If anyone is not a student, faculty or staff of UF, Shands or the VA, then we have to determine if they are “affiliated” with any other institution with an FWA (Federal Wide Assurance). If they are, then that institution is potentially engaged in that research, and thus that institution needs to approve the research as well. If a student is an active student at another institution, then that institution would be engaged, if he is not taking classes while involved in a UF research project, then he is considered “unaffiliated.” This is a federal rule, not a local one.
If the individual is a volunteer (ie: someone not a student, faculty or staff of UF, Shands or the VA), and thus not affiliated with us in any way, then the Privacy Office has to approve a volunteers access to PHI (if their role in the research involves access to PHI).
Per the UF policy, provided in the link above, a volunteer may not have access to PHI nor consent subjects.
6/14/2017: Coming Soon! The IRB-01 Local Training [IRB800] has an update coming. The new course can be completed in half the time as the old one. Release expected July 2017.
6/14/2017: Single IRB (sIRB) is now live in myIRB. NIH released a policy mandating the use of a Single Institutional Review Board of Record (sIRB) to conduct the ethical review required by the Department of Health and Human Services regulations for the Protection of Human Subjects (45 CFR 46) for multi-site research involving non-exempt human subjects research funded by the NIH. The effective date of this policy is September 25, 2017.
6/7/2017: The meeting deadlines table posted on our website has now been updated with revised tabled deadlines. Instead of Mondays at 9AM the deadlines have been set to Tuesdays at 5PM starting with the meeting next week.
3/9/2017: In preparation for AAHRPP accreditation, the IRB has recently updated its policies and procedures, and written guidelines to help researchers and board members better understand the various regulatory issues when conducting human research. Visit the IRB website, or this link IRB Policies, Guidelines and Guidances for details.
11/16/2016: Please plan accordingly, myIRB will be down for a system upgrade the weekend of December 2nd. There will be no user access beginning at 5:30pm Friday, December 2nd
10/24/2016: Early Voting: Monday, 10/24 through Saturday, 11/5, 9AM - 6PM, Every day. Early Voting Locations: Supervisor of Elections Office, 515 N. Main St, Gainesville; Millhopper Branch Library, 3145 NW 43rd St., Gainesville; Tower Road Branch Library, 3020 SW 75th St., Gainesville
11/24/2015: The IRB has recently learned that myTraining will not allow you to take the IRB01 Local Training Refresher (IRB802), if your IRB01 Local Training (IRB800) certificate, or latest Refresher, has already expired. Please pay attention to the expiration date of your training if you would like to take advantage of the Refresher course. Otherwise, you will need to repeat the main IRB Local Training course (IRB800) again, in its entirety.
10/15/2015: On Monday, October 19, IRB-02 will start accepting protocols via myIRB for studies involving social and behavioral research that qualify as Exempt. Click here for a link to the detailed announcement and instructions.
9/18/2015: Coming Soon!myIRB is getting ready to accept electronic submissions for IRB-02 (Campus/Behavioral) and IRB-03 (Jacksonville). We look forward to welcoming them to our myIRB community.
9/17/2015: myIRB is now accepting paper studies for conversion from paper to electronic for IRB-01. Contact the office for details.
3/6/2015: myIRB will be accepting paper studies for conversion from paper to electronic. Stay tuned to your regular IRB-01 news sources for upcoming details.
2/20/2015: IRB01 Local Training Video Refresher [IRB802] course is now available at myTraining. Local IRB01 training is required every 3 years. Visit the IRB-01 Training website for complete details.
11/14/2014: The means of payment/reimbursement for research participants changed in July 2014. If you have questions about paying or reimbursing participants, contact the HSP program by email, Treasury-HSP@admin.ufl.edu, or by phone at (352) 392-9057.
10/19/2014: myIRB has been upgraded to Click version 6.0.5. This version includes new features to make the site easier to use. Improvements are included for searching and filtering project in your Inbox, and for View Differences, among others.
5/9/2014: Early registrants will now be required to provide additional registration information when they Agree To Participate. If you were an early registrant in myIRB, you were not required to provide certain contact information, credentials and department affiliation data that has been required from more recent registrants. In order to assist IRB Reviewers to assess role and function assignments for research, study team members may need to complete and/or update the additional items on the Agree To Participate activity form. Also, please review the credentials you have already provided in the Degree/Title box. If this is not complete or up to date, you can refresh that data as well.
