Part 1: Purpose
The purpose of this procedure is to establish the guidelines, processes, and responsibilities for the protection of human subjects involved in research conducted by LSC faculty, staff, or students or on behalf of the college, or has as its subjects the college’s faculty, staff, or students.
Part 2: IRB Membership
The Institutional Review Board shall have five members, consisting of:
- The Institutional Research Analyst, Chair of the Board,
- The Vice President of Academic and Student Affairs,
- One Academic Dean selected at the recommendation of the Vice President
- The Executive Diversity Officer, and
- One LSC faculty member selected at the recommendation of the local MSCF.
Whenever the Institutional Review Board conducts a Full Review or determines that additional research expertise would be helpful in conducting its review, the Board shall be expanded by adding one additional member appointed by the Vice President of Academic and Student Affairs. The additional member shall be a two- or four-year educator with subject matter expertise.
Part 3: IRB Review
Subpart A: Types
The IRB shall conduct three types of reviews:
- Exempt reviews will be conducted when research involves no risk to the subjects and the research meets applicable criteria in the Code of Federal Regulations (Title 45, Part 46) for exemption from full IRB review.
- Expedited reviews will be conducted when the research involves no more than minimal risk for the subjects and the research meets the applicable criteria in the Code of Federal Regulations (Title 45, Part 46) for expedited IRB review.
- Full reviews will be conducted when the research involves more than minimal risk for the subjects. More than minimal risk for subjects in involved when, by way of example, physically invasive procedures are conducted, vulnerable populations are involved, or sensitive information such as sexual practices or illegal behaviors are surveyed.
Subpart B: Review Criteria
In reviewing research proposals, the IRB shall consider all applicable criteria contained in the Code of Federal Regulations (Title 45, Part 46), including whether:
- Risks to subjects are minimized.
- Risks to subjects are reasonable in relation to anticipated benefits and the importance of knowledge that may be reasonably expected to result.
- The selection of subjects is equitable.
- Informed consent will be obtained from each subject and properly documented.
- The research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects.
- There are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.
Part 4: Forms and Procedures
The IRB committee maintains appropriate forms for the operation of the Board.
- The Principal Investigator (PI) or co-investigators must complete the Application for IRB Review and the IRB Screening forms to provide all necessary information about the study. If the PI is requesting an exempt status, they must also complete the Request for Exempt Status form.
- The IRB Chair will review each request and gather more information as needed to make an informed decision.
- The IRB Chair will provide all request information to the IRB committee for feedback or approval.
- The IRB Committee will render a decision within:
- 5 business days for an Exempt Review, one that does not disrupt or manipulate a subject’s normal life or involve intrusive procedures;
- 10 business days for an Expedited Review, one that involves minimal risk and does not involve deception, at-risk populations, or sensitive topics;
- 10-15 business days for a Full IRB Review, one that involves more than minimal risk, intentional deception, or at-risk populations.
- Disapproved studies may not be conducted at, or in association with, Lake Superior College. The Principal Investigator may modify the IRB request for resubmission and review by the IRB committee.
Part 5: Other IRB Approval
When a proposal for research on human subjects at LSC is subject to IRB review at a four year institution and the proposal has been reviewed and approved by that institution’s own IRB, the Lake Superior College IRB may, upon receipt of adequate documentation of the approval, rely on the determination of the other institution’s IRB in lieu of its own review. LSC does not provide approval for research on human subjects at other institutions.
Part 6: Records
Written and/or digital records of all IRB activities shall be maintained by the Institutional Research Analyst. Copy of final research document/publication must be provided to Lake Superior College Institutional Research Analyst.
Date Implemented: April 2022
History: LSC policy 3.50 (previously numbered as 3.30) included procedure. Procedure separated out and updated to create procedure 3.50.1.
President’s Signature Date: April 28, 2022