Helpful Hints for a Successful IRB Review

  1. Determine whether or not you need to seek IRB review. If you will be publishing or presenting the results of your research in a public forum (even as a thesis report), then your work probably does qualify as research. HOWEVER, if you are doing research which will only be used internally by an organization (e.g., evaluating a classroom protocol, determining whether or not something is a successful marketing campaign), then IRB approval does not fall under federal guidelines for research.
  2. Determine your level of review. People with many years of experience in reviewing proposals can differ over which level of review is most appropriate for a given research project. Please read the guidelines provided as carefully as you can. There are five main criteria that go into determining your level of review, listed below. A general rule is that the more criteria your research meets, the higher the level of review your proposal will need.
    1. Are the participants from a vulnerable population? Federal regulations list several vulnerable populations, including children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons (see 45 CFR 46.111 (a)(3)). UST also includes several other populations, which are listed in the IRB application (question 10d). Note that non-English speaking persons are listed as a “special population”; this is due to potential concerns involving informed consent. If any of your participants fall within one or more of these populations, your proposal will very likely need to have at least an expedited review.
    2. What is the degree of risk to participants in your research? Generally speaking, any study with greater than a minimal risk to participants will require a full board review. Minimal risk means that “the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests” (45 CFR 46.102 (i)). If you are unsure if your research contains more than minimal risk, please contact your research advisor, department chair, or the IRB (irb@stthomas.edu).
    3. Is the participation of subjects truly voluntary? If a current or prior relationship between you and the potential subject exists (e.g. co-worker, client, teacher or student, supervisor or supervisee, etc.), then the potential for coerced consent exists. You will need to include safeguards in your proposal to ensure that your subjects are not coerced to participate in your research, particularly if you are or have been in a position of authority over the potential subject. Depending on the research population, you will need to complete at least an expedited level proposal if the potential for coerced consent exists.
    4. What is the ability of your participants to give informed consent? Several populations may not have the ability to accurately understand the procedures, benefits, and risks of your study, including children, persons with cognitive disabilities, and non-English speaking persons. In addition, prisoners may not have the ability to make a truly voluntary and non-coerced decision about participating in a study. If the possibility exists that your participants may not be able to fully give informed consent, your proposal will have a higher level of review, especially if it involves more than minimal risk.
    5. Anonymity/Privacy Issues: Your research sample is anonymous if no one, including yourself, is able to determine the identity of your subjects based on the data you collect from them. An example of such a method of collecting data is a survey mailed to randomly selected participants that does not ask for identifying information. If you or anyone affiliated with your study knows the identity of your subjects, or if anyone reviewing your research can identify your subjects based on the data you publish, then you will need to implement additional measures in order to safeguard the privacy of your subjects. In this case, your proposal will be at a higher level of review based on the potential for harm to your subjects if the confidentiality of your data is compromised.
  3. Plan on the IRB process taking “real time”. Why?
    1. When applications are submitted, faculty members who review them will be notified that a project is available for review in IRBnet.
    2. The term “expedited review” is a misnomer. This is the term used by the federal government to indicate that you do not need to have a full board review. Faculty members need to read proposals with care and in order to aid the applicant they also provide detailed information about the types of revisions needed. Exempt protocols are reviewed within 72 hours; expedited are reviewed in 10 days; full board reviews are reviewed at specific meeting times and need to be submitted one week prior to a meeting (see meeting schedule.) As you can imagine, during busy times of the semester, it may take faculty IRB members an extended amount of time to completely read through expedited and full board proposals.
    3. Once the faculty reviews are completed the administrator has to integrate the faculty feedback into a coherent response to the applicant. Once again, later in the semester there can be numerous applications in process. The administrator can only respond to so many in any given day or week. For this reason, researchers should allow time after submitting their proposal before expecting to hear from the IRB about the status of your proposal. During J-Term and the summer months (end of May through the beginning of fall semester), the IRB committee will not be available as often to process reviews, so any proposal submitted during those months could be delayed. Please contact the IRB administrator for more information.
    4. Almost always there are revisions required in order to meet federal and UST guidelines. These have to be completed, submitted, and REVIEWED before approval is possible. The IRB makes every effort to process reviews in as timely a manner as possible. But, we do get inundated with proposals toward the end of fall semester, so please understand that we do our best.
    5. Overall, expect the process of IRB review, from submission of your proposal to the final approval of your project, to take no less than 10 days. Again, this time depends on the amount of revision your proposal needs, and how quickly you submit these revisions to the IRB administrator.