Research Ethics and Vulnerable Group - PowerPoint PPT Presentation

1 / 34
About This Presentation

Research Ethics and Vulnerable Group


Medical progress is based on research which ultimately must rest in part on ... Medical research should not proceed on vulnerable groups unless the research is ... – PowerPoint PPT presentation

Number of Views:2297
Avg rating:5.0/5.0
Slides: 35
Provided by: wafaaab


Transcript and Presenter's Notes

Title: Research Ethics and Vulnerable Group

(No Transcript)
Research Ethics and Vulnerable Group
Prof. Dr. Wafaa E. Abdel-AalHead of Pathology
Department and Member of the RECNational
Research CenterCairo, Egypt
E Medicine Conference 29th March 2007
Medical progress is based on research which
ultimately must rest in part on experimentation
involving human subjects. Research investigators
should be aware of the ethical, legal and
regulatory requirements.
Scientific progress relevant to the needs of
certain populations often requires the inclusion
of vulnerable populations in clinical
research. Research with such special group
raises additional concerns because of their
vulnerability or the diminished capacity to
protect their interests.
But who is vulnerable?!!And what is the basis of
their vulnerability?!!
The Main Issues to be Discussed
  • Definition of vulnerability
  • Types of Vulnerability
  • Historical background
  • Safeguards to protect the rights of vulnerable
  • Developing Countries and vulnerability

  • Definition vulnerable
  • Susceptible to physical or emotional injury.

A condition either intrinsic or situational that
puts individuals at a greater risk of being used
in ethically inappropriate ways in research.
  • Vulnerable persons are those who are relatively
    (or absolutely) incapable of protecting their own
    interests. More formally, they may have
    insufficient power, intelligence, education,
    resources, strength, or other needed attributes
    to protect their own interests.

Special population
  • The term special population is synonymous with
    the term vulnerable subjects. Special populations
    include any subject group or community with
    qualities or characteristics that require
    specific considerations in addition to those
    required to protect the rights and welfare of a
    fully autonomous protections.

Types of Vulnerability
  • Decision making incapacity
  • Cognitive vulnerability
  • Situational vulnerability
  • Communicative vulnerability
  • Medical
  • Serious health conditions
  • Economic
  • Undue inducements

Types of Vulnerability
  • Lack of freedom (Institutional)
  • -Prisoners, military, communities in developing

  • Dependant Relationships
  • -Patient and physician
  • -Students, employee
  • -Citizens and Government

Who are the vulnerable groups
  • Women
  • Prisoners
  • Children
  • Mentally impaired
  • Geriatric persons
  • Geriatrics who have dementia? Communities in
    developing countries

Conducting a research on children means dealing
with a vulnerable group.Pregnant women are the
most vulnerable population ..and the fetus as
Historical background
  • One important theme of human experimentation that
    many subjects were from vulnerable populations
    children, mentally ill people, poor people,
    prisoners and minorities.
  • Examples are

  • The Nazi experiments conducted on human beings
    stand out as clearly the worst experiments ever
    performed on human subjects. Non of the subjects
    gave informed consent, and thousands were maimed
    or killed.

  • Researchers at Vanderbilt University in late
    1940s gave pregnant women radioactive iron to
    study the effects of radiation on fetal
    development a follow-up study found that
    children from these women had a higher than
    normal cancer rate.

  • In Oregon State Prison from 1963 to 1971,
    researchers x-rayed the testicles of 67 male
    prisoners, who were mostly African Americans, to
    study the effects of radiation on sperm function.

Safeguards to protect the rights of vulnerable
  • How can vulnerable subjects of research
    adequately protected against exploitation?!!
  • 1- Investigators responsibility
  • 2- IRB or REC responsibility
  • 3- Informed consent

  • It is the investigators responsibility to
    evaluate and define clearly the expected degree
    of vulnerability , justify the involvement of
    subjects with such characteristics, and build
    into study design any additional protection that
    might be needed.

  • In addition to the safeguards for research
    subjects IRB s must ensure that there are
    additional safeguards to protect the rights and
    welfare of these subjects.
  • REC should take into account
  • Limit the level of risk
  • Limit payment incentives

Minimization of RiskWhat are procedures to
minimize risk?
  • Substitute invasive procedures with less invasive
  • Use qualified personnel
  • Necessary infrastructure to handle emergencies
  • Monitoring

Safeguards to protect the rights of vulnerable
  • CIOMS 2002 13
  • Subjects will be assured reasonable access to
    products that become available as a result of the

Additional Protection
  • Consent requirements
  • Research on individuals who cannot decide
    requires surrogate consent
  • children and mentally impaired

Developing Countries and vulnerability
  • Research subjects in developing countries may be
    exploited in the international research sponsored
    by industrial countries.
  • It is not fair that populations in resource-poor
    countries suffer the potential burdens of
    research without the prospect of deriving
    benefits when research demonstrates the safety
    and effectiveness of an experimental drug.

Example of exploitation in developing countries
  • Havrix Case
  • Hepatitis A vaccine was tested in 1990 among
    school children's from Thailand. The study was a
    collaboration of Walter Reed Army Institute of
    research (USA) and Thailand Ministry of Public
    Health. Initially, there was a randomized ,
    double blind phase II study involving 300
    children. After demonstration of safety,

a randomized, double- blind phase III study with
hepatitis A vaccine control involving 40,000
children was done.Prior to the phase III study,
there was no formal agreement to make Havrix
widely available in Thailand, in addition, the
company ( Smith K- line Beecham Biological) made
no commitment to provide free Havrix , no promise
about what the price would be for the private
Nevertheless, at the start of the trial, all
collaborators recognized that the largest market
for Havrix would be travelers from developed
countries.The Question is Was the Havrix
study ethical?!!
  • Despite all the protection mechanisms to
    safeguards the vulnerable populations, the gaps
    in such protection are unacceptably large.

  • Medical research should not proceed on vulnerable
    groups unless the research is specifically
    related to inherent characteristics of that group
    (and not related, for example, to the needs or
    preferences of the researchers)

At last, Everyone of us , I think, is a
physician and /or a researcher.To be a Good
Researcher is the Golden Rule of all the story of
Ethics and Research Ethics Committees.
(No Transcript)
Thank You
Write a Comment
User Comments (0)