1. Basic Principles of Research Ethics
Dr. Milind Y Nadkar
Professor of Medicine
Seth GS Medical College &
KEM Hospital, Mumbai

2. The Belmont Report April 18, 1979
National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research
To identify the basic ethical principles
To develop guidelines
Directed to consider
Boundaries between research and the accepted and routine practice
Assessment of risk-benefit criteria
Guidelines for the selection of human participants
Nature and definition of informed consent

3. Boundaries Between Practice and Research Basic Ethical Principles
National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research
Boundaries Between Practice and Research
Basic Ethical Principles
Respect for Persons
Beneficence
Justice
Applications
Informed Consent
Assessment of Risk and Benefits
Selection of Subjects

4. Boundaries Between Practice & Research
Distinction between research and practice is blurred
Both often occur together
Notable departures from standard practice are often called ‘experimental’
When the terms ‘experimental’ and "research" are not carefully defined

5. ‘Practice’ ‘Research’
Interventions that are designed solely to enhance the well-being of an individual patient
Reasonable expectation of success
Purpose is to provide diagnosis, preventive treatment or therapy
‘Research’
When a clinician departs in a significant way from standard or accepted practice, the innovation does not, in and of itself, constitute research

6. ‘Research’
Activity designed to test a hypothesis, permit conclusions to be drawn, and thereby to develop or contribute to generalizable knowledge
Described in a formal protocol that sets forth an objective and a set of procedures
Radically new procedures be made the object of formal research in order to determine whether they are safe and effective

7. Basic Ethical Principles
Respect for Persons
Beneficence
Justice

8. Respect for Persons Two ethical convictions
Individuals should be treated as autonomous agents
Persons with diminished autonomy are entitled to protection
Two separate moral requirements
Acknowledge autonomy
Protect those with diminished autonomy

9. Autonomous Person
Capable of deliberation about personal goals and of acting under the direction of such deliberation
To respect autonomy
Give weight to autonomous persons' considered opinions and choices
Refraining from obstructing their actions
Lack of respect for an autonomoy
Repudiate that person's considered judgments
Deny an individual the freedom to act on those considered judgments
Withhold information necessary to make a considered judgment

10. Capable of Self-determination ?
Capacity for self-determination
Matures during an individual's life
Lose this capacity wholly or in part because of illness, mental disability, or circumstances that severely restrict liberty
Subjects enter into the research voluntarily and with adequate information
Not be deprived of the opportunity to volunteer for research

11. Beneficence
Often understood to cover acts of kindness or charity that go beyond strict obligation
Beneficence is understood in a stronger sense, as an obligation
General rules
Do not harm
Maximize possible benefits and minimize possible harms

12. One should not injure a person regardless of the benefits that might come to others
Avoiding harm requires learning what is harmful
Learning what will in fact benefit may require exposing persons to risk
When it is justifiable to seek certain benefits despite the risks involved, and when the benefits should be foregone because of the risks

13. Justice Benefits vs. Burdens of research ‘Fairness in distribution’
Some classes are systematically selected simply because of
Easy availability
Compromised position
Manipulability
Research should not unduly involve persons from groups unlikely to be among the beneficiaries of subsequent applications of the research

14. ICMR Code
International Covenant on Civil and Political Rights specifically stated ……
'No one shall be subjected to torture or to cruel, inhuman or degrading treatment or punishment. In particular, no one shall be subjected without his consent to medical or scientific treatment.'

15. General Statement Purpose Conducted
Directed towards the increase of knowledge
For the betterment of all, especially the least advantaged
Conducted
Not mere means for the betterment of others
Dignity and well being
Professional fair treatment and transparency

16. General Statement contd…
Evaluation
At all stages of the proposal
Anticipated benefits and dangers
Saving and ensuring the safety of each human life

17. ICMR: Statement of General Principles
Principles of essentiality
Absolutely essential after a due consideration of all alternatives
Considered by an appropriate and responsible body of persons who are external to the particular research

18. Principles of voluntariness, informed consent and community agreement
Participants are fully apprised of the research and the impact and risk
Right to abstain from further participation irrespective of any legal or other obligation
Subject to only minimal restitutive obligations
A person incompetent to give consent, someone who is empowered and under a duty to act on their behalf
Continually kept informed of any and all developments

19. Principles of non-exploitation
In-built mechanism for compensation
Either through insurance cover or any other appropriate means to cover all foreseeable and unforeseeable risks
Remedial action and comprehensive aftercare
Principles of privacy and confidentiality
Does not suffer from any form of hardship, discrimination or stigmatisation as a consequence of having participated

20. Principles of precaution and risk minimisation
Due care and caution is taken at all stages
Principles of professional competence
Research is conducted at all times by competent and qualified persons who act with total integrity and impartiality
Principles of accountability and transparency
Conducted in a fair, honest, impartial and transparent manner
Data and notes are retained for such reasonable period

21. Principles of institutional arrangements
Principles of the maximisation of the public interest and of distributive justice
Benefit all human kind
Not just those who are socially better off
But also the least advantaged
In particular, the research participants themselves and or the community from which they are drawn
Principles of institutional arrangements
All the procedures required to be complied with

22. Principles of public domain
brought into the public domain
results are generally made known through scientific and other publications
Principles of totality of responsibility
due observance of all the principles, guidelines or prescriptions laid down generally or in respect of the research
the researchers, those responsible for funding, and the institution
Principles of compliance
both the letter and the spirit of these guidelines are scrupulously observed and duly complied with

23. Thank You