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Federal Guidelines

The Institutional Review Board is mandated by federally regulated guidelines. Any research that deals with human subjects must be reviewed by the IRB. For information about human subject research visit the “Human Subject Research” webpage.

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About the Institutional Review Board

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 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 faculty, staff, and students of the College.

With representation from a range of disciplines within the College and from outside the academic community, the IRB strives to give prompt, but individualized attention to human research projects.

Responsibilities

The IRB is responsible for and oversees:

  • Human Subjects Research Training: CITI
  • PACS System
  • Forms and templates for proposals
  • Project proposal guidance and approval
  • Maintaining records

Scope of the IRB Review

IRB review is conducted to ensure that proposed research involving human participants meets the criteria for IRB approval in accordance with 45 CFR 46.111 and 21 CFR 56.111. Specifically, to approve a study, the IRB must find that:

  • Risks to participants are reasonable in relation to:
    • anticipated benefits (if any) to participants and
    • the importance of the knowledge that may be expected to result. In evaluating risks and benefits, the IRB should consider only those risks and benefits that may result from the research, as distinguished from risks and benefits to which participants would be exposed even if not participating in the research
  • Risks to participants are minimized by using procedures which are consistent with sound research design and which do not unnecessarily expose participants to risk.
  • Selection of participants is equitable. In making this assessment, the IRB takes into account the purposes of the research and the setting in which the research will be conducted and should be particularly cognizant of the special problems of research involving vulnerable populations, such as children, prisoners, persons with disabilities, or economically or educationally disadvantaged persons
  • Informed consent will be sought from each prospective participant or the participant's legally authorized representative in accordance with and to the extent required by part 50
  • Informed consent will be appropriately documented in accordance with and to the extent required by 50.27
  • Where appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of participants
  • Where appropriate, there are adequate provisions to protect the privacy of participants and to maintain the confidentiality of data
  • When some or all of the participants—such as children, prisoners, persons with disabilities, or economically or educationally disadvantaged persons—are likely to be vulnerable to coercion or undue influence, additional safeguards have been included in the study to protect the rights and welfare of these participants
  • The principal investigator is qualified to conduct the proposed research
Revision & Resubmission

The IRB is charged to review protocols according to criteria listed above. On occasion, it may be difficult for an IRB reviewer to adequately assess those criteria due to the quality of the submission. Poor quality may be indicated by, and include, the following:

  • Inadequate or insufficient information to determine the criteria are met,
  • Insufficient scientific justification for the research protocol or plan, or
  • Improper or incorrect supporting documentation to the protocol or research plan

In such cases, PIs will be asked to make significant revisions and resubmit their proposals.

Last Updated 8/13/19

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