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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.
New Online Platform For Proposal Submission and Review
In response to campus feedback about the proposal submission and review process, the IRB office has adopted the online PACS platform to handle all proposal activity. Overall, this new platform should make the proposal review and approval process less cumbersome and more transparent for all users.
Beginning July 1, 2018, the PACS system will be the only way to submit IRB proposals. All researchers and research advisers will need to create an account to access PACS. The IRB will be providing online and in person training to help the transition go as smoothly as possible.
If you will be submitting a research protocol, please visit the PACS page for more information about how to register for a PACS account and submit a study. If you will be submitting modifications or a continuation for an existing study, please continue to use Form K.
Student Researchers (and student research advisors):
All students who submit research proposals (e.g., student principal investigators) are required to take the Students in Research module on CITI. Student research proposals will not be approved--and may not be reviewed--if this module is not complete.
Planning to do Research this Winter?
Please note that full-board review proposals submitted after December 7, 2018 may not be reviewed until the beginning of the Spring 2019 semester.
ResearchMatch: A New Option for Recruiting Research Participants
The College at Brockport is now a participating research partner with ResearchMatch. ResearchMatch provides a registry to help match potential research participants and researchers at no cost to either party. Learn more here.
Changes to Common Rule Delayed Until January 2019.
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 are slated to go into effect on January 21, 2019.
Major Regulation Changes (effective date January 21, 2019)
Continuing Review: Will no longer be required at the federal level for some minimal risk research. However, the Brockport IRB will still require continuing review for all categories of 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 January 21, 2019.
For studies approved from July 19, 2018 through January 20, 2019, the College at Brockport IRB is permitted--but not required--to apply three burden-reducing provisions.
Those three provisions are:
- The revised definition of “research,” which deems certain activities not to be research covered by the Common Rule. Click here for details.
- The elimination of the requirement for annual continuing review with respect to certain categories of research. Please note that the Brockport IRB will still require continuing review for all categories of research.
- The elimination of the requirement that institutional review boards (IRBs) review grant applications or other funding proposals related to the research.
Institutions taking advantage of the three-burden reducing provisions must comply with all other pre-2018 Requirements during the delay period. The three burden-reducing provisions of the 2018 Requirements can only be implemented during the delay period with respect to studies initiated prior to January 21, 2019 that will transition to compliance with the revised Common Rule. Any study that implements these three burden-reducing provisions during the delay period must, beginning on January 21, 2019, comply with all of the 2018 Requirements for the balance of the study's duration.
Be advised that many of the IRB forms and documents are updated and revised on an ongoing basis. To make sure you have the most recent versions, always download forms directly from the IRB site.