1. New Oversight Area: Stem Cell Research
Prior to commencing with research using human embryonic stem cells/cell lines or other pluripotent stem cells/cell lines regardless of source (not limited to embryos, adult tissues, amniotic fluid or fetal tissue), Stony Brook University investigators must now have their research protocols approved by SBU's new Stem Cell Research Oversight Committee (SCRO).
As we work to finalize details concerning specific policies and procedures, which will quickly evolve as a result of President Obama's recent executive order expanding research opportunities in this area, we request that the SCRO application be completed to cover the activities described above that you are, or will be, conducting. An educational module is under development to satisfy the requirement for training, so just leave that question on the application blank at this time.
At some point we will handle this process electronically (via IRBNet), but for now, please feel free to either e-mail the completed application to maryoneill@notes.cc.sunysb.edu with follow-up fax/hardcopy (signatures), or simply send the hard copy to Mary O'Neill, Office of Research Compliance, Z=3368.
Obviously, this 'area' is a work in progress for us, and we appreciate everyone's patience (and input, if you feel so inclined!)
2. Update/Clarification Regarding University Hospital Approvals
Obtaining approval from CORIHS, and securing a signed contract through the Office of Sponsored Programs (if you are proposing to conduct industry-sponsored clinical trials) are two important steps in being able to conduct research involving human subjects under the auspices of SBU. But if your research activity involves the facilities, patients, and/or services of any of University Hospital's inpatient or outpatient locations, (with the exception of the outpatient clinics located at Riverhead, Southold, Plainview, or Medford), you must additionally:
- complete the newly revised 'Application for Approval to Conduct Research Activities at Stony Brook University Hospital... ' which can be found in the Forms and Reference Library within the Project Designer of IRBNet, and
- share your study on IRBNet, and obtain the electronic signature endorsements of Dr. William Greene and Rhona Vainder (or Regina Rigoroso, in her absence), and
- also share and obtain endorsement, as applicable, from:
- Jay Bock, if your study involves Pathology/Laboratory Services,
- Wayne Patterson (if your study involves the Pharmacy),
- John Ferretti (if your study requires Radiology services), or
- Ed Hines (if identifiable subject health information will be electronically transmitted outside of SBU).
Once you have these endorsements, along with CORIHS approval and a signed contract (for clinical trials) you may begin recruiting for your study.
