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What is an Institutional Review Board?
An Institutional Review Board (IRB) is an administrative body established to protect the rights and welfare of human research subjects recruited to participate in research activities conducted under the auspices of the institution with which the IRB is affiliated. The IRB has the authority to approve, require modifications in, or disapprove all research activities that fall within its jurisdiction as specified by both the federal regulations and local institutional policy.
Why does MECC have an Institutional Review Board?
MECC has moved increasingly toward a more data-driven decision-making model in recent years, creating the need to conduct more targeted studies on teaching methods and the impact of student services on student success. In addition, federal agencies are increasingly requiring grantees to incorporate rigorous program evaluation activities into grant-funded programs. As a result, research activities at the College have expanded significantly. MECC established its IRB in 2010 in order to ensure the protection of human research participants.
What are the guiding ethical principles of the IRB?
Mountain Empire Community College has adapted the ethical principles for protection of human subjects as stated in the Code of Federal Regulations: 45 CFR §46. Created by the National Research Act in 1979, the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research was established to enact these regulations. The Commission published The Belmont Report, which set forth the following basic ethical principles for the conduct of research involving human subjects:
- Respect for Persons – Acknowledgement of the autonomy of the individual and the responsibility to provide special protection for individuals with reduced autonomy.
- Beneficence – A responsibility to do no harm, to maximize possible benefits, and to minimize possible harm.
- Justice – An expectation of fairness in distribution of benefits realized from research as well as its burdens.
Does MECC have an approved IRB policy?
Yes. MECC has an IRB Policy that was last revised in December 2013.
How often does the IRB meet?
MECC’s Institutional Review Board meets at least once each year, usually in the fall, and schedules additional meetings throughout the year as needed to conduct business.
Are there deadlines for submitting an IRB review application?
MECC’s Institutional Review Board accepts applications on an ongoing basis. We recommend that applicants initiate the review process at least two months in advance of their desired approval date, in order to accommodate the scheduling of meetings.
How do I know if my research project requires IRB review?
In general, if your project can be described as a systematic investigation designed to develop or contribute to generalizable knowledge, and involves collecting information about, or interacting with, living humans, then it may meet the definition of human subject research and should be submitted for IRB review. When in doubt, investigators should contact the IRB Manager for additional guidance.
Where do I find IRB application forms?
The application form that should be used to initiate an IRB review is located in the menu on the left side of this page, under “Apply for IRB Review.” Once an initial determination is made regarding what type of review is required, additional required forms will be provided by the IRB Manager.
Do I need to complete Human Subject Protection Training?
All MECC IRB approvals are contingent upon completion of approved human subject protection training.
If you are looking for a free training option, we recommend the Protecting Human Research Participants training by the National Institutes of Health. This course allows users to create an account, save progress, and complete the training in multiple sessions. Investigators are encouraged to print a copy of the certificate of completion that is generated at the end of the course in order to document training completion.
What are my responsibilities after my research is approved by the IRB?
Investigators have a number of responsibilities beyond the initial IRB approval, including:
- Ensuring that no research activities begin until IRB approval is granted;
- Ensuring that all researchers (co-investigators, research assistants, etc.) working with the research subjects have completed appropriate human subject research training;
- Submitting a modification request if the purpose or design of the research protocol changes (investigators may not initiate changes in approved research without IRB review and approval, except in cases where changes are necessary to eliminate apparent immediate hazards to subjects);
- Submitting an application for continuing review (renewal) at least two months prior to the expiration of an existing IRB approval, if research activities (including data analysis) are expected to continue beyond the expiration date;
- Reporting any adverse events that occur during the research project;
- Submitting a close out report at the conclusion of the project;
- Maintaining records of all human subject research protocols for a minimum of three years after project completion; and
- Ensuring that research records are well organized an easily accessible by the IRB and the appropriate funding agent.
*For additional information on Principle Investigators’ responsibilities, modification requests, adverse events, etc., please see the MECC IRB Operational Manual.
Where can I find additional resources on the protection of human subject research participants?
The website for the U.S. Department of Health and Human Services Office of Human Research Protections (OHRP) provides a number of resources on the protection of human research subjects, including a variety of education and training opportunities.