FAQ's



What makes IRBco different from other independent/ central IRBs?

Our distinguished and expert board is what really sets us apart from other commercial IRBs. IRBco has been in operation since 1981, providing the highest quality of ethical reviews with solid integrity and superior customer service so you can advance your research with utmost peace of mind and ethical assurance.

At IRBco, our review board is comprised of members from various academic, industry and other backgrounds with clinical and non-clinical knowledge and a vast experience of ethical reviews and regulations.

Is IRBco AAHRPP Accredited?

Yes. IRB Company has been fully accredited by AAHRPP since 2010 and recently received renewal of accreditation in 2013 for another 5 years.

Has IRBco ever been audited by the FDA, OHRP, or any other government agency?

Yes, IRBco has been audited by the FDA, most recently in 2010. There were no significant findings in any of the audits and no FDA 483s were issued. Please contact us directly if you would like to review a copy of the Audit report.

How often does the IRBco board meet?

IRBco conducts scheduled Full-board meetings twice a week and can meet additionally as needed. Expedited reviews are conducted daily.

How do I obtain the IRBco board roster?

Please contact us directly to obtain the current IRBco board roster.

What type of review experience does IRBco board have?

Our expert board at IRBco has an extensive experience with all phases of clinical research including Phase I-IV IND studies, IDE studies, socio-behavioral studies, chart reviews, investigator initiated studies, etc.

Our board has experience reviewing numerous specialty areas in clinical research such as CNS, Oncology, Dermatology, Ophthalmology, Plastic surgery, OBGYN, Cardiology, Internal Medicine and rare diseases among others.

Does IRBco review studies conducted at Universities/ Institutions/ Hospitals?

Yes. IRBco will collaborate your institutional/hospital IRB to conduct reviews in accordance with the FDA and DHHS regulations.

What is the review timeline for submission of a new protocol?

After the complete submission is obtained, the review is generally conducted within a week. The board determination is provided to investigators within 1 day of the meeting.

Full board meetings are conducted twice a week and expedited reviews are performed daily (all business days). If you have a strict timeline, our team at IRBco will gladly work with you to try and accommodate your needs. Please contact our staff directly to help determine whether your research study falls under Full board, Expedited or Exempt category.

What is the review timeline for recruitment material and advertisements?

Most recruitment material and advertisements qualify for expedited review. At IRBco, expedited reviews are conducted daily (all business days).

Does IRBco have electronic submission and how do I access/ track the pertinent documents?

Yes. IRBco has a 100% state-of-the-art secure web-based submission system. Our robust electronic system provides 24/7 tracking and access to all the study documents for better integration between Sites, CROs, Sponsors and study staff.

What documents are needed for initial submissions?

At IRBco, we utilize a 100% web based submission portal for 24/7 tracking and access to documents. Please visit our online portal or contact us directly for specific requirements.

We generally require following documents for initial review:
  • Completed IRBco Electronic Application
  • Final Protocol
  • Informed Consent Forms
  • Investigator Brochure or Package Insert (for all drugs/ devices involved with the study)
  • CV (and current Medical License, if applicable) of Principal Investigator
  • FDA Form 1572/ Financial disclosure, if applicable
  • Site Questionnaires
  • Recruitment Materials (such as flyers, advertisement scripts etc.)

What documents are needed by sites/ Principal Investigators for a Multicenter study?

At IRBco, we utilize a 100% web based submission portal for 24/7 tracking and access to documents. Please visit our online portal or contact us directly for specific requirements.

We generally require following documents for initial review:
  • CV (and current Medical License, if applicable) of Principal Investigator
  • FDA Form 1572/ Financial disclosure, if applicable
  • Site Questionnaires
  • Recruitment Materials (such as flyers, advertisement scripts etc.)

How do I submit Recruitment materials/ advertisement information for review?

IRBco accepts electronic submission of all Subject Recruitment materials including flyers, audio/ video files, telephone scripts and other type of advertisement information (all of which may be easily uploaded online).

How do I report safety information (protocol deviations, adverse events, unanticipated events etc.) to IRBco?

IRBco requires prompt reporting of all major protocol deviations/violations and serious adverse events and unanticipated events. Please use IRBco forms available on our electronic system for submission of these repots. For details or to obtain reporting forms, please contact us directly.

What are the fees associated with IRB review?

IRBco provides competitive pricing and we are happy to work with your budget. Please contact us directly for a detailed and customized fee schedule.

How are investigators, CROs, and Sponsors informed of approvals or requests by the IRB?

Approvals, IRB determinations or any information requests are submitted directly to investigators within 1 day of the board meeting.

Is IRBco registered with the Office of Human Research Protections and FDA?

Yes. IRBco’s registration number is 00006177.

Will I get a single point of contact?

Yes. You will be assigned a dedicated study coordinator to help you every step of the way. The single point of contact helps maintain solid and open communication, while ensuring rapid resolutions to your questions.

What are the other services provided by IRBco?

In addition to IRB services, we also provide Research consultation, Training and DSMB services in USA and India.

Does IRBco provide consultation for protocol and informed consent development for my planned research project?

Yes, IRBco provides comprehensive and expert consultation services including protocol and informed consent development. We can provide templates and protocol building software so you can generate your study/ investigation documents promptly and accurately. Please contact us for more information.
 
 

Awards

IRBco is awarded Full Accreditation by the Association for the Accreditation of Human Research Protection Programs Inc. (AAHRPP). Accreditation validates our comprehensive program which integrates ethical reviews, state-of-the-art technology and staff development to create an environment of responsible and ethical human subject protection. We provide our services at levels beyond client expectations and that exceed federal requirements for safeguarding participants. We believe that accreditation leads to an increased level of professional accountability.

 
 
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