Human subjects in research

GTU 301/3
Dr Idris Long (PhD)
Ext: 7778
 Outcomes We l e a d

General outcomes
Understand research involving human subjects
Specific outcomes
history over humans usage
ethical considerations/legislation on humans research
informed consent and autonomous principles
 Introduction We l e a d

research conducted with people or about people

pilot study
full study
done in a systematic way
contribute to the field of knowledge
 Introduction We l e a d

data
interventionexperiments, biological specimens
genetic samples
medical information
identifiable private information
interaction surveys, questionnaire, interview, focus
group
observation
identifiable information medical records, school
records
 Introduction We l e a d

studies that are not human subjects research

Internal data collection
teaching evaluation, customer service surveys
Information gathering interviews
where questions focus on things, products or
policies rather than people
Course related activity
designed specifically for educational and teaching
purposes not to be used outside the classroom
 Introduction We l e a d

studies that are not human subjects research

publicly available data

cadavers
 Introduction We l e a d

require review by the Institutional Review Board

ethics committee
reviewing proposal and provide ethical clearance
 The history We l e a d

The Nuremberg Trial (1946)

American Military Tribunal
24 defendants (German physicians and
administrators)
war crimes and crimes against humanity-Holocaust
medical experiments on camp prisoners without
consent (good of the state takes precedence over
individuals)
subjects died or permanently crippled
 The history We l e a d

The Nuremberg Code (1948)

The voluntary consent of the human subject is

absolutely essential
The core informed consent

- individual consent
- proxy consent
 The history We l e a d

The Nuremberg Code (1948)

The benefits of the research must outweigh the risks

- yield fruitful results

- for the good of society
- not unnecessary
 The history We l e a d

The Nuremberg Code (1948)

The experiments should be designed as to avoid all

unnecessary physical and mental suffering and
injury
- minimal suffering time
- minimal dosage
- minimal contact with experimental variables
 The history We l e a d

The Nuremberg Code (1948)

The experiment should be conducted only by

scientifically qualified persons
 The history We l e a d

The Declaration of Helsinki

World Medical Association (WMA)

defines rules for research combined with clinical care

and non-therapeutic research.

the basis of Good Clinical Practices used today

 The history We l e a d

The Declaration of Helsinki issues addressed

Research goals should never take precedence over the

right and interests of individual research subjects
 The history We l e a d

The Declaration of Helsinki issues addressed

Research with humans should be based on the results

from laboratory and animal experimentation
 The history We l e a d

The Declaration of Helsinki issues addressed

Informed consent from research participants is

necessary
 The history We l e a d

The Declaration of Helsinki issues addressed

Appropriate compensation and treatment for subjects

who are harmed as a result of participating in research
must be ensured
 The history We l e a d

The Declaration of Helsinki issues addressed

Medical research involving human subjects may only be

conducted if the importance of the objective outweighs
the risks and burdens to the research subjects
 The history We l e a d

The Tuskegee Syphilis Study (1932 1972)

project by the US Public Health Service
600 low-income, African-American males, 400 with
syphilis
monitored for 40 years
free medical examinations conducted; however, the
subjects were not told about their disease
1950s proven cure (penicillin) became available.
however participants being denied treatments and the
study continued
 The history We l e a d

The Tuskegee Syphilis Study (1932 1972)

turning point
consensus development for guidelines for ethical
conduct in research
National Commission for the Protection of Human
Subjects of Biomedical and Behavioral Research
was formed
basis of Belmont Report
 The history We l e a d

Belmont Report (1979)

Statement of the basic ethical principles and guidelines

that should assist in resolving the ethical problems that
surround the conduct of research with human subjects
 The history We l e a d

Belmont Report (1979)

Redefine research
activity designed to test a hypothesis and permit
conclusions to be drawn

usually described in a formal format with objectives and set

of procedures
 The history We l e a d

Belmont Report (1979)

Core Principles

Respect for person

Beneficence

Justice
 The history We l e a d

Belmont Report (1979)

