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Frequently Asked Questions (FAQs)

Still have questions? We have answers. If your question is not addressed below, feel free to contact us at 619-469-0108—or send your question to email@aspire-irb.com.

Aspire IRB Compliance Statement

Aspire IRB is duly constituted and has written procedures in compliance with requirements defined in 21 CFR Parts 50 and 56, 312, 812, 45 CFR 46 and ICH Guidelines relating to Good Clinical Practice. Aspire IRB's mission is to ensure that research is conducted ethically according to the principles of the Belmont Report and the Declaration of Helsinki, in compliance with federal regulations, international regulations, ICH Guidelines for Good Clinical Practice, applicable state and local laws, Aspire IRB Standard Operating Procedures, and that the rights and welfare of human subjects are protected.



1. Is Aspire IRB accredited by the Association for the Accreditation of Human Research Protection Programs (AAHRPP)?

Yes. Aspire received Full AAHRPP accreditation in December 2008.



2. What is accreditation?

Accreditation benefits research organizations, participants, and the research enterprise as a whole. The accreditation process requires organizations to take a comprehensive look at their human research protection programs (HRPPs)—to identify and address any weaknesses and to build upon their strengths. The result is a more cohesive HRPP with systems that protect research participants while advancing research more efficiently and effectively. For more information on accreditation, please visit www.aahrpp.org.



3. How often does your board meet?

Our board meets twice weekly, on Tuesday evenings and Thursday afternoons. Special meetings may also be arranged upon request.



4. How long will it take for my study submission to be reviewed?

This depends on whether your submission qualifies for expedited review, or whether it requires full board review. Expedited review takes approximately 3 to 5 days, while full board review takes approximately 7 to 10 days. If you need something returned sooner than the standard time frame, please contact your Project Lead. Every effort will be made to accommodate you and assist you in meeting specified timelines.



5. What is your submission deadline?

We ask that your completed submission be in our office one week and one day before the scheduled review date. For the Tuesday meeting, we ask that review items be received by Monday of the prior week; for the Thursday meeting, we ask that review items be received Wednesday of the prior week.. In the event you are delayed, please contact your Project Lead, who may be able to assist you with meeting your submission deadline.

If the submission date falls on a holiday, your submission will be accepted the following business day.



6. Does Aspire offer deadline flexibility?

Aspire IRB is able to be extremely flexible with the placement of meeting items and the distribution of approval documentation. In addition, we feel communication is key, so keeping us informed of your timelines and delays allows us to assist you in meeting your deadlines.



7. Can Aspire provide pre-review of a "Draft Protocol?"

Aspire does offer pre-review or review of a draft protocol. We also provide comments and suggestions.



8. What documents are required for a new study submission? (For more submission information, click here)

The following items must be received to complete a full IRB review of a study:

  • Initial Study Application or Initial Device Study Application
  • Protocol
  • Investigator's Brochure(s), Package Insert (if applicable), Device Description
  • Informed Consent Document(s) (E-mailed or sent on a diskette)
  • Form FDA 1572 (or 1572 Equivalent, provided by Aspire IRB, if applicable)
  • Curriculum Vitae for PI (signed and dated within 2 years)
  • Current Medical License for PI only (if applicable)
  • Site Information Form (one per site required every two years)
  • Additional information may be requested on a case by case basis



9.What documents does a site (PI on a multicenter) need to submit? (For more submission information, click here)

  • Form FDA 1572 (or 1572 Equivalent, provided by Aspire IRB, if applicable)
  • Curriculum Vitae for PI (signed and dated within 2 years)
  • Current Medical License for PI only (if applicable)
  • Site Information Form (one per site required every two years)
  • Additional information may be requested on a case by case basis



10. Do you need the original copies (of applications, signature pages, etc.)?

Photocopies of original documentation are acceptable as long as they are typed and legible.



11. Is there a form for address changes, advertisement submissions or amendments?

There is no specific form required to submit changes or amendments. Simply mail, fax or email your request to your Project Lead or send your request to submissions@aspire-irb.com

Please be sure to include the protocol number and name of the Principal Investigator.



