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Frequently Asked Questions About the NCI’s Central Institutional Review Board (CIRB) Initiative


    General Information about the CIRB Initiative:
 
    Q1: What are the most useful documents to introduce me to the CIRB Initiative?
    Q2: What is the mission of the CIRB Initiative?
    Q3: What is the CIRB Initiative?
    Q4: What studies does the CIRB review?
    Q5: Is there a fee for enrolling in and using the CIRB?
    Q6: How many studies must an IRB open using the CIRB each year?
    Q7: Can you describe the CIRB membership?
    Q8: When does the CIRB meet?
    Q9: What is the CIRB’s FWA number?
    Q10: What is the IORG number for the CIRB?
    Q11: What are the IRB registration numbers for the Adult and Pediatric CIRBs?
    Q12: How do I provide the CIRB Operations Office with feedback, questions, or comments about the Initiative?
 
    Enrolling in the CIRB Initiative:
 
    Q13: What are the requirements for enrolling in the CIRB Initiative?
    Q14: We have questions about enrolling in the CIRB Initiative, how can we get answers?
    Q15: Where can I obtain a list of enrolled signatory institutions?
    Q16: Can we see CIRB’s study-specific review documents before enrolling?
    Q17: How do I enroll in the CIRB Initiative?
 
   Facilitated Review:
 
    Q18: What is facilitated review?
    Q19: How does my local IRB set up a process for conducting facilitated review?
    Q20: Is my IRB required to notify the CIRB Operations Office that it has conducted facilitated review?
 
   Communication From the CIRB Operations Office to the Local Institution:
 
    Q21: What are the various ways the CIRB Operations Office communicates with local institutions?
    Q22: How do I know when study-specific documents have been posted to the CIRB Website?
 
   Communication From the Local Institution to the CIRB Operations Office:
 
    Q23: How do I contact the CIRB Operations Office?
    Q24: How do I add, change, or remove personnel or affiliated institutions?
    Q25: Why do personnel changes need to be submitted by the IRB at the signatory institution?
    Q26: How do I close a study or transfer review responsibility back to my local IRB?
 
   CIRB Policies and Procedures:
 
    Q27: Where can I find a copy of the CIRB’s SOPs?
    Q28: Does the CIRB review individual adverse event reports that are distributed by the Cooperative Groups?
    Q29: Why does the CIRB complete its continuing review so far in advance of the study’s expiration date?
    Q30: When a local IRB accepts facilitated review, what approval expiration date should be used?
    Q31: Will the CIRB review recruitment material I have developed for my site?
    Q32: When a study has been amended, how do I know if I need to notify study participants?
 
   Postings on Study-Specific Webpages:
 
    Q33: Under the Amendment tab, why is the first amendment posted for this study titled as Amendment #2?
    Q34: Why isn’t the Investigator’s Brochure (IB) posted on the CIRB Website?
 
   Technical Information:
 
    Q35: Who do I contact to obtain my username and password for the Participant’s Area of the CIRB Website?
    Q36: Who do I contact to obtain my username and password for the Participant’s Area of the CIRB Website if I have forgotten it?
    Q37: Can I change my username and password for the Participant’s Area of the CIRB Website to something easier to remember?
    Q38: Why are PDF Acrobat files sometimes displayed as a blank page?
    Q39: What are the minimum technical requirements for using the CIRB Website?
 
   General Information about the CIRB Initiative:
 
   Q1: What are the most useful documents to introduce me to the CIRB Initiative?
   A1: Click on any link below to be taken to the document you wish to view.
  1. Quickguide to Facilitated Review

  2. NCI CIRB Handbook for Local Sites

  3. NCI CIRB Standard Operating Procedures

  4. Request for 30-Day NCI CIRB Website Access Form

  5. NCI CIRB Institution Enrollment Worksheet

  6. Authorization Agreement and accompanying Division of Responsibilities between the Central IRB and Enrolled Local Institutions

  7. Link to Participant’s Area

  8. Forms to Update Personnel and Institution Information
 
   Q2: What is the mission of the CIRB Initiative?
   A2: The mission of the CIRB Initiative is to reduce the administrative burden on local IRBs and investigators by partnering with local IRBs to provide a high level of protection for study participants in NCI’s Cooperative Group clinical trials.
 
