All Studes Must Transition to PittPRO by July 30, 2020

The Human Research Protection Office (HRPO) would like to thank the study teams who have transitioned their projects from OSIRIS into PittPRO. It is critically important that all remaining studies (including those in paper) be submitted for transition no later than July 30, 2020.

The only exception at this time are single IRB review studies (those with EXT prefixes or where Pitt is the IRB of Record for multiple sites). Those will transition at a later date and study teams will be notified.

There are two reasons for this move: 1) OSIRIS is an old system and can no longer be updated; and 2) PittPRO will be integrated with other University electronic platforms in the near future. This will aid in the submission of grants, contracts, and material or data use agreements.  

To assist the research community, HRPO has developed a series of FAQs:

What if I don't transition before the deadline?   HRPO will not process any submissions for modifications of your existing protocols in OSIRIS or PittPRO and will not process any new submissions until all of your approved studies are transitioned from OSIRIS to PittPRO.

My study doesn't expire until after the July 30th deadline. Do I have to transition now or can I wait until closer to the expiration date?  Regardless of the expiration date you were given, submission for transition by the deadline is required.

My study doesn't have an expiration date. Do I have to transition?  Yes. For studies without expiration dates, you should have already been contacted about the need for transition. Even though you don't have an expiration date, this is considered a continuing review (renewal) so completion of a continuing review form in PittPRO will be required.  Follow the instructions at PittPRO Transition of Studies: Released from Continuing Review

My study is in paper. Do I have transition it into PittPRO? Yes. We can no longer support paper applications. Please terminate inactive paper studies or transition any active studies into PittPRO.

My study is exempt. Do I have to transition it into PittPRO?  All exempt studies in OSIRIS were moved to an archived state in May 2020.  They do not need to be transitioned into PittPRO.  If an investigator needs to make a change to an archived exemption, a new submission would need to be opened in PittPRO.

My study is in data analysis only. Do I have to transition? Studies that are in data analysis have to transition only if identifiable data is being utilized during this phase of the project. If a de-identified dataset can used for this purpose, a final report can be submitted in lieu of transitioning. Note that under the Revised Common Rule, data and specimens can be maintained without an active IRB approval even if identifiable. If there is another project where the data and/or specimens will be utilized, a separate IRB application would be required.

Are there specific instructions for transitioning studies where there is no further interaction with subjects (data analysis only, long term follow-up)?  Yes. Follow the instructions at Transition of Studies in Data Analysis Only and Long-Term Follow-Up into PittPRO.  There is an abbreviated process for these studies since many of the PittPRO questions do not apply to studies in these states. 

Is there a document that can help in determining where to put information from OSIRIS into PittPRO since the application is different? Yes. There is a document in the PittPRO Help Center which maps the questions from OSIRIS to PittPRO. It is called Tip Sheet for OSIRIS Conversions and is available in the HRPO A-Z Guidance.

Who can I contact if I have questions? Please send all questions to askirb@pitt.edu

6/18/2020

 

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Modifications and new studies will not be processed for those investigators not transitioning