Guidance for Institutional 
Review Boards (IRBs) 
 
Frequently Asked 
Questions  IRB 
Registration
 
 
 
 
Additional copies of this guidance are available from: 
 
Good Clinical Practice Program, HF-34  
Office of Science and Health Coordination, Office of the Commissioner 
Food and Drug Administration 
5600 Fishers Lane 
Rockville, MD 20857 
(Tel) (301) 827-3340 
 
http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/
GuidancesInformationSheetsandNotices/default.htm 
 
 
 
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Office of the Commissioner 
Office of Science and Health Coordination 
Good Clinical Practice Program 
 
 
July 2009 Contains Nonbinding Recommendations 
 
TABLE OF CONTENTS 
 
I.  RATIONALE FOR THE NEW REQUIREMENT...............................................................2 
1. Why is FDA requiring all IRBs that review FDA-regulated studies to register?..............................2 
2. Why does FDA believe this information is necessary?......................................................................3 
3. Does registration imply that an IRB is in full compliance with 21 CFR Part 56 or is otherwise 
meeting a particular standard of competence or expertise?..................................................................3 
II.  REGISTRATION REQUIREMENTS.................................................................................3 
4. Who must register?..............................................................................................................................3 
5. May IRBs other than those required under 21 CFR 56.106(a), including those located outside of 
the U.S., register if they wish?.................................................................................................................4 
6. How does an IRB submit an initial registration?...............................................................................4 
7. What if my IRB is already registered in the OHRP system?..............................................................4 
8. What is the effective date of the final rule and, by what date, must IRBs complete an initial 
registration or submit additional information as required by the FDA rule?.......................................4 
9. Is assistance available if my IRB encounters technical problems when attempting to register 
electronically?..........................................................................................................................................5 
10. Will my IRB receive confirmation that its registration was completed?.........................................5 
11. What information does the final rule require from each IRB in the U.S. that reviews FDA-
regulated studies?....................................................................................................................................5 
III.  REVISIONS TO INFORMATION.....................................................................................5 
12. Once my IRB is registered or its existing information is updated to comply with this rule, is 
registration permanent unless there is a change in required information?..........................................5 
13. Once registered, when is an IRB required to revise its registration information?..........................5 
14. Does an IRB need to update the number of active protocols under review when changes occur?6 
IV.  CONSEQUENCES OF FAILURE TO REGISTER..........................................................6 
15. What are the consequences of an IRB failing to register as required by the final rule?................6 
V.  AVAILABILITY OF INFORMATION................................................................................6 
16. Will the information in the registration system be available to the public?....................................6 
 
 
  1 Contains Nonbinding Recommendations 
 Guidance for IRBs 
Frequently Asked Questions  
IRB Registration 
 
 
 
 
This Level 1, direct to implementation, guidance document represents the Food and Drug 
Administration's (FDA's) current thinking on this topic.  It does not create or confer any rights for or on 
any person and does not operate to bind FDA or the public.  You can use an alternative approach if it 
satisfies the requirements of the applicable statutes and regulations.  If you want to discuss an alternative 
approach, contact the FDA staff responsible for implementing this guidance.  If you cannot identify the 
appropriate FDA staff, call the appropriate number listed on the title page of this guidance. 
 
 
 
This guidance is intended to assist institutional review boards (IRBs) in complying with the new 
requirement for IRB registration.  (See 74 FR 2358 (Jan. 15, 2009))1  This requirement is an 
amendment to Part 56, Institutional Review Boards, (21 CFR 56.106), that requires each IRB in 
the United States (U.S.) that reviews FDA-regulated studies to register.  IRB registration 
information is entered into an Internet-based registration system maintained by the Department 
of Health and Human Services (HHS).  This system is a modification of the one used by the 
Office for Human Research Protections (OHRP) for registration of IRBs that are designated by 
institutions under Federalwide Assurances (FWAs).  OHRP has issued a similar rule requiring 
IRBs designed under FWAs to register or update their registration information at this modified 
site.  (See 74 FR 2399 (Jan. 15, 2009))2 
  
FDA's guidance documents, including this guidance, do not establish legally enforceable 
responsibilities.  Instead, guidances describe the Agency's current thinking on a topic and should 
be viewed only as recommendations, unless specific regulatory or statutory requirements are 
cited.  The use of the word should in Agency guidances means that something is suggested or 
recommended, but not required.   
 