   Q3: What is the CIRB Initiative?
   A3: The CIRB Initiative is a partnership between the NCI CIRB and local IRBs based on the signed Authorization Agreement and Division of Responsibilities document. The CIRB conducts initial reviews, continuing reviews, amendment reviews, and reviews of all documents distributed by the Cooperative Group, including review of study-wide unanticipated problems. The local IRB retains oversight for local conduct of the research, including locally-occurring unanticipated problems. For additional information on the CIRB Initiative and how it works, click here to access the Webpage “How the CIRB process works”.
 
   Q4: What studies does the CIRB review?
   A4: The CIRB reviews all CTEP-sponsored adult Phase 3 Cooperative Group studies as well as pediatric Pilot, Phase 2, and Phase 3 Cooperative Group studies. Select DCP-sponsored pediatric and adult trials are also reviewed by the CIRB.
 
   Q5: Is there a fee for enrolling in and using the CIRB?
   A5: There is no fee for enrolling in or using the CIRB.
 
   Q6: How many studies must an IRB open using the CIRB each year?
   A6: There is no minimum number of studies required for an IRB to maintain enrollment in the CIRB Initiative. The local IRB decides on a study-by-study basis whether to use the CIRB or to conduct its own full board review.
 
   Q7: Can you describe the CIRB membership?
   A7: The Pediatric and Adult CIRB members are a diverse group of distinguished healthcare professionals and patient advocates with expertise in oncology. No CIRB member is employed by the NCI. To see a listing of current CIRB members and their bios, click here.
 
   Q8: When does the CIRB meet?
   A8: The Adult CIRB generally meets on the first and third Thursday of each month. The Pediatric CIRB generally meets on the second Thursday of each month. You may access the schedule of CIRB meetings by clicking here.
 
   Q9: What is the CIRB’s FWA number?
   A9: Per OHRP’s direction, the CIRB does not have an FWA since it does not conduct research.
 
   Q10: What is the IORG number for the CIRB?
   A10: The IORG number for the Adult and Pediatric CIRBs is IORG0000460.
 
   Q11: What are the IRB registration numbers for the Adult and Pediatric CIRBs?
   A11: The IRB registration number for the Adult CIRB is IRB00000781. The IRB number for the Pediatric CIRB is IRB00004296.
 
   Q12: How do I provide the CIRB Operations Office with feedback, questions, or comments about the Initiative?
   A12: Contact the CIRB Helpdesk at 1-888-657-3711 or email ncicirbcontact@emmes.com with any feedback, questions, or comments.
 
 

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   Enrolling in the CIRB Initiative:
 
   Q13: What are the requirements for enrolling in the CIRB Initiative?
   A13: The following two criteria must be met to enroll in the CIRB:

  1. The institution must have an IRB.

  2. The IRB must currently be reviewing Cooperative Group adult Phase 3 clinical trials or pediatric Pilot, Phase 2 or Phase 3 clinical trials.
 
   Q14: We have questions about enrolling in the CIRB Initiative, how can we get answers?
   A14: There are several resources available to assist you with enrollment questions:

  1. The NCI CIRB Handbook for Local Sites provides detailed information about participating in the CIRB Initiative. The Handbook is available on the CIRB Website and can be accessed directly by clicking here.

  2. The Enrollment Packet contains the required forms for enrollment and helpful information, click here to access the Enrollment Packet.

  3. When requested, the CIRB Operations Office can arrange a conference call to answer CIRB enrollment and/or utilization questions. Contact the CIRB Helpdesk at 1-888-657-3711 or via email at ncicirbcontact@emmes.com to arrange a call.

