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Any biomedical or behavioural research involving human participants, their biological materials or data collected from them constitute clinical research and require approval of a duly constituted Ethics Committee for the conduct of the same.

The four basic ethical principles while conducting biomedical and health research for protecting the dignity, rights, safety and well-being of research participants are:

• autonomy (respect for persons)
• beneficence (doing good),
• non-maleficence (do no harm) and
• justice (equitable distribution of benefits and risks)

The ethical issues related to reviewing a protocol include:

• Social values
• Scientific design and conduct of the study
• Benefit-risk assessment
• Selection of the study population and recruitment of research participants
• Payment for participation
• Protection of research participants' privacy and confidentiality
• Distributive justice
• Community considerations
• Qualifications of researchers and adequacy assessment of study sites
• Disclosure or declaration of potential Conflict of interest
• Review of the informed consent process
• Post research access, plans for benefit sharing, medical management and compensation for study related injury
• Provision for ancillary care
• Protection of vulnerable participants

The ethical issues related to reviewing a protocol include: Privacy of a participant is ensured by keeping his/her identity and records confidential, and access to information is limited to authorized personnel. However, under certain circumstances (suicidal ideation, homicidal tendency, HIV positive status, when required by a court of law etc.) privacy of the participant can be breached in consultation with the Ethics Committee (EC) for valid scientific or legal reasons as the right to life of an individual supersedes the right to privacy of the research participant.

Institutions should constitute an Ethics Committee to ensure quality ethical review and monitoring and provide logistical support and training opportunities. The institution where the research is conducted and the investigator is employed becomes the sponsor, and it is the responsibility of the host institution to provide compensation and/or cover for insurance through an in-built mechanism for research-related injury or harm. Institutions should also set up policies to ensure research integrity and publication practices and an appellate mechanism for addressing research-related grievances.

Ancillary care is defined as free medical care/ referrals offered to research participants for non-research-related illnesses or incidental findings that occur during the course of participation in the research, provided such compensation does not lead to undue inducement as determined by the EC.

Yes, the Ethics Committee has a right to examine the scientific validity of the study to make the research ethically viable and ensure the quality of research and/ or safety of research participants.

A community can be defined as a social group of people of any size sharing the same geographical location, beliefs, culture, age, gender, profession, lifestyle, disease, etc. The community should be meaningfully engaged before, during, and after the research to mitigate culturally sensitive issues and ensure greater responsiveness to their health needs and requirements.

Involving the community in a meaningful participatory process while devising methods, interpreting observations and disseminating the results ensures that the community's health needs and expectations are addressed. Engaging the community also helps us to assess the impact on socio-cultural context, religious or philosophical context, if any. In the case of collaborative research, an EC should review the protocols in the local social and cultural context and ensure respect for the sensitivities and values of participants and communities at collaborative sites.

Community advisory board/group (CAB/CAG) can act as an interface between the community (from which participants are to be drawn), the researchers, and the concerned EC. Members of the community can also be represented in the EC either as members or as special invitees to share their views and concerns.

Yes, the research participant has the right to withdraw from the study unless the samples or data are already anonymized, without penalty or loss of benefits to which he/she would otherwise be entitled. The participants also have the right to refuse the use of their study data or biological specimens for the study and/ or for future studies, and the samples may be destroyed

Risk to research participants is categorized into four types depending on the magnitude of harm as (1) less than minimal risk, (2) minimal risk, (3) minor increase over minimal risk or low risk and (4) more than minimal risk or high risk. Also, for further details, refer to Section 3.15 ICMR National Ethical Guidelines for Biomedical and Health Research Involving Human Participants, 2017.

Conflict of interest (COI) is defined as a set of conditions where professional judgement concerning a primary interest, such as participant’s welfare or the validity of research, tends to be unduly influenced by a secondary interest, financial or non-financial (personal, academic or political). Researchers, institutions and EC members must identify COI associated with the proposal, disclose them and should take steps to mitigate them.

Research institute must

• Develop and implement policies that can identify, mitigate and manage COI;
• Prepare SOPs to address COI issues that are dynamic, transparent and actively communicated;
• Implement policies and procedures to address COI and conflicts of commitment, and educate their staff about such policies;
• Monitor the research or check research results for accuracy and objectivity; and
• Not interfere in the functioning and decision making of the EC.

Research-related injury includes harm or loss that occurs to an individual as a result of participation in research, irrespective of the manner in which it has occurred, and includes both expected and unexpected adverse events and serious adverse events related to the intervention, whenever they occur, as well as any medical injury caused due to procedures. Free medical management of adverse events (AEs) and serious adverse events (SAEs) should be given for as long as required or till such time as it is established that the injury is not related to study, whichever is earlier. The researcher should ensure free treatment for participants irrespective of relatedness to the study and if required, payment of compensation over and above medical management by the investigator and/institution and sponsor(s), as the case may be. All such cases should be recorded and reported to the EC. SAEs must be reported for all studies and if applicable timelines as specified by regulators to be followed (EC, sponsor, and regulator, as applicable).

Research design should have an in-built provision for mitigating any research-related harm, and participants who suffer any direct injury as a result of their participation in research are entitled to immediate treatment and compensation, if required, after due assessment. It is the responsibility of the Sponsor/ Funding Agency/ Principal Investigator/ institution to provide appropriate care/ referral/ compensation for any research-related injury through the budget of a sponsored/ funded research project/ insurance policy.

Research participants may be reimbursed for expenses incurred relating to their participation in research, such as travel-related expenses, inconvenience incurred for participation, time spent and other incidental expenses in either cash or kind or both as deemed necessary (e.g., loss of wages and food supplies).

Research participants who suffer from direct physical, psychological, social, legal or economic harm as a result of their participation are entitled, after due assessment, to financial or other assistance to compensate them equitably for any temporary or permanent impairment or disability. In case of death, the participant’s dependents are entitled to financial compensation.

Responsible Conduct of Research (RCR) involves the various components such as values of research; policies; planning and conducting research; reviewing and reporting research; and responsible authorship and publication. RCR emphasizes on researcher’s responsibility to abide by the standards prescribed by their professions, disciplines and institutions and also by relevant laws.

Research misconduct involves fabrication, falsification, and plagiarism of data, which are serious issues both nationally and internationally. For further details, refer to Box 3.4 in ICMR National Ethical Guidelines and ICMR RIPE Policy. (https://ethics.ncdirindia.org//asset/pdf/ICMR_PRIPE2019.pdf)

The institutions should develop policies to address scientific/research misconduct and must investigate all allegations of misconduct as it may harm present or future participants’ lives and the credibility of the institution. Such investigations must be done in a timely, fair and transparent manner, and the results should be made available in the public domain.

