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Ethics in Human Research

Interim Assessment for Sunday, February 26 2023
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 Learning Objectives 3

 Explore the concept of ethics as used in the social sciences

 Examine the various stakeholders in social research

 Understand ethical issues from the view points of various stakeholders

 Know how to conduct ethical research

 Be sensitive to ethical issues and even how to handle grey areas of ethics
 What Are Ethics? 4

You must accept the responsibility to behave ethically toward those who will be affected by
your research

Ethics is the study of proper action

Research ethics concerns the responsibility of researchers to be honest and respectful to

all individuals who may be affected by their research studies or their reports of the
studies’ results
 Continued
Ethics are the principles for guiding decision making and reconciling
conflicting values

People may disagree on ‘ethics’ because it is based on people's personal value

systems

What one person considers to be good or right may be considered bad or

wrong by another person
 Types of Ethics?
There are two main types of ethics:

First, ethics refers to well-founded standards of right and wrong that prescribe what
humans ought to do:

 usually in terms of rights, obligations, benefits to society, fairness, or specific virtues.

 those standards that impose the reasonable obligations to refrain from rape, stealing, murder, assault, slander, and
fraud.

 those that enjoin virtues of honesty, compassion, and loyalty. standards relating to rights, such as the right to life,
the right to freedom from injury, and the right to privacy.

www.scu.edu/ethics.com
 Ethics As A Study of Standards
Secondly, ethics refers to the study and development of one's ethical
standards.

 it is necessary to constantly examine one's standards to ensure that they are reasonable and
well-founded.

 the continuous effort of studying our own moral beliefs and our moral conduct, and

 striving to ensure that we, and the institutions we help to shape, live up to standards that are
reasonable and solidly-based.
www.scu.edu/ethics.com
 WHAT IS HUMAN RESEARCH?
Human Research is Research conducted with people

Research conducted about people research dealing in

their data or issue
 WHY IS RESEARCH ETHICS IMPORTANT?
 It is a reflection of respect for those who ‘take part’ in research

 It ensures no unreasonable, unsafe or thoughtless demands are made by researchers

 It ensures sufficient knowledge is shared by all concerned

 It imposes a common standard in all the above respects

 It has become the norm as an expectation for research activity

 A professional requirement for practitioners in some disciplines e.g. psychology

 A requirement for access to participants in others e.g. health

 A requirement to comply with external REF’s to obtain funding e.g. ESRC

NAZI MEDICAL WAR CRIMES (1939–1945)

Medical Research involving human beings have created a lot of potential pitfalls
that led to tragedies in the last century.
TUSKEGEE SYPHILIS STUDY - ALABAMA

The study was stopped in 1973 by the U.S. Department of Health, Education, and Welfare only after its existence was
publicized and it became a political embarrassment.

In 1997, under mounting pressure, President Clinton apologized to the study subjects and their families.
 Cont
• The study initially involved 600 Black men – 399 with syphilis, 201 who
did not have the disease.

• Participants’ informed consent was not collected.

• Researchers told the men they were being treated for “bad blood,” a local
term used to describe several ailments, including syphilis.

• In exchange for taking part in the study, the men received free medical
exams, free meals, and burial insurance.
By 1943, penicillin was the treatment of choice for syphilis and
becoming widely available, but the participants in the study were not offered
treatment.

In 1972, an Associated Press story about the study was published.

As a result, an Ad Hoc Advisory Panel to review the study.

The panel concluded that:

 the study was “ethically unjustified”;
 that is, the “results [were] disproportionately meager compared with known risks to human subjects involved.”
OTHER MAJOR VIOLATIONS TO HUMAN RESEARCH SUBJECTS

1963 -- Brooklyn - Jewish Chronic Diseases Hospital:

Cancer cells were injected into debilitated elderly patients to see if they would
immunologically reject the cells.

1972 - Willowbrook State Hospital in New York:

Retarded children were deliberately infected with viral hepatitis to study its natural history.
ETHICAL PRINCIPLES GUIDING RESEARCH
Respect for human dignity

Respect for free and informed consent

Respect for vulnerable persons

Respect for privacy and confidentiality

Respect for justice and inclusiveness

Balancing harms and benefit

Minimize harm
Maximizing benefit
National Commission for the Protection of Human Subjects of Biomedical and Behavioral
Research in 1974.

•Respect for persons

•Beneficence
•Justice
 THE FOUR PRINCIPLES OF ETHICS: Belmont Report

1. Autonomy (Respect for the person)

2. Beneficence (Do Good)

3. Non-malfeasance (Do No Harm)

4. Justice
 AUTONOMY (RESPECT FOR HUMAN DIGNITY)

This Principle includes

 The right to self-determination

 The right to self-determination means that prospective participants have

the right to decide voluntarily whether to participate in a study, without
risking penalty or prejudicial treatment.

