Institutional Research Board
Prairie State College (PSC) seeks to uphold the highest standards in the ethical conduct
of research including the protection of human participants, including any and all
identifying participant data, while enabling faculty, staff, administration, and students
to conduct research in a timely and efficient manner.
Mission
Prairie State College (PSC) seeks to uphold the highest standards in the ethical conduct of research including the protection of human participants, including any and all identifying participant data, while enabling faculty, staff, administration, and students to conduct research in a timely and efficient manner. The primary objective of the PSC Institutional Review Board (IRB) is to facilitate those goals by reviewing, approving, modifying, or disapproving research protocols submitted by PSC researchers. The IRB process is determined by roles and regulations for federally funded research, primarily the provisions of the Protection of Human Subject in the Code of Federal Regulations (45 CFR 46) and supporting materials such as the Belmont Report. The PSC IRB is striving to create a culture of respect for, and awareness of, the rights and welfare of human research participants, while furthering knowledge and the highest standard of research. Download the Belmont Report
Office for Human Research Protection (OHRP)
The Office for Human Research Protections (OHRP) provides the below graphic aids as a guide for institutional review boards (IRBs), investigators, and others who decide if an activity is research involving human subjects that must be reviewed by an IRB under the requirements of the U.S. Department of Health and Human Services (HHS) regulations at 45 CFR part 46. OHRP welcomes comments on the decision charts, which address decisions on the following:
- whether an activity is research that must be reviewed by an IRB
- whether the review may be performed by expedited procedures, and
- whether informed consent or its documentation may be waived.
Considerations
The charts are intended to assist IRBs, institutions, and investigators in their decision‐making process and should not be used as substitutes for consulting the regulations. OHRP cautions that the full text of applicable regulatory provisions should be considered in making final decisions.
These charts are necessarily generalizations and may not be specific enough for particular situations. Other guidance documents are available related to specific topics, at OHRP Policy Guidance by Topic. OHRP invites inquiries for additional information.
The charts do not address requirements that may be imposed by other organizations, such as the Food and Drug Administration, National Institutes of Health, other sponsors, or state or local governments.
Chart 1: Is an Activity Research Involving Human Subjects?
Chart 2: Is the Human Subjects Research Eligible for Exemption?
Chart 3: Does Exemption 45 CFR 46.101(b)(1) (for Educational Settings) Apply?
Chart 6: Does Exemption 45 CFR 46.101(b)(5) (for Public Benefit or Service Programs) Apply?
Chart 7: Does Exemption 45 CFR 46.101(b)(6) (for Food Taste and Acceptance Studies) Apply?
Chart 8: May the IRB Review Be Done by Expedited Procedures?
Chart 9: May the IRB Continuing Review Be Done by Expedited Procedures?
Chart 10: May Informed Consent Be Waived or Consent Elements Be Altered under 45 CFR46.116(d)?
Chart 11: May Documentation of Informed Consent Be Waived Under 45 CFR 46.117(c)?
Documents
IRB Protocol Approval Request for Research
Request for Continuing IRB Approval
All human subject research requires approval from the IRB, though the definition of such research may be unclear. At the present time, please contact the IRB Chair, Cynthia Cornejo, PsyD at ccornejo2@prairiestate.edu or call (708) 709-7775 for the appropriate decision tree and proposal forms which will be helpful in determining whether or not research requires IRB approval or qualifies for an exemption.
Source: Appreciation is extended to William Smith, J.D., IRB Director at Nova Southeastern University, Ft. Lauderdale-Davie, FL, for permission to use document templates, ideas, and assistance.