I.  Rationale for the new requirement 
 
1. Why is FDA requiring all IRBs that review FDA-regulated studies to register?  
 
Because our information at the present time is derived from research and marketing applications, 
FDA (we) cannot be certain that we have current information about IRBs that review FDA-
regulated studies.   For example, some drug and device studies are exempt from the 
Investigational New Drug (IND, 21 CFR Part 312) and Investigational Device Exemptions (IDE, 
21 CFR 812) submission requirements and are conducted without FDA involvement.  In 
addition, many device studies (e.g., non-significant risk and many in vitro diagnostic (IVD) 
studies) are conducted with only IRB approval.  We, therefore, do not have real-time information 
about these studies or the IRBs that review them. 
                                                 
1  The Federal Register notice can be found at http://edocket.access.gpo.gov/2009/E9-682.htm  
2  This Federal Register notice can be found at http://edocket.access.gpo.gov/2009/E9-588.htm  
  2 Contains Nonbinding Recommendations 
 
In addition, several reports from the HHS Office of Inspector General (OIG) regarding our 
oversight of the conduct of clinical studies3 recommended IRB registration, stressing the 
importance of a comprehensive listing of all IRBs that review FDA-regulated research.  The 
2001 OIG report also expressed concern about our ability to assure an equivalent level of human 
subject protection in clinical studies of FDA-regulated products conducted outside of the U.S. as 
compared to those conducted in the U.S.  While registration of non-U.S. IRBs (often referred to 
as Independent or Research Ethics Committees  IECs/RECs) is voluntary, information we 
receive from them will be helpful in addressing this concern. 
 
2. Why does FDA believe this information is necessary?  
 
The new rule will provide FDA, as well as other interested parties (e.g., the IRB community, 
sponsors, and clinical investigators), with a comprehensive listing of all U.S. IRBs that review 
FDA-regulated research.  It will also provide information about non-U.S. IRBs/IECs/RECs that 
review FDA-regulated research and choose to voluntarily register.  This more complete 
knowledge of IRBs that actively review FDA-regulated studies will: 
 
  Facilitate our sharing of educational and other information with IRBs.  We believe 
that the lack of an accurate, complete, and regularly updated listing of IRBs involved 
with the review of FDA-regulated studies limits our outreach and educational efforts;  
 
  Assist us in scheduling and conducting IRB inspections under our bioresearch 
monitoring (BIMO) inspection program, by assuring up-to-date contact information; 
and 
 
  Help us to prioritize IRB inspections.  
 
3. Does registration imply that an IRB is in full compliance with 21 CFR Part 56 or is 
otherwise meeting a particular standard of competence or expertise? 
 
No.  IRB registration is not a form of accreditation or certification by FDA that the IRB is in full 
compliance with 21 CFR Part 56.  While a U.S. IRB that reviews FDA-regulated studies must 
register to be in compliance with 21 CFR Part 56.106(a), IRB registration does not address issues 
regarding an IRBs competence or expertise nor does it require IRBs to meet a particular 
standard in order to conduct a review. 
 
II.  Registration requirements 
 
4. Who must register? 
 
Each IRB in the U.S. that either:  
 
a.  reviews clinical investigations regulated by FDA under sections 505(i) (21 U.S.C. 355(i)) 
or 520(g) (21 U.S.C. 360j(g)) of the Federal Food, Drug, and Cosmetic Act (the Act); 
                                                 
3 Institutional Review Boards  A Time for Reform (1998) available at http://www.oig.hhs.gov/oei/reports/oei-01-
97-00193.pdf;; The Globalization of Clinical Trials (2001) available at http://oig.hhs.gov/oei/reports/oei-01-00-
00190.pdf; and The Food and Drug Administrations Oversight of Clinical Trials (2007) available at 
http://www.oig.hhs.gov/oei/reports/oei-01-06-00160.pdf.  
  3 Contains Nonbinding Recommendations 
 
or 
 
b.  reviews clinical investigations that are intended to support applications for research or 
marketing permits for FDA-regulated products.  [See 21 CFR 56.106(a)] 
 
5. May IRBs other than those required under 21 CFR 56.106(a), including those located 
outside of the U.S., register if they wish? 
 
