Principle of essentiality

 Human participants deemed essential after evaluating alternatives.

 Ethics committee independent of the research must vet the necessity.

Principle of Voluntariness:
 Participant's right to agree, refuse, or withdraw is paramount.
 Informed consent process safeguards participant rights.

Principle of non-exploitation
 Equitable selection of research participants.
 Fair distribution of benefits and burdens without discrimination.
 Safeguards for vulnerable groups

Principle of social responsibility

 Research planned to avoid social divisions or disruptions.
 Consideration for community relationships and harmony.

Principle of ensuring privacy and confidentiality:

 Maintenance of participant privacy and confidentiality.
 Limited access to authorized personnel.
 Breach under certain circumstances with EC consultation for valid
reasons.

Principle of risk minimization:

 Stakeholders ensure risk minimization at all research stages.
 Adequate care and compensation in case of harm.
Principle of professional competence :
 Research conducted by competent individuals with relevant
qualifications, experience, and training.
Principle of maximization of benefit:
 Design and conduct research to maximize benefits for participants
and society.

Principle of institutional arrangements

 Institutions facilitate research with appropriate governance policies.
 Provide infrastructure, manpower, funds, and training opportunities.

Principle of transparency and accountability:

 Research plan and outcomes disclosed in public domain.
 Stakeholders disclose and manage conflicts of interest.
 Conduct research in a fair, honest, and transparent manner.
 Retain records for external scrutiny/audit.

Principle of totality of responsibility:

 All stakeholders responsible for actions.
 Compliance with ethical guidelines and regulations.

Principle of environmental protection:

 Researchers accountable for environmental protection.
 Compliance with existing guidelines and regulations at all research
stages.
Paraphrased Text:
Studying people helps us:
 Understand diseases better
 Develop better treatments
 Improve overall health
But research can also have risks for participants:
 Physical or emotional discomfort
 Privacy concerns
So, it's important to protect participants by:
 Designing studies with safety in mind
 Following ethical principles:
o Respecting people's choices (autonomy)
o Doing good and avoiding harm (beneficence & non-
maleficence)
o Ensuring fairness and justice
These principles apply to all research:
 Medical
 Social
 Behavioral
 And more!
They help us protect participants' dignity, rights, safety, and well-being.
I hope this paraphrase is clear and concise! Let me know if you have any
other questions.
Professional Paraphrase:
Biomedical and health research relies on human participation to generate
generalizable knowledge that fosters improved health, enhances disease
understanding, and possesses demonstrable social value. However,
inherent risks and potential for harm or inconvenience exist for both
participants and communities involved. Consequently, safeguarding
participant well-being must be integral to study design.
The cornerstone of ethical healthcare across various medical systems has
long been the principle of "non-maleficence," which translates to "do no
harm." To ensure the dignity, rights, safety, and well-being of research
participants, four fundamental ethical principles are applied during
biomedical and health research: respect for autonomy, beneficence, non-
maleficence, and justice.
These core principles have been further expanded into twelve
comprehensive guidelines applicable to all biomedical, social, and
behavioural science research involving human participants, their biological
samples, and associated data.
This revised paraphrase adopts a more formal tone, employs technical
vocabulary appropriate for the research domain, and emphasizes the
critical aspects of participant protection and ethical research conduct.
Benefit-risk assessment

 Benefit-Risk Balance: The positive outcomes of research, whether

direct or indirect, should outweigh the potential risks such as
physical, psychological, social, economic, or legal harm.

 Maximizing Benefits, Minimizing Risks: Researchers, sponsors,

and the Ethics Committee (EC) should work to increase the benefits
and reduce the risks to participants, ensuring a balance that leads to
potential benefits at individual, societal, and community levels.
 EC’s Role in Risk Assessment: The EC should evaluate the
inherent benefits and risks, ensure a favorable balance, assess plans
for minimizing risk and discomfort, and decide on the research’s
merit before approval.
 Continuing Review: The EC should also evaluate any changes in
risks during the ongoing review of the study.

