Research Ethics

Introduction

Ethics comes from the Greek word; ethos means the ‘character’ or’ moral’. It is
set of rules of conduct which might or might not be written and it does not have
attributes of a law. For example, doctors have unwritten ethical rules or practices
that they adhere to because it's the right thing to do but it's not a law that he
has to.

Research ethics refers to the application of fundamental ethical principles to

steps in scientific research process. It Provides guidelines for the responsible
conduct of biomedical research. It also educates and monitors scientists
conducting research to ensure a high ethical standard.

The ethics of scientific research is somewhat unique within professional ethics

in the sense that good science requires the ethical practice of science. Health
research has played a significant role in minimizing the burden of various
diseases. Health research aims at solving health and health related problems. At
the same time, it has also raised ethical questions. Public attention was drawn
to ethical questions by reported abuses of human participants in biomedical
experiments especially during the Second World War. Since then ethics has
become an evolving issue which has drawn global attention.

Some documented unethical studies (reading assignment)

1. Nazi medical experiment

2. The Tuskegee syphilis study
3. The Willow brook study
4. The Jewish chronic disease hospital study

Basic Principles of Bioethics

i. Respect for a person

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Respect for persons addresses three main ethical considerations such as respect
for autonomy, informed consent and confidentiality.

a. Autonomy

This principle aspires to protecting the multiple and interdependent interests of

the person _ from bodily to psychological to cultural integrity. It refers to the
obligation on the part of the investigator to respect each participant as a person
capable of making an informed decision regarding participation in the research
study. This recognizes the capacity and rights of all individuals to make their
own choices and decisions.

b. Confidentiality

The second very important research ethic is the participants right of privacy
through our assurance of confidentiality. The researcher(s) shall assure that
information that has been obtained in the course of investigation remains
confidential to protect participants from possible harm at the revelation of such
information. Data unlinked from individual(s) or group(s) does/do not jeopardize
confidentiality. The privacy of individual participant needs to be kept throughout
the investigation by the researcher(s).

It is the principle of ‘safe guarding’ the personal information which has been
gathered in a study. Never report data about an individual without explicit
permission. Contained in this principles is also a duty to store data safely and
explain to participants who will have access to their data & sharing of data with
others.

c. Informed Consent

Whenever you are proposing research with human participants you must provide
a form, known as an Informed Consent Form (ICF), with each proposal to indicate
that the research participant has decided to take part in the research of her/his
own free will.

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It is also called voluntary participation and requires freedom from coercion and
undue influence

If the research involves more than one group of individuals, for example
healthcare users and healthcare providers, you must provide a separate
informed consent form for each group which has been tailored specifically for
them. This ensures that each group of participants will get the information they
need to make an informed decision. For the same reason, each new intervention
also requires a separate informed consent form.

The importance of informed consent of research participants is unquestionable

and should be analyzed in terms of containing the three basic elements i.e.
information, comprehension and voluntarism.

Information: Sufficient information should be given on research procedure,

duration, purpose, risks and anticipated benefits, the opportunity to ask
questions and to withdraw at any time. Truthful answers should always be given
to direct questions about the research.

Comprehension: The manner and context in which information is conveyed is as

important as the information itself. Example: The following may adversely affect
subject's ability to make an informed choice:

Presenting information in a disorganized and rapid fashion, and allowing too

little time for consideration or curtailing opportunities for questioning

Voluntariness: The participant's consent to participate must be voluntary free of

any coercion or promises of benefits unlikely to result from participation.

The information shall be given in writing and signed by the participant. When
the informed consent is that of a third party, the reasons for the indirect
approach shall be stated and be part of the protocol.

The consent form has two parts: (a) an information sheet describing the research
and the nature of the participant's involvement in it, and (b) a certificate of

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consent attesting to the participant's consent. Both parts should be written in
sufficiently large letters and in simple language so that the participant can easily
read and understand the contents.

The information sheet should be written in third person (e.g. "you will meet with
the researcher…") whereas the certificate of consent should be written in first
person (e.g. "I have been informed that…."). Medical terminology should be
avoided in writing up the informed consent form.

