Ethical Issues

• Researchers must protect the dignity, rights, safety and well-being of research participants.
• Researcher should have appropriate qualifications, competence in research methodology and be compliant towards the scientific, medical, ethical, legal and social requirements of research.
• The researcher must conduct a benefit–risk assessment and actively attempt to maximize benefits and minimize risks to participants.
• Benefits to the individual, community or society refer to any sort of favorable outcome of the research, whether direct or indirect. The social and scientific value of research should justify the risk, which is the probability of causing discomfort or harm anticipated as physical, psychological, social, economic or legal.
• Risk can be categorized as less than minimal risk, minimal risk, and minor increase over minimal or low risk and more than minimal or high risk.
• The researcher must obtain informed consent from the participant/legally acceptable/authorized representative (LAR) in writing.
• Informed consent documents (participant information sheet and informed consent form) should carry the specified elements in simple, layman's language. These documents should be approved by the EC.
• Oral consent/waiver of consent/re-consent may be obtained under certain conditions, after due approval by the EC.
• Researcher(s) should safeguard the privacy and confidentiality of participants and research-related data from unauthorized access.
• Benefits and burdens of research should be equitably distributed among the participating individuals or communities.
• Participants should not be made to pay for research-related expenses incurred beyond routine clinical care. Reimbursement for expenses incurred can be made in cash or kind or both.
• The researcher must report all serious adverse events (SAEs) to the EC within 24 hours of knowledge and submit a report on SAE relatedness to research within 14 days.
• Research participants who suffer direct physical, psychological, social, legal or economic harm are entitled to financial compensation or other forms of assistance.
• In investigator initiated/student research, the investigator/institution where the research is conducted becomes the sponsor and must provide compensation for research-related injury through insurance, corpus funds or grants.
• Free medical care may be offered as ancillary care for non-research-related conditions or incidental findings if it does not amount to undue inducement as determined by EC.
• The selection of vulnerable and special groups needs careful consideration, with provisions for additional safeguards and close monitoring.
• Engaging with the community from the beginning of research till after its completion helps to improve design and conduct of research and ensures greater responsiveness to health needs. However, every individual participant's consent is essential.
• Post-research access and benefit-sharing may be done with individuals, communities and populations, wherever applicable after completion of study.

Responsible Conduct of Research

• Major components of RCR are values and policies; planning and conducting research; reviewing and reporting research; responsible authorship and publication aspects.
• Institutional Research Committee must facilitate research, manage grants and provide research oversight.
• Researchers must follow professional codes of conduct and have personal conviction about ethical requirements.
• The following should be established prior to conducting research:
  • Conflict of Interest policies
  • Safeguards for data acquisition, management, sharing and ownership
  • Policies for handling research misconduct including fabrication, falsification and plagiarism
• Completed research, irrespective of results, must be published in accordance with the guidelines of the International Committee of Medical Journal Editors (ICMJE).
• Clinical studies on human participants should be registered prospectively with the Clinical Trial Registry - India (CTRI). This is mandatory for regulatory trials.
• Issues related to ownership, sharing of materials/data, IPR, joint publications, research findings, conflict of interest, and commercialization should be addressed in collaborative research.
• In multicenter research, common ethics review by a designated EC can help to reduce time for getting ethical approvals from across the sites and improve coordination among participating sites. However, the local EC will look at site specific concerns and monitor research.

Process of Informed Consent

Voluntary written informed consent should be obtained in an informed consent document (ICD) from each participant to protect each individual's freedom of choice. Informed consent is a continuous process involving three main components:

• Providing relevant information to potential participants
• Ensuring competence and comprehension of the information
• Voluntariness of participation

Informed Consent Document (ICD) Elements

Conditions for Granting Waiver of Consent

The EC may grant consent waiver in the following situations:

• Research cannot practically be carried out without the waiver and the waiver is scientifically justified
• Retrospective studies, where the participants are de-identified or cannot be contacted
• Research on anonymized biological samples/data
• Certain types of public health studies/surveillance programmes/programme evaluation studies
• Research on data available in the public domain
• Research during humanitarian emergencies and disasters, when the participant may not be in position to give consent

Special Considerations for Consent

• Appropriate ICD should be prepared for differently abled participants to ensure accessibility and understanding.
• For research involving children:
  • Parental/guardian consent is mandatory
  • Verbal assent from children aged 7-12 years
  • Simplified written assent for participants aged 12-18 years
• For participants who are medically or legally incompetent, consent must be obtained from the Legally Acceptable Representative (LAR).
• Electronic/online consent may be used for:
  • Research involving sensitive topics
  • Regulatory clinical trials
  • When proper information security and data protection measures are in place
• Individual consent is always required, even when community leaders or representatives have given permission for the research study.

Vulnerability in Research Participants

Individuals/groups/populations are considered vulnerable if they are relatively or absolutely incapable of protecting their own interests because of personal disability; environmental burdens; social injustice; lack of power, understanding or ability to communicate or other reasons.

Vulnerable Individuals Include Those Who Are:

• Socially, economically or politically disadvantaged and susceptible to exploitation
• Incapable of making a voluntary informed decision for themselves or if their autonomy is compromised temporarily or permanently (e.g., people who are unconscious, differently abled)
• Able to give consent, but their voluntariness or understanding is compromised due to their situational conditions
• Unduly influenced either by the expectation of benefits or fear of retaliation in case of refusal to participate

Additional Safeguards for Vulnerable Populations

• Researchers must justify the inclusion/exclusion of a vulnerable population in their study
• A community representative may be invited to EC meetings to ensure the research is responsive to their needs and the informed consent process is appropriate
• Additional precautions should be taken by all stakeholders (researchers, ECs, sponsors) to avoid exploitation of vulnerable participants
• Informed consent process should be well documented with additional measures if required, such as audiovisual/audio recording of assent/consent/reconsent
• Research proposals involving vulnerable populations will undergo review in a full committee meeting

Special Considerations

• General Protection: Protection of privacy and dignity as well as provision of quality health care is required in dealing with vulnerable people, especially minorities
• Children: Research involving children should follow the National Ethical Guidelines for Biomedical Research Involving Children, ICMR, 2017
• Tribal Areas: Due approvals are needed from competent authorities before entering tribal areas
• Cognitive Impairment: Research involving cognitively impaired individuals or those with mental illness must be done carefully, especially if there is risk to themselves, to others or suicidal ideation
• Benefit-Risk Analysis: The EC will carry out a thorough benefit-risk analysis and examine risk minimization strategies for studies involving vulnerable populations