  4. To contact an Enrollment Specialist, phone the CIRB Helpdesk at 1-888-657-3711 or via email at ncicirbcontact@emmes.com. The Helpdesk is staffed from 8am to 4pm Eastern time on weekdays (except for Federal holidays).
 
   Q15: Where can I obtain a list of enrolled signatory institutions?
   A15: A list of signatory institutions enrolled in the CIRB Initiative can be found by clicking here. The list is divided into two sections labeled respectively; Adult CIRB Signatory Institutions and Pediatric CIRB Signatory Institutions. Institutions enrolled in both the Adult and Pediatric CIRB, are indicated by an asterisk (*).
 
   Q16: Can we see CIRB’s study-specific review documents before enrolling?
   A16: Yes, 30-day access to the Participant's Area of the CIRB Website is available. The Participant’s Area is the secured-access section of the CIRB Website where regulatory documents are posted. To request 30-day access to the Participant’s Area of the CIRB Website, complete the request form located here. Submit the completed form via email to ncicirbcontact@emmes.com or fax to the attention of the CIRB Enrollment Specialist at 301-560-6538.
 
   Q17: How do I enroll in the CIRB Initiative?
   A17: Institutions enroll in the CIRB Initiative by completing the following steps:

  1. Complete the NCI CIRB Institution Enrollment Worksheet;
  2. Modify the institution’s FWA Item #5 titled “Designation of Institutional Review Boards (IRBs)” on the FWA form to include the CIRB. OHRP’s instructions for revising an FWA are located here;

  3. Sign the Authorization Agreement;

  4. Return the NCI CIRB Institution Enrollment Worksheet and the signed Authorization Agreement to the CIRB Operations Office;

  5. Create a local IRB SOP for utilizing the CIRB. A sample SOP can be found here; and

  6. Notify local investigators of the new process.
If you have any questions about enrolling in the CIRB Initiative contact the CIRB Helpdesk at 1-888-657-3711 or via email at ncicirbcontact@emmes.com.
 
 

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   Facilitated Review:
 
   Q18: What is facilitated review?
   A18: Facilitated review is the process used by local IRBs to make a determination whether or not to accept the CIRB’s review of a study. The IRB Chair, designee, or subcommittee reviews the CIRB’s study-specific review documents and ensures that all local context considerations are addressed.

If there are no concerns related to local context, the local IRB accepts the CIRB’s review and must report the facilitated review acceptance to the CIRB via the CIRB Website. If there are local context considerations not addressed by the CIRB, the local IRB retains the option to not accept the CIRB’s review and can choose to conduct its own full board review.

For a one-page visual on facilitated review, view the “Quickguide for Facilitated Review” by clicking here. For more detailed information, consult the “NCI CIRB Handbook for Local Sites” by clicking here.
 
   Q19: How does my local IRB set up a process for conducting facilitated review?
   A19: Enrolled institutions develop their own process for conducting facilitated review. The CIRB Operations Office has developed a sample SOP to assist your institution in developing its SOP for facilitated review. You may revise the sample SOP as you wish to suit your circumstances. The sample SOP is publicly available and no credit for its use is necessary. To access the “Sample Standard Operating Procedure for Utilizing the CIRB” click here.
 
   Q20: Is my IRB required to notify the CIRB Operations Office that it has conducted facilitated review?
   A20: Yes, IRBs must report facilitated review to the CIRB Operations Office by completing and submitting an on-line form titled the Facilitated Review Acceptance Form (FRAF). An FRAF is found on each study-specific webpage. Once this form is completed and submitted, the CIRB is the IRB responsible for review of the study at your site for the life of the study.
 
 

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   Communication From the CIRB Operations Office to the Local Institution:
 
   Q21: What are the various ways the CIRB Operations Office communicates with local institutions?
   A21: The multiple ways the CIRB Operations Office communicates with local institutions include:
  1. Participant’s Area of the Website is a restricted area where all study-specific documents are posted.

  2. The CIRB Website Postings Summary that is distributed via email on the 1st and 15th of the month. The CIRB Website Postings Summary lists all documents posted since the previous distribution.

