Introduction to the ISCR Councils
ISCR has seven functioning councils which constitute the major activities of the Society. Each of the Councils has a Council Coordinator and Members who drive the respective agenda of the Councils, guided by the overall objectives and mission of the Society.
About Ethics Council
Ethical aspects of a clinical trial form the critical and integral core of any clinical research project.
There is a definite ethical responsibility for all stakeholders be it the sponsor representative , the CRO or CRO representative, investigator / site staff, the IEC or IRB members at various stages of the clinical trial from designing of the protocol, to review, approval, trial conduct or execution and even post completion of the clinical trial.
The increased number of clinical trials in India has led to a growing concern about the ethics of clinical trials conducted in India attracting adverse coverage in the media and medical journals.
It is therefore a collective responsibility of all stakeholders involved to ensure that regulatory reform and ethical practices keep pace with the rapid increase in the number of clinical research projects. The Ethics Council is focused on ensuring that the rapid growth in the field is supported by a strong foundation of ethics.
The main aims of the Ethics Council are to:
- Increase awareness and support discussion on ethical aspects within the clinical research fraternity and thereby, contribute in safeguarding the dignity, rights, safety, and well-being of all trial participants with active participation from regional chapters of ISCR.
- To share new developments, latest regulations and their implications, with members of ISCR and general public through the ISCR website and interactive sessions at various locations in the country.
- To provide a useful framework for understanding the principles of ethics which includes respect for human dignity, autonomy, informed consent, vulnerable persons, confidentiality, the lack of harm, maximum benefit, and justice.
- To help members and others interested in enhancing their knowledge on ethical aspects in a clinical trial by conducting training programs and developing e learning modules to facilitate the same.
Council Chair and Co-Chair
Dr. Partha Gokhale
Dr. Nivedita Madkaikar