12/10/2013: Starting January 1st, 2014 all new studies must be submitted to IRB-01 through our myIRB system. We are hosting another session on submitting a new study in myIRB on Wednesday January 15th from 2 PM to 3:30 PM in our conference room at Broad 104. Seating is limited, please RSVP to email@example.com.
10/1/2013: myIRB is now accepting Full Board and Banking studies. The earliest meeting available for these submissions is 11/20/2013. Refer to the October 1, 2013 IRB-01 email announcement for details.
7/11/2013: The Office of Research has established qualifications for Principal Investigators conducting human subjects research. This announcement comes from the Vice President for Research, Dr. David Norton:
Working with the three UF IRB’s (IRB-01, 02, 03), faculty stakeholders, and research deans in affected colleges, the Office of Research has developed guidelines to better define the qualifications needed to be a Principal Investigator (PI) of a human subjects research project. The new guidelines are posted on the UF IRB website and specifically address the role that students can play in overseeing human subject research. The University must ensure that PIs are suitably qualified and accountable for all aspects of research projects, and that other investigators are qualified to fulfill the requested role. The IRBs designate as Principal Investigator the person who either conducts and\or oversees the entire protocol. The PI is also the person held accountable by the University and IRBs to insure all human subjects’ regulations and any financial issues are addressed. A PI often delegates some of the research activities to students, study coordinators or others, the P.I. remains accountable for the protocol. These guidelines were updated to be consistent with peer institutions.
11/29/2012: Effective January 07, 2013 mandatory training goes into effect for research conducted at IRB-01. For more information, please visit: http://irb.ufl.edu/irb01/irb-01/trainreq.html IMPORTANT NOTE: The new IRB-01 local video training, CITI training, and HIPAA for Research training must be completed via myUFL. In October 2012 myUFL underwent an upgrade that enables everyone to complete training in the system. As a result, since October 2012 students, Shands employees, VA only employees, and Unaffiliated Investigators may also complete training via myUFL. However, in order to do so they need to have a role added to their profile in PeopleSoft. UF administrators (not the IRB) designated the role of non-faculty/staff as "Person of Interest" (POI).
Students should contact the HR Administrator in their college/department to provide them with the "Person of Interest" role.
Shands employees, VA employees, and unaffiliated investigators should contact the Office of Research HR Administrator, Dorothy Long, at 352−392−9330 and request to be registered as a "Person of Interest".
11/8/2012: Supervisor signoff on new research is no longer required by IRB-01 as of November 15, 2012. myIRB will no longer go through Department Review. When a PI clicks submit the study will automatically be forwarded to the IRB office for processing. We will have a follow up announcement describing some new tools that Departments can use to track PI submissions as well as alternative ways to review studies in myIRB. NOTE: Projects submitted before November 15 still require Department Review.
8/28/2012: As of September 3, 2012, all new “Expedited” protocols will need to be submitted via the electronic myIRB system. At this same time, we will be doing our final training of the IRB-01 Executive reviewers (ie: the Vice Chairs). If we find that the submissions are coming in at too fast a clip, we might temporarily turn off new “Expedited” submissions and ask PIs to revert back to paper for a short time as to not get too far behind. Hopefully this won’t happen, but we will send an announcement if we decide it is necessary. An announcement of Full Board protocols will be forthcoming.
7/6/2012: Effective August 1st, 2012 all new Exempt and Nonhuman studies must be submitted to IRB-01 via myIRB. After that date IRB-01 will no longer accept paper versions of these types of protocols.
5/1/2012: Principal Investigators and research staff from all departments are encouraged to pre-register for myIRB so their credentials can be verified in advance. All researchers must have completed PRV801: HIPAA & Privacy for Researcher training prior to participating in research on myIRB.
4/1/2012: myIRB is currently accepting only Pilot projects for submission. Research projects accepted for piloting will be identified by the IRB staff, in gradually increasing levels of complexity until the Pilot phase is complete. Eligible units will be notified. myIRB accepted its first pilot project on April 9, 2012.
3/1/2012:myIRB was launched into its production environment for the first time.