
• Avoid stigmatization, prejudice, economic loss
• Prepare research staff for special situations
• Propose measures against eminent risks during the
study
• Avoid harmful publicity
• Respect local social and cultural norms
• Confidentiality
• Disclosure of conflict of interest
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 Types of harm
• Physical

• Psychological

• Financial

• Harm to ones reputation (name/dignity)

52
ii. Beneficence: Types of Benefits

• Individual/ Direct benefits

• Community/ Societal benefits

53
Types of Benefits…

• Individual/ Direct benefits—research

subject gets something from
participation that he/she would not get
otherwise

• Examples—access to medical care

information from a blood test, chance to
talk about an important issue, learn a
new skill

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 Types of Benefits…

• Community/ Societal benefits:

– Contribution to basic scientific knowledge

– Development of new product, technique

– Information for decision-making

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 Principles of Beneficence

• Is the ethical obligation to maximize possible

benefits & minimize possible harms (90/ 10)
• The risks of research must be reasonable
in the light of the expected benefits
• Use sound research design, and involve
competent investigators to conduct the
research and to safeguard the welfare of
the research subjects
• No deliberate infliction of harm on persons

56
Principles of Beneficence…

Maximizing benefits: considerations

• Communication of study results

• Provision of health care

• Training of local health staff

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 C. Principle of Justice

• Is the ethical obligation to treat each person

in accordance with what is morally right
and proper

Distributive justice - equitable distribution of

both the burdens and the benefits of
participation in research

• Special provision for the protection of the

rights and welfare of vulnerable persons.
58
Principle of Justice…

• Cases considered to be alike should be

treated alike

• Cases considered to be different

should be treated in ways that
acknowledge the difference

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Principle of Justice…

• Studies should be designed to obtain

knowledge that benefits the class of persons
of which the subjects are representative

• The class of persons bearing the burden

should receive an appropriate benefit, and

• The class primarily intended to benefit

should bear a fair proportion of the risks and
burdens of the study

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 Vulnerable Subjects

• It is about ability to give informed consent.

–Children—assent and parental permission

–Cognitively impaired—determination of
ability to give consent, proxies

–Comatose or unconscious patients—

proxies
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Vulnerable Subjects…

Voluntary consent/absence of coercion

–Prisoners
–Students
–Employees
• Heightened risk
–Pregnant women
–Sick people

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Vulnerable Subjects…

• Justice (equitable distribution of risks,

benefits):

– Women
– Elderly
– Racial/ethnic minorities
– Economically disadvantaged
– Terminally ill people

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 JUSTICE: COMPONENTS

• Ensure local participation and

community involvement
• Fair and sound selection of research
participants
• Justified use of placebo and
randomization
• Provision of standard care for research
participants
• Compensation of research participants
• Clear dissemination procedure
64
• Clear memorandum of understanding
and terms of reference in respect to:
– (a) authorship for publications;
– (b) Intellectual property right
• Specifications on post trial
responsibilities
• Permission for sample handling,
transport, storage, and use

65
 Essential procedures in Ethics
(1)Passage through an Independent Ethical
Review, Approval and Clearance system
(as appropriate).
 Institutional
 Regional
 National

(2) Putting in place Progressive Monitoring

about the Ethical Conduct.

66
 MAJOR HEALTH RESEACH ETHICS GUIDELINES
(An OVERVIEW of the sources)

1. Nuremburg Code
2. Declaration of Helsinki
3. Belmont Report
4. International Ethical Guidelines for
Biomedical Research
5. Operational Guidelines for Ethics
Committees that Review Biomedical
Research and National Guidelines
67
 (1) Nuremberg Code

Historical Precedence:
– World War II – Nazi experimentation
– Promulgation 1947 by the then Allied
Nations

68
 Nuremberg Code: Directives for Human Experimentation

1. The voluntary consent of the human

subject is absolutely essential.
2. The experiment should be such as to
yield fruitful results for the good of
society.
3. The experiment should be so designed
and based on the results of prior animal
experimentation and a knowledge of the
natural history of the disease.
69
Nuremberg Code…

4.The experiment should avoid all

unnecessary physical and mental suffering
and injury.

5. No experiment should be conducted

knowing that death or disabling injury will
occur.

6. The degree of risk to be taken should never

exceed benefit from the experiment.
70
Nuremberg Code…

7. All measures be ready to protect the

experimental subject against even remote
possibilities of injury, disability, or death.
8. The experiment should be conducted only

by scientifically qualified persons.

9. During the course of the experiment the
human subject should be at liberty to
bring the experiment to an end (right to
withdraw).
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 Nuremberg Code...

10. The experiment shall be terminated at

any stage, if continuation of the
experiment is likely to result in injury,
disability, or death to the experimental
subject.

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 (2) The Helsinki Declaration
• Adapted by the 18th World Medical
Association (WMA) general assembly,
Helsinki, Finland, June 1964.