It also means that people have that right to ask question, to refuse to give
information, and to withdraw from the study
 AUTONOMY (RESPECT FOR HUMAN DIGNITY)

 The right to full disclosure

 The principle of respect for human dignity encompasses people’s right to
make informed, voluntary decision about study participation. Which
requires full disclosure.

Full Disclosure means that the research has fully described the Nature of
the study, the person’s right to refuse Participation, the researcher’s
responsibilities, And likely risks and benefits
 BENEFICENCE
Beneficence imposes a duty on researchers to minimize harm and to maximize
beneficence. This principle covers multiple dimensions

 The right to freedom from harm and discomfort.

Researchers have an obligation to avoid, prevent, or minimize harm in studies with humans.

Harm and discomfort can take many forms:- can be physical (eg.,injury),emotional
(eg.,stress) social (eg.,loss of social port)of financial (eg., loss of wages).

Ethical researchers must use strategies to minimize all types of harm and discomfort , even
ones that are temporary.
 BENEFICENCE
 The right to protection from exploitation

Involvement in a study should not place participants at a disadvantage or

expose them to situations for which they have not been prepared.

Participants need to be assured that their participation, or information they

might provide, will not be used against them in any way
 JUSTICE
The third broad principle articulated in the Belmont Report concerns justice, which includes
participants 'right to fair treatment and their right to privacy

The right to fair treatment

 One aspect of the justice principle concerns the equitable distribution of benefits and
burdens of research
 The selection of study participants should be based on research requirements and not on
the vulnerability or compromised position of certain people

The right to privacy

 Virtually all research with humans involves intruding into personal lives; researchers
should ensure that their research is not more intrusive than it needs to be and that
participants’ privacy is maintained throughout the study.
 Participants have the right to expect that any data they provide will be kept in strictest
confidence.
Other Ethical Considerations in Social Science
Research
 Informed Consent
Seeking informed consent:

Its unethical to collect information about participants without their express

knowledge/willingness;

Participants must be competent to give consent;

Provide sufficient information for a reasoned decision; and,

Consent must be voluntary, not coerced

 The Question of Incentives
Is it ethical to provide an incentive to participants/respondents for sharing information with
you?

 Some provide incentives to respondents as a sigh of their token for their time/efforts

 Others argue that this might compromise the respondents

 Most people participate in research because they believe it is for a greater good, and not
because of incentives

 But any incentive given as a sign of gratitude after the information is collected can be
justified
 Sensitive and Confidential Information
Seeking sensitive and confidential information can be a dicey issue in social science
research
 Some private, government and voluntary organizations have information they don’t want
to make public and will fight to keep it that way

Asking for this information may either embarrass your respondents or even put them in
trouble

Not asking for it might compromise the research because the information might be key to
your research
 Questions on sexual behavior, drug use, age, income, marital status are considered personal and some people
don’t want to talk about them
 These questions can and should be asked on condition that you can provide and assure them confidentiality
 The Question of Confidentiality
Sharing information about a respondent for any other reason other than research is unethical

But sometimes, you need to identify your respondents to put the study in context. So say:
 ‘according to some respondents……..’
 ‘one of the interviewees said……….’
 ‘a respondent claimed that……….’

It is unethical to be negligent in protecting the anonymity and confidentiality of information

gathered on your respondents
INSTITUTIONAL REVIEW BOARD (IRB)

Also known as an Independent Ethics Committee (IEC) or Ethical Review Board

(ERB) is a committee that has been formally designated to approve, monitor, and review
biomedical and behavioral research involving humans with the aim to protect the rights
and welfare of the research subjects .
The IRB must have at least five members.

The members must have enough experience, expertise, and diversity

If the IRB works with studies that include vulnerable populations, the
IRB should have members who are familiar with these groups.
RESPONSIBILITIES OF IRB
Risks to study participants are minimized

Risks are reasonable in relation to anticipated benefits

Selection of study participants is equitable

Informed consent is obtained and appropriately documented for each participant

Adequate provisions for monitoring data collection to ensure safety of the study
participants

Participant privacy and confidentiality is protected

 Stakeholders in Social Research
Social science researchers are also bound by a set of ethical rules in relation to how
researchers deal with their core stakeholders like:

Research Participants;
 Anyone that is directly or indirectly involved in the research is a participant
 Anyone that is likely to be affected by the research finding is a participant

The researcher;
 Anyone who collects information for the specific purpose of understanding, consolidating
of propagating of professional knowledge is a researcher
 This include academic researchers

Funding bodies;
 Organizations and institutions that fund research are also stakeholders
 Businesses, pharmaceutical organizations, governments, NGOs, all provide funding for
 Stakeholder Interest and Research Ethics
Each of these stakeholders have a vested interest, aims, motivations, and
objectives that could directly affect the research

Its important to make sure the research is not affected by the self-interest of
any stakeholder

The research should also be carried out in a way that does not harm any of the
stakeholders