INFORMED CONSENT IN BIO-MEDICAL RESEARCH
INVOLVING HUMAN PARTICIPANTS
Selina khatun
MPH, Mphil
Lecturer(Anatomy Department)
MMC
INFORMED CONSENT
 Concept and Importance
 Historical Background
 Obtaining Informed Consent:
Elements for Informed Consent
Essential Information for prospective participants.
 Procedure
 Exceptions
 Informed Consent Form
CONCEPT OF INFORMED COSENT
˚ Medical advances should not require some
people to sacrifice their health and rights for
the good of all.
˚ Informed consent is a process which is designed
to empower the individual to make a voluntary
informed decision regarding participation in
the research.
˚ Voluntary consent means that the participants
were able to consent, were not being coerced to
do the study and understood the risks and
benefit involved.
Informed Consent
˚ Informed consent is a key instrument in protecting
the right.
˚ Procurement of consent ensures human dignity of
the participants and also shows respect for them.
˚ Informed consent is one of the primary ethical
principles governing human subject research.
˚ Informed consent assures that prospective research
subjects will understand the nature of the research
and can knowledgeably and voluntarily decide
whether or not to participate
Informed Consent
˚ The fundamental ethical duty of respect for persons
requires that we do not act against a person’s
wishes, and thus genuine consent to participate in
research must be obtained.
Informed Consent
˚ Why get informed consent?
- Respect for person; Autonomy
- Justice
Informed Consent
˚ Importance of Informed Consent.
- Informed Consent is the first and longest of the 10
principles in the Nuremberg code.
- Informed Consent is included in every guidelines
on Research Ethics.
- Informed Consent is one of the 8 requirements for
clinical research.
Informed Consent
˚ Informed Consent allows individuals:
- To determine whether participating in research fits
with their values and interests.
- To decide whether to contribute to this specific
research project.
- To protect themselves from risks.
- To decide whether they can fulfill the
requirements necessary for the research.
HISTORICAL BACKGROUND OF INFORMED
CONSENT
Early References
1891- Prussian Minister of Interior , tuberculin for
the treatment of tuberculosis must not be used
against a person’s will.
1898- Dr. Albert Neisser was fined by the Royal
disciplinary court of Prussia for not seeking
patient’s consent for his experimental studies of
vaccination for Syphilis.
1907- Sir Willium Osler endorsed the necessity of
informed consent in medical research.
1931- Health Department regulations of German
Reich stated that both human experimentation
and the use of novel treatment required consent
in a clear and undebatable manner.
World war-II and unethical clinical trials done
by US Health Services gave birth of Bioethics.
Creation of IRB and notion of Informed
Consent.
- During World War –II
- In Nazis Concentration camp and in America
and Britain
- President F. Roosevelt-Office of Scientific
research to combat Dyscentry, Influenza,
Malaria
- Use orphan, mentally retarded, psychotic
patients
- Penicillin to prisoners to settle the dose.
- Attitude was different
- NIH- funds for experimentation, No right for
participants.
- 1945-1966 NIH funded 2000 research projects,
none of them use informed consent
- Thalidomide- Birth defects
- Amendment to FD and cosmetic acts.
- June 16th,1966. Henry Beecher- NEJM, describe
22 examples done on vulnerable group.
- IRB(1960)+ FDA
- Tuskegee Syphilis study 1932-1972
- 1997:President Clinton apologized
-
(1960-1970)
-
National Research Act
-
National Commission for protection of
research participants in Biomedical and
Behavioral Research.
-
1979,Belmont Report
Belmont Report
º Expanded the definition of Informed
consent.
º
Participants-kept
experiment,
informed
º Understand risks and benefits.
º Protection of vulnerable group.
throughout
the