Any study, project, thesis work, consultancy research work that involves human participants to provide any type of data, sample, interventional drug/implant etc. When in doubt you can reach out IEC office bearer: iitd_iec@iitd.ac.in

Research involving human participants are regulated by Nuremberg convention and Indian guidelines given by ICMR https://ethics.ncdirindia.org/ICMR_Ethical_Guidelines.aspx

The standard assessment of risk in research proposal across countries entails assessing the proposal for physical harm, distress, discomfort, and lowered health due to research participation. Guidelines set by the medical council enable assessing the risk involved in the research proposal

Any kind of research involving human participants (including data collected for social behavioral, cognitive, psychological sciences, management sciences, studies in design, policy, AI and technology studies) requires institute ethical approval.

The basic assumption is that the research involving human participants should be assessed for ethical consideration for potential risk to physical and mental health to the participant. Currently, all Indian research involving human subjects are mandated to follow guidelines approved by ICMR

Ethics approval is crucial for all research, including qualitative studies. While a qualitative study may involve some flexibility in how questions are phrased during the interview, a well-developed plan is still essential.

1. The ethics committee needs to understand the overall research goals, interview topics, and potential risks to participants. Minor adjustments to wording or phrasing to improve comprehension are expected and don't require an amendment to your protocol.

2. However, if the changes you make are significant and affect the core aspects of your research, like purpose, hypothesis, or key interview questions, it's important to submit an amendment to your approved protocol with the ethics committee.

If you're unsure whether a change requires an amendment, don't hesitate to contact the ethics committee office. They can provide guidance and help you navigate the process if contacted in a time-bound manner.

The certificate's validity is one year from the date of issuance. If your work extends beyond that period, you must inform the IEC office about the extension with a progress report and ask for an extension and renewed certificate with a new validity date. Alternatively, you can provide a closure/completion report to conclude the project.

The ethical review process usually takes around 4-6 weeks from the date of submission of a complete proposal. However, this timeframe may vary depending on the project's complexity and the committee's workload. The ethics committee is scheduled to meet every month in the third week. You should submit the application before the 5th of the month to be considered for the upcoming ethics committee review (end of the month). You are advised to prepare your application well in time and take 2 months to turn around the cycle for your application.

A Participant information sheet (PIS) should be included in the application.

1. It should be simple language for the participant to understand.
2. It should be in a language the participant can understand.
3. If the participant is illiterate, then oral consent can be obtained, i.e., the interviewer reads out the PIS and seeks oral confirmation for participation. Audio recording of the oral consent must be stored for verification.
4. A copy of informed consent signed by the participant and interviewer should be provided to the participant.
5. The privacy of the participant must be protected and raw data identifying the participant should be only with the principal investigator or co-principal investigators.
6. Tentative time required from the participant should be mentioned in the PIS
7. Any kind of financial inducement for the study participant is not recommended, only time and travel compensation are permissible. In the past, the studies compensating participants up to 150 – 200 Rs/hr. have been approved. This information should be included in the PIS.
8. If the participants are from a particular organization, appropriate approval from the representative is required to conduct the study.
9. PI are advised to avoid recruiting participants who are the students enrolled in the courses, this helps in retaining participant’s freedom to not participate in the research.

For surveys, interviews and qualitative ethnographic studies.
1. A list of questionnaires should be submitted along with the application.
2. If the questionnaire is part of a known study protocol, it should be referenced and provided in the application. Advisable to attach author’s permission to use the material and ensure there is no copy right violations.
3. In case of ethnographic studies, list of questions and topics, variables/themes to be covered should be provided in the application. It is advised that this list of questions, themes, variables, constructs are related to the research hypothesis, and questions. This ensures that the participant’s time is utilized in a suitable manner.

You can learn about ethics applications, review processes, and best practices in studies involving human subjects through various online resources:

1. ICMR-National Institute of Epidemiology (ICMR-NIE) offers online courses on their website (https://nie.gov.in/icmr_sph/Online-courses.html).

2. NPTEL-NOC IITM has a YouTube channel with a playlist titled "Ethics Review of Health Research" that covers relevant topics.

3. Sangath e-Learning Platform provides both free and paid courses related to research ethics and human subjects, which can be accessed through their website.

These resources should give you a comprehensive understanding of the ethics application process and best practices in studies involving human subjects.

All research involving human participants should be supervised by a regular/permanent faculty in the institute. Students and contractual staff (including post doc fellows) work under the guidance of a supervisor/mentor/host who is a permanent employee of the institute and the same could serve as a PI for the proposal with the student/staff as co-PI. Documents related to the study must be maintained for at least 5 years, and the legal obligation to maintain these documents rests with the permanent faculty supervisor.

The study can only start after the approval obtained from the IEC IIT Delhi. This is to protect the rights of the participant and institute reputation. The institute's ethics committee carries out the responsibility of assessing research proposals involving human participants to ensure that the research carries no risk and no harm to the participants.

The ICMR 2017 guidelines state the definition and aim of a pilot study, A pilot study, project or experiment is a small-scale preliminary study conducted in order to evaluate feasibility, time, cost, adverse events and effect size(statistical variability) in an attempt to predict an appropriate sample size and improve upon the study design prior to performance of a full-scale research project.’ Tentatively, the sample size of the participants in pilot study is less (N < 10). Ethical approval cannot be given to a pilot study in absence of a research proposal (research query and design) submitted with justification for, and usage of pilot data in the full proposal.

Firstly, Check the terms of use and data privacy policies of the social media platform where you're collecting data. Some platforms may restrict certain types of research.Secondly, employ robust anonymization techniques to ensure data cannot be re-identified back to individual participants.

