1. How often does RCRC IRB hold meetings? Board meetings are held every Monday, except when a holiday falls on a Monday. If a holiday is on a Monday, the meeting is usually held on the next business day. Please refer to the RCRC IRB meeting calendar. Unscheduled 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 many members are on the Board and what is a quorum? The two Boards are each comprised of five regular members plus alternate members to fulfill the required representative capacities. A quorum is met when the majority of members are present. With a membership of five, the quorum for each Board is three members.
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3. How may I submit study correspondence to RCRC IRB? You may contact us via U.S. mail, overnight delivery or courier service, fax (+512 747 6012) or by e-mail. Be sure to include the Sponsor name, Protocol number, and Investigator name (if applicable) on all correspondence. Please address your package to: RCRC IRB, 706B West Ben White Boulevard Austin, Texas 78704. 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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4. How may I submit a study for Initial Review? You may submit your study via U.S. mail, overnight delivery or courier service or you may submit electronically via e-mail. If using U.S. mail, overnight delivery or courier service, please send only one set of documents with no staples.
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For single site studies you must complete and submit FORM 100 (using FORM 105 as a guide) and FORM 110 (using FORM 115 as a guide) with required supporting documents.
For multi-site studies the Project Manager/Sponsor’s Representative may complete and submit FORM 100 (using FORM 105 as a guide) and all required supporting documents. Once the protocol has been approved by the Board, individual Principal Investigators may then complete and submit FORM 110 (using FORM 115 as a guide) with required supporting documents. Please address your package to: RCRC IRB, 706B West Ben White Boulevard, Austin, Texas 78704. We do not accept packages marked "Bill Recipient." You must send your overnight package at your own expense. You may also e-mail us at rcrc@rcrc-irb.com.
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5. Does RCRC IRB have specific requirements for the Informed Consent Document? Yes, per [21CFR 50.25] the informed consent document must include all required elements and any applicable additional elements. You must format your proposed Informed Consent Document according to our template. For drug studies refer to FORM 650 as a template and for device studies please use FORM 660 as a template. RCRC IRB will verify that you document includes all required elements prior to Board review. Please refer to FORM 630 for guidance on authoring an informed consent document. Also, see FORM 640 for guidance on administering the informed consent process.
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6. What is the deadline for submission? The submission deadline is Thursday, 12:00 noon CST. If your submission is received by the deadline, and is complete, your study documents will be placed on the agenda for the following Monday's meeting. Having your submission in on Thursday 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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7. What if I miss the deadline? Please contact our office at +800 688 2132. We may be able to accommodate your late submission. However, you will be assessed a late fee.
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8. When and how will I be notified of the Board decision? Within 24 hours of the Board meeting, you will be notified either by e-mail or telephone of the Board’s determination.
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9. When will I receive my study documents? You will receive study documents by the close of business on the Friday following Monday's meeting. All study documents are sent via email unless you have indicated another method of receipt.
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10. If I need my study documents right away, can you fax or e-mail them to me? Yes, please contact our office to have documents faxed or emailed to you. There is a small processing fee.
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11. 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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12. 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, although this is not our usual and customary practice. These "unscheduled 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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13. 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. Expedited does not necessarily imply a more timely review.
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14. 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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15. 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 member (the Chairman or the Vice-Chairman) reviews the submission, as opposed to the full Board.
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16. 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. You will need to send a request for review of the modifications to the consent documents. Also, please attach the current approved Informed Consent Document with handwritten changes or track change revisions.
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17. 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.
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18. 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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19. How can I have a document translated? In order to assure accurate translation of research information in a language understandable to the participant, RCRC IRB does not accept translated documents. This includes informed consent documents, study material, participant diaries, surveys, questionnaires, and recruitment material. RCRC IRB utilizes a translation service to ensure quality and consistency, and to ensure appropriate revisions to previously approved translated documents. Please submit your documents with a request for translation. If you are requesting translation of material at the time of initial review, please indicate this. Please note: Once the Board approves a document in English, any translated version of that document is considered approved when accompanied by an affidavit of accuracy provided by the translation service we use. The date of translation does not change the original approval date of the document.
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20. 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. You must submit either a Continuing Review Report FORM 120 (using FORM 125 as a guide) or a Final Report FORM 130 (using FORM 135 as a guide) 30 days prior to the expiration date. We strongly advise that you note the expiration date on your original approval letter, and arrange to submit your Continuing Review Report, 30 days before the expiration date. We PREFER that you fax the completed Continuing Review Report or Final Report to 512-747-9382. Even if you do not receive a reminder notice, the Principal Investigator is ultimately responsible for submitting the Continuing Review Report 30 days prior to the expiration date.
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21. What if I am expecting a Close-out visit after the Expiration date? A Continuing Review Report or a Final Report must 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 delinquent 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, RCRC IRB requires you to submit a Final Report. If any new information is obtained during the close-out visit, please submit a "Note to File" outlining the changes. Failure to submit either a Continuing Review Report or a Final Report 30 days prior to the Expiration date may result in Suspension or Termination and notification to the FDA in accordance with [21CFR 56.108 (b)(3)].
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22. What if I do not submit Continuing Review Report or Final Report 30 days prior to the expiration date? If we have not received either a Continuing Review Report or a Final Report, 30 days prior to your approval expiration date, you are considered non-compliant. Your research may be suspended or terminated by the Board in accordance with [21 CFR 56.113]. Please call 800-688-2132 for additional information.
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23. 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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24. What if I need to add or change a site, or my research facility address changes? Complete and submit FORM 140 (using FORM 145 as a guide). 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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25. How do we notify you of a change in Principal Investigator at our site? Complete and submit FORM 150 (using FORM 155 as a guide). Be sure to attach all required supporting documents.
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26. What if I need a copy of a document after I have already submitted my final report to the IRB? Please contact us at 800-688-2132 in most cases we can retrieve these documents for you.
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27. Do you review Principal Investigators in Massachusetts? Yes, we have a signed agreement with the Commonwealth of Massachusetts to review research in that state. For these sites, we must initiate a site evaluation visit upon approval, unless we have previously conducted a site evaluation at their location during the past 12 months. We also require additional Massachusetts licenses to be submitted.
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28. What are RCRC IRB's reporting requirements for serious adverse events/device effects, protocol violations, protocol deviations and protocol exemptions? Investigators must report only those events that are: unexpected, serious, definitely related, or probably related. An unanticipated problem involving risks to participants or others is a problem that is (1) unexpected and (2) indicates that participants or others are at increased risk of harm. Unexpected means not described in the information provided to the IRB such as the Protocol and Investigator’s Brochure.