• Amended by the WMA general

assembly 8 times (1975 to 2008).

• Was developed by the WMA for use by

the medical community following
dissemination of the Nuremberg
Code.
73
• 1st significant attempt by the medical
community to regulate itself

• Like the Nuremberg Code, the Declaration

made informed consent a central
requirement for ethical research while
allowing for surrogate consent when the
research participant is incompetent,
physically or mentally incapable of giving
consent, or a minor.
74
The Declaration of Helsinki…

• Two category of Principles:

–Principles for all medical research
[No.11-30]

–Additional principles for medical

research combined with medical care
[No.31-35]

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The Helsinki Declaration-Principles

• Independent review of experimental

research protocols;

• Participation consideration for the less

than fully autonomous subjects;

• Assessment of the benefit/risk balance

by participant and science and society;
76
The Helsinki Declaration Principles…

• Detailed description of critical information

a prior the consent fulfillment by the
research participant;
• Importance of written consent format;
• Disclosure of conflicts of interest;
• Avoidance of coercion;
• Consents of minors and others;
• Inclusion of a novel sanction for those
investigators who violate the declaration.
• Waiver on consent.
77
 (3) The Belmont Report
Evolution/Source:

• US National Commission for the

Protection of Human Subjects of
Biomedical and Behavioral Research.
• Initially adopted on April 18, 1979.
• Later, supplemented by the US National
Bioethics Advisory Commission.
• Comprises of three basic principles of
ethics

78
The Belmont Report…

i. Respect for Persons

– individuals should be treated as autonomous
agents
– persons with diminished autonomy are entitled
to protection.

ii. Non-maleficence and Beneficence.

– do no harm; maximize possible benefits

iii. Justice: fairness in distribution of benefits and

risks

79
 (4) International Ethical Guidelines
for Biomedical Research
Evolution/Source
• Council for International Organizations of
Medical Sciences (CIOMS) in collaboration
with WHO.
• 1982 with a revision in 1993.
• Unique emphasis on the amendments and
application aspects of the Declaration of
Helsinki in light of the special circumstances
of many developing countries.

80
Principles
• Address the problem of research in
developing countries sponsored by
external agencies.
• Recognize the primacy of local
concerns when evaluating the objective
of the research protocol.
• Specific recommendations with respect
to medical care for research participants
and compensation in case of injury.

81
• Specifically addresses items such as
information to be given, opportunity to
ask questions, issues of deception,
undue influence, intimidation,
documentation and continuing consent.

82
• Independent review in addition to the
informed consent.

• Recognition of cultural and legal

variability by settings and thereof
certain limitations of international
guidelines.

83
 (5) National Health Research Ethics
Review Guideline

An operational guideline last revised 2014 (5th Edition,

Sept.,2014).
• Encompasses respect for ethical principles.

Specifications:
• The role of ethics review committees
– Establishment of an ethical review system
– Constitution of an ethical committee
– Application and submission for ethics review
• Review process
– Decision-making and communicating
– Follow up
– Documentation
– Material transfer agreement 84
 Institutional Review Board

• At least five members

• At least one non-scientist
• At least one person unaffiliated with organization
• Consideration of gender
• Experts in areas of research conducted by
organization
• Registered at the Secretariat of the Federal Science
and Technology Ministry/now renamed as Federal
Ministry of Innovation and Technology (the National
Health Science and Technology Council-NHSTC)

85
 Types of Ethical Review

Exempt review—no risk

– Determination made by IRB chair
Expedited review—minimal risk
– Complete review by IRB chair or one
designated member
Full committee review—greater than
minimal risk
– All committee members conduct review
86
Criteria for a research to be Ethical
For research to be ethical the following eight
criteria must be met:
1. Ethical justification and scientific validity:
Rigorous methodology
2. Science and social value: Valid scientific basis
for a generalizable knowledge and benefit
individuals and the community.
3. Favorable risk-benefit ratio to research
participants and their communities.
87
4. Fair selection and enrollment of human
subjects: The justification for selection and
the equitable nature of distribution of
research subjects.
5. Privacy: Privacy and confidentiality
maintained, opportunity to withdraw at any
time or refuse components
6. Independent IRB review: Individuals not
affiliated with the research/ no conflict of
interest

88
7. Informed consent process: Information provided to
the research participants should be complete and
appropriate to the participants’ level of
understanding, entirely voluntary informed consent,
without coercion, manipulation, undue influence or
intimidation.
8. Community engagement: Research is quite often
generalized to the community from which individual
participants are drawn from.
 Such generalization can result in different positive or
negative impacts to the community in terms of stigma,
resource drainage, health outcomes, and more.
 Hence, researchers are encouraged to involve the
community in decision making about design and conduct of
the study. 89
 Criteria for Approval

• Scientifically sound methodology

• Risks to subjects are minimized
• Risks are reasonable in relation to any anticipated
benefits
• Selection of subjects is equitable
• Informed consent will be sought
• Informed consent will be appropriately documented
• Privacy is protected
• When appropriate, safety monitoring is provided
• Appropriate safeguards are in place if vulnerable
subjects are involved

90
 Weighing the Science

• A poorly designed study will not answer

the research question/hypotheses and is
therefore, unlikely to have a benefit.

