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 designated Institutional Official, Dr. Dennis G. O’Connell. Any questions/comments related to misconduct should be directed to Dr. Travis Frampton.

Hardin-Simmons University faculty/staff (part-time or full-time) or students (part-time or full-time) conducting human research as a function of their relationship with Hardin-Simmons University or any individuals (ex. External investigators) who wish to collect data on human subjects with, at, or affiliated with Hardin-Simmons University must comply with guidelines below.

All investigators should read the “Frequently Asked Questions” document on this website for further clarification.

Required Steps

  • Complete the Research Review Request Template.
  • All proposals must include an Informed Consent Form (when appropriate) or a cover letter for survey research where submission of the survey implies consent. Consent forms should be included as appendices within a proposal. Sample consents are found here.
  • When possible, investigators should attach photos, sketches, diagrams or other supporting materials to the proposal as appendices to help explain methods. These materials will assist IRB committee members in understanding the risks and safeguards discussed within the proposal and consent documents.
  • Investigators must complete a free three (3) hour Protection of Human Subjects course prior to submission of a request. The purpose of the course is to provide a more in-depth education on the responsibilities of an investigator conducting experiments involving human participants.
  • The preferred mode of submission is an email of the proposal and any accompanying documents using Microsoft Word to the IRB Chair.
  • 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 generally take 2-4-weeks, so investigators can expect to hear back from the committee chair within that period. Delays are expected around holidays, breaks or vacations (i.e., summer). Please allow time to provide clarifications to the committee.
    • Proposals are categorized 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.

Required Submission Pieces

Investigators – Group 1a (Investigator seeking initial approval from an IRB and/or HSU employees/students) Submit

  • HSU Faculty/Staff conducting their own investigations as the Primary Investigator (PI)
    • (If using HSU IRB as primary, submit information as per Group 1a. If using other institution as primary IRB, submit information as per Group 1b.)HSU Faculty/Staff completing degree requirements at another institution
  • HSU Students who are conducting human research as a course or degree requirement, including undergraduate or graduate research projects, theses, dissertations, etc.
  • Cover letter/email to HSU IRB
  • Proposal, i.e., consent form and appendices as needed
  • Protection of Human Subjects Certificate of Completion for each investigator

Investigators – Group 1b (Proposal has been approved by a federally sanctioned IRB)

  • Faculty/Staff/Students from other institutions
  • HSU Faculty/Staff who are collaborating with Primary Investigators (PI) from other institutions
  • Cover letter/email to HSU IRB
  • IRB approval letter from home institution
  • Proposal, i.e., consent form and appendices as needed in original format from approving institution

Students & Professor – Group 2 (In-class projects only)

  • Students who are completing a class assignment on classmates where the research process/results will only be discussed in class.
  • Written statement from professor making IRB aware of course requirement

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.

Investigators – Group 1a (Investigator seeking initial approval from an IRB and/or HSU employees/students) Submit

  • HSU Faculty/Staff conducting their own investigations as the Primary Investigator (PI)
    • (If using HSU IRB as primary, submit information as per Group 1a. If using other institution as primary IRB, submit information as per Group 1b.)HSU Faculty/Staff completing degree requirements at another institution
  • HSU Students who are conducting human research as a course or degree requirement, including undergraduate or graduate research projects, theses, dissertations, etc.
  • Cover letter/email to HSU IRB
  • Proposal, i.e., consent form and appendices as needed

Investigators – Group 1b (Proposal has been approved by a federally sanctioned IRB)

  • Faculty/Staff/Students from other institutions
  • HSU Faculty/Staff who are collaborating with Primary Investigators (PI) from other institutions
  • Cover letter/email to HSU IRB
  • IRB approval letter from home institution
  • Proposal, i.e., consent form and appendices as needed in original format from approving institution

Students & Professor – Group 2 (In-class projects only)

  • Students who are completing a class assignment on classmates where the research process/results will only be discussed in class.
  • Written statement from professor making IRB aware of course requirement

The level of review for each proposal is determined by the IRB.

Two categories of review include Exempt and Non-exempt. Research proposals within the Non-exempt Category may undergo either an expedited review or full review based on their complexity relating to the protection of human subjects.

  • 1. Research Exempted from Review
    Education research projects for instructional purposes and/or class demonstration provided that the data obtained is not for formal analysis or future off-campus presentation or publication.

    • Confidentiality of all respondents or participants is still required.
    • Research involving the collection or study or existing data from publicly available sources. Student research within a particular class may fall under this designation and interested instructors should discuss this with the IRB Chair.

    Research fitting this category will be reviewed by two members of the HSU IRB, usually the Chair and Vice-Chair.

    The IRB understands that the University Administration, Department Heads, and others require information from faculty, staff, and students about a variety of topics related to the “administrative working” of the university. This includes but is not limited to surveys on food services, surveys of new student engagement, institutional effectiveness, faculty and staff member or the year, etc.

    These types of surveys are considered exempt from review or approval by the IRB as they are for the betterment of the university faculty, staff, students, and other related parties.

    It is understood that the completion, non-completion, or answers provided on these campus-wide surveys will not be tied to:

    • Individual faculty tenure/promotion; or faculty/staff hiring/firing/advancement/demotion and/or
    • Individual student promotion, demotion, and/or disciplinary actions.

    It is further understood that the information gathered with these surveys will be used internally for university-related decision-making process and will not be published, presented or otherwise used elsewhere.

  • 2. Non-Exempt Research
    • a. Expedited Review
      Research conducted at Hardin-Simmons University, intended for publication or presentation representing the University, which falls within the following categories, may undergo an expedited review:

      1. Research not entailing the use of human subjects.
      2. Research for the validation or reliability of equipment or products that do not require human subjects.
      3. Research involving existing data from human subjects that cannot be traced to the subjects and will not impact the subjects or their standing at Hardin-Simmons University in any way. It does not include subjects from protected classes.

      Research fitting this category will be reviewed by two members of the HSU IRB, usually the Chair and Vice-Chair.

    • b. Full Review
      All other human subjects research. Research fitting this category will be reviewed by the HSU IRB Chair, Vice-Chair, and committee.

Most proposals are reviewed and feedback provided within 3-4 weeks unless they are submitted close to or during a typical vacation time (ie. spring break, Christmas and summer vacations) when a delay can occur. Investigators are encouraged to communicate with the IRB chair anytime during business hours, in particular, 2-weeks after a proposal has been identified as being received by the IRB to learn of the proposal’s status.

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. This consent form may take several forms and examples are provided under “Documents” above. All subjects should be provided with a personal copy of the consent forms.

  • 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.
  • 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.
  • 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 or protected classes generally require a longer review period.
  • Consent for HSU Students –Students under the age of 18 years of age should be excluded from investigations unless consent is provided by a parent or legal guardian.

Samples of these consent templates can be found under Documents.

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.