Lesson 2: Research Ethics Flashcards
(40 cards)
refers to the correct rules of conduct necessary
when carrying out research.
Research ethics
This means that they must abide by certain moral
principles and rules of conduct. They protect research participants
Reseach ethics
is an administrative body established to protect the rights and welfare of human research subjects
IRB Institutional Review Board
After the World War II, trial was conducted on
23 Nazi doctors, Among the 23, 15 were convicted.
Seven were condemned to death by hanging, 8 received prison sentences from 10 years to life.
The code highlighted on the need for informed consent, prior animal work, qualified scientists, risk justification by anticipated benefits, avoidance of physical and mental suffering, death, or disabling injury.
Nuremberg Code.1947
children were deliberately infected
with mild form of hepatitis, and
consent was obtained from parents
without informing about the hazards
Willowbrook Hepatitis Study (1956),
conducted where cancer cells
were inoculated in senile subject
without proper explanation on risk.
(1963) Jewish Chronic Disease Study
Both these studies used a vulnerable group of patients who could not take independent decision. The situation was highlighted in an article published in 1966 which described 22 such
Code of Medical Ethics 1966
The declaration of WMA binds the physician with the words, “The health of my patient will be my first consideration,” and the International declares that, “A physician shall act in the patient’s best interest when providing medical care.”
Declaration of Helsinki
African-American participants and even after the development of penicillin, the
trial participants were denied of the treatment and when it came to light it has already claimed 28 lives
and led to permanent disability in 100 subjects;
(Tuskegee Syphilis Study) 1972(Tuskegee Syphilis Study)
which stressed on three basic ethical principles: autonomy, beneficence, and justice.
(Belmont report) 1979
first released a policy statement on ethical considerations involved
in research on human subjects in 1980.
Indian
Council of Medical Research (ICMR)
In India, the ethics guidelines are given the legal status by way of
Schedule Y Drugs and Cosmetics Rules,
1945
With the advent of multi centric studies involving different countries, having a uniform GCP was a felt-need.current GCPs of the European Union, Japan, and the United States, as well as those
of Australia, Canada, the Nordic countries, and the World Health Organization
International Conference on Harmonization-GCP
It is the largest professional and scientific organization of psychologists in the United States.
APA American Psychological Association
Membership in the APA is not limited to scientists
or clinicians; it also includes educators and psychology students.
True
Functions of the American Psychological Association
1.Advancing and Promoting Psychology
2. Regulating Official Titles
3. Publishing the Official Style Manual
General Principles
Competence:
Integrity:
Concern for Others’ Welfare:
Social Responsibility:
Informed Consent to Research (APA Standard 8.02)
A. When obtaining informed consent as required in Standard 3.10, Informed Consent, psychologists inform participants about
a. the purpose of the research,
b. their right to decline
c. the foreseeable consequences
d. reasonably foreseeable factors to influence their willingness
e. any prospective research benefits;
f. limits of confidentiality;
g. incentives for participation; and
h. whom to contact
B. Psychologists conducting intervention research involving the use of experimental treatments clarify to participants at the outset of the research
a. the experimental nature of treatment
b. the services that will or will not be available to the control group(s) if appropriate;
c. the means by which assignment to treatment and control groups will be made;
d. available treatment alternatives if
e. compensation for or monetary costs
occurs when researchers purposely mislead research subjects by providing them with false information or misdirect them in some way about some aspect of the research procedure and/or purpose of the research.
Deception
occurs when the researchers
withhold information about some aspect of the research from the subjects.
Incomplete Disclosure
is a crucial component of the consent
process for any research involving the use of
deception or incomplete disclosure. Debriefing
Debriefing
refers to a condition in which the researcher knows the identity of a research subject, but takes
steps to protect that identity from being discovered by others.
Confidentiality