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Indian Society for Clinical Research
  • About ISCR
    • About Us
    • Mission, Vision & Objectives
    • Office Bearers
    • Corporate Members
    • Updates
      • Others
  • Membership
    • Who Can Join ISCR
    • Individual Member Registration
    • Organization Registration
    • Membership Payment
    • Rules & Regulations
  • Annual Conference
  • Events & Workshops
    • Forthcoming Events
    • Past Events & Workshops
    • Events Registration
    • Payment – Events & Workshops
    • Summary – Events & Workshops
  • ISCR Councils
    • CDM, BS & MW
    • Ethics Council
    • Investigator Council
      • Investigator SOP
      • Information Repository
      • Investigator Helpline
      • Insight Newsletter
    • Pharmacovigilance Council
    • Regulatory Council
    • Training Council
    • Real World Evidence Council
  • Regional Chapters
  • ACCRI
    • About ACCRI
    • ACCRI Members
    • Academic Partners
    • Activities
      • Workshops
      • CR Excellence Awards
      • RCRM
  • Resources
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    • Environment Overview
    • Film On Clinical Research
    • Patient Leaflets
    • Causality Assessment Tool
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    • Online Survey
  • Gallery
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ETHICAL ASPECTS ARE CRITICAL AND INTEGRAL FOR CLINICAL RESEARCH PROJECTS.

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.

Help Desk

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Council Chair and Co-Chair

Chair

Dr. Partha Gokhale

Co-chair

Dr. Nivedita Madkaikar

LINKS

PIL Updates

ISCR Journal - Perspectives in Clinical Research (PICR)

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NEWS

Title

Date

Publication

Clinical trials: Not a case of trial & errorJanuary 18, 2018The Financial Express
Number of clinical trials in India may surge by 2018-19July 13 2017ET Healthworld
There is also a need to increase awareness about the good that clinical research has done for patientsJune 19 2017BioSpectrum
Clinically NeededMay 25 2017Financial Express
Patient Story and Clinical TrialsMarch 2017TECHAGAPPE
Clinical TrialsJanuary 22 2017The WEEK

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