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Tilman J. Fertitta Family College of Medicine

Student IRB Guide

Student Institutional Review Board (IRB) Guide

  • What is Research?

    The University of Houston defines research as, “a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge."1 Student theses and dissertations, by default, are designed to contribute to generalizable knowledge. Individual projects in research methods courses may or may not fall under the definition of "Research," based on the ultimate intent of disseminating results, however such activity does require notification to the IRB office if the project involves typical research-related activities (including but not limited to informed consent, interviews, focus groups, and surveys involving human subjects.”

    • 45 CFR 46.103(d)

  • What is Human Subjects Research?

    According to the University of Houston, HUMAN SUBJECT means a living individual about whom an investigator (whether professional or student) conducting research (i) obtains information or biospecimens through intervention or interaction with the individual, and uses studies, or analyzes the information or biospecimens; or (ii) obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.2 An algorithm for determining whether an activity is Human Research can be found in the "WORKSHEET: Human Research Determination (HRP-310)," located under the "Worksheets" tab in the ICON library. Use this document for guidance as to whether an activity meets either the DHHS or FDA definition of Human Research, keeping in mind that the IRB makes the ultimate determination in questionable cases as to whether an activity constitutes Human Research subject to IRB oversight. You are responsible for not conducting Human Research without prior IRB review and approval (or an organizational review and approval of exempt Human Research). If you have questions about whether an activity is Human Research, contact the IRB Office any time at CPHS@central.uh.edu, and they will provide you with a determination.

    • 45 CFR 46.102(f)

  • Type of Research

    In general, studies involving cadavers and literature reviews do not require IRB approval. Protocols using publicly available datasets requiring user registration need to be reviewed by the IRB. The IRB is the only party that can determine the review category. Depending on the nature of the data set and the analysis involved, may be considered exempt or expedited. Quality improvement activities may not meet regulatory criteria for research, but best practice would be to obtain an official letter of determination from the UH IRB. Research studies involving protected populations (i.e. minors, pregnant women, incarcerated individuals, etc.) or sensitive information (i.e. medical record, related to alcohol or drugs, sexual activity) typically need to be reviewed by the IRB.

  • Overview of the IRB Process

    Before any research potentially involving human subjects can take place, the IRB must review and approve the research. The IRB cannot grant retroactive approval of studies, even if they would be classified as Not Human Subjects Research or Exempt.  It is important to allow enough time for the IRB review process.

    The process to create and submit an IRB protocol may look like the following:

    • Determination of whether the study requires IRB review
    • Completing any relevant trainings (i.e. CITI training)
    • Drafting the IRB protocol
    • Completing revisions from faculty mentors
    • Submitting the IRB protocol along with any surveys, forms, flyers, scripts
    • Completing any requested revisions from the IRB
    • Secure any other required approvals

    Researchers should allow plenty of time for this process. It may take several weeks or longer, depending on the specific scenario.

    Consideration When Writing the Protocol

    When writing your IRB protocol, where applicable, be sure to describe the following:

    • How participant privacy will be protected
    • How data will be protected and secured
    • How participants will be recruited
    • How consent will be obtained and/or documented
    • Safeguards for vulnerable subjects
    • Risks to participants are minimized yet reasonable in relationship to potential benefits

    Consent

    Obtaining a waiver of document for consent means the requirement to obtain a participant signature is waived. This may be appropriate for interviews or surveys. In other instances, a full waiver of consent may be requested such as for a retrospective review of data. In general, full informed consent may be obtained when collecting sensitive information or conducting an interview.

    Collaborative Institutional Training Initiative (CITI) Program

    All UH human subject investigators and research personnel are required to complete the CITI training program before commencing their research activity.

    To begin the online course, visit the CITI website and select “Register for the Course”. Select University of Houston as your institution, and a username and password (see detailed instructions below). For the training record to be automatically pulled into the UH Research Portal (ICON), you must use your UH email address ending in uh.edu.   

    There are three options for human subject research training. Depending on your research topic, please choose “Group 1” or “Group 2” and complete the required courses. None of you should select “Group 3”. 

    Group 1: Biomedical Researchers (and students) 

    Group 2: Socio-Behavioral-Educational Researchers (and students) 

    Group 3: IRB Members 

     

    Additional Human Research Training

    If conducting research that collects or uses Protected Health Information (PHI), the Information Privacy & Security Training must also be taken.

    If collecting educational data, the Family Educational Rights and Privacy Act (FERPA) training is also required.

    Investigators and clinical trial staff responsible for the conduct, management and oversight of NIH-funded clinical trials must complete training in Good Clinical Practice (GCP).

    Integrated Compliance Oversight Network (ICON) System

    All study protocols and documents need to be entered into ICON.

    For more detailed information and video tutorials, see below:

    When submitting a study in ICON, a departmental reviewer is required. The faculty mentor or Department Chair can provide more information.

     

    University of Houston IRB Committees

    IRB Committee 1 reviews human subjects research protocols submitted by faculty or staff by the College of Medicine. The submission deadlines and meeting dates for full committee review are listed here. Protocols that may be considered expedited or exempt are reviewed on a rolling basis.

    IRB Committee 3 reviews all student-led human subjects research. Faculty sponsors are required. The submission deadlines and meeting dates for full committee review are listed here.

    The University of Houston IRB has special office hours for students.

     

    Post-IRB Approval Activities

    If your study continues beyond the original end date, you may need to extend your IRB protocol submission. The UH IRB should also be informed as soon as possible if something occurs that places participants at risk or is concerning. If something changes in the approved study protocol such as adding a new team member or changing survey questions, you must submit a modification request through ICON before proceeding with the new changes. At the end of the project, make sure data is stored appropriately and/or transferred if a student graduates before. Students joining existing projects with UH faculty must be added as an internal team member to the IRB protocol.

     

    External IRBs

    Students or faculty may be involved in a project with external faculty members. Even if the project is approved by an external IRB, because of the learner’s affiliation with the University of Houston, UH IRB must be involved. They may decide to cede oversight to the external IRB or require full committee review. While there are reciprocity agreements in place, researchers should involve the UH IRB early. A UH faculty member is required to act as an administrative support for students.

IMPORTANT: While the information provided here is designed to facilitate your research and scholarly activity at the College of Medicine, students with questions should follow up with the University of Houston Institutional Review Board (IRB) or Institutional Animal Care and Use Committee (IACUC). Failure to obtain the correct approvals in a timely manner can jeopardize the collected data, prevent the publishing or presentation of results, and place the researcher and the university in violation of federal regulations. It is the responsibility of the mentors and students to make sure they are conducting their research in accordance with all UH and other institutional policies and procedures.