Informed consent process

 Informed Consent: This process protects an individual’s freedom to
choose whether to participate in research. It involves providing
relevant information, ensuring comprehension, and confirming
voluntary participation.
 Language and Clarity: The information should be explained in
simple terms and in a language that the participant understands.
 Informed Consent Document (ICD): This includes the
Patient/Participant Information Sheet (PIS) and Informed Consent
Form (ICF), which should contain the required elements and be
approved by the Ethics Committee (EC) before participant
enrollment.
 Responsibility of the Researcher: It is the researcher’s primary
duty to obtain written, informed consent from the participant or their
Legally Acceptable/Authorized Representative (LAR).
 Consent for Incapable Individuals: If a participant is unable to
give informed consent, the LAR’s consent should be obtained.
 Illiterate Participants: If a participant or LAR is illiterate, a literate
impartial witness should be present during the consent process.
  Audio/Visual Recording: In certain circumstances, such as specific
clinical trials, audio or visual recording of the consent process may
be required.
 Verbal Consent/Waiver of Consent/Re-consent: These may be
obtained under certain conditions, with EC approval.

Privacy and confidentiality

 Privacy and Confidentiality: Privacy is an individual’s right to
control their personal information, while confidentiality is the
researcher’s duty to protect this information from unauthorized
access or disclosure.
 Safeguarding Confidentiality: Researchers should protect the
confidentiality of research data related to participants and the
community.
 Limitations of Confidentiality: Participants should be informed
about potential limitations in maintaining strict confidentiality.
 Privacy in Publications: Any research publication should respect
the privacy of individuals and avoid revealing their identities. Re-
consent is required for publication if not previously obtained.
 Sensitive Information: Certain information, such as HIV status,
sexual orientation, genetic information, etc., is sensitive and should
be protected to prevent stigmatization or discrimination.
 Anonymization in Research: When conducting research with
stored biological samples or medical records, personal information
should be coded or anonymized, and access should be limited.
 Disclosure of Data: Under certain circumstances, such as court
orders, threats to life, public health risks, or serious adverse events,
participant data may be disclosed with the permission of the Ethics
Committee (EC).

Distributive justice

 Equitable Selection: Research participants should be chosen in a

manner that fairly distributes the benefits and burdens of the
research.

 Protection of Vulnerable Groups: Vulnerable individuals or

groups should not be included in research solely for the benefit of
others who are more privileged.
  Avoiding Inequalities: Research activities should not contribute to
social, racial, or ethnic disparities.
 Benefit Sharing: Any potential benefits from the research, direct or
indirect, especially those with commercial potential, should be
shared with the participants, biological material donors, or data
providers. This should be decided beforehand in consultation with
all stakeholders and reviewed by the Ethics Committee (EC).

Payment for participation

 Reimbursement: Participants may be reimbursed for expenses
related to their participation in research, such as travel costs,
inconvenience, time spent, and other incidental expenses.
 No Extra Costs: Participants should not have to pay for any
expenses beyond routine clinical care that are related to the research.
 Additional Services: If available, participants may receive
additional medical services at no cost.
 Consent by LAR: When a Legally Acceptable/Authorized
Representative (LAR) gives consent on behalf of a participant,
payment should not be an undue inducement. Reimbursement may
be offered for travel and other incidental expenses due to the
participation of the child/ward in the research.
 EC Review: Ethics Committees (ECs) must review and approve the
payments and free services, ensuring they do not amount to undue
inducement.

Compensation for research-related harm:

 Compensation for Harm: Research participants who suffer harm
due to their participation are entitled to compensation. This includes
physical, psychological, social, legal, or economic harm. In case of
death, the participant’s dependents are entitled to financial
compensation.
 Reporting Serious Adverse Events (SAEs): The researcher is
responsible for reporting all SAEs to the Ethics Committee (EC)
within 24 hours. A report on how the SAE was related to the
research must also be submitted within 14 days.
  EC’s Role in SAEs: The EC is responsible for reviewing the
relatedness of the SAE to the research and determining the type and
amount of assistance to be provided to the participants.
 Clinical Trials: For clinical trials under the purview of CDSCO, the
timeline and procedures as notified from time to time may be
followed.
 Medical Care and Compensation: All research participants who
suffer harm should be offered appropriate medical care, psycho-
social support, referrals, clinical facilities, etc. Medical management
should be free if the harm is related to the research. Compensation
should be given to any participant when the injury is related to the
research.
 Deliberation on Compensation: The EC should consider aspects
including the type of research, extent of injury, loss of wages, etc.,
while deliberating on the amount of compensation to be awarded to
participants who have suffered research-related injury.
 Sponsored Research: For other sponsored research, it is the
responsibility of the sponsor to include insurance coverage or
provision for possible compensation for research-related injury or
harm within the budget.
 Adverse Events (AEs): All AEs should be recorded and reported to
the EC according to a pre-planned timetable, depending on the level
of risk and as recommended by the EC.
 Investigator Initiated Research/Student Research: In such
research, the investigator/institution where the research is conducted
becomes the sponsor. It is the responsibility of the host institution to
provide compensation and/or cover for insurance for research-related
injury or harm to be paid as decided by the EC. The institution
should create an in-built mechanism to be able to provide for
compensation, such as a corpus fund in the institution.
 Research Grants: In the applications for research grants to funding
agencies, the researcher should keep a budgetary provision for
insurance coverage and/or compensation depending upon the type of
research, anticipated risks, and proposed number of participants.

