EC ethics & responsibilities

Apr 6, 2017Download as PPT, PDF2 likes78 views

The document outlines the procedures and responsibilities of an Ethics Committee for overseeing clinical trials. It discusses procedures for the composition of the committee, handling conflicts of interest, reviewing study protocols and informed consent documents, making decisions on studies, monitoring approved studies, and archiving documentation. The Ethics Committee is qualified to ensure scientific integrity and subject protection in clinical trials under its purview.

Ethics CommitteeEthics Committee
Ethics Committee (EC) is adequately qualified,
experienced, and knowledgeable in ethical
issues and applicable rules and regulations for
conduct of clinical trials ensuring scientific
integrity and protection of subject rights,
safety and wellbeing.

List of mandatory procedures for
Ethics Committee are as follows:
i. Composition (names and qualification of the members),i. Composition (names and qualification of the members),
new induction, resignation, replacement or removal ofnew induction, resignation, replacement or removal of
members.members.
ii. Declaration of conflict of interest and confidentialityii. Declaration of conflict of interest and confidentiality
agreement.agreement.
iii. Frequency of ethics committee meetings.iii. Frequency of ethics committee meetings.
iv. Financial declaration of payments received and disbursed.iv. Financial declaration of payments received and disbursed.
v. Policy regarding training for new and existing committeev. Policy regarding training for new and existing committee
members.members.
vi. Policy of communication with different stake holders.vi. Policy of communication with different stake holders.
vii. Any other or to do all such other lawful acts, deeds andvii. Any other or to do all such other lawful acts, deeds and
things as are incidental & conducive to attainment of objectsthings as are incidental & conducive to attainment of objects
of any of them.of any of them.

Protocol submissionProtocol submission
i. Procedure for receipt of applications – original, revised,
amended with supporting annexes.

Ethical reviewEthical review
i. Review and decision making of proposals.i. Review and decision making of proposals.
ii. Procedure to be followed for vulnerable population.ii. Procedure to be followed for vulnerable population.
iii. Procedure for risk-benefit analysis.iii. Procedure for risk-benefit analysis.
iv. Procedure for review of Informed Consent Documentiv. Procedure for review of Informed Consent Document
(subject Information Sheet and Informed Consent Form)(subject Information Sheet and Informed Consent Form)
and informed consent process.and informed consent process.
v. Generally to do all such other things as are incidental orv. Generally to do all such other things as are incidental or
conducive to the attainments of above objectsconducive to the attainments of above objects..

Decision making , minutes recording , post meeting activitiesDecision making , minutes recording , post meeting activities
including monitoringincluding monitoring
i. Procedure for deliberations and maintaining minutesi. Procedure for deliberations and maintaining minutes
ii. Procedure for reporting, analysis of SAEs and makingii. Procedure for reporting, analysis of SAEs and making
opinion on compensation.opinion on compensation.
iii. Procedure for periodic review and oversight.iii. Procedure for periodic review and oversight.
iv. Procedure for handling issues related to non-compliance,iv. Procedure for handling issues related to non-compliance,
protocol violation, negligence, complaints by the participantsprotocol violation, negligence, complaints by the participants
and other stake holders.and other stake holders.
v. Procedure for review of protocol amendmentsv. Procedure for review of protocol amendments.

Documentation and archivingDocumentation and archiving
i. Procedure for control and archiving of records withi. Procedure for control and archiving of records with
confidentialityconfidentiality..

The document outlines standards for ethics committee accreditation related to good clinical practice. It discusses that ethics committees should be qualified to assess risk and protect subject rights in clinical trials. Section 1 details standards for ethics committee authority, standard operating procedures, composition, subject protection, administrative support, and review processes. It emphasizes that ethics committees must follow documented procedures to competently review trials and ensure scientific integrity and subject safety.

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EC ethics & responsibilities

1. Ethics CommitteeEthics Committee Ethics Committee (EC) is adequately qualified, experienced, and knowledgeable in ethical issues and applicable rules and regulations for conduct of clinical trials ensuring scientific integrity and protection of subject rights, safety and wellbeing.

2. List of mandatory procedures for Ethics Committee are as follows: i. Composition (names and qualification of the members),i. Composition (names and qualification of the members), new induction, resignation, replacement or removal ofnew induction, resignation, replacement or removal of members.members. ii. Declaration of conflict of interest and confidentialityii. Declaration of conflict of interest and confidentiality agreement.agreement. iii. Frequency of ethics committee meetings.iii. Frequency of ethics committee meetings. iv. Financial declaration of payments received and disbursed.iv. Financial declaration of payments received and disbursed. v. Policy regarding training for new and existing committeev. Policy regarding training for new and existing committee members.members. vi. Policy of communication with different stake holders.vi. Policy of communication with different stake holders. vii. Any other or to do all such other lawful acts, deeds andvii. Any other or to do all such other lawful acts, deeds and things as are incidental & conducive to attainment of objectsthings as are incidental & conducive to attainment of objects of any of them.of any of them.

3. Protocol submissionProtocol submission i. Procedure for receipt of applications – original, revised, amended with supporting annexes.

4. Protocol submissionProtocol submission i. Procedure for receipt of applications – original, revised, amended with supporting annexes.

5. Ethical reviewEthical review i. Review and decision making of proposals.i. Review and decision making of proposals. ii. Procedure to be followed for vulnerable population.ii. Procedure to be followed for vulnerable population. iii. Procedure for risk-benefit analysis.iii. Procedure for risk-benefit analysis. iv. Procedure for review of Informed Consent Documentiv. Procedure for review of Informed Consent Document (subject Information Sheet and Informed Consent Form)(subject Information Sheet and Informed Consent Form) and informed consent process.and informed consent process. v. Generally to do all such other things as are incidental orv. Generally to do all such other things as are incidental or conducive to the attainments of above objectsconducive to the attainments of above objects..

6. Decision making , minutes recording , post meeting activitiesDecision making , minutes recording , post meeting activities including monitoringincluding monitoring i. Procedure for deliberations and maintaining minutesi. Procedure for deliberations and maintaining minutes ii. Procedure for reporting, analysis of SAEs and makingii. Procedure for reporting, analysis of SAEs and making opinion on compensation.opinion on compensation. iii. Procedure for periodic review and oversight.iii. Procedure for periodic review and oversight. iv. Procedure for handling issues related to non-compliance,iv. Procedure for handling issues related to non-compliance, protocol violation, negligence, complaints by the participantsprotocol violation, negligence, complaints by the participants and other stake holders.and other stake holders. v. Procedure for review of protocol amendmentsv. Procedure for review of protocol amendments.

7. Documentation and archivingDocumentation and archiving i. Procedure for control and archiving of records withi. Procedure for control and archiving of records with confidentialityconfidentiality..

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EC ethics & responsibilities

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