The information sheet is given or read to each prospective participant. Any

questions the participant may have are then answered and, if consent is given,
the certificate is signed by the participant. If consent is oral, the certificate is
signed by a literate witness who was present when the information was read to
the participant and who confirms that the information was understood, and
consent was given freely. The researcher/staff member who provided the
information to the participant also signs the certificate, likewise confirming that
the information was provided and understood, and that consent was voluntary.
A signed certificate of consent must be obtained in this way for each participant
admitted to the research study and a copy of the entire informed consent form
must be offered to the participant.

When research involves children or people considered to be unable or not

competent to sign for themselves, a consent from a parent or guardian is
required. However, children or others considered to be unable to sign for
themselves, should be given the opportunity, where at all appropriate, to have
their permission or concerns recorded as well. This is known as Assent and there
is a separate form for the recording of assent. The minor child should be given
appropriate information based on the child’s level of comprehension whatever
the complexity of the research procedures. The age at which assent is required
depends upon local legal requirements or, in their absence, upon both the local
culture and the content of the research. For instance, as per the Ethiopian
national ethics guideline, assent should be sought from a study participant

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under the age of 18 years old. An assent, a child’s affirmative agreement to
participate in research shall be sought from all children 12 years of age and
above, in addition to the consent of a parent, next-of-kin, or guardian.

In general, researchers should consider obtaining assent from children over 7

years with mandatory assent required from the age of 12. Assent which is denied
must be taken very seriously.

The consent form, particularly an information sheet, for research need to include
the following contents.

 Identification of the researcher  Notation of risks to the

 Identification of the sponsoring participant
institution  Guarantee of confidentiality to the
 Indication of how the participants participant
were selected  Assurance that the participant
 The purpose of the research can withdraw at any time
 The benefits for participating and  Provision of names and addresses
community at large of persons to contact if questions
 Identification of the level and type arise
of participant involvement

The Certificate of Consent is the second part of the Informed Consent Form and
is not a stand-alone document. By presenting it as a continuation, or part two,
of the informed consent rather than as its own separate document, both
researchers and participants can be assured that the information about the
study and about the participant's rights have been shared with the participant.

The certificate of consent should be written the first person (e.g. "I have been
informed…") and should have a paragraph such as the following:

I have read the foregoing information, or it has been read to me. I have had the
opportunity to ask questions about it and any questions that I have asked have

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been answered to my satisfaction. I consent voluntarily to participate as a
participant in this study.

The informed consent document is to be signed and dated by the participant or,
when the participant is illiterate or physically unable, by a literate witness who
ascertains that it was understood and confirms that consent was given freely.
Whenever possible, the witness should be selected by the participant and he/she
should not be connected with the research team. Whenever feasible, the
recruitment of illiterate participants should take place in the presence of a
literate witness. The witness and the researcher each sign under a statement
such as the following:

I have accurately read or witnessed the reading of the consent form to the potential
participant, and the individual has had the opportunity to ask questions. I confirm
that consent was given freely.

ii. Beneficence

Beneficence is participants are treated in an ethical manner not only by

respecting their decisions, but also protecting them from harm and making
efforts to secure their well-being. Two general rules have been formulated as
complementary expressions of beneficence these are do not harm and maximize
possible benefits and minimize possible harms. The Hippocratic oath that stated
“do no harm” has remained a fundamental principle of medical ethics. This was
extended to the act of research, i.e., one should not injure study participants
regardless of the benefits that might come to others.

The role of the principle of beneficence is sometimes ambiguous, e.g., a study

that presents more than minimal risk without immediate prospect of direct
benefit to the children involved. There can be two different scenarios with regard
to decisions. One scenario is that the research should not be allowed, while the
other is that this limit would rule out much research promising great benefit to
children in the future. This could make the choice difficult. Beneficence has two
components: benefits and risks.