All clinical and biomedical research involving human participants, including any intervention such as drugs, surgical procedures, devices, biomedical, educational or behavioural research, public health intervention studies, observational studies, implementation research and preclinical studies of experimental therapeutics and preventive or traditional systems studies as per Ministry of AYUSH, GOI (including Ayurveda, Yoga, Naturopathy, Unani, Siddha, Homoeopathy) and SOWARIGPA (Amchi or Tibetan medicine) may be registered prospectively with the CTRI.

No. All clinical trials and biomedical health research studies involving human participants must be registered prospectively before initiation with the Clinical Trial Registry - India (CTRI).

All biomedical and Health research should acquire approval from the respective regulatory authorities of India. For example- protocol-specific permissions, such as the stem cell committee, the Ethics Committee, IC-SCR (permissible research), National Apex Committee for Stem Cell Research and Therapy (NAC-SCRT) (restricted research), and CDSCO (IND products and drugs) as the case may be. HMSC for international collaboration, e.g., Global studies in HIV/AIDS in specific communities.

• Institutional Ethics Committee (IEC)
• Institutional Animal Ethics Committee (IAEC)
• Institutional Committee for Stem Cell Research (IC-SCR)
• National Apex Committee for Stem cell research and Therapy (NACSCRT)
• Institutional Biosafety committee (IBSC)
• Review Committee on Genetic Manipulation (RCGM)
• Genetic Engineering Approval Committee (GEAC)
• Health Ministry's Screening Committee (HMSC)
• Central Licensing Authority (CLA)
• Atomic Energy Regulatory Board (AERB)

According to the International Committee of Medical Journal Editors (ICMJE), authorship entails:
• substantial contributions to the conception or design of the work, or the acquisition, analysis or interpretation of data for any of the work,
• drafting the work or revising it for important intellectual content
• final approval of the version to be published
• agreement to be accountable for all aspects of the work and ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.

No, the EC member cannot be listed as an author in the publication. If the EC member is associated with the project as a faculty, he/she should have declared a Conflict of Interest in the beginning and not be involved in the review and decision making process. The authorship of research should be considered at the time of its initiation. For further details, refer to Box 3.3 (criteria for authorship, ICMJE), in ICMR National Ethical Guidelines for Biomedical and Health Research Involving Human Participants, 2017. https://ethics.ncdirindia.org/asset/pdf/ICMR_National_Ethical_Guidelines.pdf

MoU should clearly define the nature and purpose of collaboration, need, roles and responsibilities of both parties, timelines, and address the issues regarding the transfer of biological material or data, intellectual property issues, authorship, sensitive research, etc.

An ethics approval must be obtained from the institutional Ethics Committee formulated as per the ICMR National Ethical Guidelines, 2017. If the institution does not have its own EC, it may utilize the services of an independent EC or the EC of another institution, and there should be an appropriate MoU between the institutions. In the case of collaborative studies, common ethics review can be carried out by a designated EC. However, the final approval for each site is the responsibility of the local /participating EC.

All biomedical and health research involving foreign assistance and/or collaboration should be submitted to the Health Ministry Screening Committee (HMSC), ICMR Headquarters, New Delhi, for approval before initiation. The participating Centres/collaborators shall follow the necessary ethical considerations mentioned in section 3.8.1 in ICMR National Ethical Guidelines for Biomedical and Health Research Involving Human Participants, 2017.

No. Any research to be carried out in India by a foreign national or an Indian national based in a foreign institution would require collaboration with an investigator based in a research institution in India who will lead the activity here and seek needful approvals from the local EC. In addition, the Indian investigators have to apply to the Health Ministry Screening Committee (HMSC) for research with international collaboration. Local Ethics Committee approval is mandatory even if ethical approval from a foreign university is in place. The HMSC secretariate will not accept any application from an Indian collaborator without their EC approval.

The patient/ participant owns the biological sample, and data collected from her/ him and researchers have no claim for ownership. Institutes hosting/ implementing the research are the custodians of the data/samples.

Data should be shared or placed in a public domain in a de-identified/anonymized form unless required otherwise, for which applicable permissions/re-consent should be obtained beforehand. After the study is completed, the researcher may communicate with the community representative, local institution or the government department from where the data was collected to help in the dissemination of the results to the entire community.

In case the PI is shifting to any other institution, the project could be transferred to the new institution with prior approval from the regulatory authorities, sponsors/funding agencies, and both institutes.

All research proposals must be submitted to the EC. A researcher can ask for exempt/expedited review but cannot decide that her/his proposal falls in the exempted, expedited, or full review category, which comes under the purview of ECs. Depending on the type of research and the risk involved, the EC can conduct the expedited or full review or could exempt it from review. For more details, refer to Section 4 of ICMR in National Ethical Guidelines for Biomedical and Health Research Involving Human Participants (2017).

Yes, the Institutional EC clearance is mandatory as it is responsible for scientific and ethical review of all research proposals, including retrospective studies with or without identifiers.

EC approval is mandatory for any Biomedical and Health Research before the initiation of the study when it is conducted on humans or involves human samples or their clinical information/ data.

Yes, every Biomedical and Health Research, irrespective of the type of study, including observational studies, should be submitted to the EC for review and approval.

The Ind EC must be established as a registered legal entity governed by individuals who are not members of the proposed EC and who will oversee and monitor the functioning of the Ind EC. It can be used by the researchers who do not have institutional attachments. There is no territorial restriction, but it is suggested that EC should preferably be located in the local/ nearby area to monitor research and conduct site visits as per requirement. For regulatory studies, a distance of 50 km is prescribed by the CLA.

Every institution should allocate reasonable funds for the smooth functioning of the EC. A reasonable fee for review may also be charged by the EC to cover the expenses related to optimal functioning in accordance with Institutional policies. Institutions, both government and private, can charge a fee for the review of proposals, and there is no predetermined limit, and it can be an internal decision based on running costs.

A newly constituted Ethics Committee can start functioning and conduct biomedical and health research according to the ICMR National Ethical Guidelines for Biomedical and Health Research Involving Human Participants, 2017. They should register with the Department of Health Research (DHR) at the earliest. (Visit http://ethics.ncdirindia.org/Registration_of_EC_reviewing.aspx).

As per ICMR National Ethical Guidelines, 2017, it is suggested that the institute should establish an Ethics Committee (EC) if it is engaged in research on human participants. If the institute does not have its own EC, it can utilize the services of the EC of another institution (host institution), preferably in the adjoining/ nearby area, after signing an MoU or MoA.

The EC can adopt any format for giving an approval letter based on the SOP or institutional policy. However, the study approval letter should mention the study title, name of the PI, particulars of the EC meeting (time & date), along with the list of EC members present at the meeting, their respective roles in the EC and EC decision and suggestion/comments of the EC. The approval letter should also mention the duration of the study, the timeline for submission of continuing reports, and reporting of AE/SAEs, amendments, etc. (as per institutional SOP).

