LSCS encourages and supports the scholarly endeavors of students, faculty and staff of the System. Scholarly work and research often involves the use of human subjects. All research involving human subjects conducted at or sponsored by LSCS, whether funded or unfunded and whether conducted by LSCS faculty or others must comply with policies for the protection of human subjects and must be submitted for review to the Institutional Review. Researchers may not solicit subject participation or begin data collection until they have obtained clearance from the IRB.
LSCS and federal policies require that projects involving human subjects be reviewed in order to consider:
- The rights and welfare of the subjects involved.
- The appropriateness of methods used to secure informed consent.
- The balance of risks and potential benefits of the investigation.
NOTE: It is expected that all research investigators will read all material on the IRB Web site and fully complete the application for IRB approval. The IRB will provide research investigators with more information regarding the protection of human subjects upon request. It is NOT the goal or the responsibility of the IRB to comment on the quality of the research design or of the proposed research.
Submitting a Proposal
Please see Frequently Asked Questions to get a general overview of the IRB responsibilities and general definitions.
Once you have determined that you are conducting human subject research, please follow the steps below to complete the review process. Please allow one full month from the time you submit your completed application, with all necessary attachments, for the review process to take place.
All researchers must show proof of having taken a training course on research with human subjects. You may take the online course found at the National Institute of Health website, or you may provide verification of having taken a similar course. If your research is being sponsored by or is connected with another institution which also requires you to obtain an IRB approval from them, please include a copy of that approval letter with your application to the LSCS IRB, or some indication that your organization is aware of your research.
Fill out either the IRB Research Application Form or the IRB Research Application Form for Classroom Projects and submit to April.M.Odell@lonestar.edu via e-mail. Also submit the required forms and additional documentation as listed on the application form. (Be sure to save a copy for yourself.) On the IRB Links/Training link, you can find information that may be helpful to you in filling out the application.
Current LSCS faculty working on a dissertation or thesis, if not using LSCS students, faculty or staff as research subjects, may submit an approved IRB from their home institution in lieu of this application. Approval is not guaranteed. At the discretion of the LSCS IRB, you may be asked to submit an LSCS IRB application.
Once the proposal is submitted, the committee will review it and make a determination as to the status of the proposal. The proposal will fall into one of four review categories:
Some proposals fall into one of the Exempt categories as provided in federal regulations and as determined by the IRB. These proposals meet particular regulation and minimal risk requirements and may be eligible for a streamlined review by the IRB Chair or the IRB Administrator. Exempt proposals are not exempt from review but exempt from a full committee vote, and possibly exempt from any continuing review based on length of the study. Only the IRB can determine Exempt status. Exempt reviews are normally faster than the full committee review and do not require a vote. The results will be communicated to the investigator in writing and also reported at the next IRB meeting. IRB members may ask for discussion of any expedited reviews, or the referral to a full committee review.
The following types of research generally fall into the Exempt review category:
- Research conducted in established or commonly accepted educational settings, involving normal educational practices.
- Research involving the use of educational tests, interviews, surveys, or observation, unless information is identifiable and disclosure would place subjects at risk. (Survey and interview research with children is never exempt.)
- Research involving the collection or study of existing data if the sources are publicly available or the information is recorded in a way in which the subjects cannot be identified.
- Research and demonstration programs designed to study, evaluate or examine federal public benefit or service programs.
An expedited review consists of a review by the IRB Chair and one or more committee members. Expedited reviews are for proposals that meet minimal risk standards as determined by the regulations and the Chair. Expedited reviews are normally faster than the full committee review and do not require a vote. The results will be communicated to the investigator in writing and also reported at the next IRB meeting. IRB members may ask for discussion of any expedited reviews, or the referral to a full committee review.
Proposals that involve more than minimal risk must go through a full IRB review. Proposals that do not meet exempt review criteria, or proposals that the IRB Chair cannot Expedite because they require further discussion are sent to the entire IRB Committee for Full Review. The researcher may be invited to an IRB Committee meeting to discuss the application.
Once the category is determined, the IRB Committee or designees will review the Research Application Form and recommend one of the following:
- Approval: Proposal satisfies regulations and IRB requirements and research may commence.
- Conditional Approval: Approval will be given once specific recommendations from the IRB are met. Recommendations will be given to the investigator in writing, and no research may begin until a revised Research Application Form has been submitted and the revisions have been evaluated.
- Tabled: Not enough information provided on the Research Application to make an informed decision, additional discussion is required, or a majority of voting members could not be obtained.
- Not Approved: Research proposal does not meet federal regulation or institutional requirements. Reasons for non-approval will be given to the investigator in writing.
Once the committee has reviewed the Research Application Form, the Principal Investigator will be informed in writing, typically via e-mail, of the status and recommendation. If approved, research may begin immediately upon receipt of the official correspondence.
Please note that approval by the IRB does not constitute approval of the Office of Institutional Research and Effectiveness (ORIE) to release student records.
The LSCS IRB requests that you share the results of this research project with the IRB office when you have completed it. The data from your study could be very useful to grant writers and to others in the LSCS system. You will be given complete credit for its authorship.