HSU Institutional Review Board

Welcome from the Hardin-Simmons University Institutional Review Board (IRB). We are excited that you are choosing to perform research at Hardin-Simmons University.

If you are a new investigator, we are very pleased to assist you as we believe that quality research is an essential part of the educational process. We will attempt to make the proposal process as informative and painless as possible. Of course, if you are a seasoned investigator, our purpose is the same, to assist you in the conduct of research at Hardin-Simmons University.

The purpose of the Hardin-Simmons University IRB is to protect the rights and welfare of individuals who volunteer to participate as research subjects. It is the responsibility of each investigator, whether they are an administrator, faculty member, staff, or student to protect the rights of subjects. Ultimately, the IRB provides a safeguard for the promotion of ethical and responsible treatment of human subjects by reviewing all human research and subsequently providing education and guidance to the research community.

All research involving human subjects must be reviewed and either exempted from IRB review or approved by the IRB before the research project can be initiated. Hardin-Simmons University and the members of the IRB are guided by federal regulations, university policies, and the ethical principles of the Belmont Report. The Institutional Review Board here at Hardin-Simmons operates under a Federal Wide Assurance (FWA) filed with the U.S. Department of Health and Human Services (HHS) Office of Human Research Protection (OHRP) (FWA 00022307) through September 5, 2019. Hardin Simmons University’s IRB is registered with OHRP and the FDA.

The Hardin-Simmons University IRB is composed primarily of HSU faculty/staff with expertise in education, health-care, psychology, philosophy, and research design/statistics. There is also a member of the IRB that is employed outside of Hardin Simmons University and is an expert in K-12 education. The IRB reserves the right to ask for expert guidance from community members as needed. Hardin-Simmons University is a private, faith-based institution and as such reserves the right to support research that is supportive of its mission and values.

Please follow the steps found on this website to complete the review process. If you have any questions about the submission or review process, please do not hesitate to contact the IRB Chair. Any questions/comments related to misconduct should be directed to the IRB Chair, Dr. Jennifer Hennigan, and the Institutional Official, Dr. Christopher McNair, Provost and Chief Academic Officer. If you have any questions about the submission or review process, please do not hesitate to contact the IRB Chair by email at IRB@hsutx.edu.

To submit a study involving human subjects, first the type of review requested must be determined, either Exempted Research, Expedited Review, or Full Review.

  • Exempted Research must fall into one of 8 categories as outlined on the Exempt Research Application. Examples may include studies using only surveys, interviews, educational tests, and benign interventions.
  • Expedited Review may be conducted for research that is minimal risk and falls in one of 7 categories outlined on the Expedited Review Application. Examples may include collection of sound and video recordings, collection of biological samples from noninvasive procedures.
  • Full Review must be conducted for all research that are more than minimal risk and do not fall in either the Exempt or Expedited categories.

The following flowcharts serve as abbreviated guides for the most common applications received by the HSU IRB. If you believe your research falls under an exemption, please ensure to review the ENTIRE Exempt research application to select the correct exemption. Incorrect form submission will delay the processing of your application.

A flow chart for the Institutional Review Board process.

 

A flowchart for the Institutional Review Board process.

Exempt Research Application

Full Review Application

If you need additional guidance, more detailed flowcharts provided by the Office for Human Research Protections (OHRP) may be found here: https://www.hhs.gov/ohrp/sites/default/files/full-2016-decision-charts.pdf.

Download and complete the appropriate application for your research from the Applications linked below. Complete all supplementary documents that are required for each application. Email all documents as separate files to IRB@hsutx.edu.

Submit all documents with the last name and first initial of the Principal Investigator before the assigned file name.

  • Ex. Smith J HSU Exempt Research Application.docx
  • Flower P Full Review Application.docx
  • Flower P Investigator and Faculty Advisor Assurance Form.pdf

Note: All Submissions must be accompanied by the signed Investigator and Faculty Advisor Assurance Form.

For Exempt Applications submit the following

For Expedited Review Applications submit the following

For Full Review Applications submit the following

Should you have any questions regarding the email submission process, please contact the IRB at IRB@hsutx.edu  or the chair of the IRB  Jennifer Hennigan at 325-670-1396.

Proposals are typically distributed to committee members within a week of their receipt (except during University holidays and breaks). Investigators will receive confirmation their proposal was received when it is sent out for review. Reviews may take 4-6-weeks. Delays are expected around holidays, breaks or vacations (i.e., summer). Please allow time to provide clarifications to the committee.