Yes, an institution can organize ethics training on its own for the members of its EC. It could be either a physical or an online full-day program or an hourly program per day for an entire week. Members should be trained in Indian ethical guidelines, human research protection, EC functions and SOPs and should be conversant with ICMR National Ethical Guidelines, Indian Good Clinical Practice (GCP) Guidelines (if applicable), NDCT Rules 2019 and other relevant regulations of the country. Relevant professional faculty/ speakers may be invited to the program based on the agenda and institutional norms. Training on international guidelines or other topics such as Informed consent, Risk-benefit analysis, Biobanking, public health research etc. can also be taken additionally.

No. All research proposals for Biomedical and Health Research involving human participants must be reviewed and approved by an appropriately constituted EC. If any institution does not have its own EC, it may utilize the services of an independent EC or the EC of another institution.

Yes, the EC is responsible for scientific and ethical reviews of research proposals. Although ECs may obtain documentation from a prior scientific review, they must determine that the research methods are scientifically sound and should examine the ethical implications of the chosen research design or strategy.

Any surveys conducted on human participants should get approval from the EC of an institution with which the investigator is affiliated. If any institution does not have its own EC, it may utilize the services of an independent EC or the EC of another institution. In addition, permission from the school/ college authority (such as management, principal, and teachers), needful consent from parents, and assent from children are required.

The Head of the institute can appoint an EC in accordance with the ICMR National Ethical Guidelines. ECs should be multi-disciplinary and multi-sectoral. If the EC is involved in the review of biomedical and health research (clinical, basic science, policy, implementation, epidemiological, behavioural, public health research, etc.), it should be registered with the National Ethics Committee Registry for Biomedical and Health Research (NECRBHR) under the Department of Health Research (https://naitik.gov.in/DHR/Homepage) and if it reviews clinical trials for new drugs it should be registered with CDSCO on SUGAM online portal – https://www.cdscoonline.gov.in/CDSCO/homepage

The members of EC reviewing Biomedical and Health research should preferably be between 7 and 15 with an adequate representation of age and gender. It should be multi-disciplinary and multi-sectoral with a balance between medical and non-medical members, >50% non-affiliated members. For more details, refer to Table 4.1 of ICMR National Ethical Guidelines.

• Chairperson/Vice Chairperson
• Member Secretary/ Alternate Member Secretary
• Basic Medical Scientist(s)
• Clinician(s)
• Legal expert/s
• Social scientist/ philosopher/ethicist/theologian
• Lay person(s)

Although training is not a pre-requisite for the formation of an Ethics Committee, it is mandatory that EC members either be trained in ICMR National Ethical Guidelines and/or GCP at the time of induction into the EC or must undergo training and submit training certificates within 6 months of appointment. They also need to undergo training from time to time to keep themselves updated on emerging ethical issues, new guidelines or regulations.

No. 50% of the members should preferably be non-affiliated or from outside the institution. The Chairperson/Vice Chairperson of the EC should surely be non-affiliated to ensure efficient functioning and independence of the decision-making.

Yes, a minimum quorum of five members should be present to conduct an EC meeting. A meeting is considered valid only if the quorum is fulfilled, and this should be maintained throughout and at the decision-making time. The quorum should include medical, non-medical or technical or/and non-technical members. A minimum of one non-affiliated member should be part of the quorum.

The complaint/grievance against the EC can go to the appellate authority that appoints the EC. The complaint may be filed per the procedures mentioned in the Standard Operating Procedures of the Institutional EC. Also, the Chairperson/ Vice Chairperson handles complaints against researchers, EC members, conflict of interest issues, requests for the use of EC data, etc.

No. To maintain fair decision making, the head of the institution should not be part of the EC but should act as an appellate authority to appoint the committee or to handle disputes. This should also be mentioned in the Ethics Committee's Standard Operating Procedures (SOPs), along with the procedure for appointments/ reappointments/ membership etc.

A Chairperson/Vice Chairperson is a non-affiliated member. He/She is a well-respected person from any background with prior experience of having served/ serving in an EC. They conduct EC meetings and are accountable for the independent and efficient functioning of the committee. For further details, refer to Table 4.1 of ICMR National Ethical Guidelines.

Yes. Any member listed as a non-affiliate member can become a Vice-Chairperson. In the absence of the Chairperson, any non-affiliated member may act as an acting Chairperson if there is no designated Vice Chairperson.

Yes. A Chairperson of an EC may be re-appointed for another term or more. The procedure for appointments/ reappointments/ extension of the term(s) should be clearly stated in the SOPs of the EC, which need to be followed.

Yes, the Vice-Chairperson must fulfil the qualifications or experience requirements mentioned for the Chairperson. They need previous EC experience as a mandatory requirement.

A Member Secretary is a staff member of the institute with experience in clinical research and ethics. They organize an effective and efficient procedure for receiving, preparing, circulating and maintaining each proposal for review; ensure proper EC functioning; schedule and organize EC meetings; prepare agendas and minutes; train EC members; make EC documentation, communications and archiving. Yes, any person listed as an affiliated member can become a Member Secretary.

No, only a member of the EC can act as a Vice-Chairperson (non-affiliated) and an alternate Member Secretary (affiliated) in the absence of the Chairperson or Member Secretary, respectively and will have all the designated powers for the meeting. The alternate Member Secretary should be an affiliated member and can be appointed by the Head of the Institution at the time of the constitution of the committee/ or any other affiliated member can act as an alternate Member Secretary in the meeting (if the Member Secretary declares COI/ or is unavailable) as per requirement.

The Chairperson / Vice-chairperson and Member Secretary, in addition to their position, can also take up the role of a clinician, legal expert, social scientist, basic scientist, lay person etc., based on their qualifications. All other members are appointed for their specific roles.

No, EC members cannot nominate anyone else on their behalf as each member is appointed by the concerned authority of any institution. Only alternate members who are formally appointed and listed in the membership roster may be invited by the committee. Subject experts/independent consultants are also invited to give opinions/comments and cannot be part of decision making.

A lay person should be a non-affiliated literate person from the public or community who has not pursued a medical science/ health-related career in the last 5 years and should be aware of the local language, cultural and moral values of the community.

To meet the quorum requirements, the EC may additionally have a set of alternate members who may be invited for decision making. These members can attend meetings in the absence of regular members and have the same terms of reference as regular members. However, the EC may invite subject experts as independent consultants or include a representative from a specific patient group as a member of the EC or special invitee, for an opinion on a specific proposal, for example, HIV, genetic disorders, cancer, etc. The subject experts do not have any decision making power.

An alternate member is a member of the EC with all powers to be part of decision making as a regular member. A subject expert may be invited to attend the meeting to give an expert opinion on a specific proposal but will not have decision-making power.