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iii. Justice

Justice connotes fairness and equity, and concerns in the distribution of benefits
and burdens of research. Generally, Justice does not mean treating all
individuals the same. Kitchener (1984) points out that the formal meaning of
justice is "treating equals equally and unequal unequally but in proportion to
their relevant differences" (p.49). It also demands equitable selection of
participants, i.e., avoiding participant populations that may be unfairly coerced
into participating, such as prisoners and institutionalized children. Injustice
may arise when selecting participants only from a specific socio-economic class,
age, sex, racial, cultural, and institutional make up.

iv. Non-maleficence

The principle of nonmaleficence holds that there is an obligation not to inflict

harm on others. It involves an ethical and legal duty to avoid harming others. It
is based on Latin maxim primum non nocere or “First do no harm”. The principle
of nonmaleficence supports the following rules:

 Do not kill.  Do not incapacitate.

 Do not cause pain or  Do not cause offense.
suffering.
v. veracity

veracity is the ethical principles of telling the truth. Researchers must be honest
to his/her subjects about potential risks and benefits, the right to decide whether
to participate or not and withdraw at any time from study.

Importance of ethics in research

Ethics has the following major importance in research.

 To safeguard the study participants from any harm related to research

 To make sure that research participants are voluntarily participating in
the study with written informed consent.

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  To assure that individual/community benefits and civil rights are being
respected and fairness is maintained.
 To monitor and evaluate ongoing & post research implications on the
participants and the community
 To ensure justice to research participants
 To ensure the scientific & ethics standards of research projects

Ethics review system

To effectively, efficiently and institutionally deliver ethics review services

functional and structural arrangements are established at national, regional and
institutional levels.

All projects that meet the definition of research and that involve human subjects
should be reviewed for ethical standards prior to any data collection to determine
the appropriate level of review, and, as appropriate, approve them. There are
three major types of review: Exempt, Expedited, and Full.

Exempt review

Research that is classified as Exempt will not require any further review after the
initial approval and only needs to be reviewed by the chair of the IRB.

If the proposed research involves no greater than minimal risk to participants or

when there is no possibility of harm arising as a result of the conduct of the
research project or when the information being collected is available from the
public domain, it may qualify for exempt status.

Expedited review

Research that is classified as Expedited only needs to be reviewed by the chair

or by a qualified member of the IRB that has been designated by the chair. A
research project is appropriate for Expedited review if it involves only minimal
risk, but is not classified as Exempt. Minimal risk is defined as risk that is not

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greater than what one encounters in ordinary daily life or during the performance
of routine physical or psychological examinations or tests.

Full board review

If your project involves more than minimal risk to participants as defined

previously, your project requires a Full Board review. Protocols involving any of
the following will also require Full Board review:

 Minor subjects (children 17 years of age or younger)

 Special populations (prisoners, pregnant women, individuals with
disabilities)
 The use of video- or audiotape to record subjects
 Asking questions that may be highly embarrassing or compromising
 Exposing subjects to graphically violent or pornographic materials
 Inflicting physical pain upon, attaching electrodes to, or injecting any
substance into
 subjects
 Creating high levels of stress, fear, discomfort, or tension
 Threatening subjects in any way
 Causing subjects to violate laws or official university regulations
 Providing some subjects with benefits denied to others
 Causing physical or mental exhaustion or engaging subjects in intense
exercise
 Placing individuals in confining physical settings or attaching other
devices
 Exposing subjects to extreme conditions (e.g., bright lights, loud noise,
intense
 pressure, strong odors, complete darkness, extreme heat or cold, sudden
movement, etc.)
 Leaving subjects alone for periods of time longer than 20 minutes
 Taking hair samples or nail clippings from subjects

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  Taking human tissue samples, drawing blood, or sampling any other
bodily fluid

Material Transfer Agreements & Management of Samples

A Material Transfer Agreements (MTA) is a contract governing the transfer of

research materials between two organizations. It defines the rights of the
provider and the recipient with respect to the materials and any derivatives.
MTAs can help to ensure a common understanding as to what is being shared,
for what purpose, and how it can be used. MTAs regularly govern the transfer of
biological materials, such as samples but can also cover associated data, such
as clinical information.

