SOP & Guidelines

Ethical Standards…

  • Impartial and Fair Review of the Clinical Study submitted , ensuring that the rights, safety and well-being of the subjects are protected.
  • A review by UEC is well rounded in all aspects – Medical, Scientific, Non-Scientific, Social, Religious aspects as well as Clinical Research competence and the credibility of the study design.
  • Comprehensive follow up of all clinical studies from review to report.

Standard Operating Procedures – UEC

Universal Ethics Committee adheres to the national and international mandates and guidelines apart from following our Standard Operating Procedures, for every ethical review, voting process and approval.

Our Procedures and Functions SOP handles the basic principles, convening of meeting, member selection, composition, training, alternate member selection, the aid of expert panel apart from the review, voting and approval process. The SOP also clearly elucidates the communication of the decision of UEC by the Member Secretary and maintenance of pertinent records.

As per the expert guidance of CDSCO and ICMR, our review and approval process of a Clinical Trial on Vulnerable Population is specially crafted owing to the sensitivity and attention that is required in the situation.

Universal Ethics Committee handles any Conflict of interest that may arise during the convening or ethical review of a proposed human clinical trial by adhering to the third SOP.

1. SOP – Universal Ethics Committee – Procedures and Functions
Annexure I – Principles of UEC
Annexure II – Template Application Form
Annexure III – Template Review Form
Annexure IV – Template Approval Letter
Annexure V – Template Application for Continued Approval.

2. SOP for Protection of Vulnerable Population in Clinical Trial

3. SOP on Handling Conflict of Interest
Annexure I – Declaration of Interest Form.


Guidelines

1. Declaration of Helsinki_2013

2. ICH GCP 

3. Schedule Y

4. ICMR Ethical Guideline for Biomedical Research

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