Important Updates
All of Us
The All of Us Research Program includes a database that works to improve health care through research. All of Us is building a diverse database that can inform thousands of studies on a variety of health conditions.
To find out more about All of Us and what makes this research database different you can go to:
https://allofus.nih.gov/about/program-overview/what-makes-all-us-different
To contact All of Us you can go to:
https://allofus.nih.gov/about/contact-us
Read more about available research databases here.
The Office of Research Compliance, Human Research Protection Program would like to announce recent changes made to the Standard Operating Procedures. These changes include the following:
Added a definition of “federal regulations”:
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- “Federal regulations”: Regulations are published by executive branch agencies to clarify their interpretation of a law and how a law will be implemented. Regulations also state requirements or prohibitions.
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Added information regarding “program evaluation”:
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- Program evaluation is defined as “the systematic collection of information about the activities, characteristics, and outcomes of programs to make judgments about the program, improve program effectiveness, and/or inform decisions about future program development. What distinguishes program evaluation from research is that they serve different purposes. While research seeks to prove; evaluation seeks to improve.” (Center for Disease Control, Office of Policy, Performance, and Evaluation) Individuals can assess the value and impact of the program when they ask questions, consult partners, make assessments, and obtain feedback. The information collected is then used to improve the program.
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Added information regarding “classroom activities”:
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- College classes ask students to perform certain activities for course requirements. To meet the definition of research according to federal guidelines, the project must be for the purpose of developing or contributing to generalizable knowledge. Most classroom projects are not done for the purpose of contributing to generalizable knowledge, but to teach the student about research methods. Information gathered from classroom projects or coursework is then reviewed by fellow classmates and instructors rather than published as a journal article
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Added information regarding “Data Management and Sharing”:
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- The NIH Data Management and Sharing Policy applies only to research grants, not training grants, fellowships, infrastructure grants, instrument grants, nor non-competitive renewals. The policy dictates how data generated using support from these grants must be managed and shared. Scientific Data is defined as “recorded factual material commonly accepted in the scientific community as of sufficient quality to validate and replicate research findings, regardless of whether the data are used to support scholarly publications.”The NIH definition excludes “data not necessary (or of sufficient quality) to validate and replicate research findings”, laboratory notebooks, preliminary analyses, completed case report forms, peer reviews, communications with colleagues, and physical objects. (For additional information regarding the NIH Data Management and Sharing Policy see section 17.13 of the Human Research Protection Program policies and procedures.)
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Added information regarding the Family Educational Rights and Privacy Act (FERPA)
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- The Family Educational Rights and Privacy Act (FERPA) is a federal law regarding privacy of student records and the obligation of institutions to protect that privacy restricting access to those records. Educational institutions that receive federal funding (administered by the US Secretary of Education) are bound by FERPA requirements. Funding can be withheld if institutions do not comply with FERPA. For FERPA to be set in motion, the information has to be directly related to a particular student and maintained by an educational institution. (For more information regarding the Family Educational Rights and Privacy Act see section 17.18 of the Human Research Protection Program policies and procedures.)
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Added information regarding reporting events that are not serious, unanticipated, or related to the research plan.
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- Adverse events that do not meet the criteria of serious, are anticipated and related to the research may be batched, summarized and submitted at the time of continuing review.
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Dear Colleagues,
The Office of Research Compliance has hired a “Research Monitor”. This position is a new position and the individual hired to conduct these activities is Stephanie Roncone. Since the position is new, Stephanie is undergoing training to learn the Human Subject Protection Program policies and procedures, federal regulations as well as how reviews are conducted for exempt, expedite and full board studies.
Activities include but are not limited to the following:
- Pre-study resource evaluations
- Monitoring of ongoing trials
- Close-out monitoring of completed trials
- For-cause audits at the request of the IRB
The research monitor will conduct monitoring activities in accordance with established written procedures; using appropriate monitoring checklists, report templates and source documents to record and report monitoring findings. The goal is to work collaboratively with the study team and communicate findings that lead to improved clinical research. Following the monitoring, a report is created which is sent to the Principal Investigator outlining the results of the audit.
For information about the Research Monitor position please feel free to contact Stephanie Roncone at Stephanie.Roncone@stonybrook.edu or 631-632-1559.
Dear Colleagues,
The National Science Foundation (NSF) has issued a new mandate that expands the existing Responsible and Ethical Conduct of Research (RECR) training requirements.
What is new?
For proposals submitted to NSF on or after July 31, 2023, all researchers, including faculty, post-docs, graduate and undergraduate students, and other senior personnel named on proposals to NSF must complete RECR training before engaging in research projects sponsored by the NSF.
How is this different from NSF’s previous policy?
This requirement reflects two changes:
- the RECR training requirement has expanded, and now applies to faculty and other senior personnel, as well as undergraduates, graduate students and postdoctoral researchers, and
- the RECR training must include training on mentorship.
What is the Principal Investigator’s responsibility?
Principal Investigators are responsible for ensuring all researchers, including faculty, post-docs, graduate and undergraduate students, and other senior personnel supported through their grant(s) complete training at the start of work on the research project.
What training is required to satisfy the NSF RECR requirement?
The Office of the Vice-President for Research is reviewing current RECR training modules in the CITI Program and the implementation of this new requirement. More information will be coming soon.
What do you need to do now?
The Office of Research Compliance will be issuing additional guidance for this new training requirement. The implementation of this guidance will be in a manner that minimizes burden on investigators and study team members. New guidance will include both CITI Program modules to be completed as well as a timeframe for completion.
Who do I need to contact for more information?
For questions about this the NSF RECR policy or questions about RECR training, please contact Rebecca Dahl at rebecca.dahl@stonybrook.edu in the Office of Research Compliance.
The Human Research Protection Program (HRPP) has recently completed work on an Emergency Preparedness and Response Plan ("Plan") for human subject research. This Plan can be accessed at: https://www.stonybrook.edu/commcms/research-compliance/Human-Subjects/sops
This Plan establishes HRPP specific emergency planning and is intended to supplement, not replace, emergency response planning by Stony Brook University (SBU) leadership and/or SBU-wide response measures.
Information contained in 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. If you have questions about the Plan, please contact Rebecca Dahl at 631-632-6541.