M6S1: Principles of Ethics for studies in Health-care

At the end of this session, you will be able to –

 Explain the significance of ethics in relation to healthcare research

 State the four cardinal principles of ethical research
 Mention the four pillars of ethical research, and
 List the general principles of ethics of human researchp

Adherence to Ethics promotes and ensures respect for all human beings and protects their health and
rights. This also protects the dignity, rights and welfare of research participants and addresses the
conflicts of interest at various levels amongst researchers, funders, policy makers and research
participants. Overall, the practice of ethical principles helps in safety, effectiveness, accessibility and
quality in research.
The four cardinal principles of ethical research are Autonomy, Beneficence, Non-maleficence and
Justice
Autonomy means Right of the individual. This is when acting intentionally by the research participant
after sufficient information and time to understand information is given about their participation in
research. From this evolves the sub principles of Consent, privacy & confidentiality, human dignity &
rights.
Beneficence means Good to the individual. This is when we ensure the well-being of research
participant in particular and society in general
Non – maleficence means Do no harm. This is ensured by careful decision making and having
adequate training about research
Justice means Right to the individual. This is ensured when there is equitable access to research and
resources by the research participant. From this evolves the sub principles of Equality &Equity, Non-
discrimination & Non-stigmatisation, and Fairness.
The four pillars of ethical research are – Honesty, Transparency, Competence and Credit

Honesty means being true to yourself and your research. This is ensured when you don’t alter, distort
or select results to suit your needs and declare all the biases
Transparency means sharing as much as possible about the research. This is ensured when you share
the entire research process, results/data including the limitations
Competence means having the appropriate knowledge and skills to carry out research. This is ensured
when you know that you lack particular research skill and you also know that you must collaborate
with those persons who have those skills. (Dunning and Kruger effect)
Credit means fully acknowledging the contribution of others in the research work. This is ensured
when you cite or acknowledge team members /colleagues /peers and also when co authorships are
decided based on individual contributions to the said research work.
The general principles of ethics of human research are -
Principle of Essentiality – this means whether the proposed research is absolutely essential and is
likely to benefit humanity. This is considered after scrutinising the existing scientific knowledge by a
responsible and independent body of persons.
Principle of voluntariness, informed consent and community agreement – this means research
participant is fully aware of research and associated risks, benefits, right to abstain from research,
right to withdraw consent at any time. If research involves community, then voluntariness and
informed consent applies to both community and individual members.
Principle of Non-exploitation – this means every research should have mechanism of compensation
by insurance coverage or other means for any damage arising out during the research to the research
participant. This also includes comprehensive aftercare for all the foreseeable and the non-foreseeable
physical and psychological risks
Principle of privacy and confidentiality – this means the identity and records of all research
participants are kept confidential to prevent any hardship, discrimination, stigma for participating in
research. The only exception to this principle is for legal purposes when any law demands disclosure.
Principle of precaution and risk minimisation – this means due care is taken to minimise risk to all the
research participants / community and they don’t suffer from any known irreversible adverse effects.
Interim reviews to be carried out to assess the risks and when increased risks are anticipated, then
research is stopped to prevent further harm to research participants / community
Principle of professional competence – this means that research is carried out by only competent
qualified persons who act ethically, impartially and with total integrity
Principle of Accountability and transparency – this means research is carried out by researchers in
fair, honest, transparent and impartial manner disclosing all conflicts of interest/s (if any). The
research records are stored for such period as law demands even after completion of study and are
available for legal scrutiny, post research monitoring and further research
Principle of the maximisation of public interest and distributive justice – this means the research
should always aim towards benefiting all human kind and not only those who are socioeconomically
better off in the society.
Principle of Public domain – this means all research findings (both positive and negative) should be
brought to public domain through scientific publications and deliberations to consolidate scientific
knowledge. This prevents undue replication of studies which pose undue harm to research participants
Principle of totality of responsibility – this means professional and moral responsibility should be
borne by researchers / institutes / sponsors for observance of all principles, guidelines, legal
provisions in research. And they should allow monitoring and review of research and do remedial
actions if need arises.
At the end of this session, are you able to –

 Explain the significance of ethics in relation to healthcare research

 State the four cardinal principles of ethical research
 Mention the four pillars of ethical research, and
 List the general principles of ethics of human research.