Respect for person
principle of autonomy
informed consent
protect the vulnerable populations
provide adequate information
truthful
 The history We l e a d

Belmont Report (1979)

Beneficience vs non-maleficence
balance of potential benefits and harm
maximise benefits, minimise harms

Justice
fair and well-considered procedures
may not exploit vulnerable individuals
fair subject selections
 The history We l e a d

Belmont Report (1979)

 The present We l e a d

Common rule adopted by the world

requirements for assuring compliance by research
institutions
requirements for researchers obtaining and
documenting informed consent
requirements for Institutional Review Board (IRB)
review of research, and record keeping
additional protection for certain vulnerable research
subjects
 Informed Consent We l e a d

Continuing process where investigators and

participants have an on-going dialogue about a
research study

Knowledgeable decision making and voluntary

participants
 Informed Consent We l e a d

Importance of informed consent

autonomy and individual responsibility

It is a moral requirement to acknowledge autonomy and

protect those without autonomy

A person is an autonomous agent. Those with

diminished autonomy are entitled to protection.
(Belmont report)
 Informed Consent We l e a d

Importance of informed consent

ignorance of medicine and study procedure
rights to control own body
rights to determine medical treatment
rights to control own life
explanation of the truth
protect the best interest of the human subject
privacy and confidentiality
respect for cultural diversity
 Informed Consent We l e a d

Potential participants

Explanation of study to the participants or

legal representative

Documentation of the informed consent

(signature and date)

Ongoing discussions regarding participation

 Informed Consent We l e a d

The ethical justification of informed consent stems from

its promotion of autonomy and wellbeing (as individual
themselves define wellbeing). There are two sometimes
competing grounds upon which policies are ethically
evaluated (1) based upon rights and duties and (2)
based upon the consequences (Berg & Parker, 2001)
 Informed Consent We l e a d

Criteria of a consent form

consent must be informed
clear and plain language to make the subjects
understand
understood by average person
avoid technical jargon if possible
readable and comprehensible
not pushing, bribing, forcing, threatening
Informed consent We l e a d

Capacity to consent
able to understand given information
able to appreciate the nature of the situation
able to assess given facts
able to exercise choice
able to make reasonable and realistic information
able to understand the consequences of action
Informed consent We l e a d

When consent may become non-practical

impractical to trace patients
age of the documents and samples
patients missing

action must be taken quickly

emergency situation
 Informed Consent We l e a d

Person not able to consent

not yet able to make own decisions
minors
no longer able to make own decisions
dementia, Alzheimer
temporarily unable to make own decisions
unconscious
permanently unable to make own decisions
permanent mental health patients
 Informed Consent We l e a d

Challenges
time
communication barrier
the ability to understand the research
cultural differences
every culture is unique and different
religion
barrier
 Informed Consent We l e a d

Criteria of a consent form

Research title
Researchers name
Introduction about the research
Purpose of the study
objectives
Research subjects
inclusion criteria
exclusion criteria
 Informed Consent We l e a d

Criteria of a consent form

Risk
Contact person (person in charge and ethics)
Voluntary participation in the study
Escape clause
Benefits to individual, community, university
Confidentiality statement
Signature page
 Summary We l e a d

Blueprint of current ethics based on

Nuremberg Code
Declaration of Helsinki
Belmont Report
Important to observe good research practice
get ethical approval
follow through
Thank you
Berg et all, 2001, Informed consent, oxford University press
Baylis, F. (2009). "For love or money? The saga of Korean women who
provided eggs for embryonic stem cell research." Theor Med Bioeth 30(5):
385-396.
Burgess Michael, M 2007, Proposing modesty for informed consent, social
sciences and Medicine 65(2007), 2284-2295
Mandal, J, Achaya S, Parija S., (2011) Ethics in Human Research. Trop Parasitol
1(1); 2-3

Presented by
Dr Idris Long | PPSK, USM