Principles of requesting and transferring biological
materials for research.
1. Principles of access to RHTR materials.
1.1. The RHTR functions in compliance with
laws and regulations governing the protections of human subjects’ rights, as
stipulated by the Russian Federation legislation.
1.2. Samples of biological materials are
collected, processed, stored, and tracked in compliance with international
standard operating procedures pertaining to biospecimens.
1.3. All personal, protected health
information about the donors of biological materials is confidential. Each
registrant is assigned a unique ID number, and only RHTR personnel who signed
a letter of commitment about confidentiality of personal data are granted
access to it.
1.4. Each registrant signed an Informed
Consent document for their involvement in research.
1.5. Older biomaterials stored at the RHTR,
collected before laws on personal data came into force, are in compliance
with Russian Federal regulations.
1.6. All donors and representatives agreed
to unlimited length of storage time, and they have the right to withdraw their
specimens at any time by written request to the RHTR manager. In such
instances, a letter confirming the biomaterial withdrawal is signed by the
SUBI Director and sent to the requesting individual.
1.7. Permission to transfer specimens and
data to third parties is granted solely by the Federal Medical and Biological
Administration of the Russian Federation (FMBA), upon the recommendation for
approval of applications for access to stored materials (see Application Tab
on this web site). Information and specimens are transferred in coded,
de-identified form without links to personal protected health information.
1.8. Oversight of the basic principles of
human rights protections in the RHTR is provided bythe SUB Review Board.
2. Procedure of transfer and use of RHTR biological material.
2.1. Biological material can be obtained through application to the RHTR
manager. The application form can be found on the RHTR web site (see
2.2. Approval of the application is made
within 30 days, according to the detailed procedures described in the
Application Tab of this web site.
2.3. Transfer of biomaterials abroad must
comply with Russian Federation and international regulation on the exchange of
2.4. Biological specimen delivered to an
applicant may be used only within the framework of the approved scientific
project and cannot be transferred to third persons.
3. Scientific Review Group.
A Scientific Review Group appointed by the RHTR Manager evaluated the
feasibility and scientific justification provided by applicants for the use of
the biological materials stored in the RHTR, and provides a recommendation to
the FMBA for or against approval of the application. The SRG includes: the
RHTR manager, a representative of FMBA of Russia, a competent Russian
scientist (recommended by FMBA of Russia), the Principal Investigator of U.S.
Department of Energy’s Project 2.8 (who works with the RHTR to assess and
improve quality), and a competent scientist from the U.S. or elsewhere
(recommended by PI of DOE Project 2.8).