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 Application Tab).
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 biological materials.
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 Energys 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).

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