Institutional Review Board

The UMHB IRB must approve activities in the following categories:

• Research projects involving the use of humans as subjects:
  • whether the procedure involves no risk or considerable risk;
  • whether or not the protocol involves deception of subjects;
  • if the subjects are UMHB students;
  • if the investigators are UMHB employees.
• Classroom or laboratory activities involving any of the following:
  • physically invasive activities such as blood drawing;
  • physically taxing activities such as a stress test; any activity where the student must ingest any substance (other than food);
  • any psychological or personality testing or any testing procedure not aimed at academic evaluation;
  • any activity where there is a risk of personal information becoming public;
  • any painful procedure;
  • any procedure involving psychological risk;
  • any activity where the student is or might be exposed to risk of contact with any potentially dangerous, infectious, toxic, or radioactive substances.

Research activities in which the only involvement of adult human subjects will be in one of the following categories are exempt from IRB review:

1. Anonymous surveys or questionnaires
2. Research involving the study of existing data, documents or records if these sources are publicly available or if the information is recorded in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.
3. Interviews of a non-personal nature

These exemptions do not include studies involving minors as participants or archival data previously gathered from minors. The IRB retains final judgment as to whether a particular activity is covered by this policy. Investigators who believe their study is exempt from review must submit a completed proposal to the IRB chairman to receive an exemption waiver to perform the activity at UMHB.

1. The clarity and quality of explanation of the study as it influences the IRB's ability to understand the background, aim(s), scope, procedure(s) and experimental method(s) of the protocol. This is very important and lack of explanation in any of these areas could lead to a delay in the approval process.
2. The nature and proposed implementation of the safeguards the author(s) proposes to limit the possibility of any risks that are associated with the study.
3. The structure and content of the "Informed Consent Form" ensures that the form explains the aims and procedures of the experiment to the participants. The IRB encourages all applicants to use the Informed Consent Checklist document as a resource when constructing the application.
4. The assessment of the risk to benefit ratio to the study participants.

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.

The IRB typically meets on the second Tuesday of each month. This may be adjusted for academic events, holidays, or other scheduled events. The rolling deadline for submission of IRB proposals is the typically the last business day of each month by 5pm unless otherwise specified. This deadline is strictly adhered to in order to allow ample time for the IRB members to review all applications.

Fall 2023

Spring 2024

Summer 2024

Applications that are reviewed in an expedited fashion are reviewed as they are recieved. Typical response time is 10-14 business days from the day of the submission.

For applications reviewed at the monthly IRB meetings, after the committee meets an email stating the decision is sent to the author of the proposal with copies to the faculty advisor (if applicable).

• Proposals “approved” as written are allowed to begin upon receiving the email containing the electronic version of the approval letter from the Chair of the IRB. The time frame for issuing this letter is typically 1-3 business days following the meeting.
• Proposals exempt from review are allowed to begin upon notification. The Chair of the IRB will send an exemption waiver electronically to the author for their records within 1-3 business days following the the determination of exempt status assuming no revisions are needed.
• Proposals “approved with modifications” must not begin until all requirements are met and final approval is given in writing. Within 5-7 business days, the author(s) will receive an email from the Chair of the IRB with a list of revisions. The time frame for approval if a proposal is approved with minor revisions (that are mandatory) is highly dependent on the author and the time that it takes to make all revisions.
• Proposals “not approved” may be revised and submitted. Within 5-7 business days, the author(s) will receive an email from the Chair of the IRB with a list of concerns that must be addressed. In this case, the author must resubmit a full application which will be subject to full review at a subsequent IRB meeting. In the event that a proposal lacks too much information for the IRB to make a decision on the proposal, the application will be not be approved.

The primary reason that an application could be “not approved” usually results from an incomplete application. Any missing items or lack of clarification of important information in the proposal can result in the proposal being denied and thus will be delayed until the next scheduled meeting (~one month).

The University, the Institutional Review Board (IRB) and individual investigators share a collective responsibility to ensure that research involving human subjects is guided by the highest ethical standards and is conducted in compliance with federal, state and university regulations governing such research. To assist the IRB and investigators in meeting these requirements, all researchers and investigators (students, staff, faculty, etc.) must complete an online training module that provides UMHB investigators convenient access to comprehensive and regularly updated human subject’s research guidance. The training module can be obtained through:

• Training

Please scroll past the course that is for a fee and select the course that is offered for free. You will create a login and add the free course to your account. Once you complete the course, view your transcript and score on the end of course exam and save this as a file on your computer. The transcript is what you will submit with your IRB application. Within the next two weeks, the software will shift from providing transcripts to providing certificates of completion and you can then start submitting certificates with your IRB application. The following instructional video may help.

Submitting Training Documentation to the UMHB IRB
Course training transcripts/certifications should be submitted with IRB applications for all investigators involved with a study. Training should be renewed every three years. If you have a current NIH or CITI certificate, you may continue to submit those with your IRB application.

As of September 1, 2018, submission of IRB applications will occur through software and will no longer be submitted by email. Please follow the link below to login in and access the software. To log in, use your UMHB OneLogin credentials.

• Mentor Login

If you would like to write or revise your content before submitting in the software, you can use the links below. Once you have finalized your content, you can copy and paste the content into the software. Please do not submit these documents to the IRB.

• IRB App Form
• IRB Application PDF
• UMHB Informed Consent Checklist

Below is a list of links that could be useful during the research and IRB process:

• The Office of Human Research Protections (OHRP)
• Compliance Oversight Information on the federal guidelines regarding the protection of human subjects (Title 45, Part 46, of the Code of Federal Regulations).
• Qualtrics link for faculty - students will be provided with a link by their faculty member