PROTOCOL FOR ETHICAL CONSIDERATIONS

1. Research Proposal Submission and Ethical Review

1.1 Researchers must submit research proposals to the RLKUMC Institutional Review Board (IRB) for ethical review and approval.
1.2 The IRB shall review research proposals to assess their compliance with ethical considerations and principles outlined in the Ethical Considerations Policy.
1.3 Ethical review shall include evaluating the protection of participant rights, potential risks and benefits, informed consent procedures, and adherence to relevant ethical guidelines. 2 Respect for Autonomy and Informed Consent 2.1 Researchers must respect the autonomy and dignity of research participants, ensuring their voluntary participation.
2.2 Informed consent shall be obtained from all participants, providing clear and understandable information about the research purpose, procedures, risks, benefits, and their right to withdraw without penalty.
2.3 Informed consent forms and processes shall be reviewed and approved by the IRB.

3. Beneficence and Non-Maleficence

3.1 Researchers shall prioritize research participants' well-being, safety, and welfare.
3.2 Research protocols shall be designed to minimize risks and potential harms to participants while maximizing potential benefits.
3.1 Justice and Equity
3.1.1 Researchers shall ensure fairness in selecting and recruiting research participants, avoiding discrimination or bias.
3.1.1 Research benefits and burdens should be distributed equally among participants and society.
3.2 Privacy and Confidentiality
3.2.1 Researchers shall protect the privacy and confidentiality of research participants' personal information.
3.2.2 Measures should be provided by researchers in IRB applications regarding how they will safeguard participant data during data collection, storage, analysis, and dissemination.
3.2.3 Data sharing or publication should be done in a manner that does not compromise participant confidentiality.
3.3 Scientific Integrity
3.3.1 Researchers shall uphold the principles of scientific integrity, including honesty, accuracy, transparency, and objectivity.
3.3.2 Fabrication, falsification, or plagiarism in research activities is strictly prohibited.
33.3 Researchers shall comply with relevant guidelines and best practices for data management, analysis, and reporting.
3.4 Animal Welfare (Where applicable)
3.4.1 Researchers working with animals must adhere to relevant ethical guidelines and regulations for animal care, use, and treatment.
3.4.2 Animal research protocols should prioritize animal welfare and minimize potential suffering or harm.
3.4.3 The use of animals in research should be justified, and alternatives to animal models should be considered whenever possible.

4. Institutional Review Board (IRB)

4.1 The Research Advisory Committee shall establish and maintain an IRB responsible for ethical review and oversight of research activities.
4.2 Researchers must submit their research proposals to the IRB for review before commencing any research activities involving human participants or animals.
4.3 The IRB shall review proposals, provide feedback to researchers, and approve studies that meet ethical standards.

5. Review and Updates

5.1 The Ethical Considerations Policy shall be reviewed periodically to reflect changes in laws, regulations, and ethical standards.
5.2 Any proposed revisions to the policy shall be reviewed and approved by the appropriate institutional authorities.
5.3 Updated versions of the Ethical Considerations Policy shall be communicated to all relevant stakeholders.