Yes. If there is an exchange of biological material involved between collaborating sites, the EC may require appropriate MoU (Memorandums of Understanding) and/or MTA (Material Transfer Agreements) to safeguard the interests of participants and ensure compliance while addressing issues related to confidentiality, sharing of data, joint publications, benefit sharing, etc. The review, conduct and monitoring of collaborative research should be overseen, and stakeholders must be aware of the requirements of various regulatory and funding agencies. An EC should review the protocols in the local social and cultural context and ensure respect for the sensitivities and values of participants and communities at collaborative sites.

Multicentre research is conducted at more than one centre by different researchers usually following a common protocol. A large number of clinical trials, clinical studies and public health research, including surveys, are conducted at several research centres within the country or at international sites.

All sites are required to obtain approval from their respective ECs, which would consider the local needs and requirements of the populations being researchers and safeguard the dignity, rights, safety, and well-being of the participants. They may decide to utilize the services of one common EC from a participating site identified as Designated EC (DEC) to save time, prevent duplication of effort and streamline the review process. This EC should be located in India and registered with the relevant authority. However, the local site requirements, such as the informed consent process, research implementation and its monitoring, etc., will be performed by the local ECs, which will be referred to as the Participating ECs (PEC), who will be giving the final approval for the project at their respective participating site.

If any EC at a site does not approve the study, the reasons must be shared with other ECs. This would require good communication and coordination between the researchers and EC secretariats of participating sites. The EC can suggest site-specific protocols and informed consent modifications as per local needs. However, it should be followed after it is duly approved by the EC of the host institutes/decision of the main EC is accepted. A separate review may be requested for studies with a higher degree of risk, clinical trials or intervention studies where conduct may vary depending on the site or any other reason which requires closer review and attention.

The informed consent document (ICD) should be submitted for Ethics Committee review in both English and the local language(s) and should be preferably prepared by the Investigator. If a multicentric study is planned in different regions, an informed consent document should be drafted in all the local languages of the respective regions. Simple manual translations in local languages and back translation certificates (if applicable) should also be submitted. The purpose of translation is to communicate the contents of the ICD in a simple language and Grade 7 reading level that participants can follow and read without changing the original meaning. It should not use complicated medical terminology or terms that are difficult to understand.

The meeting of the designated main EC can be attended by nominated members of ECs of the participating centres to discuss their concerns, if any, about ethics or human rights and seek solutions and communicate the decision of the main EC to their respective ECs. Meetings should be organized at the initial and, if required, intermediary stages of the study to ensure uniform procedures at all centres.

Yes, all types of biomedical and health research (clinical, basic science, policy, implementation, epidemiological, behavioural, public health research, etc.) must be reviewed and approved by an EC before it is conducted. Only the EC, through the Member Secretary/Secretariat in consultation with the Chairperson, if needed, can screen the proposals to categorize them into three types of review, namely, exemption from review, expedited review, and full committee review, depending on the risk involved.

Yes. An institution can appoint more than one EC as per their requirement and workload and facilitate the smooth functioning of ECs. However, all the committees should follow the same SOPs for their functioning. The EC can also have subcommittees comprising the Chair/Vice Chair, Member Secretary and two or more members for ease of functioning, e.g., expedited review committee, SAE committee, etc.

Standard Operating Procedures (SOP) are detailed written instructions in a certain format describing all activities and actions to be undertaken by an organization to achieve uniformity in the performance of a specific function. Every institution should draft its own customized SOPs according to which the EC should function. These SOPs should be updated periodically to reflect changing requirements.

A private general practitioner can work as an independent researcher. They can utilize the services of the EC of another institution (host institution) preferably in the adjoining/nearby area or approach an Independent EC (Ind EC) that functions outside the institutions. In case of collaboration with Institutions or research centres, it is advised to have a memorandum of understanding (MoU) to safeguard the interests of the researcher and ensure compliance while addressing issues related to confidentiality, sharing of data, joint publications, benefit sharing, etc. The EC granting approval shall be responsible for monitoring and continued review of the study.

In the context of Ethics Committees at institutions, the head of the institution will be the appellate authority for appointing a committee/ member and any grievances against the EC decisions. Further, the appellate authority has the power to dissolve the EC or reappoint an EC.

For all biomedical and health research involving human participants, it is the primary responsibility of the researcher to obtain the voluntary written consent of the prospective participant or legally acceptable/authorized representative (LAR) for participation in the research study. An informed consent document is a written, signed and dated paper confirming a participant's willingness to voluntarily participate in a particular research after having been informed of all aspects of the research that are relevant to the participant's decision to participate in their local language. The informed consent process involves three components – providing relevant information to potential participants, ensuring the information is comprehended by them and assuring voluntariness of participation.

The ICD has two parts – the participant information sheet (PIS) and the informed consent form (ICF). Information on known facts about the research, which has relevance to participation in a simplified language and manner, is included in the PIS. This is followed by the ICF in which the participant acknowledges that she/he has been explained and has understood the information and is volunteering to be included in that research.

If a participant or LAR is illiterate, then a literate impartial witness who is not connected to the research should be present throughout the consent process as a witness. It may be other patients in the ward who are not in the study, staff from the social service department and counsellors etc. The impartial witness should be able to read the participant information sheet and consent form, understand the participant's language, and sign the document.

It is a simple oral or written test designed to identify if the participant has understood the details related to her/his voluntary participation in research before signing the Informed Consent Document (ICD). Administering a test of understanding is important, particularly for sensitive studies. If needed, the test may be repeated until the participant has really understood the contents. For example, open-ended questions such as “If you decide not to take part in this research study, do you know what your options are?”, “Do you know that you do not have to take part in this research study if you do not wish to?”, “Do you have any questions?”, etc. will clarify the understanding of the participant. If an oral ‘test of understanding’ is administered, an impartial witness should sign the document. The Ethics Committee may suggest the need for a test of understanding for certain research studies.

Consent involves informing and obtaining voluntary permission from potential participants about the research and its risks and benefits and documenting their understanding and agreement to participate. A permission/agreement obtained from an adult to participate in a study is called “consent”, which is a mandatory requirement to be documented for her/his enrolment in that study.

The researcher should only use the EC-approved version of the consent form, including its local translations. In biomedical and health research, there are various types of informed consent, namely:

• Blanket or broad consent
• Tiered consent
• Specific consent
• Delayed consent
• Dynamic consent
• Withdrawal of consent
• Waiver of consent
• Re-consent
• Community consent
• Assent

Assent means to agree or approve an idea or suggestion after thoughtful consideration to participate in research by a young person between the ages of 7-18 years who can understand the implications of any proposed research but is not legally eligible to give consent. Assent can be oral (7-12 years) or written (12-18 years). The assent has to be corroborated with the informed consent of the parent/LAR.

Electronic media can be used as a source to obtain informed consent, which can be administered and documented using electronic informed consent systems such as text, graphics, audio, video, podcasts or interactive websites. The process, electronic materials, method of documentation (including electronic/digital signatures), etc. must be reviewed and approved by the EC a priori. The electronic consent must contain all elements of informed consent in a language understandable by the participant. The PI or her/his designee must supervise the process.

