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Human Subjects

Mission Statement

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 Revised Common Rule & Other Changes 

HHS.gov and OHRP- 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 please go to the Office of the Federal Register website.

Revised 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

Exemptions

  • 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"

Continuing Review

  • 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

Informed Consent

  • New "Key Elements" section 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. The new Revised Final Rule in its entirety can be found at https://www.hhs.gov/ohrp/regulations-and-policy/regulations/finalized-revisions-common-rule/index.html

We encourage you to call the IRB office at x73918 or at hsrrc@binghamton.edu to ask any question you may have regarding the Revised Common Rule and how it may impact your research.

Further information on the Revised 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

 
 

Contact Us

  • 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
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Last Updated: 8/6/19