12. How long will it take for my advertisement/recruitment materials to be reviewed?

Most advertisements and subject recruitment materials qualify for expedited review. The standard review period for expedited review is 3 to 5 days. Simple print ads or single page subject recruitment materials are often returned within 24 to 48 hours. If you need something immediately, please contact your Project Lead. Every effort will be made to accommodate you.



13. Am I required to submit a template Informed Consent document, or can Aspire generate one upon request?

Aspire can write your Informed Consent document for you upon request.



14. Does Aspire IRB review HIPAA language?

Aspire IRB does review HIPAA language upon request to ensure that all required points are included in the document.



15. How do I know if I'm a covered entity?

Aspire IRB cannot assist you with your determination of whether or not you are a covered entity. This is a decision that must be made by each individual site. The Office for Civil Rights enforces the HIPAA Privacy Rule, which protects the privacy of individually identifiable health information, and is therefore not under the purview of the IRB.



16. Will I have a main point of contact for the duration of my study?

Yes. You will be assigned a Project Lead who will remain with you throughout the duration of the study. Your Project Lead is available to assist you with any questions and will help you meet submission deadlines.

If you are not sure who your Project Lead is, please call (619) 469-0108 or send a request to
submissions@aspire-irb.com.



17. Does Aspire IRB conduct a pre-study teleconference for multicenter studies?

Yes. A pre-study teleconference is recommended for all multicenter studies to determine the preferences of the sponsor and/or CRO. We welcome regularly scheduled teleconferences through the duration of the trial to ensure that we continue to meet your expectations.



18. Does Aspire have a web portal for posting approval documents?

Aspire provides a custom web portal, ASAP (Aspire's Simple Automated Portal), where approval documents are posted and may be retrieved at any time, 24 hours a day, by the sponsor and/or CRO.



19. Can Aspire help clients with their translation services, or can I submit translated items to you for approval?

Yes. If a translation of the ICF is requested, Aspire IRB will provide that service for the cost of the translator, plus a processing fee. If you choose to submit your documents already translated, Aspire will only accept documents translated by a certified translator. There will be an administrative review charge for the approval of submitted ICFs that have been translated into a foreign language by a certified translator. A cover letter verifying the translation, which includes a copy of the name and certification of the translator, is required.



20. Are annual IRB reviews required on all studies?

Aspire IRB performs continuing review of previously approved research at intervals appropriate to the degree of risk and the vulnerability of the study subject population, but not less than once per year. Not less than once per year means that the research must be reviewed before the expiration date.



21. How do I know when my study is due for renewal?

The study expiration date is located on the Study Approval Notification and on the Continuing Approval Notification for subsequent approvals. Aspire IRB sends out a Research Status Report Form approximately 60 days prior to expiration of study approval.

Continuing review is the responsibility of the Principal Investigator. The Research Status Report Form must be received by the IRB office by the designated due date in order for the IRB to have sufficient time to perform its review prior to the expiration date.



22. I am going to have a few sites in Canada. Does Aspire offer review and oversight of Canadian sites?

Aspire IRB has a Research Ethics Board for review and approval of Canadian research sites.



23. Can Aspire review studies for a study taking place in a hospital?

Yes. Aspire IRB must have a written agreement that describes the respective responsibilities of Aspire IRB and any institution that chooses to engage in cooperative review or waive/defer oversight of its research studies. The purpose is to avoid duplication of research review. This policy is in accordance with the FDA and Department of Health and Human Services (DHHS) regulations.



24. Is Aspire IRB registered with FDA and OHRP? Do you have a Federal Wide Assurance number?

Aspire IRB is registered with the FDA. Aspire is also registered with OHRP (IORG#0003876 and IRB00004587). Since we are not a facility that performs research, we do not have an FWA number.



25. Has Aspire been audited by the FDA?

Yes, Aspire has been audited by the FDA. If you would like a copy of the FDA Audit report, please call or send a request to email@aspire-irb.com.



26. How can I obtain a copy the Aspire IRB Board Roster?

A current IRB membership roster is sent out with all new study approval notifications, and upon request. If you would like a copy of our board roster, please call the Aspire IRB office at (619) 469-0108 or send a request to email@aspire-irb.com.



27. How may I obtain a copy of your Fee Schedule?

Our Fee Schedule is available upon request. You may call the Aspire IRB office at (619) 469-0108 or send a request to John Bancroft at john@aspire-irb.com.