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NOTE: VAMCs that do not have their own Institutional Review Board(s) (IRB) but that rely on the IRB of another organization should not submit an IRB Registration. Only institutions that operate their own IRB(s) should submit an IRB Registration form.
If the IRB is operated by another organization, the VAMC must send an update to ORO annually by March 31. However, ORO will not forward the update to OHRP, as this is the responsibility of the institution operating the IRB.
VA requirements for IRB registration, renewal and update differ from the OHRP instructions in the following ways:
| a. |
The VA timetable for update is more stringent than OHRP. VA requires update when changes occur and annually on the anniversary date if no changes. For example, if the OHRP website shows that the last IRB submission was on April 30, 2005, the next submission is due to ORO on April 29, 2006
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| b. |
VA facilities must file an IRB Registration update either electronically or via fax to ORO to:
- Register a new IRB
- Update and IRB membership
- Add an IRB
- Drop an IRB
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There are Frequently Asked Questions and Answers found at http://www.hhs.gov/ohrp/humansubjects/assurance/regirbi.htm .
Completing the IRB Registration Form
VA facilities are encouraged to file IRB registrations and updates electronically. If not filing electronically, the Form approved by OMB No. 0990-0279 approved for use through 1/31/2008 must be used.
"New Filing" versus "Update or Renewal":
Indicate by an {X} whether this is a "New Filing" or an update:
ITEM #1 - Organization Operating the IRB(s):
Type or print the full legal name of the institution or organization that is registering the IRB and full mailing address, including country if outside the United States . Also, include the street address if it is different than the mailing address.
Use the same Institutional name consistently on both the IRB Registration and the FWA. This is the way the name will appear on the OHRP website. If the VAMC name is not consistently registered it will be difficult to locate your data on the OHRP website. Also, your IRB may not be properly cross-references with your FWA. OHRP may delay processing in order to ask you for a "name change."
ITEM #2 - Head Official of Organization Operating the IRB(s):
The Senior or Head Official is the same as the Institutional Official, the VA Medical Center (VAMC) or Health Care System (HCS) Director. Type or print the name, degree(s), organizational title (e.g., Director, CEO), telephone number, fax number, e-mail address, and full mailing address for the person in your organization who is ultimately responsible for the performance and conduct of the IRB(s).
ITEM #3 - Person Providing this Information:
Type or print the name, title, telephone number, fax number, and e-mail address for the person providing the information submitted on the IRB Registration form.
ITEM #4 - How Many IRB(s) are to be Registered, Updated or Renewed with this Submission?
| a. |
Indicate how many IRB(s) are to be registered with this submission.
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| b. |
Type or print the information for each IRB to be registered. If more than one IRB is being registered, attach additional pages to provide the information requested for item #4 for each IRB and clearly identify the pages for each IRB.
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| c. |
For new IRBs provide the sequence number(s) (e.g., IRB#1, IRB#2).
Choose a name (suffix) for each IRB. For example, VAMC name if only one IRB, or Behavioral studies if more than one IRB. Use this name consistently. Once registered, the IRB Registered name and the IRB Registration number can be found on the OHRP website at http://ohrp.cit.nih.gov/search/asearch.asp#IORG.
List ALL IRBs designated by the facility on the form.
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| d. |
The form asks for nine optional pieces of information related to the IRB. VHA prefers that these questions be answered. Indicate the choice with either an [X] or a check mark.
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| e. |
Type or print the full name, degree(s), organizational title, telephone number, fax number, e-mail address, and the full mailing address for the IRB Chairperson. Please make sure to include an e-mail address to facilitate future correspondence (e.g., either regarding the registration or for forwarding of new or revised OHRP guidance documents).
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| f. |
IRB Roster Format - General Information: The IRB Roster is required by VA and OHRP. If more space is needed, you may attach additional pages.
Type or print the list of members on the IRB. Voting members should be listed in the top section of the form and alternate members in the lower section.
Type or print the "Gender" (e.g., male or female) and the "Earned Degree" (e.g., Ph.D., M.D.). Use full name of degree if not commonly recognized.
Type or print the IRB member's "Primary Scientific or Nonscientific Specialty" (e.g., Sociology, Internal Medicine, Library Services, Cardiology). Also, indicate if a given member provides special representation for the IRB (e.g., prisoner representative or advocate) either in the "Primary Scientific or Nonscientific" field or in "Comments." (Do not answer this question with PS, NS, or OS.)
Type or print the IRB member's "Affiliation with the Institution" (e.g., employees, students, board members, alumni, etc. should be listed as "Y" or "Yes"; members with no affiliation or relationship with the institution other than being an active IRB member should be listed as "N" or "No").
Type or print any additional relevant information regarding a given IRB member in the "Comments" section (e.g., prisoner representative or advocate).
When listing the alternate members, designate in the comments section for a given alternate member the corresponding number of the regular member or members with whom he/she may alternate.
Signatory Officials may not be IRB members. Also, please see VHA Handbook 1200.5 for VA requirements for IRB membership. Please consider whether there is a potential for conflict of interest or undue influence when appointing IRB members. In general, R&D office managers and administrative staff should not be voting members.
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SUBMITTING AN IRB REGISTRATION TO ORO: Please review and proofread all materials to be submitted and ensure that all parts of the registration form are complete and accurate. Incomplete or incorrect documents may delay processing.
If filing electronically, obtain an OHRP submission number and enter the IRB registration or update information then "Save and Exit." Contact Priscilla Craig by phone or e-mail to review. Normally the review will be done immediately. After the submission is approved by ORO, the facility may electronically "submit" the completed registration to OHRP for processing. Questions may be addressed to Priscilla A. Craig at (202) 565-8162.
If submitting via fax, submit the IRB registration single-sided to ORO to Priscilla A. Craig at (202) 565-9194. If you want to submit your IRB Registration by regular mail, express mail, or hand delivery, send to:
Priscilla A. Craig
Office of Research Oversight (ORO)
811 Vermont Avenue, NW, Suite 574 (10R)
Washington , DC 20420
(202) 565-8162 (Office)
(202) 445-8849 (Cell)
(202) 565-9194 (Fax)
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