Proposals are determined by the committee as either:

    • Approved
    • Approved with Modifications
    • Further Information Needed
    • Denied

Approved proposals may be initiated immediately. Proposals requiring modifications should be resubmitted with the required changes within one month. Proposals requiring more information or those that are denied may be reworked and resubmitted to the committee at a later date.

Projects are generally approved for a period of one year. Investigators who are conducting projects that extend beyond this time frame should notify the IRB of the expected date of completion and request extended approval. Likewise, primary investigators are expected to report significant changes in protocol or adverse effects immediately to the IRB.

HSU complies with the Department of Health and Human Services regulations 45 CFR 46. Prior to the initiation of any study involving human subjects, investigators must have sufficient training to ensure the protection of human subjects. All HSU investigators must complete a free Clinical Research Training (https://crt.nihtraining.com/login.php) course prior to submission of a request or provide evidence of the completion of an equivalent course. Certificates of completion are required for the approval of the research study. Training must be completed every 4 years

If you are a HSU Faculty or Staff member who is collaborating with Primary Investigators from another institution and obtain IRB approval from the collaborating institution, please submit the following to IRB@hsutx.edu.

  • IRB approval letter from the home institution
  • Proposal Submitted
  • Investigator Human Protections Training Certificates
  • Signed Investigator and Faculty Advisor Assurance Form
  • Any supplementary information provided to the home institution (e.g., consent form, surveys, etc.).

If you are an external researcher wishing to conduct research with HSU faculty, staff or students, please the complete the External Research Review form and email it to IRB@hsutx.edu.

Frequently Asked Questions (FAQ)

The Institutional Review Board (IRB) has been created to protect the rights of human subjects. As such, the IRB pays special attention to the Methodology section of a proposal, as well as Informed Consent. An investigator must clearly spell out what a subject is required to do, the risks that the subjects might incur, and how subjects will be protected from these risks.

Within the context of a review, student investigators often do not provide enough detail about methodology, research design, and statistical analysis in their proposal. When questions arise, either prior to a formal proposal review or following it, the investigators will be asked to address each item prior to final disposition of the proposal.

The IRB Chair will communicate with the investigator as necessary. Upon receiving a proposal, the IRB Chair may request clarification or the submission of missing information. Investigators should respond to the IRB Chair as promptly as possible.

As feedback arrives from the committee members, the Chair compiles comments and communicates with the investigator using detailed, numbered comments. The investigator should respond to each numbered comment, and make appropriate modifications within the proposal, consent forms, or appendices. A letter, restating each comment, where and how comments were addressed should be included in a response to the IRB. Color highlighting (and mention of that in the cover letter) is often helpful in demonstrating where changes have been made.

A consent form is needed for all proposals. All subjects should be provided with a personal copy of the consent forms. It is the responsibility of the investigator to maintain records of the consent forms.

45 CFR 46 requires specific elements to be included in an informed consent and these are outlined in 46.116. Briefly they are as follows:

  1. A statement that the study involves research, an explanation of the purpose and expected duration of the subjects’ participation.
  2. A description of the procedures and reasonably foreseeable risks or discomforts
  3. A description of the benefits to subjects or others
  4. A disclosure of appropriate alternative procedures or treatments
  5. A statement describing the extent of confidentiality
  6. An explanation of whom to contact for answers to questions or subjects’ rights, and whom to contact in the event of a research-related injury
  7. A statement that participation is voluntary or participant may withdraw at any time

Some examples are provided:

  • Traditional Face-to-Face Research – With more traditional research occurring in a classroom or lab, a paper-pencil consent form is useful where subjects provide an actual signature.

In Person Consent Template

  • Computer/Email Surveys –The consent letter should contain the same elements as a traditional consent form, however, the subject provides consent by initiating the survey.

Computer-based Consent Template

  • Consent/Assent for Minors –Studies involving minors or those who are unable to provide their own consent must have the consent of a parent or guardian. If able, those subjects should provide assent to participate. Studies involving minors often must undergo an expedited or full review.

Yes. In order to avoid survey fatigue, survey research is limited to the delivery of 1-2 proposals per month. Please check with the IRB chair in this regard. Survey research will be managed in collaboration with the IRB and Institutional Technology. Student email addresses are not shared with investigators. There may be a charge for the conduct of these projects depending on their complexity and availability of IT staff.

For all studies that were approved by expedited for full board review, any and all proposed changes must be approved prior to implementation (except to prevent the immediate harm to participants).

If the study is not being amended in a way that changes its classification, please submit the following to IRB@hsutx.edu.

If the study is being amended in a way that changes its classification (ex. increasing risk from minor to moderate, or causing it to no longer fall under an exemption), please submit a NEW application to IRB@hsutx.edu using the corrected form. Additional information will be required to approve the proposal.