Any sample/specimen transfer requires material transfer agreement, which shall

be submitted using the form prior to the commencement of the research project.
The letter of agreement shall be attached to the project document submitted for
ethics review.

Kinds of human biological samples/ specimens requiring permit to be

transferred human blood or serum sample, biopsy of human body tissues,
human urine and human body fluids.

Samples may be allowed to be outward transferred if:

 Require hi-tech laboratory activity that is not performed in any national

laboratories
 For forensic purposes in which the results need a recheck by a skilled
expert
 Purpose of quality control assurance of the work of any laboratory.
 Number of samples to be allowed for outward transfer should never exceed
the number indicated in the original proposal of the research work.
 Student research related sample

Samples may be allowed to be inward Transferred if:

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  Proved to be safe and nonhazardous to the community
 To be used for the purpose collected.
 There is clear material transfer agreement and defined purpose

All transferred samples/specimens shall be used for the purpose it is collected

only. Furthermore, all transferred samples/specimens are properties of
providing institutions, unless there is an official agreement otherwise

Research misconducts

Research misconduct also called scientific misconduct. It is fabrication,

falsification, or plagiarism in proposing, performing, or reviewing research, in
reporting research results.

Fabrication is making up data or results & recording or reporting them

Falsification is manipulating research materials, equipment, or processes, or

changing or omitting data or results such that the research is not accurately
represented in the research record.

Plagiarism: it is appropriation of another person’s ideas, process results, or

words without giving appropriate credit, including those obtained through
confidential review of others’ research proposals & manuscripts.

Self-plagiarism -is the reuse of significant, identical, or nearly identical portions

of one’s own work without acknowledging that one is doing so or without citing
the original work. Articles of this nature are often referred to as multiple
publications.

Plagiarism can be: -

Deliberate miscues: providing inaccurate information regarding the sources

making it impossible to find them.

Accidental plagiarism: where students do not understand what document is and

how to do it

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Intentional plagiarism: i.e., cutting/pasting, or presenting other’s work as their
own.

How to avoid plagiarism?

Most cases of plagiarism can be avoided by:

 Citing the proper sources and acknowledging the original material.

 Providing the sustainable model developed by the institutions in order to
detect and prevent plagiarism.
 Teaching students about plagiarism and how to avoid it helps to minimize
plagiarism.
 Creating a culture of research rather than detecting and punishing for
plagiarism.
 Introducing laws against plagiarism.

Conflict of Interest

A situation where the goals or obligations of an investigator or reviewer conflict

with an obligation to uphold another party’s interest. Conflicts of interest arise
when a person’s (or an organization’s) obligations to a particular research project
conflict with their personal interests or obligations and may lead to research
misconduct. It can compromise the objectivity and impartiality of the research.
Lead to bias in design, conduct or reporting of research.

Sources of pressure that leads to the conflict interest may include:

The Institution

The institution may want researchers to bring in research funds, publish on a

regular basis, in addition to teaching, clinical service responsibilities.

Research sponsors

Research sponsors may want the researcher to implement the studies (to work
only the research) and produce favorable results.

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The researcher

The researcher may desire for private (personal) financial gain, earn
prestige/respect of peers (by successful research).

Conflict of interest can be: -

Financial - an investigator’s monetary interest causes bias in the design, conduct

or reporting of research

Non-financial – when factors like competition for research funding, previous

disagreements between investigators, and opportunities for career advancement.

Ethical clearance procedures in Ethiopia

The National Ethical Review Committee works under the auspices of the
Ethiopian Ministry of Science and Higher and Education (MoSHE). The
committee is composed of members with a diverse educational background
drawn from different research institutes and universities. Health research ethics
review committees were established at three levels in order to review proposals
for their ethical merits.

These committees include:

A. National C. Institutional Ethics Review

B. Regional and Committees

The committee reviews research proposals on health issues, neutrally &

independently by using the guideline.

NOTE: For more, read National Health Research Ethics Review Guidelines of
Ethiopia!

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