  3. The CIRB Website homepage under the What’s New header.

  4. When study-specific notifications are required, the CIRB Operations Office broadcasts emails to all the appropriate stakeholders.

  5. Attendance at Cooperative Group meetings and IRB conference where the CIRB Operations Office may have a presentation and/or maintain a booth.
 
   Q22: How do I know when study-specific documents have been posted to the CIRB Website?
   A22: New study-specific review documents are posted on the CIRB Website daily as soon as the sponsoring Cooperative Group activates the study or amendment. The CIRB Operations Office notifies local IRBs and research staff of these postings via the NCI CIRB Website Postings Summary distributed by email on the 1st and 15th of the month. These emails include a link to a PDF document listing everything posted to the Website since the previous email notification was sent approximately two weeks previously. An archive of Website Postings Summaries can be found here. If you are not receiving these emails and would find them helpful, contact the CIRB Helpdesk at 1-888-657-3711 or via email at ncicirbcontact@emmes.com.
 
 

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   Communication From the Local Institution to the CIRB Operations Office:
 
   Q23: How do I contact the CIRB Operations Office?
   A23: There are four ways to contact the CIRB Operations Office. They include:

  1. The CIRB Helpdesk via phone at 1-888-657-3711

  2. The CIRB Helpdesk via email at ncicirbcontact@emmes.com

  3. The CIRB Helpdesk via fax at 1-301-560-6538.

  4. The CIRB Helpdesk via mail:
    NCI CIRB Operations Office
    c/o The EMMES Corporation
    401 N. Washington Street, Suite 700
    Rockville, MD 20850
 
   Q24: How do I add, change, or remove personnel or affiliated institutions?
   A24: The IRB Contact Person has privileges to add, change, or remove personnel or affiliated institutions and should submit an updated contact form including these changes. The form can be found on the CIRB Website by clicking here.
 
   Q25: Why do personnel changes need to be submitted by the IRB at the signatory institution?
   A25: Since the CIRB has confidential information on its website, confirmation of the legitimacy of the person requesting access is required. Because the CIRB partners with local IRBs and the local IRB is responsible for local conduct of the Cooperative Group research, it is the local IRB’s responsibility to submit to the CIRB Operations Office only names of research staff who are legitimately requesting access to the CIRB Website.
 
   Q26: How do I close a study or transfer review responsibility back to my local IRB?
   A26: Local IRBs may close a study with the CIRB, or transfer review responsibility back to the local IRB, using the Study Closure or Review Responsibility Transfer Form (SCRRTF). The form can be accessed by logging in to the Participant's Area and clicking on "Click here for the Facilitated Review (FR) Submission Report" at the top of the Webpage. A link to the Form is found at the bottom of the FR Submission report.
 
 

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   CIRB Policies and Procedures:
 
   Q27: Where can I find a copy of the CIRB’s SOPs?
   A27: The CIRB’s SOPs are publicly available on the CIRB Website. You may access them by clicking here.
 
   Q28: Does the CIRB review individual adverse event reports that are distributed by the Cooperative Groups?
   A28: The CIRB is responsible for review of individual adverse event reports distributed by the Cooperative Groups. The CIRB fulfills this responsibility by complying with the recommendations contained in OHRP, FDA, and NIH Guidances. Since the Federal Guidances recommend that sponsors can better assess individual adverse event reports than IRBs, the CIRB’s SOPs were changed to reflect the Guidances.

The CIRB's memorandum, "Review of Adverse Events for Phase 3 Clinical Trials," dated April 1, 2010, described a change in process for the CIRB’s review of adverse event reports distributed by the Cooperative Groups for Phase 3 Clinical Trials. This change in process does not shift responsibility for review of these reports to the local IRB.

You may access the April 1, 2010 memorandum by clicking here.
 
   Q29: Why does the CIRB complete its continuing review so far in advance of the study’s expiration date?
   A29: The CIRB completes its continuing review of a study at least 45 days in advance of the expiration date as a result of requests from local IRB and research staff. Local IRBs and research staff have requested continuing review approval 45 days before the trial is set to expire in order to update their regulatory files with documentation of CIRB approval for continuation.
 
