Rising India Research Foundation's Ethical Committee

About the Committee

The Ethics Committee of the Rising India Research Foundation (RIRF) is constituted to ensure the highest standards of ethical conduct in research involving human participants. It is established with the primary aim of providing public assurance of protection by reviewing and approving research protocols, as well as evaluating the suitability of investigators, facilities, methods, and materials used in research studies.

The Committee is committed to safeguarding the rights, dignity, safety, and well-being of all participants, while ensuring that research activities adhere to applicable national and international ethical and regulatory frameworks, including the New Drugs and Clinical Trials Rules and the ICMR National Ethical Guidelines for Biomedical and Health Research on Human Participants.

It functions as an independent and competent body that conducts timely and systematic review of research proposals and ensures scientific validity, ethical integrity, and regulatory compliance across studies conducted under RIRF.

Objectives

• To protect the rights, safety, and well-being of human participants in research
• To review and approve biomedical and health research protocols
• To ensure robust and ethically sound informed consent processes
• To assess the scientific validity and ethical acceptability of studies
• To ensure compliance with national and international ethical guidelines
• To provide public assurance of ethical research practices

Scope of Work

• Biomedical and health research involving human participants
• Psychology, nutrition, mental health, and behavioral studies
• Academic research including DNB, institutional projects, and independent studies
• Investigator-initiated and externally submitted proposals
• Collaborative national and international research projects

The committee also evaluates:

• Investigator qualifications
• Research facilities and infrastructure
• Scientific merit and ethical compliance

Roles & Responsibilities

• Scientific and ethical review of research proposals
• Monitoring ongoing studies and reviewing progress reports
• Evaluation of Serious Adverse Events (SAEs)
• Ensuring confidentiality and data protection
• Maintaining proper documentation and records
• Providing ethical guidance to investigators
• Reviewing final study outcomes

Members are also responsible for maintaining confidentiality, declaring conflicts of interest, and participating in ethics training programs.

Submission Guidelines

Researchers seeking ethical approval must submit:

• Research Protocol
• Informed Consent Documents
• Data Collection Tools
• Investigator Details
• Supporting Documents (as applicable)

Process:

• Submission via official email
• Initial screening by Secretariat
• Review allocation to committee members
• Decision communicated to investigator

Fee Structure:

• Internal proposals: No fee
• External proposals: ₹10,000 (subject to study type and review level)

Meeting & Review Process

• Meetings are conducted periodically, as scheduled
• Minimum quorum: At least 5 members

Minimum quorum includes:

• Medical scientist
• Clinician
• Legal expert
• Social scientist / NGO representative
• Layperson

Types of Review:

• Full Committee Review
• Expedited Review
• Ongoing Monitoring & Annual Review

Decisions are valid only when quorum requirements are fulfilled.

Ethical Guidelines Followed

• ICMR National Ethical Guidelines (2017)
• New Drugs and Clinical Trials Rules (2019 & amendments)
• Good Clinical Practice (GCP) – CDSCO & ICH
• Declaration of Helsinki
• CIOMS Guidelines
• WHO Operational Guidelines for Ethics Committees

Transparency Statement

• Independent and unbiased ethical review
• Strict conflict of interest management
• Confidential handling of research data
• Transparent decision-making processes
• Accountability to regulatory and ethical standards
• Mandatory disclosure of conflicts of interest and confidentiality compliance