Investigators must report unanticipated problems involving risks to participants or others (i.e. serious adverse events/device effects that fit the criteria within 10 working days of when the investigator becomes aware of them. Non-compliance with this requirement will be reported to the FDA. See FORM 310 for specific reporting requirements and submit all reports on FORM 300.

Events that are already described in the Protocol and Investigator’s Brochure (in frequency and severity) are not unexpected and do not have to be reported to RCRC IRB. The Sponsor may have additional reporting requirements. The initial and all subsequent reports until resolution of the event has occurred must be reported. If the event has the potential to recur, a protocol amendment should be considered.

Investigators (or Project Managers) must report IND/IDE Safety Reports, Safety Letters that they receive from the Sponsor. Submit only those Safety Reports that are serious, unanticipated, and probably related, or definitely related. Please also include a cover letter to RCRC IRB requesting a review of the documents. Do not complete FORM 300 for Safety Reports.

All correspondence to our office must include the sponsor, protocol number, and RCRC IRB-approved Principal Investigator name. We PREFER that you fax Unanticipated Problems and Safety Reports submissions to us at 512-747- 9671.
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29. Does the IRB review and approve HIPAA authorizations, or grant "waivers of authorization"? The IRB is not required to review HIPAA Authorizations unless the authorization is part of the consent document. RCRC IRB recommends that investigators contact the local organization or institution (i.e. the covered entity to which they belong), state, legal counsel about how the Privacy Rule may apply to a specific research project. Individual state requirements are the responsibility of the Investigator. By definition, RCRC IRB is not a Covered Entity, and therefore does not have the oversight or control of the HIPAA Authorization process. However, if present, RCRC IRB will review HIPAA Authorization document within the context of the study, but not as an additional service, to ensure inclusion of the required elements, and that these elements are presented in a meaningful way. Any missing elements are noted and added by the administrative staff on the advice of the Board. RCRC IRB does not grant waivers of HIPAA Authorization.
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30. May I request a copy of the membership Roster? The membership roster is provided to clients at the time of initial approval, and customized to include protocol specific information (i.e. sponsor name, protocol number, approval date), and to indicate which members were present for the meeting at which their protocol was reviewed. The membership roster does not expire and is updated as needed. A change in membership will prompt an update to the roster at which time a revised version will be redistributed to all current clients at the next approval.
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31. May I request a copy of your fee schedule? Our current fee schedule is available here on our Web site.
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32. Do you give volume discounts for multi-site studies? Volume discounts or sliding scale pricing may apply to large scale multi-site studies. Each study is considered on a case-by-case basis. Please contact us for a price proposal for your particular study and/or for additional information.
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33. What do I do if I am not satisfied with RCRC IRB? RCRC IRB aims to promote a user-friendly and consultative relationship with our clients. Our staff is available to answer specific questions regarding our procedures and submission requirements. It is our goal to provide our clients with the best customer service possible. However, if you are dissatisfied with RCRC IRB for any reason, please contact us. We also encourage you to complete and submit our Client Satisfaction Survey FORM 750 to provide us with feedback on our services and ways we can improve our services to you.
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