RESEARCH ETHICS

Dr Sarwat Nasreen
Assistant Professor
Department of Dermatology
Ziauddin University

Need of Research

Scientific growth
New drugs
Policy making

www.newmediaexplorer.org/.../CA_chmcalWrfare.jpg

Tuskegee study
Tuskegee study of untreated syphilis in the negro
male
Conducted between 1932 and 1972
In Tuskegee Alabama by U.S. Public Health
Service
By 1947 Penicillin standard treatment for syphilis

Tuskegee study

By the time study was terminated (1972)

399 patients, 128 had died
40 wives had been infected with syphilis
19 children had contracted disease at birth

Research ethics

Application of fundamental ethical principles

to medical research

Moral problems in research

No benefit to
participants
People, means to
developing useful

knowledge and at risk

Requirements of ethical research

Social value
Scientific validity
Fair subject selection
Favorable risk benefit ratio
Independent review
Community partnership
Informed consent
Respect for enrolled subjects

Guidelines

1930s-1970s---Tuskegee study
1946---Nuremberg doctors trial
1947---Nuremberg code
1964---Declaration of Helsinki
1979---Belmont report

Guidelines

1982--- First CIOMS guidelines

2000---Last updated version of Helsinki
2002---CIOMSlatest version
(www.cioms.ch)

Nuremberg trial
1946 American military tribunal opened criminal
proceedings against 23 German physicians
Medical experiments conducted on thousands
of concentration camp prisoners without their
consent

Nuremberg code
Voluntary consent essential
Reduce unnecessary physical and mental
stress
Risk should not exceed benefit

Declaration of Helsinki
Expansion of Nuremberg code
Included statements on vulnerable
population

Belmont Report

Respect for persons

Maximize benefits
Fair distribution of costs and benefits

CIOMS
The Council for International Organizations of
Medical Sciences
Non governmental organization established jointly
by WHO and UNESCO

CIOMS
General instructions and principles of ethical
biomedical research
Informed consent
Standards for external review
Recruitment of participants

Independent review

Institutional review boards (IRBs)

Ethical review committees (ERCs)
Approve, monitor and review research
Protection of rights and welfare of
participants

Informed consent
Respect persons and their decisions.
They can decide whether to enroll in
research
Whether research fits with their values,
interests and goals
Vulnerable population

The AIDS Clinical Trials Group

(ACTG)
In 1994 Aids Clinical trial Group (ACTG) 076
regimen of zidovudine shown to reduce maternal
fetal transmission by half
Studies conducted in 16 southeast Asian,
Caribbean and sub-Saharan African countries
continued to have control group
Control group should not be used once effective
treatment exists
Argument given was that standard of care in these
countries was no treatment at all

Dos
Scientifically valid
Scientific objectivity for
subject selection
Minimize risks
Review by the review
committees
Informed consent
Respect for enrolled
subjects

Donts
Studies with higher risk
benefit ratio
Consent not properly
taken or recorded
Vulnerable population
misused
Participants privacy or
well being not kept in
mind

References
Wikipedia

Ezekiel J. Emanuel, MD, PhD; David Wendler, PhD;

Christine Grady, PhD JAMA. 2000;283:2701-2711.

Henry Silverman, MD, MA

medschool.umaryland.edu/mereti/workshopmatrixfolder/fol
der_two/powerpointslides_two/internationalresearchhenry
2.ppt

Shuster E: Fifty years later: The significance of the

Nuremberg Code. N Engl J Med 1997, 337:1436-1440
http://www.cioms.ch/frame_guidelines_nov-2002.htm

Links to more information

http://www.wma.net
http://www.cioms.ch
http://ohrp.osophs.dhhs.gov
http://ohsr.od.nih.gov
http://www/fda.gov
http://www.bioethics.nih.gov/international/declarat/v
ol 1.pdf
http://www.who.int/tdr/publications/publications/ethi
cs.htm