• A well-designed but high risk study that

addresses minor issue is likely to have
benefits of less weight than the risks.

91
 Checklist for Ethical Review by the
National Ethics Review Committee
• Adhering to standard protocol format
• Signature of investigators
• CVs of investigators
• Institutional and or regional ethical clearance
• Ethical clearance from initiating country or countries
• Consent form
• Material transfer agreement if applicable
• Proposal
• Clear objective scientifically and ethically sound
methodology
• Ethical consideration (provision of standard care, risk/benefit
ratio, voluntary participation, confidentiality, etc

92
 What does the IHRERC observe for ethical
approval?
Tries to see A to Z of the protocol.
• Clarity and appropriateness of the research
title
• Format and organization of the document
– Standard format
– Scientifically organized
• Clarity of the problem statement
• Clarity of objectives
93
• Appropriateness of supportive evidences
(literature review)
• Appropriateness of the study design and
methods to meet the stated objectives
• Sample size determination, sampling
technique, representativeness for
generalizability and data collection techniques .
• Ethical considerations (risk benefits)
• Language (grammar) usage
• Acknowledgment, citations of references

94
• Appropriateness of the tools for data collection.
• Recentness/up-to-dateness and appropriateness of
references (who, when and where questions)
• Sound cost estimates (prevent misuse of public money in
the name of research)
• Technical capacity of the researcher
• Considerations of local language usage ...and the like

• In general the IHRERC tries to ensure the proposal is

methodologically and ethically sound and does respect the
rights of participants and no foreseeable harm is there.

95
 Participant information sheet and
consent form

• Template is distributed (word

document)
• Please preserve the template to use it
in your research thesis proposal
development.

96
 Guidelines for research ethics applicants
• Sample content flow guideline is distributed
in the class (Standard for the COHMS,
Haramaya University).
• Please preserve the guideline to use it in your
research thesis proposal development.
• Not adhering to the guideline may result in
unnecessary delay in the approval process.

97
 Note:
• Any research that involves invasive procedures like
randomized clinical trials or researches funded/ sponsored by
international organizations or foreign governments, shall
finally be approved by the National Health Research Ethics
Committee or a designated IRB after acceptance by the
IHRERC.

• Regional Health Research Ethics Committees may also

enquire for re-approval of any research in their region which
is their right according to the National Guideline.

• A well scrutinized protocol (methodologically and ethically

well prepared document) takes short time for approval at any
level of review.
98
 Ethical considerations conclusive
brief summary
• There are several ethical issues that must be
considered when designing research that will
utilize participants who are human beings.

99
• Respect for persons: anonymity is difficult to maintain
in the 21st century; therefore, it may be useful to
inform participants, particularly in case studies,
of possible identification through tracing and then ask
them to agree to participation with that stipulation.  

• Beneficence: enumerate the potential benefits and

harm to participants: 
– new techniques should be beneficial...expected to improve
our understanding of...

• Justice ensure that participants have fair access to

benefits
• Inform participants of research procedures:
– Data collection tools
– Data collection instructions, and duration
– Potential disruptions during data collection
– Who has data access and for how long?
– Steps to promote anonymity
– Steps for removing participants and their data
from the study
– Potential for participants to review their data
verbatim

101
Ethical approval for research:

• This is a license to go ahead with research.

• Typically, a social or educational researcher will need to

submit a proposal to their college or university ethics
committee, where it will be reviewed in terms of the
appropriateness of its design given the research aims, and
the impact of that design on human participants.

• If granted, the ethical approval is in effect a license that

merely permits one to seek 'informed consent' from
potential participants.

102
Informed consent:
• This refers to participants' agreement that they are
willing to take part in the research, having been told
what they will be expected to do during the research.

• They must be given enough information about what

they will be expected to do during the research
procedure that they can reasonably make an informed
decision about whether they agree to participate or not.
• They may also be given time to contemplate/seek advice
before they decide.

• There should be no compulsion/pressure to participate,

although positive incentives can be offered.
103
Rights of participants to withdraw:

• Participants need to be told that they are allowed to

withdraw from research at any time and to have any data
collected from their participation destroyed.

• They can withdraw at any time, before, during and even after
they have participated.

• Clearly, if too many participants withdraw, the quality of the

research will suffer.

• For this reason it is important to make sure that they have

been provided with good information when asking for their
informed consent.
104
NRB
/RRB