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

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

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

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

‘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

‘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

Basic Ethical Principles Respect for Persons Beneficence Justice

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

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

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

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

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

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

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.'

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

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

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

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

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

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

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

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

Thank You