U.S. Department of Health and Human Services (DHHS) Institutional Review Board (IRB)/Independent Ethics Committee (IEC) Registration

OMB No. 0990-0279
Approved for use through March 31, 2011

[ ] New Filing [ ] 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:
Mailing Address:
Street Address (if different from Mailing Address above):
City:	State (if USA):	Zip Code (if USA):
Country (if outside USA):

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

First Name:	Middle Initial:	Last Name:
Degrees or Suffix:	Organizational Title:
Telephone:	FAX:	E-Mail:
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

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? ______

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

b) IRB Registration Number: __________________ (e.g., IRB0000xxxx, 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.

Has the IRB or its parent organization been accredited by a human subject protection accrediting organization?
[] Yes [] No

If yes, provide the name of the accrediting organization: ___________________________________
and the date of accreditation: ______________
Approximate total number of currently active protocols: [] none = 0 [] small = 1-25
[] medium = 26-99 [] large = 100 or more
Approximate number of full-time positions devoted to this IRB�s administrative activities: _______
Does the IRB review or intend to review research supported by the U.S. Government?
[] Yes [] No
Approximate number of currently active protocols supported by DHHS (e.g., NIH, CDC, SAMHSA, AHRQ, CMS):
[] none = 0 [] small = 1-25
[] medium = 26-99 [] large = 100 or more
Approximate number of currently active protocols supported by other Federal departments or agencies: [] none = 0 [] small = 1-25
[] medium = 26-99 [] large = 100 or more
Does the IRB review or intend to review FDA-regulated research? [] Yes [] No
Approximate number of currently active protocols involving FDA-regulated products:
[] none = 0 [] small = 1-25
[] medium = 26-99 [] large = 100 or more
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:	Middle Initial:	Last Name:
Degrees or Suffix (e.g., MD, PhD):	Organizational Title:
Telephone:	FAX:	E-Mail:
Mailing Address:
City:	State (if USA):	Zip Code (if USA):
Country (if outside USA):

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 Specialty	Affiliation* with Institution(s) Y / N	Comments, e.g., prisoner rep., advocate, alternate member**
1. IRB Chair:
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
16.
17.
18.
Alternate Members**:
1.
2.
3.
4.
5.

* 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.

Public burden for this collection of information is estimated to average one hour for an initial IRB registration or a complete update of an existing IRB registration and 30 minutes for a limited update of an IRB registration. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to: OS Reports Clearance Officer, Room 537H, 200 Independence Avenue, SW., Washington, DC 20201. Do not return the completed form to this address.

OMB No. 0990-0279
Approved for use through March 31, 2011