Common Forms for Ethics Committee Review

The application form for initial review is a comprehensive document that requires detailed information from researchers and institutions planning to conduct studies involving human participants. The form is divided into several sections, including administrative details, funding details, overview of research, methodology, participant-related information, benefits and risks, informed consent, payment/compensation, storage and confidentiality, publication, benefit sharing, and IPR issues.

The document requires researchers to provide information on the study's objectives, methods, participants, benefits, and potential risks. It also asks about the involvement of vulnerable persons, the use of external laboratories or outsourcing, and the procedures for obtaining informed consent from participants.

The form includes a checklist that verifies the submission of required documents, such as participant information sheets, informed consent forms, and advertisements. The document also requires researchers to declare their intention to comply with applicable regulations and guidelines, including those related to ethics, GCP, and IPR issues.

Annexures are provided for reasons why expedited review from EC is requested, waiver of consent being requested, and research involving vulnerable persons. The form is designed to ensure that researchers provide accurate and complete information about their studies, allowing the Ethics Committee to assess the risks and benefits associated with each proposal.