Has IntegReview been audited by the FDA?
How often does the Board meet?
How do I get copies of your current forms?
When will my study be reviewed?
Does IntegReview review research conducted in Canada?
What is the submission deadline for a new study?
How do I submit a new study or additional Principal Investigator to a previously approved study?
What is the review and approval process after I submit my study?
How will I receive my study documents?
How do I submit a request for changes to previously approved study documents?
What is the charge to review a study, additional Principal Investigator, protocol amendment, etc.?
How do I submit a request for a private conference on the Internet Web Board?
When do I notify IntegReview when a study has been completed?
When do I notify IntegReview when the PI or research personnel deviate from or violate the protocol?
Is IntegReview registered with the FDA and/or OHRP?
What is IntegReview?
Established in January 1999, IntegReview Ethical Review Board is an independent IRB located in Austin, Texas. IntegReview staff and Board members exceeds 100 years of IRB and research experience. The composition of the Board and/or consultants represents a variety of expertise including:
| cardiology | infectious disease | oncology |
| dermatology | rheumatology | ophthalmology |
| endocrinology | musculoskeletal | oral surgery |
| toxicology | pulmonary | psychology |
| hematology | nutrition | pharmacology/neuropharmacology |
| neurology | radiolabeled compounds | central nervous system |
| allergy/asthma | immunology | inflammatory/autoimmune |
| antimicrobial | pediatrics |
Has IntegReview been audited by the FDA?
FDA inspections performed at IntegReview include:
- January 26-29, 2004
- July 27-31, 2009
How often does the Board meet?
IntegReview has six Boards that meet weekly.
How do I get copies of your current forms?
All of our forms can be downloaded from the Forms page of our Website.
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When will my study be reviewed?
IntegReview schedules six (6) meetings per week, all of which have unique deadlines. Please see our submission deadlines page for more information.
IMPORTANT: Only complete submissions will be reviewed, please be sure that all questions are answered and all required attachments are submitted.
Does IntegReview review research conducted in Canada?
IntegReview has established a Canadian Research Ethics Board (REB) to review research conducted in Canada. Please see our Canadian REB page for more information.
What is the submission deadline for a new study?
IntegReview schedules six (6) meetings per week, all of which have unique deadlines. Please see our submission deadlines page for more information.
What is the submission deadline for an additional Principal Investigator to a previously approved study?
There are no submission deadlines for submissions of additional investigators being added to a currently approved study or additional investigators scheduled for continuing review.
How do I submit a new study or additional Principal Investigator to a previously approved study?
In order to adequately review the conditions surrounding the research, a New Study Submission form is required, which is available on the FORMS page of our Website. We do not require hard copies, therefore we prefer that all submissions be e-mailed to our Quality Assurance Department at submissions@integreview.com , or they may be sent by another delivery method. Documents sent by U.S. Postal Service or other delivery service should not be stapled.
What is the review and approval process after I submit my study?
Your study will be assigned to one of the six Boards for review at the next convened meeting. Following Board review the study and study documents will be processed and distributed within 2 business days of board review. A complete process flowchart for new studies, as well as additional Principal Investigators is available on the PROCESSES page of our Website.
What is the turnaround time for new studies and additional Principal Investigators to a previously approved study?
IntegReview’s proven track record of turning around new study documents within 2 business days of Board review is uniquely efficient. For additional investigators, board action is distributed to the Investigator within 2 business days following completed submission.
How will I receive my study documents?
IntegReview attempts to use the Internet as much as possible when distributing study documents, as it is quick and convenient. If you have access to the Internet, and your or the Sponsor’s SOP’s permit, we will either e-mail study documents to you or set up a private password-protected conference on our Internet Web Board where study documents can be posted for you to download and print. You will indicate your preferred distribution method on the New Study Submission form.
How do I submit a request for a private conference on the Internet Web Board?
To request a private conference on our Internet Web Board, download the Request for Web Board Conference form. Once you have completed the form, you may fax it to 512-697-0085 or e-mail the form to Victoria Govea, Operations Manager at vgovea@integreview.com. Once we set up your private conference we will send you instructions via e-mail on how to access/use the site. To learn more about the Web Board CLICK HERE.
How do I submit a request for changes to previously approved study documents?
In an effort to simplify the process as well as conserve your time, IntegReview has developed several forms for each type of submission. These forms are available on the FORMS page of our Website
What is the charge to review a study, additional Principal Investigator, protocol amendment, etc.?
Our fee schedule is available on the SERVICES & FEES page of our website.
When do I notify IntegReview when a study has been completed?
One of the procedural requirements found in Title 21 CFR 56.108(a)(3) requires ensuring “prompt reporting to the IRB of changes in a research activity.” Therefore, upon completion of the study IntegReview requires notification. Please utilize IntegReview’s Closure Notification form available on the FORMS page of our Website.
When do I notify IntegReview when the PI or research personnel deviate from or violate the protocol?
As indicated in IntegReview’s approval letter, significant protocol deviations are to be reported within 10 days of discovery. IntegReview does not consider protocol deviations to be different from protocol violations. Significant protocol deviations are those that deviate from the approved protocol and affect or can potentially affect the safety of subjects. Please utilize IntegReview’s Significant Protocol Deviation Report form available on the FORMS page of our Website.
Is IntegReview registered with the FDA and/or OHRP?
IntegReview is in compliance with current IRB registration requirements as it is registered with the Office for Human Research Protections (OHRP). Registration numbers assigned by OHRP to IntegReview’s five (5) boards are IRB00001035, IRB00003657, IRB00004920, IRB00006075 and IRB00008463, respectively. These registered boards are all under IntegReview’s IRB Organization (IORG) number IORG0000689. More information is available on the FDA/OHRP IRB Registration page
Should you have other questions or concerns regarding the IntegReview FAQs, please call us at 512-326-3001 or send us an email at integreview@integreview.com.