The Institutional Review Board functions as a federally regulated entity charged with reviewing all biomedical and social behavioral research studies that take place within or under the authority of Binghamton University. 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 IRB prior to commencing study procedures. This includes research involving subjects from outside the University and research that is not funded. The purpose of review is to determine if the proposed research meets established regulatory, policy, and ethical criteria to protect the rights and welfare of the human research subjects.
The Binghamton University IRB review process is guided by the ethical principles set forth in the Belmont Report. The minimum standards which must be met by researchers are specified in the Department of Health and Human Services regulations at 45 CFR 46 and the Food and Drug Administration’s regulations at 21 CFR 50 and 21 CFR 56.
The IRB office staff will work one-on-one with new (and not so new) investigators, and can arrange meetings in the IRB offices, or at the investigator’s research space – both to help navigate the PACS IRB submission process, and to facilitate the preparation of research applications. At the request of a Binghamton University community member, we can facilitate individual and group training sessions for faculty, staff, and students who are conducting, or learning to conduct, human subjects research. We understand that the changing landscape in regulatory oversight often requires investigators to obtain input from the IRB prior to submitting an IRB application and we encourage anyone with questions to reach out to email@example.com or call 607-777-3818. We hope you will have an opportunity to get to know the human subjects research compliance professional staff and the generous faculty and community members who volunteer their time serving as members of the IRB, protecting human subjects, and facilitat
THE REVISED COMMON RULE & OTHER CHANGES
The revised Federal Policy for the Protection of Human Subjects (a.k.a. the "Revised Common Rule"), issued by the Department of Health and Human Services (HHS), went into effect on January 21, 2019. For more information regarding the Common Rule please visit the Office of the Federal Register website.
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
- 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 has been added
- Rearrangement of content is designed to facilitate a potential subject's decision whether to participate or decline participation
Note: Broad Consent in the Revised Common Rule serves as an option to seek from subjects consent to participate in future, unspecified research. Broad consent must be agreed to by the subject in order for storage and secondary research use of identifiable private information or biospecimens. The facilitation of broad consent is complex and requires a comprehensive infrastructure. At this time, Binghamton University will not entertain this option.
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. A summary can be found through the HHS.Gov website at Revised Common Rule Resources