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The purpose of the IRB is to ensure that research projects at Roane State are conducted in full compliance with federal regulations designed to protect the rights and welfare of human subjects. The IRB ensures that research participants’ risks are minimized and that there is informed and voluntary participation in research studies. For IRB purposes, minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.
The approval process for research has been informal and has always been done through the Office of Institutional Effectiveness and Research. The TBR recently adopted a general research policy and guidelines for human subject research and in order to comply with the board’s policy a formal institutional policy and process needs to be implemented. The fact that we did not previously have an IRB does NOT mean that researchers at RSCC have been unethical; it means that the institution had not formally documented whether the research adhered to all regulatory requirements found in 45 CFR 46. Having an IRB allows an institution to formally document that the institution is following the generally accepted method of assuring that human research participants are properly protected.
Having a properly composed IRB makes research eligible for federal grants. All institutions that apply for federal funds for human subject research must assure funding agencies that proposals submitted are compliant with federal regulations that govern research with human subjects. Before a federal grant proposal can be submitted the status of human subject review must be indicated on the application. Having our own formal IRB has the potential to open up more possibilities for research projects, giving faculty more opportunities for professional development and collaboration with faculty at other institutions.
A formal IRB will allow us to apply and maintain federal-wide assurance with the Department of Health and Human Services (DHHS), Office of for Human Research Protection (OHRP). Virtually all grant projects and much of education research involves human subjects, and national grantors (e.g., NSF) require IRB review prior to proceeding with a grant award recommendation. In the future, grant proposals will have to indicate the status of the human subject review prior to submission, before a grant can even be submitted.
The RSCC IRB is responsible for assessing whether the risks to research participants outweigh and justify the anticipated benefits to the participants or populace. It is important to note that the creation of the IRB does NOT address all of the researchers’ ethical issues. Each researcher must adhere to the ethical codes of conduct that govern scientific research in general.
At least five members with varying backgrounds.
Shelley Esquivel (Chair)
Erin Burr (external committee member)
Karen Brunner (ex-officio member)
An IRB must consist of at least five members of varied backgrounds to facilitate diversity in its composition. In addition, the federal regulations require members with the specific varying backgrounds as listed above. Diversity of representation is necessary.
Upon acceptance and willingness to serve on the IRB, board members are not allowed to participate in the review of any project in which the member has a conflicting interest. That would include researchers involved in the project and administrators involved in grant proposals.
All committee members are or will be have some record of training. Completion of training requirements and/or educational expertise will be documented and kept on file to ensure that all IRB members have received relevant information.
A living human about who a researcher/investigator obtains data through intervention or interaction with the individual and/or personally identifiable information.
Much of the data collected within or on behalf of the institution does NOT meet the regulatory definition of “research” and, thus, would likely not require IRB review. Research involving the collection of data from human subjects would likely need to be submitted to the IRB for review. IF you are unsure if your data should undergo review, please review the Institutional Effectiveness and Research Website for further information. If you are still unsure, you should submit an IRB proposal or contact the Director of Institutional Research, Dr. Shelley Esquivel.
Yes. There are exempt, expedited and full reviews based on the research being proposed.
According to Federal Guidelines (45 CFR 46), research that presents little or no risk to human subjects (non-vulnerable subjects) does not require review by a convened IRB. Although the project does not require full board approval, the IRB Chair must certify exemption before the research project is authorized to begin. If the risks to human subjects appear questionable or the project does not fit into the federally defined categories for exemption, the IRB Chair will notify the investigator that he/she must submit the study for review for either an expedited or full review.
Examples could be: Census Data, national survey data, etc.
A research project eligible for an expedited review is any research project in which the involvement of human subjects is considered low risk. An expedited review requires only the review of the IRB Chair, Director of Institutional Research. For further information on expedited review categories (based on federal regulations), please go to the IRB website.
The IRB has the authority to approve, require modifications of a research protocol, defer action, and/ or disapprove research protocols involving human subjects. This board will provide oversight for research. This body can request additional information prior to making a final decision relative to a research protocol submitted for review. This body can take other actions, within the policy limits, as appropriate.
Engaging in human subject research without IRB approval can have serious ethical implications and violates college and federal policies. Students, faculty and staff are required to submit an IRB application before embarking upon any data collection for projects involving human subjects.
After review of the research protocol submission, the IRB Director will prepare a letter advising the investigator about the status of the research. Investigators may have to submit additional information for review prior to approval. Sometimes projects simply cannot be approved because there is insufficient information or inappropriate information; therefore, the IRB could not make an approval decision.
Forms are available at the Roane State Community College, Institutional Effectiveness and Research, IRB website.