Binghamton University is guided by the ethical principles regarding all research involving humans as subjects set forth in the report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research titled Ethical Principles and Guidelines for the Protection of Human Subjects of Research (the "Belmont Report").
Binghamton University has established the Human Subjects Research Review Committee (HSRRC) as the institutional review board (IRB) responsible for the institution's obligations to review research involving human research. All human subjects research, as defined by DHHS and the Office of Human Research Protections, conducted by University faculty, staff and students or done under the sponsorship or auspices of the institution must be reviewed and approved by the HSRRC. This includes research involving subjects from outside the University and research that is not funded.
As a research participant, if you have any questions, concerns or complaints concerning your involvement in a research study, please contact our office.
The New Common Rule & Other Changes
HHS.gov and OHRP- Final revisions to the Federal Policy for the Protection of Human Subjects (a.k.a. the "Common Rule") were issued by the Department of Health and Human Services (HHS) on January 18, 2017.
NOTE: The U.S. Department of Health and Human Services (HHS) and 16 other federal departments and agencies announced a Notice of Proposed Rulemaking (NPRM) proposing to delay for an additional 6 months the general compliance date for the revisions to the Federal Policy for the Protection of Human Subjects (the "Common Rule"), which was scheduled to go into effect on July 19, 2018. Under the NPRM proposal, the compliance date would be changed from July 19, 2018, to January 21, 2019. For more information please go to the Office of the Federal Register website.
New Common Rule Changes
- Some Activities No Longer Deemed Human Subjects Research
- More Exemptions
- Reduction of Some Continuing Reviews
- Informed Consent Format and Content
- Single IRB of Record
Human Subjects Research Regulation Changes
What will no longer fall under the purview of the IRB?
- Scholarly and journalistic activities that focus directly on the specific individuals about whom the information is collected
- Public health surveillance activities limited to those necessary to identify, monitor, assess, or investigate conditions of public health importance
- Collection and analysis of materials for criminal justice purposes
- Authorized operational activities for national security purposes
- Two new Exempt categories and clarification of existing categories will be introduced
- Some Exemptions may require "limited IRB review" while others may qualify for "self-determination"
- No longer required for some minimal risk research (expedited reviews), including studies where the only remaining activity is the analysis of identifiable data/biospecimens or activity to obtain follow-up clinical data
- New "Key Elements" section added
- Rearrangement of content is designed to facilitate a potential subject's decision whether to participate or decline participation
Single IRB-of-Record (sIRB)
- IRB oversight for most federally-funded collaborative research projects located in the U.S. will be required to use a single IRB
There are more changes but those listed above are considered the main areas of change.
The new Final Rule in its entirety can be found at https://www.hhs.gov/ohrp/regulations-and-policy/regulations/finalized-revisions-common-rule/index.html
In anticipation of the New Common Rule going into effect, the Binghamton University Human Subjects Research Office (IRB) will be changing a few of the protocol submission documents and templates in the coming days to ensure compliance with the changes to assist PIs in protocol preparation. We will keep you informed as these changes are implemented. We encourage you to call the IRB office at x73918 or at firstname.lastname@example.org to ask any question you may have regarding these pending changes.
Further information on the New Common Rule and Resources can be found through our CITI Program at https://about.citiprogram.org/en/final-rule-resources/#overview
A summary can be found through PRIM&R for the revised common rule: quick summary guide
Fall 2018 Schedule (for full board review)
These deadlines do not apply to studies receiving expedited or exempt review.
Please submit your IRB application as soon as they are ready.
We are required to do an initial review of all full board protocols. The schedule above allows our office to review all documents and request additional information and/or documentation from the principal investigator prior to the convened meeting.
- Human Subjects
P: (607) 777-3818
F: (607) 777-5025
- Mail Stop
PO Box 6000
Binghamton, NY 13902-6000
- Courier Service
4400 Vestal Pkwy E
Vestal, NY 13850