A gatekeeper could be the guardian or local authority normally responsible for participants’ well-being, such as community heads or leaders/culturally appropriate local authorities/healthcare providers/head of institutions or organizations responsible for community welfare or their appointed advocates who give permission for participation. However, community consent and individual consent cannot be ignored unless the concerned EC has granted a waiver.

Yes. Re-consent may be obtained under certain conditions after due consideration and approval by the EC. Re-consent is required when new information pertaining to the study becomes available, which has implications for a participant or changes the benefit and risk ratio. For e.g.,

• a research participant who is unconscious regains consciousness or who had suffered a loss of insight regains mental competence and is able to understand the implications of the research;
• a child becomes an adult during the course of the study;
• research requires a long-term follow-up or requires an extension;
• there is a change in treatment modality, procedures, site visits, data collection methods or tenure of participation which may impact the participant’s decision to continue in the research;
• there is a possibility of disclosure of identity through data presentation or photographs (this should be camouflaged adequately) in an upcoming publication;
• the partner/spouse may also be required to give additional re-consent in some of the above cases.

In the case of differently abled participants, such as individuals with physical, neurological or mental disabilities, appropriate methods should be used to enhance the participants’ understanding, for example, braille for the visually impaired. Differently abled participants belong to vulnerable populations group, and they lack the ability to consent; therefore, a LAR should be involved in decision-making. For e.g., in cognitively impaired children or children with developmental disorders, their parents are also vulnerable, and there is a high likelihood of therapeutic misconception. The potential benefits and risks must be carefully explained to parents/LAR so as to make them understand the proposed research.

When a participant is willing to participate but not willing to sign or give a thumb impression or cannot do so, then verbal/oral consent may be taken on approval by the EC in the presence of an impartial witness who should sign and date the consent document. This process can be documented by audio or video recording of the participant, the PI, and the impartial witness. However, with the approval of the EC, verbal/oral consent should only be obtained in exceptional circumstances and for specific, justifiable reasons. It should not be done on a routine basis.

Written informed consent has to be obtained from research participants before they can be included in any research. This is applicable to all types of research, including clinical, biomedical, socio-behavioural, public health, and others.

Yes. After consent is obtained, the participant should be given a copy of the patient information sheet (PIS) and signed ICF unless the participant is unwilling to take these documents (as in the case of stigmatizing diseases). Such reluctance should be recorded.

If the research involves less than minimal risk to participants, such as de-identified samples or data, and the waiver will not adversely affect the rights and welfare of the participants, the researcher can apply to the EC for a waiver of consent.

Some types of research, such as socio-behavioural studies, may require deception due to the nature of the research design. True informed consent may lead to modification in behaviour and may defeat the purpose of research. True informed consent in studies involving deception is difficult due to the nature of the research. A two-step procedure comprising an initial consent and a debriefing after participation may be required.

Vulnerable persons are those individuals who 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 are in a situation that prevents them from doing so.

The vulnerable persons (individuals/populations/groups) have some common characteristics:

• Socially, economically or politically disadvantaged and therefore susceptible to being exploited;
• Incapable of making a voluntary informed decision for themselves or whose autonomy is compromised
• Able to give consent, but whose voluntariness or understanding is compromised due to their situational conditions; or
• Unduly influenced either by the expectation of benefits or fear of retaliation in case of refusal to participate, which may lead them to give consent.

Vulnerable groups and individuals may have an increased likelihood of incurring additional harm as they may be relatively (or absolutely) incapable of protecting their own interests. Researchers must justify the inclusion of vulnerable populations and should ensure precautions to avoid exploitation of vulnerable participants, take appropriate consent from LARs, recording of assent and reconsent, when applicable. The researchers must also justify the exclusion of vulnerable populations in the study. There should be no coercion, force, duress, undue influence, threat or misrepresentation or incentives for participation during the entire research period.

No. Any research involving vulnerable populations should undergo full committee review, even if the risk is minimal.

In the case of institutionalized individuals, in addition to individual/LAR consent, permission for conducting the research should be obtained from the head of that institution.

Yes. Research on tribal populations should only be conducted if it is of a specific therapeutic, diagnostic and preventive nature with appropriate benefits to the tribal population. Due approval from competent administrative authorities, consultation with community elders and persons who know the local language/dialect of the tribal population and in the presence of appropriate witnesses and above all, appropriate individual informed consent should be taken. Whenever possible, seek the assistance of government functionaries/local bodies or registered NGOs who work closely with tribal groups and have their trust.

As per New Drugs and Clinical Trials (NDCT) Rules, 2019, a “clinical trial” in relation to a new drug or investigational new drug means any systematic study of such new drug or investigational new drug in human subjects to generate data for discovering or verifying its (i) clinical or; (ii) pharmacological including pharmacodynamics, pharmacokinetics or; (iii) adverse effects, with the objective of determining the safety, efficacy or tolerance of such new drug or investigational new drug.

As per the NDCT Rules, 2019, an “academic clinical trial” means a clinical trial of a drug already approved for a certain claim and initiated by any investigator, academic or research institution for a new indication or new route of administration or new dose or new dosage form, where the results of such a trial are intended to be used only for academic or research purposes and not for seeking approval of the Central Licencing Authority or regulatory authority of any country for marketing or commercial purpose. It is the responsibility of EC to approve and monitor these trials.

Yes, the NDCT Rules, 2019 mentions a formula for the calculation of the quantum of financial compensation for clinical trials-related injury. For clinical trials under the purview of CDSCO (Regulatory), the timeline and procedures as notified should be followed to calculate financial compensation for SAEs (both adult and paediatric populations).

According to ICMR National Ethical Guidelines, there is no separate formula to calculate SAEs in biomedical and health research. However, the EC is responsible for reviewing the relatedness of the SAE to the research, as reported by the researcher, and determining the quantum and type of assistance to be provided to the participants based on the formula provided by the NDCT Rules, 2019.

It is mandatory to prospectively register all clinical trials which require regulatory approval (CDSCO/ CLA) with the Clinical Trials Registry - India (CTRI). All clinical research involving human participants, including any intervention such as drugs, surgical procedures, devices, biomedical, educational or behavioural research, public health intervention studies, observational studies, implementation research and preclinical studies of experimental therapeutics and preventives or AYUSH studies may be registered prospectively with the CTRI. On the other hand, it is voluntary but not mandatory to register other types of biomedical health research or non-regulatory clinical trials.

If the clinical trial is for a product for commercial use or marketing purposes, approval needs to be taken from CDSCO/CLA. Researchers are required to contact the Drug Controller General of India (DCGI's) office for clarification in this regard, as clinical trials are under the purview of CDSCO.