Yes, any IRB may choose to register voluntarily. 
 
6. How does an IRB submit an initial registration?  
 
IRBs that are not already in the registration system must submit an initial registration.  IRBs can 
submit this registration electronically through http://ohrp.cit.nih.gov/efile.  If your IRB lacks the 
ability to register electronically, it must send its registration information, in writing, to the Good 
Clinical Practice Program (HF-34), Office of Science and Health Coordination, Food and Drug 
Administration, 5600 Fishers Lane, Rockville, MD 20857.  
 
As noted above, we are utilizing a modified version of the Internet-based system OHRP has 
employed for registration of IRBs designated under FWAs.   Both OHRP and FDA will be using 
this same modified system.  
 
The electronic registration system provides instructions to assist you in providing the appropriate 
information, depending on whether your IRB is subject to regulation by only OHRP, only FDA, 
or both OHRP and FDA. 
 
 7. What if my IRB is already registered in the OHRP system?  
 
If your IRB is already registered in the OHRP system, the registration information must be 
updated to include all of the information required by FDA (see # 11 below).  For IRBs that are 
currently reviewing FDA-regulated research, the additional information must be added to the 
database by September 14, 2009.  For IRBs that are not currently reviewing FDA-regulated 
research, this must be done before any research involving FDA-regulated products is reviewed 
once the compliance date has passed.   (See below for more information on the effective and 
compliance dates.) 
 
8. What is the effective date of the final rule and, by what date, must IRBs complete an initial 
registration or submit additional information as required by the FDA rule? 
 
This rule is effective July 14, 2009.  However, in order to allow IRBs to submit their initial 
registrations or the additional information required by the rule, FDA will not enforce the rule 
until September 14, 2009, the compliance date.   Therefore, as stated above, IRBs that are not 
already in the OHRP system must submit an initial registration by September 14, 2009.  For 
IRBs that are already in the OHRP system and are reviewing FDA-regulated research, the 
required additional information must be added to the database by this compliance date.  After 
September 14, 2009, if an IRB that is not reviewing FDA-regulated research decides to do so, 
this additional information must be submitted before the IRB reviews research involving FDA-
regulated products.  
  4 Contains Nonbinding Recommendations 
 
9. Is assistance available if my IRB encounters technical problems when attempting to register 
electronically? 
 
If your IRB encounters technical problems with the electronic registration system, it should 
contact an OHRP IRB Coordinator listed at http://www.hhs.gov/ohrp/daqi-staff.html.  
 
10. Will my IRB receive confirmation that its registration was completed? 
 
If your IRB registers electronically, it will receive a notification that registration was accepted by 
HHS, sent to the electronic e-mail address that it provided as part of the registration process. 
 
If your IRB submits written information, as described in #6 above, an electronic notification will 
be sent once the information is successfully entered into the system and accepted by HHS.   
 
11. What information does the final rule require from each IRB in the U.S. that reviews FDA-
regulated studies? 
 
The final rule requires the following information [see 21 CFR 56.106(b)]: 
 
(1) The name, mailing address, and street address (if different from the mailing address) of 
the institution operating the IRB and the name, mailing address, phone number, facsimile  
number, and electronic mail address of the senior officer of that institution who is 
responsible for overseeing activities performed by the IRB; 
 
(2) The IRBs name, mailing address, street address (if different from mailing address), 
phone number, facsimile number, and electronic mail address; each IRB chairpersons 
name, phone number, and electronic mail address; and the name, mailing address, phone 
number, facsimile number, and electronic mail address of the contact person providing 
the registration information;  
 
(3) The approximate number of active protocols involving FDA-regulated products 
reviewed.  For purposes of this rule, an active protocol is any protocol for which an 
IRB conducted an initial review or a continuing review at a convened meeting or under 
an expedited review procedure during the preceding 12 months; and 
 
A description of the types of FDA-regulated products (such as biological products, color 
additives, food additives, human drugs, or medical devices) involved in the protocols that the 
IRB reviews. 
 