1. Even without individual consent, seeking ethical approval for your research is crucial. Ethics committees can help you navigate the complexities of using non-consented data and ensure your study minimizes risks to participants.

2. Clearly explain in the proposal as well as the ethics committee why obtaining individual consent isn't feasible in your case.

3. Demonstrate that your research design minimizes risks to participants. Anonymization and data security measures are vital. Furthermore, clearly explain the potential benefits of your research, both for the participants and for society as a whole.

The PI has 25 days to respond to feedback/suggestions after the IEC meeting discussion. If they do not respond within 25 days, they will need to start the fresh application process.

Any changes or amendments to the approved research project must be promptly communicated to the IEC office for review and approval. This includes modifications to the study protocol, participant recruitment procedures, data collection methods, or any other significant changes that may impact ethical considerations (Refer Annexure 4 on IITD ethics website).

The criteria for submission of an application under expedited review:

1. Involves non-identifiable specimens and human tissue obtained from sources like blood banks, tissue banks, and leftover clinical samples.

2. Involves non-identifiable clinical documentation materials such as data, documents, and records.

3. Involves modifications or amendments to an approved protocol, including administrative changes, correction of typographical errors, or changes in researcher(s).

4. Represents a revised proposal that was previously approved through expedited review, full review, or continuing review of an approved proposal.

5. Involves minor deviations from the originally approved research that pose no or minimal risk.

6. Includes progress or annual reports where there is no additional risk, such as activities limited to data analysis.

7. The expedited review of Serious Adverse Events (SAEs) or unexpected Adverse Events (AEs) will be conducted by the SAE subcommittee.

8. For multicenter research where a designated Ethics Committee (EC) has approved the proposal, a participating Ethics member may review participating center-specific information and modifications in the study proposal through a full committee meeting/expedited review depending on the importance of local consent-related issues involving specific to the center.

9. Relates to research conducted during emergencies and disasters (refer to Section 12 of the ICMR Ethical Guidelines, 2017).

The criteria for submission of an application under review exemption:

1. Research is based on data in the public domain, systematic reviews, or meta-analyses.

2. Observation of public behavior or information recorded without linked identifiers, as long as it doesn't harm the interests of the observed person.

3. Quality control and quality assurance audits within the institution.

4. Comparisons among instructional techniques, curricula, or classroom management methods.

5. Consumer acceptance studies related to taste and food quality.

6. Public health programs conducted by government agencies.

For a detailed understanding of studies exempt from review, refer to the National Ethical Guidelines for Biomedical & Health Research Involving Human Participants 2017, Page 51, Table 4.2. This includes program evaluations aimed at refining and improving programs or monitoring without individual identifiers.

1. Informed Consent- Since minors cannot give consent themselves, a legally authorized representative (usually a parent or guardian) must provide informed consent.

2. Assent Form- Whenever possible, the minor should also be involved in the decision-making process by obtaining their assent (agreement) to participate. This involves explaining the study in a way that they can understand and respect their wishes.

Here are the best practices when working with participants from vulnerable groups, along with the justification based on the ICMR guidelines from 2017:

1. Justification for Inclusion: Researchers need to clearly explain why it's necessary to involve vulnerable populations in the research. This justification ensures that the potential benefits of the research outweigh any risks or burdens for these participants.

2. Informed Consent: The informed consent process for vulnerable populations should be adapted to their specific needs and understanding. This may involve using simpler language, providing additional information sheets, or involving a trusted intermediary to explain the research in a culturally appropriate manner.

3. Training and Cultural Competence: Ensure researchers and staff working with vulnerable participants receive training on ethical considerations, cultural competence, and sensitivity. This training helps them understand and navigate the unique challenges and needs of vulnerable populations.

4. Handle Sensitive Topics Carefully: Handle sensitive topics with care and respect for cultural sensitivities. Use appropriate language and methods to collect data without causing distress to participants.

5. Include Distress Protocol: Incorporate a distress protocol into your research proposal. This protocol outlines steps to be taken if a participant from a vulnerable group experiences distress during the study, ensuring their well-being is prioritized.

The justification for these best practices can be found in Section 6 of the ICMR guidelines from 2017, which provides detailed guidance on research involving vulnerable populations. This section emphasizes the need for additional safeguards, adapted consent processes, cultural sensitivity, and justification for including vulnerable participants in research studies.

1. Clear and Accessible Information: The informed consent document should be clear, concise, and accessible to participants. This might involve offering different formats (e.g., online document, downloadable PDF) and using easy-to-understand language.

2. Online Consent Process: Ensure the online consent process is user-friendly, and participants can easily understand what they're agreeing to. This could involve including options to review information and ask questions before consenting.

3. Implement strong data security measures to protect participant information collected online. This might involve encryption, password protection, and secure storage practices.

4. Data Minimization: Collect only the data that is essential for research study. Avoid collecting unnecessary personal information.

5. Transparency about Data Use: Clearly explain to participants how their data will be used, stored, and shared in the informed consent document. Offer options for participants to withdraw their data if they wish.

Depending on the specific nature of your research, you may need to consider additional ethical issues. If you have any doubts, consult with an ethics committee or a professional familiar with research ethics.

1. Establish a formal agreement (MoU) between all participating institutions outlining roles, responsibilities, data sharing agreements, and conflict resolution mechanisms.

2. Establish a clear data sharing agreement between all institutions. This should specify data ownership, access rights, storage practices, and publication arrangements.

3. Implement robust data security measures to ensure the privacy and confidentiality of participant data across all institutions.