A therapeutic misconception is when participants believe that the purpose of the clinical trial/research study is to administer the best available treatment rather than to conduct research. Since therapeutic misconception is high in oncology or other terminal illnesses, there should be appropriate consent procedures, and the EC should carefully review such protocols and recruitment procedures.

The Principal Investigator is responsible for reporting all SAEs in biomedical health research to the EC within 24 hours of knowledge through email or fax communication (including on non-working days). A report on how the SAE was related to the research must also be submitted to EC within 14 days. The EC determines the quantum of compensation that has to be provided to the participants. The sponsor/institution/PI is responsible for making provisions to cover the costs of medical management and compensation through research grants, insurance or by setting up corpus funds.

Free medical management of AEs and SAEs should be given for as long as required or till such time as it is established that the injury is not related to the clinical trial, whichever is earlier. Also, ancillary care may be provided to clinical trial participants for non-study/trial-related illnesses arising during the period of the trial. EC must determine the amount of financial compensation, if needed, after establishing the relatedness to the trial in SAEs.

The benefits accruing from research should be made accessible to individuals, communities and populations whenever relevant. Sometimes more than the benefit to the individual participant, the community may be given benefit in an indirect way by improving their living conditions, establishing counselling centres, clinics or schools, and providing education on good health practices. These should be decided a priori before initiating the research, and ECs should be informed about this.

Yes. All studies, clinical trials, or biomedical and health research should be registered prospectively with CTRI. Requirements of the Ministry of AYUSH should be followed while doing research on traditional medicine and CDSCO/CLA for phytopharmaceuticals.

Yes. All studies, clinical trials, or biomedical and health research should be registered prospectively with CTRI. Requirements of the Ministry of AYUSH should be followed while doing research on traditional medicine and CDSCO/CLA for phytopharmaceuticals.

An academic investigator-initiated study, where the data is not going to be used to seek any marketing approval, can be reviewed by an EC that is registered with DHR. However, if the proposal submitted is with the intention of introducing a new device or product in the market and obtaining data on that, or is a sponsored clinical trial, then the EC should get itself registered with CDSCO also before it can review the study.

Yes, all types of research, including public health research, need EC approval. Public health protects both the individual and the population at large since the benefits and risks are not limited to an individual, but influence communities, populations and the environment. Investigations and interventions in public health research should therefore be conducted through an ethical reflection process, as well as the establishment of appropriate safeguards, oversight procedures, and governance mechanisms.

Registries are a systematic collection of data concerning a particular disease and/or health conditions at one or more places. A large volume of data may be accessible from state health departments, national surveys, commercial sources and other data repositories and big data sources. ECs should ensure that research using administrative data does not violate any principles of public health research ethics. Research on sensitive topics, verbal/oral consent or pseudonyms may be suitable with appropriate approval of the EC and with proper documentation. The process of obtaining such forms of consent and the associated documentation should be approved by the EC. However, the EC can consider consent waivers for studies using health-related registries depending on the type of the research.

Demographic surveillance sites are used for the testing of new health and non-health interventions in a geographically defined population. Prior approval from competent state/national authorities and from the community leadership is required to set up the demographic surveillance sites. The EC must approve strategies for conducting research at these sites, including data collection and storage, as well as plans for maintaining confidentiality and dissemination of results.

Yes. Risks involved in this field are non-measurable and dynamic in nature which might be misconstrued as no/minimum risk research but could cause more harm than anticipated. Every type of research related to health needs to be submitted to the Ethics Committee.

Social harm is a non-medical adverse consequence of study participation, including difficulties in personal relationships and stigma or discrimination from family or community. Social harm can be related to personal relationships, travel, employment, education, health, housing, institutions (government/nongovernment) and others.

ECs may permit selective withholding of information/hypothesis of the study in the consent form for achieving overall social and public good without influencing the outcome of the study. These studies are called “Deception studies”. Research employing any type of deception should undergo full committee review and should include the provision of debriefing wherever required.

Researcher(s) may come across certain facts detrimental to a participant’s self or others, such as suicidal tendency/ideation, notifiable diseases etc. In such a situation, researchers have a responsibility to disclose this information to relevant persons/authorities to save life or prevent damage contemplated by the participant.

For routine genetic diagnostic testing, written consent may be obtained as per institutional policies; however, for any research, it is a mandatory requirement. Informed written consent is also essential for procedures such as pre-symptomatic testing, next-generation sequencing (NGS), prenatal testing, genomic studies, carrier status etc.

The harms/risks associated with genetic testing may be psychosocial rather than physical in the form of anxiety, depression or disrupted family relationships. There are chances of social stigmatization and discrimination in schooling, employment, health and general insurance, which requires greater care in recruiting participants in research. Maintaining confidentiality is very important in genetic testing as results have familial and societal implications. It is important to have adequate safeguards against therapeutic misconceptions as there is often an overlap between genetic research and services.

For any gene therapy-related research, necessary precautions should be taken to safeguard the participants. The researcher should explain the specific nature of the confidentiality of data generated through genetic testing/research to the patient/participant. Stringent norms and caution should be followed in the consent process when the research of newer technologies is concerned. There is a need to consider the possibility of commercialization, patenting or rightful access; therefore, a vigorous benefit-risk evaluation is required to address the expectations and concerns of the public. There is a need for an initial cautious approach before this technology can be widely used for various applications, like somatic cell gene therapy, and gene editing technology – Clustered, Regularly Interspaced, Short Palindromic Repeat (CRISPR). Prior approval from the local EC and Department of Biotechnology (DBT) has to be obtained for the gene construct.

The results of the test have to be informed to the participant/ family/ community after proper validation of the research findings. Pre and post-test counselling are required while conveying the results.

Privacy and confidentiality of a participant should be maintained, and no information should be shared with family members or others without consent. But in cases where sharing of information is vital to prevent serious harm to the others in the family (like a spouse in case of transmittable diseases, other family members in case of heritable diseases), the duty of beneficence overcomes confidentiality, and the information may be shared with the required permissions and precautions.

Except for hemopoietic stem cell transplantation for haematological disorders, any other uses of stem cells are categorized as research and must be conducted as clinical trials. ICMR and DBT published Guidelines for Stem Cell Research and Therapy as National Guidelines for Stem Cell Research in 2017 to address issues related to stem cell research. A National Apex Committee for Stem Cell Research and Therapy (NAC-SCRT) has been established. It monitors and oversees research activities at the national level and lays guidelines for basic and clinical research. The Institutional Committee for Stem Cell Research (IC-SCR) and the IEC approve and monitor stem cell research (basic and clinical) at the institutional level. These oversight committees ensure that the review, approval and monitoring processes of all research projects in the field of stem cell research are conducted in compliance with the national guidelines. It is mandatory for all institutes and entities engaged in stem cell research to establish an IC-SCR and register the same with NAC-SCRT.