Ancillary Care:
  Ancillary Care: Participants may receive free medical care for
conditions not related to the research or for incidental findings that
occur during their participation in the research.
 Avoiding Undue Inducement: This provision of care should not
amount to undue inducement, as determined by the Ethics
Committee (EC).

Conflict of interes:
 Conflict of Interest (COI): This refers to situations where
professional judgement about a primary interest (like participant
welfare or research validity) could be unduly influenced by a
secondary interest (financial, personal, academic, or political). COI
can occur at the level of researchers, Ethics Committee (EC)
members, institutions, or sponsors.
 COI Declaration: If COI is inherent in the research, it should be
declared at the beginning and appropriate mechanisms to manage it
should be established.
 Institutional Policies: Research institutions should develop and
implement policies and procedures to identify and mitigate conflicts
of interest, and educate their staff about such conflicts.
 Disclosure by Researchers: Researchers should ensure that the
documents submitted to the EC include a disclosure of interests that
may affect the research.
 EC’s Role: The EC should evaluate each study considering any
disclosed interests and ensure that appropriate measures are taken to
mitigate them.
 COI within EC: Any COI within the EC should be declared and
managed according to the EC’s standard operating procedures
(SOPs).

Selection of vulnerable and special groups as research

participants:
 Vulnerable Groups: These are individuals or groups who may be at
increased risk of harm due to their inability to fully protect their own
interests.
  Characteristics of Vulnerability: Vulnerability can be due to legal
status (like children), clinical conditions (such as cognitive
impairment, unconsciousness), or situational conditions (including
economic or social disadvantage, certain ethnic or religious groups,
hierarchical relationships, institutionalized persons, humanitarian
emergencies, language barriers, and cultural differences).
 Inclusion in Research: Vulnerable participants should generally be
included in research only when the research directly addresses their
health needs or requirements. However, they also have an equal right
to be included in research so that they too can benefit from the
research outcomes. This requires careful consideration by
researchers and the Ethics Committee (EC).
 Role of the EC: The EC should identify vulnerability, ensure
additional safeguards and monitoring mechanisms are in place, and
provide guidance to the researcher.

Community engagement:
 Community Engagement: A community, defined as a group of
people sharing common characteristics, should be actively involved
before, during, and after the research to address culturally sensitive
issues and respond to their health needs.
 Engagement Methods: The community can be engaged in various
ways and their input can be valuable. The extent of engagement
should depend on the type of research being conducted.
 Community Advisory Board/Group (CAB/CAG): This can serve
as a link between the community, researchers, and the Ethics
Committee (EC). CAB members should not coerce community
members into participating in research and should protect their rights
and interests.
 Community Representation in EC: Community members can also
be represented in the EC, either as members or special invitees.
 Role of Community Engagement: Community engagement does
not replace individual informed consent. It ensures that the
community’s health needs are met, informed consent is appropriate,
and research benefits are accessible through research that serves the
best interests of science and the community.
 Post-Study Communication: After the study is completed, the
researcher may communicate with the community representative,
 local institution, or government department to help disseminate the
results to the entire community.

Post research access and benefit sharing

 Post-Research Benefits: The benefits from research should be
accessible to individuals, communities, and populations when
relevant. This can include indirect benefits to the community such as
improved living conditions, establishment of counselling centres,
clinics, schools, and health education.
 Communication of Findings: Efforts should be made to
communicate the research findings to the relevant individuals or
communities.
 Post-Research Access Plans: The research team should plan for
post-research access and sharing of academic or intervention
benefits with the participants, including those in the control group.
 Study Protocol: Post-research access arrangements or other care
must be described in the study protocol for the Ethics Committee
(EC) to review.
 Regulatory Approvals: If an investigational drug is to be given to a
participant post-trial, appropriate regulatory approvals should be in
place.
 A Priori Agreement: The EC should consider the need for an a
priori agreement between the researchers and sponsors regarding the
points from 2.11.1 to 2.11.3.
 Restricted Scope Studies: In studies with restricted scope, such as
student projects, post-study benefits to the participants may not be
feasible. However, the institution should make conscious efforts to
continue to support and provide better care to the participants.