R M ESEARCH Research Ethics

advertisement
RESEARCH METHODOLOGY
Research Ethics
Dr. Amira Yahia
CASE STUDY 1: ZAINAB’S STORY
Zainab is a 14-year-old girl. One day she was at her
neighbour Asha’s house for a birthday party. At the
party, Asha’s family took lots of photographs.
Recently, Zainab and her family found out that
Asha’s family has given copies of Zainab’s
photograph to numerous families for prospective
marriage proposals without their knowledge.
Zainab and her parents are very upset.
 A) Why do you think Zainab and her parents are
upset?
 B) Do you think Asha’s family should have
circulated Zainab’s photograph? Why or why not?

CASE STUDY 2: RABAB’S STORY
Rabab is an 18-year-old married girl. One day, a
journalist comes to her house, and asks if she
would like to be interviewed for an article on
married life. Before Rabab can answer, her mother
in law says, “Yes, Rabab will participate.”
 a) How would you feel if you were Rabab ?
 b) Do you think the journalist should continue with
the interview and take this as consent on Rabab’s
part?
 c) What do you think the journalist should have
done to ensure that Rabab is willing to participate
in the interview?

FUNDAMENTAL PRINCIPLES
ETHICS

Respect for persons

Beneficence

Justice

Respect for communities
OF
RESEARCH
People should not be only a way to
achieve the research objectives.
RESPECT
FOR PERSONS
Respect the dignity of research participants
 Ensure their independence (autonomy).
 Should be protected from any abuse that results
due to their vulnerability.

Each individual:

Is unique and free

Has the right and capacity to decide

Has value and dignity

Has the right to informed consent
VULNERABLE PARTICIPANTS

Minors, pregnant women,
prisoners

Persons with mental disabilities

Persons who are illiterate or have
limited formal education

Persons with limited access to
health services

Women in some settings
BENEFICENCE

The principle of beneficence makes the researcher
responsible for the physical, mental, and social
well-being of the research participant

Researcher must:
Minimize the risks associated with research, including
psychological and social risks
 Maximizing the benefits that accrue to research
participants.

JUSTICE
Researchers must:

Ensure a fair distribution of risks and benefits

Conduct equitable recruitment of research participants

Provide special protection for vulnerable groups
RESPECT
FOR COMMUNITIES

Respect for communities means that researchers
must respect the values of the community involved
in the research and protect the community from
harm.

This is very important in research which requires
community-wide
knowledge,
values,
and
relationships and, thus, the community may be
impacted by the research process or its outcomes.
GENERAL ETHICAL GUIDELINES
FOR
RESEARCH
Confidentiality
 Informed voluntary consent
 Right to refuse or withdraw at any time
 Reporting back
 Special consideration for vulnerable groups

ELEMENTS
1.
2.
3.
4.
5.
6.
7.
8.
OF INFORMED
Purpose of Research
Risks and Discomforts
Benefits
Alternatives
Confidentiality
Compensation for Injury
Research Questions
Voluntary Participation
CONSENT:
BASIC RESEARCH ETHICS DOCUMENTS
Nuremberg
Belmont
CIOMS
Helsinki

The illegal experiments performed on concentration
camp prisoners by Nazi doctors during World War II
and the subsequent Nuremberg Trials in 1946 gave
birth to the Nuremberg Code, that states that
“voluntary informed consent is absolutely necessary.”

The Declaration of Helsinki of 1964 stressed the
importance of written consent forms.

The 1974 Belmont Report highlighted the 3
fundamental principles of respect for persons,
beneficence, and justice.

In 1993, CIOMS issued guidelines to apply the
Declaration of Helsinki in developing countries.
HIGH
ALTITUDE EXPERIMENTS
HIGH
ALTITUDE EXPERIMENTS
The purpose was to investigate how much a human
being could resist high altitudes without the use of
oxygen.
 The victims were locked in the chamber, whose
pressure was then lowered to a level corresponding
to very high altitudes.
 The pressure could be very quickly altered,
allowing Researcher to simulate the conditions
which would be experienced by a pilot freefalling
from altitude without oxygen

FREEZING
EXPERIMENTS
FREEZING
EXPERIMENTS
The purpose was to determine the best way of
warming German pilots who had been forced
down in the North Sea and suffered hypothermia.
 The victims were forced to remain out of doors
naked in freezing weather for up to 14 hours, or
kept in a tank of ice water for 3 hours, their pulse
and internal temperature measured through a
series of electrodes.
 Warming of the victims was then attempted by
different methods, most usually and successfully
by immersion in very hot water.

BLOOD
COAGULATION EXPERIMENTS
Researcher predicted that the preventative use of
Polygal tablets would reduce bleeding from
gunshot wounds sustained during combat or
during surgery.
 Subjects were given a Polygal tablet, and shot
through the neck or chest, or their limbs amputated
without anaesthesia.

THE DECLARATION
OF
HELSINKI

“The well-being of the human subject should take
precedence over the interests of science and
society”

Consent should be in writing

Use caution if participant is in dependent
relationship with researcher

Limit use of placebo

Participants benefit from research
COUNCIL FOR INTERNATIONAL ORGANIZATIONS
OF MEDICAL SCIENCES (CIOMS) GUIDELINES
• Role of ethics committees
Nuremberg
• Informed consent
• Access to benefits
Helsinki
• Provision of health care services
• Distribution of burdens and benefits
CIOMS
RESOURCES

Sadaf Shallwani and Shama Mohammed. Community-Based Participatory Research. A
Training Manual for Community-Based Researchers, 2007.

Roberto Rivera,David Borasky, Florence Carayon, Robert Rice, Stella Kirkendale, Wayne
L. Wilson, and Cynthia Woodsong. Research Ethics Training Curriculum for Community
Representatives. 2004 by Family Health International.

Health Research Library http://sites.google.com/site/healthresearchlibrary/home
Download