FAQ

You don't have to figure all of this out on your own.  You can ask any question or ask for any guidance from the IRB:  IRB@gonzaga.edu



1 . What is the definition of research?^

http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html:

Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. For example, some demonstration and service programs may include research activities.
Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains
               1)  Data through intervention or interaction with the individual, or

               2)  Identifiable private information.


    Not all experiments with human subjects, human data and/or human anatomical substances constitutes (categorically) "human research." 

     For Example:  Off-label use of FDA approved medication or using cheek swab for PCR experiment, but are not part of research as defined above.

    You may also be doing Quality Improvement (QI) / Process Improvement (PI) activity, which may NOT need IRB approval.

    For Example:

    • QI is designed /intended to bring about immediate improvements in an entity.
    • QI is designed to have its findings applicable to the local institution.
    • QI is designed to sustain the improvements.
    • QI does not require rigid, fixed protocols.
    • Processes are no greater than minimal risk.
    • Continuous monitoring, data collection and assessment, allowing ongoing modification to correct deficiencies and make improvement.

    2 . When and why do I need to be concerned about research review at GU?^

    •  If you are not certain if you need IRB approval, you should contact the IRB directly at IRB@gonzaga.edu.  Please send submissions to IRBSubmission@gonzaga.edu.
    • Before starting a project at GU, all proposed research using human subjects, human data or human anatomical substances must be evaluated and approved by the Institutional Review Board (IRB).  In addition, some classifications of ongoing research are reviewed at least annually or when certain changes are made to the research's scope or activities. The University requires that all research be conducted within the highest possible legal requirements, federal policies and ethical principles.
    • Legal requirements to protect human participants apply to a much broader range of research than you may realize.  Often, additional ethical standards are applied in many disciplines.
    • Faculty, staff, or students conducting human research, or involved as key personnel in a research or training project, may complete an online educational tutorial and certification.  This tutorial is accessed through the Collaborative Institutional Training Initiative (CITI Program) at https://www.citiprogram.org/, or the National Institutes of Health, Office of Human Subjects Research website: http://ohsr.od.nih.gov/

    3 . What kind of projects are reviewed and what standards are used?^

    Every protocol is assessed for the necessary triad of qualities: 

    1. Regulatory Compliance
    2. Ethics
    3. Scientific Integrity Quality and Validity.

    GU's Institutional Review Board evaluates both (a) initial  research protocols, and (b) ongoing research projects that use human subjects, human data or human anatomical substances.  The standard includes the legal requirements and the ethical guidelines that exist for each discipline.  For example, human research often involves:

    • Private information, such as survey responses, educational records, medical information, etc., that can be identified with an individual - even if the information was not specifically collected for your research;
    • Legal permission from adults, minors, and children, such as the need for Informed Consent, the kind(s) of consent needed, and the manner of obtaining consent;
    • Safeguards, such as plans that must be put into place for protecting the confidentiality of the participants and tier relatives;
    • Materials, such as cells, blood, urine, tissues, organs, hair or nail clippings, etc. - even if you did not directly collect these materials; and audio and videotape materials.

    4 . Why is Informed Consent required from human subjects?^

    The purpose is to insure that human participants (a) are informed of the research process and procedures, (b) are informed of the risks and benefits, and (c) are protected against any possible violation of privacy or confidentiality that could cause harm to themselves or their relatives.

    Exempt research does not necessarily require a standard signed consent form.  If appropriate, you can use verbal consent and/or provide a simple information sheet with no signature line.  You may also use a full waiver of informed consent in some studies.  See http://answers.hhs.gov/ohrp/categories/1566 

    5 . What are the responsibilities of GU's IRB?^

    • Education, training, and assistance for faculty, staff, and students who are involved in research.
    • Evaluation, Approval and Monitorig of all research protocols for initial (new) research.
    • Classification of all research protocol categories.

    6 . If I obtain all the data from collaborators, do I need to obtain IRB review of my initial research protocol and reviews of ongoing research?^

    Yes, both you and your collaborators must have your respective institutions approval and ongoing approval.  However, you do NOT need ongoing (Continuing Review) if:

         (a)  the initial IRB review classifies your research proposal as Exempt (free) from continuing reviews each year, and

         (b)  no changes are made to ongoing research that alters the Exempt classification.

    7 . Where on the Internet can I find help and additional information about human research?^

    Office for Human Research Protections (OHRP) http://www.hhs.gov/ohrp/

    NHGRI Ethical and Social Issues Program http://www.nhgri.nih.gov/ELSI/

    See Reference Links page for more.

    8 . How long do I need to hold my research data?^

    Three years.