• 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.

    • Who must recieve IRB approval and what must they submit?
      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)
      • HSU Faculty/Staff completing degree requirements at another institution
        • (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 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
       
    • What types of reviews are provided by the HSU Institutional Review Board?

      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 fathered with these surveys will be used internally for university-related decision-making process and will not be publised, 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 and expedited review:
          1. Research not entailing the use of human subjects.
          2. Research for the validation or reliability of equipment or products that does 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.
         

       

    • How long does the review and approval process take?

      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 in particular 2-weeks after a proposal has been identified as being received by the IRB to learn of the proposal's status.

    • What kind of communication should investigators expect with the IRB?

      The IRB Chair will communicate with the investigator as necessary. Upon receiving a proposal, the IRB Chair may request clarificiation 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.

    • What kind of consent form is needed for research supported by HSU?

      A consent form is needed for all proposals. This consent form may take several forms and examples are provided under Documents. 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.

       

    • Is there any limit to survey research conducted at HSU?

      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 the their complexity and availability of IT staff.

    • How can I learn more about protecting the rights of human subjects as an investigator?

      Interested investigators may complete a free three (3) hour Protection of Human Subjects course if they so desire. The purpose of the course would be to provide a more in-depth education on the responsibilities of an investigator conducting experiments involving human participants.

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