Guidelines for Ethical Considerations in Social Research & Evaluation in India

For Review by the Institutional Review Board (IRB) of Morsel Research and Development Pvt Ltd
Registered with: The Division of Assurance and Quality Improvement, Office for Human Research Protections (OHRP), U.S. Department of Health and Human Services.

These ethical guidelines have been developed to ensure that social research and evaluation projects undertaken by Morsel Research and Development Pvt Ltd adhere to the highest ethical standards. The guidelines align with both Indian legal frameworks and international regulations, particularly those mandated by the U.S. Department of Health and Human Services through OHRP registration.

1. Informed Consent

• Voluntary Participation: Research participation must be entirely voluntary. Participants should understand that they are free to decline participation or withdraw from the study at any time without any negative consequences. Special attention must be given to ensure there is no coercion, either direct or indirect, from researchers, institutions, or community leaders.
• Detailed Information Provision: Participants must be provided with all necessary information about the research, including its purpose, expected duration, procedures involved, and any potential risks or benefits. This information must be conveyed in a language and manner that the participant can easily understand. In India, where many regional languages are spoken, translating the consent forms and explanations into local languages is essential.
• Forms of Consent: Written informed consent is preferred, but in cases where literacy is low or where cultural norms prevent written consent, verbal consent is permissible. Verbal consent must be properly documented, often requiring witnesses and a recorded process to ensure compliance with ethical standards.
• Ongoing Consent: In certain longitudinal studies, informed consent must be reaffirmed periodically, especially if new aspects of the research emerge that were not originally discussed with participants.

2. Confidentiality and Privacy

• Data Protection: Personal data collected during research must be treated with the highest level of confidentiality. Identifiable information such as names, addresses, or photographs should not be disclosed to unauthorized individuals. Research data should be anonymized as soon as possible to protect participants’ identities.
• Storage and Security: All data, including digital records, must be securely stored. This involves encryption for digital data and secure locked storage for physical records. Compliance with India’s Information Technology (IT) Act (2000) and the forthcoming Personal Data Protection Bill (2019) is essential, ensuring that data breaches or unauthorized access are prevented.
• Participant Privacy: Researchers must ensure that interviews, focus groups, and other forms of data collection take place in environments that respect participants’ privacy. For sensitive subjects such as health, income, or personal relationships, care should be taken to avoid any unwanted attention or social repercussions for participants.

3. Cultural Sensitivity and Respect for Local Communities

• Engagement with Local Norms: Before initiating research, researchers should engage with local community leaders or representatives to better understand cultural norms, sensitivities, and practices. This is especially important in areas with distinct tribal or indigenous populations. Failure to understand and respect local traditions can lead to mistrust or harm.
• Respect for Traditional Knowledge and Practices: If indigenous knowledge is part of the research, it should be treated with respect, acknowledging its source and ensuring benefit-sharing mechanisms, as mandated by India’s Biological Diversity Act (2002).
• Addressing Language Barriers: Research materials, consent forms, and communication must be provided in local languages. When necessary, culturally competent interpreters should be used to facilitate understanding between researchers and participants.

4. Minimizing Harm and Risk

• Physical and Emotional Safety: Researchers have an obligation to minimize any potential physical, emotional, or psychological harm to participants. This includes preparing for unanticipated adverse reactions to questions, especially in research that involves trauma, violence, or sensitive topics such as caste discrimination or sexual abuse.
• Risk Assessment: A detailed risk assessment should be conducted prior to beginning the research. This assessment must include identifying any potential hazards to participants and developing a plan to mitigate or manage them. It is essential that all possible harms, including social and reputational risks, are considered, especially when working with vulnerable groups.
• Safety Protocols for Fieldwork: In the Indian context, where certain areas may be conflict-prone or socially unstable, researchers must adopt safety protocols to ensure both their safety and that of the participants. Engaging local authorities or community leaders to secure safe working environments is often necessary.

5. Equity, Justice, and Beneficence

• Equitable Participant Selection: The selection of participants should reflect fairness and justice. Particular care must be taken not to exploit vulnerable populations, such as low-income groups, children, or those with limited education. Researchers must avoid creating or exacerbating inequalities by disproportionately recruiting participants from disadvantaged groups without offering them equivalent benefits.
• Distribution of Benefits and Burdens: The risks and benefits of the research should be equitably distributed among participants. Researchers must ensure that benefits, such as new knowledge or improved services, are accessible to the communities that participated in the research.
• Compensation: Participants must be compensated for their time and any expenses incurred due to participation. However, compensation should not be so large as to be coercive or disproportionately influence a participant’s decision to take part.

6. Accountability and Transparency

• Open Disclosure of Research Aims: Researchers must clearly explain the purpose, procedures, and possible outcomes of the research to participants. Misleading participants about the true nature of the research is unethical and violates both Indian and international standards.
• Public Reporting of Findings: Results must be reported in a truthful and transparent manner, ensuring that data are not fabricated, misrepresented, or selectively published. Researchers are expected to submit final reports to the IRB, funders, and other relevant bodies, ensuring full accountability.
• Disclosure of Sponsorship and Conflicts of Interest: All funding sources, sponsorships, and any potential conflicts of interest must be disclosed to the IRB and participants. Transparency in financial arrangements is critical to maintaining the integrity of the research process.

7. Vulnerable Populations and Special Protections

• Children, Elderly, and Disabled Individuals: Special protections must be in place for vulnerable populations. For children, assent should be obtained along with parental or guardian consent. For disabled or elderly individuals, additional steps may be needed to ensure they fully understand the research and its implications.
• Indigenous and Marginalized Communities: In India, where caste, religion, and tribal affiliations can deeply affect social standing, researchers must ensure that marginalized groups are treated fairly and respectfully. Any research that could exacerbate their vulnerability must be carefully scrutinized by the IRB.

8. Research Using Digital and Online Platforms

• Data Collection and Privacy: If online or digital platforms are used for data collection, researchers must adhere to stringent privacy standards, ensuring that personal data are securely stored and not misused. Online consent forms must be designed to be as clear and comprehensive as traditional paper forms.
• Avoidance of Deceptive Practices: Researchers should avoid using deceptive methods, such as false identities, to collect data from online platforms. This is particularly relevant for studies involving social media or public forums, where anonymity and identity concerns are heightened.

9. Monitoring, Review, and Compliance

• Regular IRB Review: For long-term projects, continuous ethical review by the IRB is essential. This ensures that any emerging risks or ethical concerns are promptly addressed.
• Compliance with Indian and International Laws: Morsel Research and Development Pvt Ltd, registered with the OHRP under the U.S. Department of Health and Human Services, must comply not only with Indian laws but also international ethical standards for human research protections.

10. Post-Research Obligations and Community Engagement

• Feedback to Participants: Once the research is completed, researchers should provide participants and their communities with a summary of findings in an accessible format. This promotes transparency and trust.
• Benefit Sharing: Researchers should ensure that communities, particularly those providing indigenous knowledge or resources, benefit from the outcomes of the research. This could include sharing royalties, providing access to the final reports, or offering other tangible benefits.

These guidelines provide a comprehensive ethical framework for conducting social research and evaluation in India. The IRB of Morsel Research and Development Pvt Ltd plays a crucial role in ensuring that all projects meet these ethical standards, safeguarding participants’ rights and well-being while promoting the advancement of knowledge.