A biobank is an organized collection of human biological materials with usually associated datasets stored for years in appropriate facilities for research and potential commercial purposes with inbuilt policies for transparency. The space occupied by the organized collection of these materials and data is termed biorepository. Both terminologies are often used interchangeably.

The major ethical responsibilities are related to the ownership, storage, and access/sharing of human biological materials by biobanks. The biobanks have to facilitate means to safeguard the rights and confidentiality of the donors and prevent exploitation at all times of storage and later use of the biological sample stored.

Biobank is just a custodian of the stored samples. The donor or the individual from whom the biological sample is collected owns the sample and the data collected from it. Biobanks can use the stored sample based on the informed consent provided by the concerned individual during the time of collection or a later modified version of the same.

A systematic de-identification or removal of personal identity from a biological sample is called anonymization. In reversible anonymization, the personal identity can be re-linked, while in irreversible anonymization, the personal identity cannot be re-linked. In irreversible anonymization, the concerned individual loses ownership over his biological sample.

Yes. In anonymous samples, no identifiers are present from the start/beginning or, if collected, are not maintained. On the other hand, a systematic de-identification or removal of personal identity from a biological sample is called anonymization, which may be either reversible or irreversible.

Every biobank must have an Ethics Committee (EC) and/or a Technical Authorization Committee (TAC). Any complaints regarding the biobank can be shared with the concerned EC or TAC.

Yes, but DNA samples or any biological material cannot be sent to the Foreign Collaborators for research purposes without obtaining approval from the relevant authorities in India. All biomedical and health research projects involving foreign assistance and/or collaboration should be submitted to the Health Ministry’s Screening Committee (HMSC) with Secretariat at ICMR before initiation.

No. If there is an exchange of biological material involved between collaborating sites, the EC may require appropriate MoU and/or MTA to safeguard the interests of participants and ensure compliance while addressing issues related to confidentiality, sharing of data, joint publications, benefit sharing, etc

If identifying information is being collected and will be used in the study, informed consent will be required. However, if de-identified samples/ anonymous data is used, a waiver of consent can be requested from EC.

The exchange of biological material/ data involved between collaborating sites requires EC approval and appropriate MoU and/or MTA and will be governed by the existing GOI guidelines for “Transfer of Biological Materials” issued by the Ministry of Health & Family Welfare in 1997. If the transfer happens to foreign collaborating sites, the collaborators should obtain HMSC clearance and other applicable regulatory clearances as mandated by laws.

Yes, the donor/participant has the right to ask for the destruction of her/his collected sample(s) and discontinuation/withdrawal from participation in the research. In longitudinal studies, a participant may withdraw from one component of the study, like continued follow-up/data collection, when withdrawal may be referred to as partial. In the case of de-identified and anonymized samples, the donor cannot claim for withdrawal of consent or sample destruction as the link to the owner no longer exists.

As per ICMR National Ethical Guidelines, the patients are the owners of their biological materials, sample and data collected from them. Leftover human biological materials can be used with appropriate approvals and with informed consent for commercial use, and the document should describe whether donors, their families, or communities would receive any kind of benefit.

The confidentiality, privacy, and re-consent are largely influenced by the degree of identifiability. As a general principle, research must be conducted on the least identifiable data and Ethics Committee approval and informed consent are required.

Genetic information may not be placed on a public database without appropriate informed consent from participants. If permission/re-consent has been sought from the participant, it may be shared or placed in the public domain in a de-identified/anonymized form. However, specific consent can be obtained for a specific research purpose. Participants are recontacted for every new use of their stored samples/data if the scope of research is outside that for which they had originally given consent.

Yes, the proposal can be reviewed through an expedited review/scheduled/unscheduled full committee meeting, and this may be decided by the Member Secretary on a case-to-case basis. If the local Ethics Committee is not functional, any recognized Ethics Committee within India can review the proposal until the local EC is able to convene its meeting. Prior pre-emptive preparedness is helpful in conducting research during an emergency and disaster.

Research is necessary for emergency situations (earthquake, flood, mass migration, conflict and outbreak of disease) to enable the provision of efficient and appropriate health and humanitarian response during the ongoing emergency which caused substantial material damage affecting persons, communities, society and state(s) and to be able to plan for future emergency situations.

Yes. Amendments might be incorporated in the proposal(s) to align with the research needs arising from the emergency, including issues related to re-consent from participants. The research may also have to be suspended, and the decision may be taken by researchers with information to EC. The researchers can go back to the EC for guidance regarding the continuation of research or not, and the EC may even decide if more frequent monitoring is required.

The victims during a humanitarian emergency situation will be traumatized and have less decision-making capacity. They usually misunderstand the difference between relief aid and research being conducted. Thus, the researchers/staff involved in such type of research should clearly explain that research participation is not required to receive humanitarian aid or for any other benefit and also make sure that no participant should consent to research having any such misconception.

Informed consent is mandatory for any research involving human participants. When consent of the participant/LAR/assent is not possible due to the situation, informed consent must be administered to the participant/LAR at a later stage, when the situation allows. However, this should be done only with the prior approval of the EC.

During a humanitarian emergency, the population/groups may be vulnerable and may lack the ability to consent; therefore, a LAR should be involved in decision-making. For e.g., If the research involves incompetent individuals (such as minors), children with untraceable or deceased relatives, institutionalized individuals or critically ill patients, then the LAR should give consent. The EC could review proposals prior to the occurrence of the emergency and determine who could be an acceptable LAR in the absence of intended LARs (authorized/ acceptable) in case of a humanitarian emergency.

Every research protocol involving human participants should be designed with the help of a statistician to calculate the appropriate sample size for determining the statistically significant outcome of the study. A study with less number of participants (underpowered studies) may not lead to significant outcomes, which makes the study unethical, as participants undergo a study protocol with no useful benefit to them, society or science. Similarly, studies with more participants than required (oversampling) result in unnecessary harm to an extra number of participants, which is again unethical. Therefore, proper sampling (no. of study participants required) and analysis methods have to be decided prior to the study initiation and have to be approved by both scientific and ethical committees.

The ICMR National guidelines for Ethics Committees reviewing research during COVID-19 have recommended that all biomedical and health research related to COVID-19 should be prospectively registered with CTRI as a good practice.

If the Local EC is unable to conduct its meeting, measures such as virtual or tele/web conferences should be attempted, and face-to-face meetings can be avoided to observe social distancing norms or the institutions can approach other nearby Ethics Committees for review.

Common review of multicentre research in India can be carried out by one main designated EC in order to save time, prevent duplication of effort, streamline the review process, and fast track decision making. The local ECs are free to accept the decision and may conduct only an expedited review for site-specific requirements in addition to the full committee common review. Further, the ECs can ensure strict monitoring and oversight at the local level.

