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Department and College Research Review Committee Program:
Procedures
Office of Research Affairs
Research Integrity and Compliance
Human Research Protection Program
Developed by the Office of Research Affairs, California State University, Sacramento
ORA v.2017-01
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Table of Contents
Important Definitions
Research
Human Subject
Minimal risk
Classroom Research
Exempt Student Research
Non-Exempt Student Research
Departmental/College Research Review Committee (Committee)
Institutional Review Board (IRB)
Committee Webpage
Exemption Determination Certification for Committee Members
Submission Form
Committee Review Reporting
Exemption Determination Form
Semester Report
Student Research Types and Procedures
1.Classroom Research (does not require IRB oversight):
2.Exempt Student Research (requires reporting to the IRB):
3.Non-Exempt Student Research (requires Expedited IRB review):
Approvals of Exempt Student Research
Modification Requests for Exempt Student Research
File Maintenance for Exempt Student Research
Internal Audit Procedures
Objective:
Findings:
Frequency of visits by IRB staff:
Records review by IRB staff:
Important Definitions
Research - A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.
- Generalizable knowledge means conclusions, facts, or principles derived from particulars (individual subjects, medical records, etc.) that are applicable to or affect a whole category (members of a class, kind, or group, a field of knowledge, etc.) and enhance scientific or academic understanding.
Human Subject -a living individual about whom an investigator (whether professional or student) conducting research obtains
(1) Data through intervention or interaction with the individual, or
(2) Identifiable private information.
Minimal risk - the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.
Classroom Research - This activity involves human subjects and is conducted by an undergraduate or a graduate student for the purpose of a course grade and will only be presented on campus and/or to the instructor and classmates. This type of research or project is not subject to the federal regulations.
Exempt Student Research –This undergraduate/graduate activity fits the federal definition of “research” and “human subject” and only falls under one or more of the exemption categories. The research will be presented at an off-campus conference or in publication (i.e. thesis).
Non-Exempt Student Research –This undergraduate/graduate activity fits the federal definition of “research” and” human subject” but does not completely fall under one or more of the exempt categories. The research will be reported at an off-campus conference or in publication (i.e. thesis). This research will either fall under an expedited category for minimal risk research, or will require full board review if the study’s risk is greater than minimal.
Departmental/College Research Review Committee (Committee) –A Research Review Committee (Committee) is the department level or college level Committee formed by department and college faculty that reviews student research and student research involving human subjects.These committees may only approve exempt student research when two or more members have received exemption determination certification.
Institutional Review Board (IRB) - The Institutional Review Board is the body of diverse faculty from Sacramento State which has a federalwide assurance with the Office of Human Research Protections to review research that is subject to the Federal Regulation for the Protection of Human Research Subjects. The IRB is the only authorized body on campus to approve expedited or full board review studies.
Committee Webpage
This document, Exemption Determination Forms, and other resources for your Committee can be found on this website:
Exemption Determination Certification for Committee Members
At least two members of a Departmental/College Research Review Committee (Committee) must be certified by the IRB in determining exemptions. The Collaborative Institutional Training Initiative(CITI) course is a pre-requisite to the Exemption Determination Certification workshop. CIT certification is valid for three years and Exemption Determination Certification is valid for two years.
Submission Form
All Committees must implement the IRB Human Subjects Research Application for uniformity across Committee and University review unless you have worked with the IRB to create a separate version for your department/college. Electronic, online versions of this application may be utilized.
Students can find a blank application on our website:
CommitteeReview Reporting
One of the following options may be used to report exemption determinations to the IRB:
Exemption Determination Form
Use this form to properly document whether the project is exempt from regulation. If a project is determined exempt, this form also serves as notification to the Office of Research Affairs that the project has been reviewed and approved by the Committee. If a project is determined non-exempt, the student will need to submit a new application to the IRB through the Cayuse IRB software.
Semester Report
Departments/colleges may decide to document their exemption determination in excel and supply the list to Research Affairs at the end of each semester.
Student Research Types and Procedures
1.Classroom Research (does not require IRB oversight):
This activity involves human subjects and is conducted by an undergraduate or a graduate student for a course grade and will only be presented on campus and/or to the instructor and classmates. This type of research or project is not subject to the federal regulations and do not need to be reported to the IRB.
