The time and resources the committee has at its disposal are limited, thus each applicant should ensure that their application is complete and has appropriately addressed each question. Incomplete applications or applications that do not adequately address each issue may result in delays or a rejection of your application.
Applications involving UMHB students, regardless of level, must be submitted by the designated Faculty Supervisor for that project. The primary student associated to that project should be copied on the email correspondence when submitting the application.
Faculty Supervisors are responsible for determining that the IRB application is complete, the information is accurate, and that all necessary forms (i.e., consent, assent, questionnaire, survey, etc.) have been included in the file. This policy helps ensure that applications are not rejected because of lack of content, thus delaying the process and possible approval.
Expedited Review:
The Institutional Review Board (IRB) at UMHB will review all appropriate applications in an expedited review process. All proposals including items that authors believe are low-risk and could be reviewed in an expedited fashion should submit their completed application to the IRB Chair and that application will be initially reviewed. If it is deemed that the application fits the expedited review criteria, the IRB Chair will distribute that application to one member for review. If approved or deemed exempt, the IRB Chair will send revision requests to the author(s) and once those are complete the approval letter or exemption waiver will be issued electronically.
Expedited review applications do not have to be reviewed at the full IRB monthly meetings. Expected time of review/approval is 10-14 days from the date of the submitted application.
Full Board Review:
Applications that involve research studies using human subjects that are above "low-risk" are required to submit a full application and appropriate documents pertaining to the study. All applications are reviewed at the regularly scheduled IRB meetings. All authors will receive a decision within 5-7 business days following each meeting. If approved, the IRB Chair will send revision requests to the author(s) and once those are complete the approval letter will be issued electronically.
All applications, expedited and full review, should follow the guidelines below:
Rationale:
The application should begin with a description of the research background and rationale for the project. The research question(s) being addressed should be clearly outlined and must align with the research design.
Methods:
The methodology to perform the project should be described completely. Key areas that must be addressed include: how many subjects will be used, how they will be recruited, possible risks to subjects (both physical and psychological), plans for the data including statistical analysis plan, method(s) and safeguards to limit risks associated with participation.
Informed Consent Document and Checklist:
An informed consent document that fully informs potential subjects of the nature of the activity should be constructed and included in every IRB application. Author(s) should refer to the Informed Consent Checklist and use it as a guideline for constructing the informed consent document. Subjects should be given a copy of the informed consent to keep for their records if the consent process takes place in person. The informed consent document should be submitted exactly as it will be used (e.g., correct formatting, on letterhead, etc.) and any changes to such document are subject to review and approval by the Chair of the IRB.
Questions concerning this research may be directed to Dr. Aaron Baggett, Chair of the IRB committee at
abaggett@umhb.edu or 254-295-4553. Questions or concerns may also be directed to Dr. Kris Ward,
Director of Research at kward@umhb.edu or 254-295-4546.
Protocols using minors as subjects must acquire parental consent since the parent bears the responsibility of consenting to the child's participation in a study. In addition, assent forms for the minor must be included as well.
Research Instrument(s) to be used (such as surveys, interview questions, etc.):
If the research study involves the use of an interview protocol or a survey questionnaire instrument, submit a copy as an appendices in the application document. Other examples of appropriate items could include subject recruitment/advertisement documents, possible signature pages, approval letters from state or district supervisors, etc.
Appendices:
Attach all information pertinent to the proposal, such as approval/consent letters already received from participating agencies, school districts, companies, etc. and refer to them in the application where appropriate.
