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FWA New Filing (DHHS)





[ ] Update or Renewal for IORG Number: ______________

includes [ ]  Addition of New IRB(s)


U.S. Department of Health and Human Services (DHHS)

Institutional Review Board (IRB) / Independent Ethics Committee (IEC) Registration



1. Organization Operating the IRB(s)

Name of Organization: Regional Government Institution for Health Care Tomsk Regional Center for Prevention and Treatment of AIDS and other Infectious Diseases

Mailing Address:		634059 Tomsk  ulitsa Smirnova #5a
Street Address (if different from Mailing Address above):
City: 	Tomsk	  		State (if US):		Zip Code (if USA):
Country (if outside USA): 	Russia



2. Senior or Head Official of Organization Operating the IRB(s)

First Name:	Alexander	 	Middle Initial:   S.	Last Name: Chernov
Degrees or Suffix:   MD			Organizational Title:		Medical Director
Telephone:   3822 777095			FAX:   3822 779593		E-Mail:   cherry@tomsk.gov.ru
								3822 775009
Mailing Address (if different from Mailing Address above):
City: 		  		State (if USA):		Zip Code (if USA):
Country (if outside USA)



3. Name, Title, Telephone Number, FAX Number, and E-mail of Person Providing this Information

Same as in #2, above.



4. Information on Each IRB to be Registered, Updated, or Renewed


a) How many IRB(s) are to be registered, updated, or renewed with this submission? 1 (one)

Please provide the information in 4(b) through and 4(f) for each IRB.


b) IRB Registration Number: __________________ (e.g., IRB000xxxx, for updates and renewals)

Sequence #: __________ (e.g., IRB#1, … IRB#3)


c) Suffix of IRB Name: [see instructions, item 4(c)]: _________________________________________

Provide City and State or Country (if different from location in item 1):

City: ________________________ State (or Country, if outside U.S.): ________________________


d) Please provide the following (optional) information about this IRB only.

(1) Has the IRB or its parent organization been accredited by a human subject protection accrediting organization?     [   ] Yes     [X] No
If yes, provide the name of the accrediting organization: ___________________________________
and the date of accreditation: ______________

(2) Approximate total number of currently active protocols:   [X] none = 0     [   ] small = 1-25     [  ] medium = 26-99     [   ] large = 100 or more

(3) Approximate number of full-time positions devoted to this IRB’s administrative activities: 2 (two)

(4) Does the IRB review or intend to review research supported by the U.S. Government?
[X] Yes     [   ] No

(5) Approximate number of currently active protocols supported by DHHS (e.g., NIH, CDC, SAMHSA, AHRQ, CMS):
[X] none = 0     [  ] small = 1-25     [  ] medium = 26-99     [  ] large = 100 or more

(6) Approximate number of currently active protocols supported by other Federal departments or agencies:
[  ] medium = 26-99     [  ] large = 100 or more

(7) Does the IRB review or intend to review FDA-regulated research?     [  ] Yes     [X] No

(8) Approximate number of currently active protocols involving FDA-regulated products:
[X] none = 0     [  ] small = 1-25     [  ] medium = 26-99     [  ] large = 100 or more

(9) Currently active FDA-regulated protocols involve (check all that apply):
[  ] human drugs     [  ] food additives     [  ] medical devices     [  ] color additives     [  ] biological products     [  ] other


e) IRB Chairperson

First Name:	Yelena		Middle Initial:	M.		Last Name:	Borzunova
Degrees or Suffix (e.g., MD, PhD) Organizational Title:  Chief of the Department for Prevention
Telephone:	(3822) 420.629		FAX:	(3822) 420.629		E-Mail:	T_aids@land.ru
Mailing Address:	634059 Tomsk, Ulitsa Smirnova №5a
City:	Tomsk			State (if USA):			Zip Code (if USA):
Country (if outside USA):	Russia


f) IRB Roster Form: Completion of the IRB/IEC Roster is required if your IRB is designated on an assurance submitted to OHRP [e.g., Federalwide Assurance (FWA)]. Otherwise, it is optional. Attach additional pages if necessary.
Name of IRB Organization: ___________________________________
IRB Registration or Sequence Number: ______________________

Member Name
(LAST, First MI)
Gender
M / F
Earned Degree(s)Primary Scientific or Nonscientific SpecialtyAffiliation* with
Institution(s)
Y / N
Comments, e.g.,
prisoner rep.,
advocate, alternate member**
1. IRB Chair: Borzunova, Yelena MFM.D.PediatricianN 
2. Pomogaieva, Albina P.FDoctor MS, professorInfectious DiseasesN 
3. Dobkina, Marina NikolaievnaFCandidate MSInfectious DiseasesY 
4. Solovieva, Svetlana AnatFCandidate MSEpidemiologyY 
5. Reshetnikov, Vadim IgorevichMCandidate MSImmunologyY 
6.     
7.     
8.     
9.     
10.     
Alternate Members**:
1.     
2.     
3.     

* Affiliated: Please indicate whether or not each individual (or a member of that person’s immediate family) is affiliated (other than as an IRB member) with the entity operating the IRB.
Yes = The IRB member is affiliated with the entity operating the IRB.
No = Other than as an IRB member, the individual is not affiliated with the entity operating the IRB.

** Alternate Members: An alternate member(s) may be designated, as needed, for a regular voting member(s). The appointment of alternate member(s) should be based on expertise similar to that of the regular voting member(s). Under comments, please designate for each alternate member the corresponding number (e.g., 1; 6; 8; or 3, 4, or 7) of the regular voting member(s) he/she represents. An alternate member may vote only when the regular voting member is absent.


NOTES:Any individual who has had substantive training or experience in a scientific discipline (i.e., behavioral or biomedical) or in a scientific method should be considered a scientist. In addition, the IRB must have members with sufficient knowledge of the specific scientific discipline(s) relevant to the research that it reviews.

List only voting members on the roster.



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Property of the Tomsk Regional Center of AIDS and Infectious Diseases Prophylaxis and Control
Created in STN.C
2006 - 2010
Last updated:
January 14, 2010