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This document outlines the format for submission of research protocols involving human subjects for clearance by the Ethics Sub-Committee of AIIMS for various degree programs including DM, M.Ch, Ph.D,
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How to fill out ethics sub-committee submission format

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How to fill out Ethics Sub-Committee Submission Format

01
Begin by downloading the Ethics Sub-Committee Submission Format template from the specified website.
02
Fill in the project title in the designated section at the top of the form.
03
Provide a detailed description of the research project, including its objectives and methodology.
04
Outline the potential risks and benefits of the research to participants.
05
Include information about how informed consent will be obtained from participants.
06
Specify the demographic details of the participants to be recruited for the study.
07
Detail any funding sources for the project and potential conflicts of interest.
08
Attach any additional documents required, such as questionnaires or consent forms.
09
Review the submission for completeness and accuracy.
10
Submit the completed form via the designated submission portal or email.

Who needs Ethics Sub-Committee Submission Format?

01
Researchers conducting studies involving human participants.
02
Academic institutions and organizations applying for ethically-sensitive research approvals.
03
Students involved in research projects that require ethical oversight.
04
Any party seeking to ensure compliance with ethical standards in research.
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Detailed Curriculum Vitae (CV) and documents/training certificates to ensure that member of the Ethics Committee are conversant with the provisions of the New Drugs and Clinical Trials Rules, 2019, Good Clinical Practices (GCP) Guidelines and other regulatory requirements to safeguard the rights, safety and well-being
Step 1: Secure Leadership Buy-In. Step 2: Educate Staff. Step 3: Choose Committee Members. Step 4: Train Committee Members. Step 5: Identify Guiding Principles. Step 6: Write a Committee Charter. Step 7: Establish Committee Processes. Step 8: Pilot Your Process and Deliberate!
It includes scientific and non-scientific persons, clinicians and non-clinicians, clinical pharmacologist, persons of the community, a legal expert, a social worker/layperson/patient representative to represent different point of view. The external members shall be in majority to ensure independence of the committee.
Subcommittees. The Rules Committee operates with two subcommittees, one focusing on legislative and budget matters and one focusing on the internal operations of the House.
Many committees, usually standing committees, have smaller subcommittees within them. The members of these subcommittees have expertise in a specific part of a committee's area of public policy. Like standing committees, subcommittees hold hearings, conduct research, and revise bills.
A minimum of five members must be present in the meeting room. The quorum should include both medical and non-medical members. A minimum of one non-affiliated member should be part of the quorum. Preferably, the layperson should be part of the quorum.
An Ethics Committee (EC) is an independent body composed of members with expertise in both scientific and nonscientific arenas which functions to ensure the protection of human rights and the well-being of research subjects based on six basic principles of autonomy, justice, beneficence, nonmaleficence, confidentiality

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The Ethics Sub-Committee Submission Format is a standardized form used to present research proposals or related ethical concerns to an ethics committee for review, ensuring that ethical standards are met.
Researchers, faculty members, and students involved in projects that require ethical review are required to file the Ethics Sub-Committee Submission Format.
To fill out the Ethics Sub-Committee Submission Format, one should carefully read the guidelines, provide detailed information about the research project, clearly outline the purpose, methodology, potential risks, and ethical considerations, and submit the form along with any required supporting documents.
The purpose of the Ethics Sub-Committee Submission Format is to ensure that research involving human or animal subjects adheres to ethical standards, protects participants' rights, and minimizes potential risks.
The information that must be reported includes the project's title, research objectives, methodology, participant selection criteria, data collection methods, potential risks and benefits, ethical considerations, and plans for obtaining informed consent.
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