Client Frequently Asked Questions (FAQ)

1. How often does RCRC IRB hold meetings? Twice weekly. Board meetings are held every Monday and Thursday, except when a meeting day falls on a holiday. When this occurs, the meeting is usually held on the next business day. Please refer to the RCRC IRB meeting calendar. Special meetings may also be arranged due to investigator timelines or when participant safety is affected and immediate IRB action is necessary.
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2. How may I submit study correspondence to RCRC IRB? You may submit documents via SafeSync™, This e-mail address is being protected from spambots. You need JavaScript enabled to view it , U.S. mail, overnight delivery, or by fax (512.382.8902). Be sure to include the Sponsor name, Protocol number, and Investigator name (if applicable) on all correspondence. If sending via mail/overnight delivery, please address your package to: RCRC IRB, 2111 West Braker Lane, Suite 400, Austin, Texas 78758. If using overnight delivery, we do not accept packages marked "Bill Recipient." You must send your overnight package at your own expense.
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3. How may I submit a study for Initial Review? Select Getting Started from the above menu for detailed instructions.
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4. Does RCRC IRB have specific requirements for the Informed Consent Document? Yes, per [21 CFR 50.25] the informed consent document must include all required elements and any applicable additional elements. You may refer to FORM 650 for assistance in creating the informed consent document.

Please refer to FORM 640 for guidance on administering the informed consent process.
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5. What is the deadline for submission for initial review of a new study, new investigator, or continuing review? The submission deadline is Monday, 12:00 noon CST for a Thursday Meeting and Thursday noon CST for a Monday Meeting. If your submission is received by the deadline, and is complete, your study documents will be placed on the agenda for the following meeting. Having your submission in on time allows our staff time to perform a quality assurance review on the documents and prepare the submission for distribution to the IRB members.
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6. What if I miss the deadline? Please contact our office at 512-380-1244. We may be able to accommodate your late submission. <top>

7. When and how will I be notified of the Board decision? Immediately following the Board meeting, you will be notified by e-mail of the Board’s determination.
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8. When will I receive my study documents? RCRC offers a 48-hour turn-around time. You will receive study documents by the close of business, no later than 2 days following the meeting. All study documents are sent via This e-mail address is being protected from spambots. You need JavaScript enabled to view it or posted to GlobeSync™, our online document repository which provides real-time access to study documents.
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9. What if the Board does not approve my submission? You will be notified of this determination, which will include a statement of the reason(s) for the Board’s decision, any modifications or requirements requested by the Board, and you will be informed of our appeal procedure. You may contact our office or respond to the Board in writing. If you have questions or concerns regarding the Board's decision, you may contact our staff and/or have the Chairperson contact you directly.
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10. What if I need a new study, additional investigator, protocol amendment or request for continuing review reviewed before the regularly scheduled Board meeting? RCRC IRB may schedule a full Board meeting outside our normal meeting schedule to accommodate the needs of a client. These "special meetings" are determined by the availability of our Board members and staff. The same procedures apply in regards to distribution of the submission documents to our Board members. They must receive the submission with ample time to adequately review the documents. Please contact our office for additional information.
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11. What is the difference between "Expedited Review" and "Full Board Review"? In accordance with [21 CFR 56.110(b)], an IRB may use the expedited review procedure to review minor changes in previously approved research. This review may be carried out by the IRB Chairperson or designee. Otherwise, significant changes must be reviewed by the full Board at a convened meeting.
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12. How do you determine whether protocol amendments are reviewed by the "Full Board" or through the "Expedited Review" procedure? Protocol amendments requiring "Full Board" review are those increasing risk to study subjects, such as a change in study design, which may or may not include additional treatments or the deletion of treatments, any changes in inclusion/exclusion criteria or change in method of dosage formulation, such as oral changed to intravenous, significant change in the number of subjects or a significant decrease or increase in dosage amount. Amendments that may be reviewed through the "expedited review" procedure include minor changes such as administrative revisions and the addition or deletion of non-procedural items, such as the addition of study personnel names or laboratories.
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13. Can minor changes to protocols, informed consent documents and advertisements be reviewed through the "Expedited Review" procedure? Yes. Expedited Review may be used only for minor changes to previously approved research, involving no more than minimal risk, during the period for which the approval is authorized. This means that only one Board member reviews the submission, as opposed to the full Board.
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14. What if I need minor changes made to the informed consent document? Consent documents are maintained by the RCRC IRB staff and any revisions to the consent documents must have IRB approval. Please send a request for review of the modifications to the consent documents by completing Form 220. Also, please attach the current approved Informed Consent Document with handwritten changes or track change revisions.
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15. How does RCRC IRB handle review of advertisements? If the advertisement is submitted as part of the initial submission, the full Board reviews the advertisement. This action will be noted in the action letter.

