Institutional Review Board

1.0    Purpose

This policy establishes guidelines for the operation of Casper College’s Institutional Review Board (IRB).

2.0    Revision History

3.0    Persons Affected

3.1    Administrative, faculty, and classified employees and students who are planning to conduct research at Casper College.

3.2    All persons or entities external to the college planning to conduct research at Casper College.

3.3    Current and potential research participants.

4.0    Policy

The policy of Casper College is to ensure the following.

4.1    The IRB reviews and approves research and grant proposals to ensure research conducted at, or in association with, Casper College is designed to ensure the protection of rights and welfare of human subjects.  

4.2    The IRB reviews research and grant proposals involving animal research designs to ensure compliance with the college’s research procedures.

4.3    Studies involving animals will secure any additional review by appropriate agencies when required (e.g., National Institutes of Health, Food and Drug Administration).

4.4    The IRB chair is the contact for all research at the college and should be consulted prior to submitting grant proposals that involve human or animal research.

4.5    The IRB consists of at least four other college employees.

5.0    Definitions

5.1    Institutional Review Board. This constituted group assures the rights and welfare of humans participating as subjects in research projects through the advanced and periodic review of research proposals, protocols, and documents. IRB has the authority to approve, require modification, or disapprove research.

The IRB has at least five but no more than eight members. One member must be a person who is not otherwise affiliated with Casper College and who is not part of the immediate family of a person so affiliated. (An affiliate is a person who is a current or past employee, clinical or adjunct faculty, trustee or other board member, volunteer, or consultant of Casper College.) The remaining members are college employees of which at least one member is from a scientific field, one member is from a non-scientific field, and the director of assessment as an ex officio member. A college employee serves as the chair for a term of two-years. There are no term limits for committee members.

5.2    Investigator. Any individual performing tasks related to conducting a research project such as obtaining informed consent forms and other information from subjects; intervening or interacting with subjects; obtaining, studying, interpreting, or analyzing identifiable private information or data; and communicating with IRB.

5.3    Principle Investigator (PI). The investigator with overall responsibility for a research project to include submitting the IRB proposal, ensuring policies are followed, and oversight of other investigators and research assistants. An employee (usually a faculty member) must be the PI when a Casper College student generates the research project. When someone other than a Casper College student generates a research project, the person submitting the IRB proposal is listed as the PI.   

5.4    Research. A systematic gathering and analysis of information designed to develop or contribute to generalizable knowledge (Health and Human Services IRB Guidebook). Casper College employees or students should seek IRB approval for research and grant proposals that involve human subjects, records gathered on human subjects, or animals. The research may take place at Casper College, other institutions, or in the community.

5.4.1    Systematic. Activities that involve predetermined methods for answering a specific question or testing hypotheses or theories. Typical systematic activities include interviews, program evaluations, and observations. Training or teaching activities used to achieve proficiency are not normally considered systematic and do not typically require IRB approval.

5.4.2    Generalizable Knowledge. Outcomes or data intended to be used beyond a department or internal use. Course or quality assurance evaluations used to improve student, faculty, staff, or the college’s performance or processes are generally not considered generalizable and do not typically require IRB approval.

5.5    Minimal Risk. A research project will be considered to have minimal risk if the probability and magnitude of harm or discomfort anticipated in the research are not greater than a person would ordinarily encounter in daily life or while participating in routine physical or psychological examinations or tests.

5.6    Exempted Review. The IRB grants this type of review when the research involves normal educational practices; the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens; or programs for the public benefit or service and procedures for obtaining benefits or service under those programs.

5.7    Expedited Review. The IRB grants this type of review when the research involves activities involving no more than “minimal risk” to the human subjects.

5.8    Full Review. The IRB grants this type of review when the research potentially exposes human subjects to more than minimal risk or involves deception.
 
5.9    Informed Consent Forms. Investigators use this document to secure written consent from research participants or from parent or legal guardians if the participant is younger than 18 years of age or has been judged incompetent. The document must include the following information in order: purpose of the study, description of methodology, duration of participant involvement, risks and benefits to the participants, statement assuring confidentiality of the data, the right of the participant to withdraw from the study at any time without negative consequences, an offer to answer any questions the participant may have, and contact information of all principal investigators and for IRB. There must be a signature line for the participant or for parents or legal guardians.

6.0    Responsibilities

6.1    The IRB is responsible for reviewing and approving, requesting modification, or denying research and grant proposals to ensure research conducted at, or in association with, Casper College protects the rights and welfare of human and animal subjects.

6.2    Investigators are responsible for submitting their research proposals to the IRB chair for review and approval prior to beginning their research, modifying their research in compliance with the IRB review, and administering the Informed Consent Forms, when required.   

6.3    The vice president of academic affairs is responsible for ensuring that the IRB is operational and functioning and for meeting with the IRB each spring.

7.0    Procedures

7.1    Investigators submit their research proposals to the IRB chair via email using the IRB forms located on the Casper College website.

7.2    The IRB reviews research and grant proposals and assigns them one of three categories: exempted review, expedited review, or full review. The IRB reviews proposals based on their categorization and either approves the proposal, approves the proposal with suggested modifications, or rejects the proposal.  

7.3    The IRB chair notifies the PI via email of the IRB’s decision regarding the proposal no later than 30 business days from the date of submission.

7.4    Investigators must secure signed Informed Consent Forms from each participant or parent or legal guardian, if the participant is younger than 18 years of age or has been judged incompetent, prior to conducting research involving humans. The PI must retain the informed consent forms for seven years. Informed Consent Forms are not required for research approved through an exempted review.

7.5    To minimize overlap and survey fatigue, the PI must notify the director of assessment prior to sending a college-wide survey to Casper College employees or students. The director will recommend survey periods. (See Casper College Survey protocol at http://www.caspercollege.edu/sites/default/files/documents/assessment/casper-college-survey-protocol.pdf.)

7.6    The IRB chair will contact the PI after the predetermined completion date for the study to verify that the study has been completed. If the study is still in progress, the IRB chair and the PI will determine a new completion date.