Institutional Review Board Policy

Introducation

1.1 This policy outlines the guidelines and procedures for the Institutional Review Board (IRB) at RLKU Medical College.
1.2 The IRB is responsible for the ethical oversight and review of all research involving human participants conducted by faculty, staff, and students affiliated with the college.
1.3 This policy aims to protect human subjects and comply with applicable regulations and ethical standards.
1.4 This policy serves as a framework for the IRB at RLKU Medical College to ensure the protection of human subjects and the ethical conduct of research involving human participants.
1.5 It outlines the IRB's composition, functions, responsibilities, and procedures in reviewing and monitoring research projects.
1.6 By adhering to this policy, the RLKU medical college upholds its commitment to the highest ethical standards and contributes to advancing knowledge and healthcare practice.

2. Composition of the IRB

Membership
2.1.1 The IRB shall consist of a diverse group of individuals with expertise in various disciplines, including but not limited to medicine, ethics, law, and statistics.
2.1.1 Membership should be appointed for a defined term and should be knowledgeable about research involving human subjects.
2.1.2 The IRB shall include both scientific and non-scientific members.
2.1.3 At least one member of the IRB should have no affiliation with the institution.
2.2 Chairperson
2.2.1 The IRB shall have a designated chairperson responsible for leading the IRB's activities.
The RAC convener shall appoint the chairperson in consultation with the Principal RLKUMC.
2.3 Conflict of Interest
2.3.1 IRB members must disclose any potential conflicts of interest related to the research under review.
2.3.2 Members with conflicts of interest may be excluded from reviewing or voting on the research protocol in question.

3. Functions and Responsibilities

3.1 Review Process
3.1.1 The IRB shall review all research proposals involving human participants conducted by individuals affiliated with the medical college.
3.1.2 The IRB shall ensure that all research involving human participants is conducted ethically and complies with applicable laws, regulations, and ethical standards.
3.1.3 The IRB shall maintain confidentiality and protect the privacy of participants and researchers involved in the review process.
3.2 Informed Consent
3.2.1 The IRB shall ensure that informed consent is obtained from all research participants or their legally authorized representatives in a manner consistent with ethical standards.
3.2.2 The IRB shall review and approve the informed consent process and documents to ensure they are understandable and appropriately inform participants of the risks, benefits, and alternatives to participation.
3.3 Reporting and Record keeping
3.3.1 The IRB shall maintain accurate and detailed records of all research proposals, reviews, and decisions.
3.4 Communication and Collaboration
3.4 The IRB shall promote open communication and collaboration between researchers, the IRB, and relevant institutional committees to facilitate the ethical conduct of research.
3.5 Quality Assurance
3.5.1 The IRB shall maintain compliance with all applicable laws, regulations, and institutional policies governing the protection of human research subjects.

4. Revision of Policy

4.1 This policy shall be reviewed and revised periodically to reflect changes in laws, regulations, and ethical standards.
4.2 Any proposed revisions to this policy shall be reviewed and approved by the appropriate institutional authorities.