ECs can conduct Virtual or Tele/Video conferences for non-COVID research proposals while ensuring physical distancing, appropriate scientific and ethical review and fulfilling the quorum requirements. It is also suggested that EC should adopt/include an SOP for Emergency Research review (Annexure I - SOP for Review of Biomedical and Health Research during COVID-19 Pandemic), which can be downloaded from the link given below:
http://ethics.ncdirindia.org//asset/pdf/SOP_Template_EC_COVID19.pdf

Yes. Any modifications/amendments to the original approved version of the protocol should be notified to the EC, and approval obtained before implementation.

EC must prioritize research review based on urgency as there is an imbalance between capacity and resources and to enable provision for efficient and appropriate health and humanitarian response during the ongoing pandemic.

No, it is not mandatory to submit hard copies of the protocol or any other relevant documents to the EC. The EC should set up a method to receive the documents electronically. The researchers can submit the research electronically through EC software or email as specified by the EC (using the ICMR Common Forms) and relevant documents to the EC for review. The EC should set up a method to secure the documents electronically. However, one set of physical documents may be required for archival purposes.

EC should continually evaluate the progress of ongoing proposals, monitor approved study sites for compliance, review SAE reports, protocol deviations/ violations/ non-compliance/ Data and Safety Monitoring Board (DSMB) reports/ any new information/ assess final reports. For protocol deviations/violations, the EC should examine the corrective actions. If the violations are serious, the EC may halt the study.

If the designated principal investigator (PI) is indisposed for a period, she/he may need to delegate parts of her/his duties temporarily to others/ co-investigator and the same should be documented and reported to the Ethics Committee at the earliest.

Yes. In light of COVID-19 infection control measures, the alternative procedures to avoid direct interaction with the patient in isolation must be explored though challenging. Needful procedures should be followed. An electronic consent/assent should be obtained, and the process can be documented through audio or video recording (if required). Electronic methods (e.g. digital signature) must be reviewed and approved by the EC a priori.

Yes, ongoing studies may need to take re-consent of already enrolled participants to implement urgent changes. It can be done via phone or video calls and obtaining oral/verbal consent supplemented with email confirmation/ documentation procedures.

Yes. As per the guidelines, any change to the originally approved procedures need EC approval before implementation. There is a need to carefully evaluate other non-COVID-19 research that is ongoing/ near term/has direct benefit(s) and, if stopped, may pose a risk to participants, and they may be continued/suggested modifications for continuation. An ongoing study may need to take re-consent of already enrolled participants to implement urgent changes; it can be done via phone or video calls and by obtaining oral consent supplemented with email confirmation and with EC approval.

When a participant cannot give a signed consent or is illiterate, then verbal/oral consent may be taken upon approval by the EC, in the presence of an impartial witness who should sign and date the consent document. This process can be documented through audio or video recording of the participant, the PI and the impartial witness, all of whom should be seen in the frame. However, verbal/oral consent should only be taken in exceptional circumstances and for specific, justifiable reasons with the approval of the EC.

Yes. Information related to COVID-19 infection may be highly sensitive in nature, with a lot of scope for stigmatization, discrimination, violence etc. Maintaining confidentiality of research-related data and its publication is important to protect the privacy of individuals and avoid any discrimination against them.

Research participants who suffer direct physical, psychological, social, legal or economic harm as a result of participating in the research are entitled to free health care and referrals as needed. However, for research related to Serious Adverse Events (SAE), appropriate financial compensation and insurance coverage be provided as per regulatory norms. The sponsor should ensure appropriate safety, funds, care and compensation, including insurance coverage. In investigator-initiated research, the investigator/institution must provide insurance, corpus funds or grants or overhead charges received by the institution as specified in ICMR Guidelines,2017.

Necessary efforts should be taken to communicate the research findings to the individuals/communities. EC should consider the need for an a priori agreement between researchers and sponsors regarding post-research access of the community to successful interventions and benefit sharing if relevant.

Yes. The study can be continued with limited parameters, and the conversion of physical visits into phone or video visits can be done with EC approval.

Yes, but the data must be anonymized. The researchers should give the rationale justifying seeking a waiver of consent. The EC can approve a waiver after careful discussion in situations such as retrospective studies, certain public health studies/surveillance programs/program evaluation studies, research on anonymized biological samples/data, in humanitarian emergencies and disasters when the participant may not be in a position to give consent or when the research cannot practically be carried out without the waiver and the waiver is scientifically justified.

Yes, storage and sharing of infectious samples require adequate safeguards. There should be clarity on custodianship, approval of the EC/ governance committee and maintenance of individual confidentiality and privacy. An appropriate MoU or MTA needs to be signed by the collaborating institutes. Appropriately trained staff should handle infectious biomedical materials to reduce the risk of exposure using relevant disinfectants, hand hygiene protection measures, personal protective equipment (PPE), or other physical barriers.

When getting the participant's written consent is impossible owing to an emergency situation, informed consent might be taken later on if the circumstances allow it. If this is the case, prior approval from the EC is required for this study. Further, participants can be informed later, and delayed consent can be taken when the situation allows.

No. ICMR permission is not required. However, research should be conducted in accordance with the “National ICMR ethical Guidelines” with EC approval.

In research that uses publicly available data for systematic reviews or meta-analyses, the researchers should submit their proposal to EC with a reason for the exemption or expedited review in accordance with ICMR guidelines. Depending on the urgency and necessity, research during emergencies may indeed be reviewed through expedited review or unscheduled full committee meetings (through virtual or tele/web conferences). Only EC can give exemption from review, and the researcher cannot decide, although it is listed under Exempt review.

The institution can take the initiative to organize physical or online training programs in view of the convenience/ availability of the members/ or physical programs involving small groups. Also, there are a number of online training programs that are organized, which may also be useful. The training may cover the topics such as ICMR National Ethical Guidelines, Guidelines for Ethics Committees during the COVID-19 Pandemic, GCP Guidelines, NDCT Rules and Roles and Responsibility of EC members. They may enrol in the online course organized by the ICMR-National Institute of Epidemiology (NIE), the NIeCer 102: Ethics Review of Health Research course, if interested. Please refer to ICMR-NIE website.

According to the New Clinical Trials Rules, 2019, ECs reviewing biomedical and health research have to register with the Department of Health Research through Naitik Portal (https://naitik.gov.in/DHR/Homepage). EC reviewing clinical trial to be registered on SUGAM portal (https://www.cdscoonline.gov.in/CDSCO/homepage). There is no need to make another committee, but the same EC has to be registered with DHR and CDSCO as per the present requirements.

The institutions may choose to have only one or more committees depending upon their workload. Most institutions in India have only one ECs to review all types of research; however, many larger institutions prefer to have two or even up to 4 Ethics Committee/subcommittee panels. For ECs reviewing both clinical trials as well as biomedical and health research, the composition has to be in compliance with regulatory requirements specified in NDCT Rules, 2019, as well as in National Ethics Guidelines. There is variation only in quorum requirements. Depending on the type of protocol, the quorum has to be verified for decision-making.