What is IntegReview IRB?
IntegReview IRB is an independent Institutional Review Board (IRB) whose primary purpose is to review, approve the initiation of and conduct periodic review of, research involving human subjects. The primary purpose of such review is to assure the protection of the rights and welfare of the human subjects.
The ethical principles employed by IntegReview IRB that govern the conduct of human research are those identified in the Belmont Report; respect for persons, beneficence and justice. IntegReview complies with the regulations as defined in the United States Food and Drug Administration (FDA), Code of Federal Regulations (CFR), Title 21, Parts 11, 50, 54, 56, 312 and 812, International Conference on Harmonisation (ICH) Guidelines for Good Clinical Practices, E6, the Department of Health and Human Services (DHHS) regulations as identified in the Code of Federal Regulations (CFR), Title 45, Part 46.
Has IntegReview IRB been audited by a federal agency?
FDA inspections performed at IntegReview IRB on:
- January 26-29, 2004
- July 27-31, 2009
- May 13-15, 2013
How do I get access to IRBManager?
To gain access to IntegReview's web-based document management system, IRBManager, access the login screen from IntegReview’s website HOME page and select the IRBManager icon OR type the direct site address https://integreview.my.irbmanager.com/ into your internet browser; select ‘Click here to register’ & complete the registration process; select ‘Register’ when complete. You will receive an email containing a username and password to login.
To learn more about IRBManager, view the User Manual and tutorials available on IntegReview's website HOME page.
How often does the Board meet?
IntegReview has five boards and there is an IRB meeting every day of the week.
How do I submit a new study or study-related documents?
All study documents must be submitted via our electronic system, IRBManager. Click on the IRBManager link on our website HOME page or click here.
When will my study be reviewed?
IntegReview IRB schedules five (5) meetings per week, all of which have unique deadlines. Please see our submission deadlines page for more information. IRBManager will notify you via email if your submission requires additional information to complete the submission process.
Does IntegReview IRB review research outside of the U.S.?
IntegReview IRB also reviews research sites located in Latin America and Japan when the research is regulated by the FDA.
Additionally, IntegReview IRB will be collaborating with Veritas IRB to provide oversight for Canadian sites involved in multi-investigator trials submitted to IntegReview. When requested by a sponsor, IntegReview IRB and Veritas IRB will collaborate on protocol-level review processes. Veritas IRB will rely on IntegReview for the scientific review of the protocol and then conduct a facilitated review in order to address issues specific to Canada. Canadian Investigators/sites will be submitted directly to Veritas IRB for review and oversight. Each IRB will be individually responsible for investigative sites under their jurisdiction.
What is the submission deadline for a new study?
IntegReview schedules five (5) weekly IRB meetings - (1) every day of the 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. They are reviewed using an expedited review procedure.
How do I submit revised documents or an additional Investigator to a previously approved study?
Log-in to IRBManager on our homepage or click here to submit your request online.
What is the review and approval process after I submit my study?
Your study will be assigned to one of the five (5) 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/additional Principal Investigator(s), 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 IRBs 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?
Log-in to IRBManager on our homepage or click here. All study documents are distributed via our online system.
How do I submit a request for changes to previously approved study documents?
Log-in to IRBManager on our homepage or click here.
How much do you charge to review research studies?
Our fee schedule can be made available to you by contacting our Business Development Department. You may obtain their contact information on the Request a Fee Schedule 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 IRB requires notification.
Log-in to IRBManager on our homepage or click here. Complete the Closure Notification form online.
When do I notify IntegReview when the PI or research personnel deviate from or violate the protocol?
As indicated in IntegReview IRB's approval letter, significant protocol deviations are to be reported within 10 days of discovery. IntegReview IRB 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.
Log-in to IRBManager on our homepage or click here. Complete the Significant Protocol Deviations form online.
Is IntegReview IRB registered with the FDA and/or OHRP?
IntegReview IRB 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 IRB’s five (5) IRBs are IRB00001035, IRB00003657, IRB00004920, IRB00006075 and IRB00008463, respectively. These registered boards are all under IntegReview’s IRB Organization (IORG) number IORG0000689.
Should you have other questions regarding IntegReview IRB - please call us at 512-326-3001 or send us an email at firstname.lastname@example.org.