Institutional Review Board and Protection of Human Subjects
Policy 296
Purpose
Glen Oaks Community College is committed to the protection and ethical treatment of students, employees, and others who may conduct or participate in research conducted by internal or external researchers. The purpose of the GOCC Institutional Review Board (IRB) is to assure, both in advance and by periodic review, that appropriate steps are taken to protect the rights and welfare of humans participating as subjects in research. The IRB will function according to the Code of Federal Regulations (CFR) Title 45, Part 46, Subpart A.
Policy Statement
All persons who wish to conduct research involving human subjects at GOCC must submit an IRB Research Proposal application. The IRB application will be reviewed by the GOCC IRB committee following established processes. The GOCC IRB functions to determine and assure:
- The welfare and rights of all human subjects are adequately protected and informed consent given, when appropriate.
- Human subjects are protected from unreasonable physical, mental, or emotional risk as a result of research, and the risks to research subjects are minimized.
- Research outcomes hold significance to the college’s interests.
- The benefits, necessity, and importance of the research outweighs any potential risks to subjects.
- Researchers are qualified to conduct research involving human subjects.
- Participant selection is equitable.
- Adequate provisions are made in regard to data collection, storage, and dissemination to ensure the safety and privacy of participants.
IRB approval must be obtained prior to commencing any work involving human subjects. Any modifications to an IRB approved research project must be approved prior to implementing those modifications.
This policy applies to all College faculty, administrators, staff, and students conducting research or for externally funded projects involving human subjects; persons who are not employees of the College but wish to access the facilities to engage human subjects for research.
The IRB shall be empowered and responsible to:
- Determine whether proposed activity constitutes the definition of research.
- Review, approve, request revisions, or deny approval of research proposals involving human subjects.
- Determine if research activities are exempt from IRB oversight.
- Provide oversight of human subject protection for ongoing research.
- Ensure adherence to IRB established policies and procedures.
The membership of the Institutional Review Board will include the following:
- IRB Chairperson (Director of Institutional Planning, Assessment, & Research)
- An instructional faculty member in science area (e.g., biology, psychology, chemistry)
- An instructional faculty member in nonscience area (e.g., history, English, art)
- A faculty, administrator, or staff member selected by the President.
- One representative external to the College
All members of the IRB must undergo training on the protection of human subjects made available by the U.S. Department of Health and Human Services Office for Human Research Protections, as outlined in the GOCC IRB Procedure Manual.
Definitions
Human Subjects.
A living individual about whom an investigator (whether professional or student) conducting research obtains data through intervention or interaction with the individual or identifiable private information.
Research.
The systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. Activities that use human subject data that (a) is regularly and routinely gathered at the institution, (b) does not require new, additional, or significantly altered data collection procedures, or (c) is not sponsored by an external agency, is unlikely to constitute research. For example, the assessment of student learning is not research.
Institutional Review Board (IRB).
An IRB is the board responsible for reviewing and approving research that involves human subjects to ensure that all human subject research is conducted in accordance with federal, institutional, and ethical guidelines.
IRB Approval.
The determination of the IRB that the research has been reviewed and may be conducted at an institution within the constraints set forth by the IRB and by other institutional and federal requirements.
Risk.
The probability of harm or injury (physical, psychological, social, or economic) occurring as a result of participation in a research study.
Minimal Risk.
The probability of harm or discomfort anticipated in the proposed research is not greater than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.
Policy History: Adopted by the Board of Trustees 1/11/2024