I'm really busy, can I have my research coordinator or my assistant respond to requests from the IRB on my behalf?
Why was I given less than a 12-month approval?
I received Exempt approval for my study. Do I still need to submit a continuation every year at The University of Texas at Austin?
Okay, so you have my UT EID in your database, does that mean that the database will notify me of my studies expiration date and I don't have to worry about it?
I received a "Cessation Notice." What does this mean?
I received a "Termination Notice." What does this mean?
Is the difference between closure and termination?
The Vice President for Research and the IRB advisory committee recognize that actions of the IRB are subject to scrutiny by the research community. The Institutional Review Board evaluates a wide range of research, and ORS wants researchers to know there is an avenue to address disagreements regarding committee decisions.
Principal investigators wishing to raise concerns with IRB decisions should first clarify their understanding of the recommendations or requirements with the ORS assigned staff member (512-471-8871 or email@example.com). It is also recommended that researchers familiarize themselves with the specific regulation requirements related to the committee concerns. These references can most often be found on the IRB website.
Federal regulations require that the IRB to communicate directly with the Primary Investigator regarding protocol-related issues. Accordingly, all correspondence from (or on behalf of) the Primary Investigator must be submitted to the IRB with the Primary Investigator's signature. The IRB may return any protocol-related correspondence that is received without evidence of the Primary Investigator's approval.
It is mandated by federal regulations that the IRB grant approvals for a period not to exceed 365 days. However, if your protocol is reviewed, and changes have to be made before your granted approval, you will only be granted approval from the day the IRB receives the changes up till 12 months from the initial review. For example, your protocol is reviewed at the November 25th meeting and the IRB finds that changes have to be made to the protocol and consent forms before they will approve your protocol. Your changes are submitted to the IRB on January 16th Your approval time period will be from January 16th, the day your turned in the changes through November 25th, one year from the day of the initial review.
No. A continuing review must be submitted in three years after initial determination expires. Failure to submit a continuation in a timely manner will result in your study being in "cessation." The study will be kept in cessation status for 30 days after which it will be "inactive."
No. The database, like any other software, may have glitches that our programmer doesn't yet know about. While the database is programmed to notify the investigator of the expiration of their study, it is still the investigator's responsibility to submit a continuing review before the study expires and in time to meet the agenda deadline (if it's Full Board).
A "Cessation Notice" is sent out to the Primary Investigator when their study has expired and the investigator has failed to submit a continuation. During the period of cessation, the investigator is prohibited from collecting further data and from recruiting more participants. The investigator should submit a continuing review application as soon as possible.
An "Inactive Notice" means that your study has lapsed its expiration date by 30 days and the IRB has now terminated it. Further research is prohibited. You will need to resubmit a new protocol for review. You may also have received a "Inactive Notice" even if you submitted a closure after receiving your "Cessation Notice." You cannot close a study once it has been suspended.
A study is terminated when it has lapsed its expiration date by 30 days. This is an automatic action taken by the IRB. A closure is an action taken by the PI to end the study. The closure can be submitted at any point prior to the suspension of the study. Once a study is suspended it cannot be closed.