   Q30: When a local IRB accepts facilitated review, what approval expiration date should be used?
   A30: Local IRBs that have accepted facilitated review for a study should use the approval expiration date as set by the CIRB.
 
   Q31: Will the CIRB review recruitment material I have developed for my site?
   A31: No. The CIRB does not review locally-produced recruitment material. The CIRB reviews recruitment material developed by the Cooperative Group. Locally-produced recruitment materials should be submitted to the local IRB for review and approval.
 
   Q32: When a study has been amended, how do I know if I need to notify study participants?
   A32: CIRB determinations regarding study participant notification of significant new findings are made in consultation with the Study Chair. As of August 1, 2011, the CIRB outcome letter for amendments will state whether or not an amendment includes significant new findings that might relate to participants’ willingness to continue participation. If there are significant new findings, the outcome letter will contain information about how to notify study participants of the findings.
 
 

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   Postings on Study-Specific Webpages:
 
   Q33: Under the Amendment tab, why is the first amendment posted for this study titled as Amendment #2?
   A33: Amendments posted to the Amendment tab are those amendments that are reviewed and approved by the CIRB after activation of the study by the Cooperative Group. Sometimes a study is amended after CIRB review and approval however prior to activation. Review documents for amendments occurring prior to activation are posted with the initial review documents under the Initial Review tab. This is done to provide local IRBs and research staff with a study’s complete review history.
 
   Q34: Why isn’t the Investigator’s Brochure (IB) posted on the CIRB Website?
   A34: Investigator’s Brochures are not posted to the CIRB Website because they include proprietary information therefore are confidential. Documentation of CIRB review of an IB is made available on the CIRB Website and is located in an approval letter at time of CIRB review or in an acknowledgement of receipt of a revised IB. If you require a copy of the IB, contact the sponsoring Cooperative Group for further guidance.
 
 

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   Technical Information:
 
   Q35: Who do I contact to obtain my username and password for the Participant’s Area of the CIRB Website?
   A35: Contact your IRB who will submit the necessary paperwork to request to add you to the institution’s personnel roster for the CIRB. Once the CIRB Operations Office receives the request from your IRB, your login information will be provided via email.
 
   Q36: Who do I contact to obtain my username and password for the Participant’s Area of the CIRB Website if I have forgotten it?
   A36: If you have forgotten either your username or password, contact the CIRB Helpdesk at 1-888-657-3711 or via email at ncicirbcontact@emmes.com and your login information will be provided via email.
 
   Q37: Can I change my username and password for the Participant’s Area of the CIRB Website to something easier to remember?
   A37: Unfortunately no. The system utilizes an auto-generated password program that does not support customized revisions to the generated password.
 
   Q38: Why are PDF Acrobat files sometimes displayed as a blank page?
   A38:

There is a known problem with older versions of Microsoft Internet Explorer that may cause a PDF Acrobat file to be displayed as a blank page. The CIRB posts multiple documents that are in PDF format. If you see a blank page when accessing a study document that is in PDF format and you are using Microsoft Internet Explorer, try pressing the Refresh button on the browser. This will sometimes fix the problem and the document will appear. If the problem persists, please contact your IT support staff, or check the Microsoft Support Website for other possible solutions. You may also let the CIRB Helpdesk know and the documents can be sent to you via email. This problem does not appear to occur on Netscape browsers.
 
   Q39: What are the minimum technical requirements for using the CIRB Website?
   A39: To successfully use the CIRB Website, it is recommended that your computer is configured as outlined below:

  1. 500 MHz CPU

  2. At least 256 MB RAM

  3. VGA resolution or better

  4. Internet Explorer 5.5+ or Netscape 6+ or Mozilla Firefox 1.0.3+ browser

  5. Adobe Acrobat version 4 or better

  6. RTF viewer like Microsoft Word, WordPad
 
   
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