2.Exempt Student Research (requires reporting to the IRB):
This undergraduate/graduate activity fits the federal definition of “research” and “human subject” and only falls under one or more of the exemption categories. The research will be presented at an off-campus conference or in publication (i.e. thesis).
Procedure:
1)The student must submit verification of training and a Human Subjects Research Application to the Committee.
2)Exempt Student Research must be reviewed and approved by Exempt CertifiedCommittee members using the Committee Exemption Determination Form(See
Exemption Determination Certification for Committee Members).
3)The Committee Exemption Determination Forms are forwarded to the Office of Research Affairs via email to fter the student has secured exempt status.
4)Approved applicationsare maintained by the Committee for three years after the date of approval and are subject to audit by the IRB and the Office of Research Affairs. Please seeApprovals of Exempt Student Researchfor more information.
3.Non-Exempt Student Research (requires Expedited IRB review):
This undergraduate/graduate activity fits the federal definition of “research” and” human subject” but does not fall under one or more of the exempt categories. The research will be reported at an off-campus conference or in publication (i.e. thesis).
This research will most likely fall under the Expedited Review and students should be directed to select this review option.
Procedure:
1)If a Committee member knows prior to submission that the study is not exempt, the student may submit directly to the IRB. Please supply the student an email reflecting this request for the Cayuse application.Otherwise, the student may submit verification of training and a Human Subjects Research Application to the Committee.
2)Studies fitting non-exemptionare to be reviewed by the Committee using the Committee Exemption Determination Form,and recommended for IRB review. The term “approval” is not to be used by the Committee, rather “recommendation for IRB Expedited review,” as approval will come from the IRB.
- If no revisions are requested by the Committee, the student may submit to the IRB via Cayuse IRB.
- If revisions are necessary in the application, please have the student revise the application prior to IRB submission on Cayuse IRB.
3)The Committee may request that the study supply the Committee Chair with a copy of the IRB approval letter to close the loop in review.
Approvals of Exempt Student Research
Exempt student research which is under the supervision of the department/college may be approved for the life of the study as annual reports are not required of exempt research. Many studies will not last longer than several months while some studies may last longer than a year. Therefore, it is recommended that no expiration dates are given in approval letters and the file to be shredded three years from the approval date.
Modification Requests for Exempt Student Research
Student researchers who have approval for their exempt research but want to make changes to their methodology, subject group, informed consent form(s), or recruitment materials must first submit a modification request and receive approval from their Committee before implementing modification(s).
If the student makes changes to the study which either 1) Increases research risk to greater than minimal, or 2) No longer qualifies the research for exemption, the student must submit a new Human Subjects Research Application to the University IRB for review. The student may only continue their research as originally approved and may not initiate modifications until the IRB has approved the research.
The IRB suggests that student researchers be directed to email the Committee Chair and copy their advisor with requested modifications and the Chair may respond with approval via email to properly document communication.
File Maintenance for Exempt Student Research
Exempt student research must be maintained by the Committee for three years after the approval date. Those files which have reached the three year mark at the end of each month may (and should) be shredded.
Internal Audit Procedures
Training and education, compliance, and accountability will be evaluated by the IRB and IRB staff whowillrequest access to student human subjects research documentation for internal auditing purposes.
Objective:
Utilizing theCommittee Exemption Determination Form,non-exempt student research submissions, and any other applicable documentation filed withthe Committee for student human subjects research, the audit serves to identify the following:
- Inconsistencies of determining student research review categories.
- Inconsistent procedures for student research reporting and IRB review.
- ImprovingCommittee procedures for meetings, documentation, and maintenance of files through recommendations from the IRB and IRB staff.
- Areas of concern forCommittees that the IRB or IRB staff can address.
Findings:
The results of the audit will be presented to the Committee under review and the department or college Chair or Dean will be copied. Appropriate actions for any findings will be provided and reviewed during a follow-up audit.
Frequency of visits by IRB staff:
One or more IRB members or IRB staff may be present for the internal audit and is expected to occur no more than once per year. However, if there are findings in the audit, a follow-up visit can occur to ensure completion of appropriate actions.
Records review by IRB staff:
The Committee Exemption Determination Formshould be utilized to document exempt determinations and notify the Office of Research Affairs of such determinations.
Student files should be maintained for three years afterapproval. These files should be accessible to the IRB or IRB staff for application review. If meeting minutes are written, these should also be accessible for the internal audit.
ORA v.2017-01