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The Role of the IRB: Protecting Human Rights
The Institutional Review Board (IRB) at The College at Brockport is responsible for ensuring the protection of human research participants. The IRB reviews protocols for research involving human participants when conducted by or under the direction of any employees, students or agents of The College at Brockport in connection with their institutional responsibilities or using any institutional property or facility. The office also provides educational resources, training sessions, and other programming to The College at Brockport faculty, staff, and students.
With representation from a range of disciplines within The College at Brockport and from outside the academic community, the IRB strives to give prompt but individualized attention to human research projects.
Changes to Common Rule Delayed; Final Rule Will Go Into Effect in July 2018
Final revisions to the Federal Policy for the Protection of Human Subjects (a.k.a. the Final Rule) were issued by the Department of Health and Human Services (HHS) on January 18, 2017. The changes should officially go into effect on July 19, 2018.
Major Regulation Changes
Continuing Review: Will no longer be required for some minimal risk research. For details, see Continuing Review
Exemptions: New categories and clarification of existing categories. Some exemptions may require limited IRB review (similar to an expedited review process that focuses on data privacy and confidentiality). For details, see Limited IRB Review.
Informed Consent: A new Key Elements section and a rearrangement of content is designed to facilitate a potential subject's decision to participate or not. For details, see Elements of Informed Consent
Definitions: Several terms will be revised, including vulnerable, human subjects, research and legally authorized representative.
Activities deemed not to be research: The final rule amends the definition of research to include four new activities that are deemed to not be research. For details, see
Does your project require IRB oversight?
What to Expect
The new regulations do not impact studies approved prior to July 19, 2018.
For existing studies, the College at Brockport IRB may choose to apply the new rules to minimize burden for investigators.
More information will be available once the Final Rule is in effect.
New Online Platform Launching Soon
In response to campus feedback about the proposal submission and review process, the IRB office will be adopting the online platform PACS to handle all proposal activity.
This change will affect all students, faculty and staff who are submitting or supervising projects that go through the IRB, including past projects that require modifications or continuation. All researchers and research advisers will need to create an account to access PACS, and the IRB will be posting instructions detailing the log-in, submission and post-submission processes before launching to help the transition go as smoothly as possible.
We are planning to go live in early spring, with a possible start date as early as February 1.
Overall, this new platform should make the proposal review and approval process less cumbersome and more transparent for all users. Stay tuned for more information!