UB-IRBs are Reorganizing: New Training and Submission Requirements

To better support and improve the UB human research program, key changes are being made that include the following:  

I.         The four (4) UB Institutional Review Boards (IRBs) are in the process of being reorganized into one UB IRB that meets on a weekly basis. This new IRB structure will create more efficiency and enable faster approval times.

II.         UB is looking to acquire a new integrated compliance software program which includes an IRB module. In preparation for that change, the UB IRBs are now requiring use of an “HRPP Toolkit” which is the “paper” version of the IRB electronic module. An Introduction to the HRPP Toolkit is provided with Good Research Practice (GRP) Training (see “C” below for information about GCP training). The Toolkit provides the following:

• High-level policy regarding the conduct of human research at the University at Buffalo
• Description of the responsibilities of the components of the HRPP, including investigators, research staff, the IRB, and the Institutional Official.
• Investigator manual
• IRB application forms (Initial, Continuing Review, Modification and Reportable New Information forms)
• Protocol and Consent document templates
• SOP for the consent process and documentation

The FULL HRPP/IRB Toolkit can be found on the UB-IRB website.

III.         To ensure compliance with human research regulations and guidance and to better foster successful relationships with research sponsors and granting agencies, the UB HRPP is now requiring Good Research Practice (GRP) training as a supplement to CITI training. The following information is taken from the GRP Training Information Sheet which provides information about the new GRP Training Requirement:

1. Who is required to complete this training?

As of 3/31/2015 ALL researchers and ALL research staff who work on studies approved by the UB IRB will be required to complete study-appropriate GRP training and CITI training before the IRB will grant new or continuing approvals. Current researchers have until then to complete the GRP training ahead of the deadline.

1. What are the course options?

Important: You MUST be present for the entire session to receive completion credit. 

Attendance will be taken.

a.    GRP Part I and Part II = PREFERRED FOR EVERYONE. Completion of GRP Part I and Part II will fulfill the GRP training requirement for ANY researcher. Each part is approximately 2 hours. You may register to complete both parts separately. The sessions may be taken out-of-order.

b.   Alternative GRP Course = the Non-Clinical option.  The Alternative GRP Option consists of ONE 2-hour session. Completion of this Alternative GRP Course will fulfill the GRP training requirement ONLY FOR individuals who are WORKING on studies that DO NOT INCLUDE ANY clinical interventions with participants OR involve any participant’s medical records. Your decision to take this course should be based on whether the study’s procedures involve any clinical procedures NOT on the role you play on the study.

1. When are the courses offered and how do I register?

• A limited number of LIVE GRP training sessions were presented in October 2014. The live sessions were videotaped. When those videotapes are ready, the videotapes for GRP Part I, GRP Part II, and the GRP Alternative Course will be offered at various dates, times, and locations including BGMC, CTRC, ECMC, UB North Campus and UB South Campus. 
• Please check the training registration page periodically to see what is available and
  TO REGISTER for any available sessions.

1. Does GRP training need to be completed in person?

• Yes.  You must be present for the entire session in order to receive completion credit for the course.  Attendance will be taken.
• Exceptions: There are only a handful of exceptions to the requirement to complete the session in person.  If you feel that you qualify for an exception, please have the PI send an email with your name and a justification for why you cannot compete this training in person.  Examples for justifiable exceptions include individuals who live out-of-state or out-of-the country. Please keep in mind that current researchers have until 3/31/2015 to complete this requirement so there will be the opportunity to complete this training in-person at a number of sites, dates, and times over the next few months.

1. Where can I find information about parking at the different training venues?

• Information about parking is provided in the “Confirmation” and “Reminder” Emails you will receive when you register.
• Parking can be challenging - especially on North and South Campus. We suggest that you take advantage of public transportation and/or campus shuttle services whenever possible. 
• For any venue, please be sure to allow enough time to park and walk to the training venue.

1. How often does GRP training need to be completed?

• Completion of GRP training Part I and Part II fulfills the GRP training requirement for 3 years
• Completion of Alternative GRP training fulfills the GRP training requirement for 3 years UNLESS  you start work on a study that involves clinical procedures – in which case, you will be required to also complete GRP Part I and Part II.

1. How can I schedule a GRP training session at my location?

If you would like to arrange for a videotaped presentation for a specific group, we would consider bringing the training to you. The guidelines are that the session must be for 100 or more individuals and the host arranges for the following:

• Securing a venue that can accommodate 100 individuals or more
• Ensuring that the venue has working audio/visual equipment, Internet accessibility, and capability of showing a video
• Notifying the attendees of the session
• Registering the attendees
• Providing registrees with directions to the venue AND with parking information
• Photocopying the handouts for the session
• Emailing with details for the request

Please direct any questions you have about these changes to the Office for Research Compliance.