LEC approval

All research involving human participants must undergo an ethics review and ethical approval must be obtained before it commences.

«BioEq» approves each trials at the Local Ethics Committee.

All notifications during the trial are also submitted to LEC.

The «BioEq» local ethics committee objective is to protect the dignity, rights and welfare of research participants, both subjects and staff, and to provide reassurance to the public that this is being done.

The «BioEq» Local Ethics Committee consists of 11 members.

Ethics Committee meets at least 2 times a month, or upon request.

Clinical trial documents are submitted to LEC 5 days prior LEC meeting. Documents review by LEC is possible before the permission to conduct a clinical study is issued by the Ministry of Health.

The list of documents required by LEC for study submission includes:

  • Application letter
  • Agreement with LEC
  • Detailed list of the documents with the version numbers and dates in electronic form
  • Clinical Trial Protocol (for international clinical trials – in the language of the study Sponsor’ country and in the Russian language)
  • Patient information sheet (patient information and informed consent form) (for international clinical trials – in the language of the study Sponsor’ country and in the Russian language)
  • CRF
  • Diaries, questionnaire for patients participating in clinical trials
  • Investigator's brochure (for international clinical trials – in the language of the study Sponsor’ country and in the Russian language)
  • List of clinical centers, where it is planned to perform the trial
  • Curriculum vitae (CV) of investigators (dated and signed by investigators)
  • Information about reimbursement and payments to study subjects
  • Subjects insurance agreements
  • Materials, including advertisement and information about the study, which is used to attract patients to participate in the trial
  • Ministry of Health permission to conduct the clinical trial.

For companies sponsoring clinical studies and CROs LEC review is paid. For more information about LEC fee, please contact the Secretary of the Local Ethics Committee.

Local Ethics Committee documents include:

  • «BioEq» LEC statement
  • Standard Operating Procedures

    1) Approval of the LEC composition 
      2) The procedure for meetings organization 
        3) The primary ethical review
          4) Subsequent ethical review
            5) Accelerated ethical review
              6) Review of notifications
                7) Periodical ethical review
                  8) Review the safety reports

                  LEC is guided by the following documents in its activities  :

                  • World Medical Association (WMA) Declaration of Helsinki (2013)
                  • Federal Law № 323-FZ "On public health protection in the Russian Federation"
                  • Federal Law № 61-FZ "On Circulation of Medicines" as of 12.04.2010
                  • International harmonized tripartite guidelines on Good Clinical Practice (ICH GCP)
                  • National Standard of the Russian Federation GOST R 52379-2005 "Good Clinical Practice"
                  • Decree by the Ministry of Health of Russia as of 04.01.2016 №200n "On approval of the rules of good clinical practice"
                  • Guidelines for Ethics Committees that Review Biomedical Research, WHO
                  • LEC Standard Operating Procedures (SOPs)
                  • «BioEq» bylaws
                  • «BioEq» LEC statement
                  • Other legal documents in the field of public health

                  You can contact the Secretary of the Ethics Committee.

                  Contacts:

                  Olga Novikova - Secretary of the Ethics Committee

                  e-mail: novikova@bioeq.ru

                  The «BioEq» LEC can also provide services to review clinical study documents for sites with no LEC.