Learn about existing protection programs, review boards and processes, informed consent, and other governing regulations in order to allow research to be conducted as smoothly as possible.

In order to ensure ethical research performance on human subjects, Stony Brook issues the Human Subjects Standard Operating Procedures Manual (click here for PDF)and expects researchers to be familiar with its policies. 

Emergency Preparedness and Response Plan

The Human Research Protection Program (HRPP) has recently completed work on an Emergency Preparedness and Response Plan ("Plan")(click here for PDF) for human subject research.

Information contained within the Emergency Preparedness and Response Plan establishes HRPP-specific emergency response planning and measures that are limited to those functions for the HRPP not otherwise covered by institutional-level plans. This plan is intended to supplement, not replace, emergency response planning by Stony Brook University (SBU) leadership and/or SBU-wide response measures.

If you have questions about the Plan, please contact Rebecca Dahl at 631-632-6541.

Memo: Case Report/Case Series Journal documentation

A case study/series is an analysis of up to 3 clinical cases and usually examines a condition, treatment, presentation, or outcome. If the analysis involves more than 3 cases it would need to be reviewed by the Human Research Protection Program and an application would need to be completed in the electronic management system myResearch.

A case study/series is not meant to draw broad conclusions about a population and does not meet the DHHS definition of research which is “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.”

Some journals now require a letter or other form of acknowledgement from the Institutional Review Board prior to the submission of a case study/series to a journal. This memo may then be sent to the journal confirming the Stony Brook University policy. To access this memo please click here.

 

Clinical Trials

PIs of certain investigator-initiated clinical trials are required to comply with federal requirements concerning registration of their studies on ClinicalTrials.gov, no later than 21 days after enrollment of the first participant if it meets the requirements found under section 17.4 of the SBU Human Subjects Standard Operating Procedures Manual.

More information on Registration and Reporting requirements for ClinicalTrials.gov can be found here.

Contact the Office of Research Compliance for first-time access to the ClinicalTrials.gov site at ORC_ClinicalTrials@stonybrook.edu with the individuals full name, institution email, and institution phone number..