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.
Yes. Aspire IRB received Full AAHRPP accreditation in December 2008.
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.
Our board meets twice weekly, on Tuesday evenings and Thursday afternoons. Special meetings may also be arranged upon request.
This depends on whether your submission qualifies for expedited review, or whether it requires full board review. Expedited review takes approximately 1 to 2 business days, while full board review takes approximately 6 to 8 business days (this turnaround is generally quicker for amendments and other changes to previously approved research). 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.
For the initial review of your research, we ask that your completed submission be in our office five days prior to the scheduled review date. For Tuesday meetings, all study materials must be received by our office by Wednesday at 12 noon the week prior to the meeting date to be placed on the Tuesday agenda. For Thursday meetings, all study materials must be received by our office by Friday at 12 noon the week prior to the meeting date to be placed on the Thursday agenda.
For changes to previously approved research and continuing review, we ask that your completed submission be in our office 3-4 business days before the scheduled review date. For the Tuesday meeting, we ask that review items be received by Thursday at 2pm Pacific of the prior week; for the Thursday meeting, we ask that review items be received Monday at 9am of that same 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.
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.
Aspire does offer pre-review or review of a draft protocol. We also provide comments and suggestions.
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)
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
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
Photocopies of original documentation are acceptable as long as they are typed and legible.
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.
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.
Aspire can write your Informed Consent document for you upon request.
Aspire IRB does review HIPAA language upon request to ensure that all required points are included in the document.
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.
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.
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.
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, CRO, institution, or site.
Yes, ASAP Forms Submission tool allows you to fill-out all study forms on line, and electronically sign them in compliance with 21 CFR part 11. You can upload other study documents on ASAP too.
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.
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.
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.
Aspire IRB has a Research Ethics Board for review and approval of Canadian research sites.
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.
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.
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.
A current IRB membership roster is sent out with all new study approval notifications, and upon request. Current and past rosters are available in ASAP in the Library section, or call the Aspire IRB office at (619) 469-0108 or send a request to email@aspire-irb.com.
“Our Fee Schedule is available upon request. You may call the Aspire IRB office at (619) 469-0108 or send a request to Yvonne Young at Yvonne@aspire-irb.com.
Aspire IRB extends our heartfelt support to those impacted by hurricanes Harvey and Irma. We are concerned for all individuals affected by these disasters and hope that all are safe and well. Disasters such as these impose additional challenges to clinical research sites and, specifically, the protection of human subjects.
We have reached out to all clinical research sites, and their sponsors, who have open studies with Aspire. We are sensitive to the fact that research sites may not be in a position to respond to our inquiries, as they may have more basic human needs to address in the aftermath of these disasters. However, as soon as feasibly possible, we are requesting that affected sites please contact us with information on their current status.
Additionally, we are monitoring our social media accounts for communication from those who still have access to social media, but not e-mail. We are available on Twitter (@WCGClinical) and LinkedIn (WIRB-Copernicus Group). You can direct message us on either platform to receive assistance related to the conduct of research and human subject protection during severe disasters.
