The document discusses ethical issues in biomedical research, highlighting historical examples such as the Tuskegee syphilis study and the Nuremberg Code. It emphasizes principles of ethics including informed consent, non-exploitation, and the right to refuse treatment, and outlines various categories of participants in research. Additionally, it addresses ethical considerations in social science research related to privacy and confidentiality.

1. ETHICAL ISSUES IN BIOMEDICAL
RESEARCH
By Vishwanath Gouda
M Pharmacy -1
Department of Pharmacy Practice

2. ETHICS?

3. Trials Tuskegee Syphilis Study-involvement of black
males
(1932-1972)

4. Compensation for those who
involved in Tuskegee studies
Free Autopsy Free Burial Free 100 bonus

5. Sulfanilamide tragedy -Elixer (1937)

6. Nazi human experimentation

7. Thalidomide disaster
1960-1962

8. Research ethics principles for human Experimentation
1947

9. Milestone in the History of Biomedical Research
in 1964 june in Helsinki, Finland

11. Declaration of Helsinki
• The Declaration of Geneva of the World Medical Association
binds the physician with the words, ‘‘The health of my patient
will be my first consideration,’’ and the International Code of
Medical Ethics declares that, ‘‘A physician shall act only in the
patient’s interest when providing medical care which might
have the effect of weakening the physical and mental condition
of the patient.’’

12. THE NUREMBERG CODE
 The voluntary consent of the human subject is absolutely
essential.
 The experiment should be such as to yield fruitful results for
the good of society
 The experiment should be so designed and based on the results
of animal experimentation
 The experiment should be so conducted as to avoid all
unnecessary physical and mental suffering and injury.
 No experiment should be conducted, where there is an a priori
reason to believe that death or disabling injury will occur,

13.  The degree of risk to be taken should never exceed
 Proper preparations should be made and adequate facilities
provided to protect the experimental subject
 The experiment should be conducted only by scientifically
qualified persons.
 During the course of the experiment, the human subject should
be at liberty to bring the experiment to an end
 During the course of the experiment, the scientist in charge
must be prepared to terminate the experiment at any stage

14. STATEMENT OF GENERAL PRINCIPLES
 Principles of essentiality
 Principles of voluntariness, informed consent and community
agreement
 Principles of non-exploitation
 Principles of privacy and confidentiality
 Principles of precaution and risk minimisation
 Principles of professional competence
 Principles of accountability and transparency

15.  Principles of the maximisation of the public interest and of
distributive justice
 Principles of institutional arrangements
 Principles of public domain
 Principles of totality of responsibility
 Principles of compliance

18. IN RESEARCH USING HUMAN SUBJECTS
Several categories of persons maybe involved:
 Normal healthy adults, including the investigator, and
elderly persons
 Sick adults, including the acutely and terminally ill
 People living in highly controlled situations, such as,
prisoners, soldiers, and students
 Children, both healthy and ill
 Mentally incompetent persons, whether adults or children

19. Right to refusal or withdrawal of treatment
• “The patient has the right to refuse or withdraw from
treatment to the extent permitted by law and to be informed of
the medical consequences of his action.”- Patient’s Bill of
Rights
• A patient may refuse or withdraw from medical treatment
because their religious convictions prohibit them from doing
so (e.g., a patient who is a member of a particular religious
sect may refuse to undergo blood transfusions)

20. Are there ethical issues in social science
or behavioral research?
 Most common methodology used involves interviewing people
and asking questions
o “We would just like to ask some questions…”
o “We would just like to observe…”
o “We would just like to share your life…”
o Focus Group discussion (FGDs), Survey
 Does not involve invasive procedures

21. Ethical Issues in Social Science &
Behavioral Research
• Privacy
• Confidentiality
• Linking behavior with medical procedure

22. References :
1. "Trials of War Criminals before the Nuremberg Military Tribunals under
Control Council Law No. 10", Vol. 2, pp. 181-182. Washington, D.C.:
U.S. Government Printing Office, 1949.
2. ETHICAL GUIDELINES FOR BIOMEDICAL RESEARCH ON
HUMAN PARTICIPANTS, ICMR , Statement of General Principles on
Ethical Considerations involving Human Participants
3. World Medical Association Declaration of Helsinki, Ethical
Principles for Medical Research Involving Human Subjects,
Adopted by the 18th WMA General Assembly, Helsinki, Finland,
June 1964; amended by the 29th WMA General Assembly, Tokyo,
Japan, October 1975; 35th WMA General Assembly, Venice, Italy,
October 1983; 41st WMA General Assembly, Hong Kong,
September 1989; 48th WMA General Assembly, Somerset West,
Republic of South Africa, October 1996, and the 52nd WMA
General Assembly, Edinburgh, Scotland, October 2000

23. THANK YOU