The Institutional Review Board of the CO “UIPHP” is an independent authority, whose main purpose is to ensure compliance with ethical and moral principles of research conduction by reviewing and approving the protocol and other materials of research, as well as ongoing monitoring of fulfillment. The IRB may consider, evaluate and supervise all types of researches with involvement of human subjects, that are conducted in Ukraine, regardless of the sponsor and investigator location.
The IRB #1 of the Charitable Organization “Ukrainian Institute on Public Health Policy” was established in 2010 by the Order of the Chairman of the Board of the organization (formerly the All-Ukrainian Charitable Organization “UIPHP”). In 2021, the Regulations on the Board were updated and in 2020 the membership of the Board was last updated.
The IRB of the CO “UIPHP” is officially registered as the Board for consideration of international researches in the Office of Human Research Protection (OHRP) of the U.S. Department of Health and Human Services: IRB #00007612, FWA #00029648 (Federalwide Assurance (FWA) for the Protection of Human Subjects).
In accordance with the FWA and the FWA Terms, the institution shall undertake to comply with the requirements, set out by the HHS regulations for protection of human subjects in part 45 of CFR 45. The FWA is the only type of guarantee, which is currently accepted and approved by the Office of Human Research Protection (OHRP) of the U.S. Department of Health and Human Services.
In its activities, the Board is guided by international regulations for conduction of researches with involvement of human subjects, in particular the Declaration of Helsinki (1964), the Belmont Report (1979), Directive 2001/20/EC of the European Parliament and the EU Council dated April 04th 2001 (as amended), “On approximation of the laws, regulations and administrative provisions of the member states concerning introduction of good clinical practice in conduction of clinical trials on medicinal products intended for human use”, the ICH regulations on good clinical practice (1997), parts 50 and 56 of section 21, and part 46 of section 45 of the U.S. Code of Federal Laws; and current regulations of Ukraine, in particular the Law of Ukraine “On Medicinal Products”, the Physician’s Code of Ukraine, the Standard Regulations on the Ethics Committee, approved by the Order No. 523 of the Ministry of Health (MoH) of Ukraine on 12.07.2012, and the Order No. 95 of the MoH on 17.02.2009.
In order to improve the organizational, technical and material support of the Board, collection of the fees for ethical review services has been implemented since 2017. The cost for review of each study shall be determined in accordance with the in-house Order No. 154 of 06.12.2017.
Membership of the Board
- I.I. Pukalo, Director of LLC “EIPHP”, Master of Public Health Protection (Chairman of the Board)
- S.V. Dvoriak, Head of the Board, Director of CO “UIPHP”, MD, PhD, D.Med.Sci (member of the Board)
- K.V. Dumchev, Scientific Director of CO “UIPHP”, MD, MPH (member of the Board)
- A.B. Karachevsky, Associate Professor of Psychopathology, Child, Forensic Psychiatry and Narcology Department at Schupyk National Medical Academy of Post-Graduate Education, MD, PhD (member of the Board)
- T.K. Kiriazova, Senior Researcher of CO “UIPHP”, biologist, PhD (member of the Board)
- O.V. Makarenko, Senior Researcher of CO “UIPHP”, MD, PhD (member of the Board)
- A.V. Sarnatska, Coordinator of NPO “Enei” Club” (member of the Board)
- A.V. Chernyshev, Head of Advocacy and External Communications Department PO “ALLIANCE.GLOBAL” (member of the Board)
- V.V. Chtenguelov, Researcher of CO “UIPHP”, MD, PhD (member of the Board)
- V.V. Yaryi, Chief Medical Officer of Kyiv city narcological clinical hospital “Sociotherapy”, MD (member of the Board)
The functions of the IRB Secretary are fulfilled by A.O. Lukash, Assistant of CO “UIPHP”
Forms of documents for submission
The forms of documents to be submitted for review of the Board at primary submission of non-pharmaceutical study shall be as follows:
1. Study Protocol (version No. and date should be given in the header and footer of the page)
2. Study tools (translated into Ukrainian or Russian)
3. Informed consent form (translated into Ukrainian or Russian)
4. CV of the Principal Investigator
5. Cover letter
6. Form of application completed
The forms of documents to be submitted for review of the Board for extension of the Board’s Notice of Approval shall be as follows:
Schedule for conduction of the IRB meetings
The Board meetings shall be conducted at least once per month if studies submitted for review are available. For review of the documents by the Board at its regular meeting, they should be sent the e-mails of the Chairman and Secretary of the Board 2 weeks prior to a planned meeting.
An approximate schedule for conduction of meetings in 2021 shall be as follows:
February 22nd, March 22nd, April 26th, May 24th, June 21st, July 26th, August 23rd, September 27th, October 25th, November 22nd, December 27th.