Stony Brook University Office of Research Services
Human Research Protection Program - July 2009 Update

I. Registration is now open for our OHRP Research Forum Conference

For program information, agenda, and registration form, click 'OHRP Research Community Forum 2009' on the left side of the web page here: http://web.cuny.edu/research/human-subjects-research/Events.html

This conference is being co-sponsored by SBU, OHRP, CUNY and Columbia University. We hope you will be able to attend this exciting event!

Please note that on September 11th, the day of the conference, the Office of Research Compliance will be closed, as all ORC staff will be assisting and/or presenting at the meeting. Our 2-9036 voicemail on that day will provide instructions for the handling of urgent matters.

II. Effective August 1, 2009: Revised Application Requirement for new CORIHS Expedited or Full Review Submissions    

We are almost ready to go-live with our new Registration Form and our Application for Expedited or Full CORIHS Review processes.  The old application will be swapped out for these new forms and will be required for all submissions received effective August 1, 2009.

To remind you, here’s what we are talking about:

  • Registration Form for Expedited or Full CORIHS Review: This is a short ‘smart’ or ‘wizard’ form that quickly captures critical, searchable data pertaining to your study. To access this document:
    • Go to your project designer
    • Select ‘Add New Document’
    • In the lower shaded box, select ‘Registration Form for Expedited or  Full Committee Review’, then hit the ‘Add’ button
    • Begin completing the Registration Form. You do not need to complete the whole form in one sitting; you can always go back and update the document by clicking the pencil icon next to the document listed in the designer.
  • Application for Expedited or Full CORIHS Review: This is a downloadable form (as the current application is right now) that will capture more detail about the answers you provided in the Registration Form.  This second form will evolve over time, to facilitate its use, and to ensure compliance with our upcoming accreditation requirements.

In addition to these 2 required documents, the following ‘supplemental’ forms will also be required, as applicable i.e., if your study involves Questionably viable, or nonviable neonates International Research, or Prisoners

III. Effective August 1, 2009: Submission requirement for all studies currently approved in IRBNet  

Now that you’ve read section II above, you may be wondering about all the studies that are already living in IRBNet. How will that ‘registration’ information get captured for them? Well, since it is important that we obtain this data for ALL studies you will need to complete and upload the Registration Form for Expedited and Full CORIHS Review at the time of continuing review for the study.

IV. New amendment cover sheet now available

Following a collaborative and productive effort between IRB members and study coordinators across campus, we are happy to introduce the new SBU CORIHS Amendment Cover Sheet, available now in the Forms and Reference Library of IRBNet. Please be sure to complete and upload this cover sheet with every amendment/modification package you submit for your studies. The cover sheet also provides a checklist of what you need to submit in order to help ensure a complete package for review. We are confident that these additions to our program will help facilitate the preparation and subsequent review of these submissions.   

V. New Checklists now available to ensure you are submitting complete new and continuing review submissions

In our ongoing efforts to help you maintain compliance with the innumerable rules and regulations to which you are subject as a researcher, we have developed 2 checklists, one for new exempt, expedited or full review submissions, and one for continuing review submissions (‘regular’ and five year). These are available in the IRBNet Forms and Reference Library, and may be viewed here as well:

VI. Accreditation application-ready Standard Operating Procedures are nearly complete

We have been working very hard to finalize our application requirements for accreditation through the Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP). Many of the updates provided above are a direct result of the incorporation of AAHRPP best practices into our program. We are confident that this process will result in a program that helps facilitate research while maximizing human subject protections. Thank you for your patience as we work to meet our goals and obtain accreditation.

If you have any questions about any topic in this update, or any other aspect of our Human Research Protection Program, please contact the Office of Research Compliance, at 2-9036.