III.  Revisions to Information 
 
12. Once my IRB is registered or its existing information is updated to comply with this rule, is 
registration permanent unless there is a change in required information? 
 
No, an IRB is required to renew its registration and verify the required information every 3 years 
from the date of the last entry/change made to the registration information.  
 
13. Once registered, when is an IRB required to revise its registration information? 
  5 Contains Nonbinding Recommendations 
 
The final rule specifies the following circumstances that require a revision to the registration 
information [see 21 CFR 56.106(e)]: 
 
  If an IRBs contact or chairperson information changes, the IRB must revise its 
registration information within 90 days of the change. 
 
  If an IRB decides to review new types of FDA-regulated products (e.g., to review device 
studies if it only reviewed drug studies previously) or to discontinue reviewing clinical 
investigations regulated by FDA, it must report this within 30 days of the change. 
 
  If an IRB decides to disband, this must be reported within 30 days of permanent cessation 
of the IRBs review of research. 
 
14. Do IRBs need to update the number of active protocols under review when changes occur? 
 
No, we realize that the number of active protocols may change quite frequently and that 
continuously updating this information would be burdensome.  Therefore, for changes in the 
number of active protocols, as well as any other additions or changes not specifically covered in 
21 CFR 56.106(e) (see previous response), IRBs may wait to modify the information until it is 
necessary to change any of the information specified in #13 or time to renew its registration. 
 
IV.  Consequences of failure to register 
 
15. What are the consequences of an IRB failing to register as required by the final rule? 
 
An IRB that fails to register could be considered noncompliant with these regulations.  As part of 
our inspectional activities, FDA may conduct an inspection of an IRB to verify compliance with 
regulatory requirements, including the requirement for an IRB to register under 21 CFR 
56.106(a). 
 
Sponsors and clinical investigators are required by FDA regulations governing the conduct of 
clinical studies (21 CFR Part 312 for drugs and biologics and 21 CFR Part 812 for devices) to 
use IRBs that comply with 21 CFR Part 56.  Therefore, if a sponsor and/or clinical investigator 
submits a study for review to an unregistered IRB, that sponsor and/or clinical investigator could 
be considered noncompliant with FDA regulations.   
 
In addition, we plan to use the information accrued through the IRB registration system to 
distribute educational materials to IRBs that review FDA-regulated studies (see #2 above).  
Therefore, sponsors and/or clinical investigators who use IRBs that are not registered run the risk 
that the IRB may not be familiar with our current policies. 
 
V.  Availability of information  
 
16. Will the information in the registration system be available to the public? 
   
As discussed in the preamble to both the proposed and final rules, the information that OHRP 
presently has publicly available on its website will remain available.  That information includes 
  6 Contains Nonbinding Recommendations 
the name and location of all organizations operating an IRB and the name and location of the 
associated IRB(s).  (This information is available at http://ohrp.cit.nih.gov/search/).   
 
Other available information is subject to public disclosure under the Freedom of Information Act 
(FOIA) as well as our public information regulations in 21 CFR Part 20 and therefore can be 
requested.  Please note, however, that certain information may be withheld from public 
disclosure or may require an individuals consent for public disclosure [see, e.g., 21 CFR 
20.63(e)].   
 
In addition, we will not issue reports on IRB registration nor certificates to show that an IRB is 
registered.  As noted previously, IRB registration does not address issues regarding an IRBs 
competence or expertise nor does it require IRBs to meet a particular standard in order to 
conduct a review. 
  7