About Ethics Committee

1.1 Overview

Ethics Committee of Clinical and Diagnostics Center of National University of Pharmacy (NUPh) is an independent body, which functions more than 10 years.

Ethics Committee performs ethical review of clinical studies conducted at Clinical and Diagnostics Center of NUPh. Based on results of review, Ethics Committee approves the clinical trials at Clinical and Diagnostics Center of NUPh or issues a motivated decision to refuse a study with the possibility of re-review after submitting by investigator of additional materials, changing of the study procedures or reformulation of information provided to study participant. Also, Ethics Committee keeps under systematic and periodic review studies conducted at Clinical and Diagnostics Center of NUPh concerning its compliance with ethical, legal and moral standards as well as protection of rights, safety and well-being of healthy volunteers/patients.

Responsibilities of Ethics Committee of Clinical and Diagnostics Center of NUPh include:

  1. Protection of rights, safety and well-being of healthy volunteers/patients involved in clinical studies of medicines.
  2. Ensuring that studies conducted at Clinical and Diagnostics Center of NUPh are complied with ethical, moral and legal standards.
  3. Review of ethical, moral and legal aspects of clinical studies including procedures of healthy volunteers/patients recruitment and obtaining an informed consent from them (their legally authorized representative or near relative).

The work of Ethics Committee of Clinical and Diagnostics Center is regulated by principles of independence, transparency, competency and pluralism.

1.2 Personnel

Ethics Committee of Clinical and Diagnostics Center of NUPh is composed of medical and non-medical specialists, persons of other specialties, public representatives who monitor protection of rights and well-being of study participants (healthy volunteers/patients) as well as ethical, moral and legal aspects of clinical studies conducting. Current composition of Ethics Committee was approved by NUPh Order dated 21.11.2017 No79-Adm.

1.3 Contact us

1.4 Working procedures

1.4.1 Legislation and regulations

Ethics Committee of Clinical and Diagnostics Center works according to Ukrainian legislation, Statute and Standard Operational Procedures (SOPs). Also, Ethics Committee takes into account recommendations and requirements of international documents concerning ethics of biomedical researches involving human subjects.

National legislation

International regulations and guidelines

Local regulations

  • NUPh Statute
  • Statute of Ethics Committee of Clinical and Diagnostics Center of NUPh

Recommendations and guidelines

    1.4.2 Meetings

    1.4.3 Standard Operational Procedures

Ethics Committee of Clinical and Diagnostics Center of NUPh operates in accordance with elaborated and approved standard operational procedures (SOPs):
  1. Ethics Committee Organization.
  2. Ethics Committee Meetings.
  3. Confidentiality agreement.
  4. Selection of independent consultants.
  5. Study monitoring.
  6. Final report review.
  7. Informed consent.
  8. Handling confidential documents.
  9. nteraction with other Ethics Committees

1.4.4 Check of compliance with ethical, legal and moral requirements

Ethics Committee of Clinical and Diagnostics Center keeps under systematic and periodic review studies conducted at Clinical and Diagnostics Center concerning its compliance with ethical, moral and legal standards. Systematic review includes the following procedures:
  1. Routine review.
    Routine examination of the data reported by Principal Investigators.
  2. On-site visits to the Clinical and Diagnostics Center.
    Checking out the study which materials were previously reviewed concerning compliance of its process with GCP requirements and standards for protection of healthy volunteers’/patients’ rights.
  3. Review of applications submitted by volunteers who are already involved or willing to participate in a clinical study.

Useful links:

Resources for researches

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