If the advertisement is submitted after the study is approved, the advertisement may be submitted and reviewed using the "expedited review" procedure. RCRC IRB staff will perform a preliminary review of all advertisements and recruitment material, to ensure that it does not include any coercive language or other elements. RCRC IRB staff may request that you make revisions prior to submission to the Chairperson or designee. Please review Form 610, for guidance on developing and using Recruitment and Study Material. Please request IRB approval by submitting Form 220.

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16. What do you require for radio or television advertisements? The text for radio and/or television advertisements should be submitted to RCRC IRB for approval prior to recording the audio/visual version(s), as the IRB may request revisions to the advertisement. Once the text is approved, the audio/visual version(s) should be submitted to RCRC IRB for approval prior to broadcast.
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17. How can I have a document translated? RCRC prefers to coordinate the translation of study documents using a preferred translation service to ensure consistency of translated documents. Please submit a request for translation along with the documents you wish to have translated. If you are requesting translation of material at the time of initial review, please indicate so on the initial submission form. If you require translation after initial approval, please send a request for translation by completing Form 220.

RCRC also accepts client translated documents. If you are submitting a document for IRB approval that has already been translated, ensure you include a copy of the Affidavit/Certification of Accuracy. Please send a request for approval of translations by completing Form 220.
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18. Will RCRC IRB remind me when my research needs to be submitted for continuing review? Yes, as a courtesy, RCRC IRB will send you a reminder notice 60 days prior to the expiration date of your research. We strongly advise that you note the expiration date on your original approval letter, and arrange to submit a study status report, 30 days before the expiration date. We prefer that you email the completed report to This e-mail address is being protected from spambots. You need JavaScript enabled to view it or utilize SafeSync™. Even if you do not receive a reminder notice, the Principal Investigator (or Sponsor/sponsor rep for protocol review of multi-site studies) is ultimately responsible for submitting the Continuing Review Report prior to the expiration date.

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19. What if I am expecting a Close-out visit after the Expiration date? A Continuing Review Report or a Final/Close-out Report should be submitted 30 days prior to the Expiration date. This allows an adequate period for us to assess your submission, verify the information reported to us, and obtain any necessary information or documents. Your research may continue during the 30 day period in which we are processing your submission. If all study related activity is complete, and you are only awaiting a close-out visit, you may submit a Final/Close-out Report. If any new information is obtained during the close-out visit, please submit a "Note to File" outlining the changes.
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20. Does RCRC require reporting of minor protocol deviations which do not affect participant safety?

RCRC does not require reporting of minor protocol deviations. Minor protocol deviations are deviations that in the Investigator’s opinion (1) do not diminish participant safety, (2) do not affect the rights or welfare of participants, and (3) do not affect the integrity of the data. Examples of these types of events are listed below. This list is not all-inclusive.

• Participant arrived late to or missed the study visit.
• Blood pressure measurement was not taken at specified visit, etc.

These events may be reported with the continuing review/interim report submissions if reporting is required by the site or sponsor.
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21. Do I need to submit 1572 revisions? If revisions to the 1572 include changes in box 1 or box 3, then yes, you need to submit the 1572 to the IRB for approval. We do not necessarily approve the 1572; rather, we approve changes in principal investigators and updates to research facilities. If your revisions are changes to the sub-investigator information or laboratory facilities, you may submit the revised 1572 to us for review. These changes do not need IRB approval. Please remember to identify the changes in your cover letter.
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22. What if I need to add or change a site, or my research facility address changes? Complete and submit Form 140. Be sure to attach all required supporting documents. If the site name changes but the physical location and 24 hour phone number remain the same you do not need to submit Form 140. Please send us correspondence stating the protocol number, Principal Investigator, new site name, and that the 24 hour number will remain the same. Also, attach the updated 1572 (if applicable).
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23. How do we notify you of a change in Principal Investigator at our site? Complete and submit Form 150. Be sure to attach all required supporting documents for the new Principal Investigator.
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24. What if I need a copy of a document after I have already submitted my final report to the IRB? Please contact us at 512.380.1244.
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25. Do you review Principal Investigators in Massachusetts? Yes, we have a signed agreement with the Commonwealth of Massachusetts to review research in that state. An annual site visit is required for investigators involved in drug research studies. Site visits are not required for device studies). The site visit may be performed by RCRC IRB or a third party auditor. RCRC IRB will contact an auditor to arrange a site visit after IRB approval. The auditor will contact the site to make arrangements and complete the audit within 130 days of initial approval.

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26. What are RCRC IRB’s reporting requirements for unanticipated problems involving risks to participants or others and other safety reports?

Due to the FDA Guidance Document on Reporting Adverse Events, effective April 5, 2010, RCRC no longer requires submission of Safety Reports unless they are determined to be an unanticipated problem by the Investigator/Sponsor.

Unanticipated problem definition: An unanticipated problem (UP) is an event or discovery of new information that is (1) unanticipated¹, (2) involves new or increased risk of harm² to research participants or others and (3) is related to the research³.

¹Unexpected/unanticipated in terms of severity, nature or frequency than previously known, when compared to the Protocol, Study Product Information, ICD and the population being studied.
²New or increased risk of harm to participants or others suggests that the research places the participants or others at a greater risk of harm [including physical, psychological, economic or social] than previously known, when compared to the Protocol, Study Product Information, ICD and the population being studied. New or increased risk may be further defined as one that may require action (e.g. modifying the ICD).
³Related to the research reasonably thought to be caused by the procedures involved in the research.

Reporting of these events should occur regardless of whether the event/information is discovered during or after study completion, after participant withdrawal or completion of the research.

Submission of Safety Reports that do not meet RCRC reporting criteria, but reporting is required by Sponsor or Site policy.

RCRC understands that most Sponsors have a policy which requires submission of all safety reports to the IRB. If you must submit to satisfy Sponsor or site policy, please send the report along with a cover letter/email stating, “The submitted report does not meet RCRC reporting criteria; submitting to satisfy sponsor requirement”. RCRC staff will review the report to be sure that it does not meet RCRC reporting requirements and will acknowledge receipt and return the acknowledgment.
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27. Does the IRB review and approve HIPAA authorizations, or grant "Waivers of HIPAA Authorizations"? The IRB is not required to review HIPAA Authorizations unless the authorization is included in the consent document. However, RCRC IRB will review stand-alone HIPAA Authorizations and will consider this document a separate consent form if not combined with the original consent document. RCRC will also consider Requests for a Waiver of HIPAA Authorizations for research in which the circumstances may warrant a waiver. Please contact our office for more information.
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28. May I request a copy of the membership roster? The membership roster can be found here and on the About Us page.

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29. May I request a copy of your fee schedule? Please This e-mail address is being protected from spambots. You need JavaScript enabled to view it to obtain our current fee schedule.
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30. Does RCRC offer volume discounts for large multi-site studies or for repeat business? Yes, each project is considered on a case-by-case basis. Please This e-mail address is being protected from spambots. You need JavaScript enabled to view it for to discuss your particular study needs and/or for additional information.
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