Some terms used in this guide to getting started have specialized meanings that are grounded in federal regulations. These terms carry significant weight. Technical terms marked by an asterisk (*) appear at the bottom of this page. Definitions are also accessible in the Glossary.
Students who wish to conduct research* on human subjects* may do so only under faculty supervision. Students may serve as principal investigator on a research project provided that a faculty member supervises both the development of the research proposal and the completion of the research project itself.
Prior to collecting research data, students affiliated with Alverno must (1) submit their proposal to conduct research on human subjects to an ethical review process approved by the Alverno College IRB and (2) receive written approval as a result of that process.
Minimal Risk Standard*
All research on which students serve as principal investigator must have no more than minimal risk. This means that you will need to understand and consider sources of risk to participants even at the earliest stages of selecting a research topic. Like all researchers, you take on two key related responsibilities that you will be required to address in writing on an IRB form that accompanies your research proposal.
Again, note that these responsibilities have immediate implications for you at the earliest moments in selecting and designing your research project.
Identifying the Appropriate Review Committee
Research Review Committees (RRCs)* conduct decentralized reviews of student research that is exempt from IRB review. Each RRC represents one of the academic schools at Alverno and the corresponding disciplinary majors within that school. The decentralized reviews that the RRCs carry out are tailored to a particular educational program and its approach to developing student research skills.
Preparing for Review
Before you request an ethical review, you will need to gain approval from your research supervisor, who often is your course instructor. In this context, you will have:
Each of these written products is part of your initial IRB review process and you submit them along with your responses on the appropriate IRB form(s).
Selecting the Right IRB Form(s)
There are more forms than you will probably need to use. The following overview of the forms and their use should help you choose where to start, but you will also benefit from talking with the faculty member supervising your research.
Exempt Research: Student researchers will most often request an exempt review. A student researcher’s request for exemption is usually made through a decentralized review process organized by an RRC. Exemption from IRB review is either approved or not approved in this process. You will receive any approval in writing. For research to be exempt it must be both no more than minimal risk and readily fall into one or more specific categories of exempt research. In these instances, the only IRB form you will likely need to complete is the following.
This form is designed to enable you to clarify whether or not—and, more specifically, how—your study is exempt from IRB review. In this context, it is important to emphasize that determining exemption from IRB review is itself an ethical review rather than lack of review. The review process almost always includes thinking about how to minimize any risks the research has for participants. Depending on your RRC, this might also mean your selecting or revising your planned research project so that it meets the criteria for one of the exempt categories. You may want in advance to ask your faculty supervisor for some strategic assistance here as well, but you can also on your own look directly at Section IV of the General Request for Exemption Determination.
Your RRC may document more specific requirements and supports in your particular educational program and major. In particular, each RRC is likely to support one or more course-based processes for writing your research proposal, which would specify the format of your proposal. If not, you would also need to complete the Alverno IRB’s Research Protocol form. In all cases, your research proposal would describe in some detail the research you plan on doing.
Non-Exempt Research: Less frequently, student researchers may seek an Alverno IRB review for research that does not meet a specific exempt research category. Some research may be no more than minimal risk, and yet, fall outside the exemption categories, even when you consider combinations of categories that might apply to different parts of your research. Each particular RRC will have its own policy on whether or not it allows an alternative application that would cover such non-exempt research. Depending upon the RRC, a student may be eligible to complete and submit the following forms that cover non-exempt research. This alternative submission would be directly to the Alverno College IRB Administrator, but also note that Faculty supervision continues.
Continuing Review: All non-exempt research undergoes continuing review after it is approved. Continuing Review includes formal documentation of the closure of research activities on your project. In continuing review, you complete another review later. This additional review would be required after a specified period of time that could be no more than a year from the last IRB approval. The Alverno IRB may specify a shorter interval and may specify other required monitoring processes. Requirements are specified in writing. If you do not seek and receive required approval, you will be asked to cease research activities until such approval is received.
Exceptions to Full-Written Informed Consent. In some cases, for example, an anonymous survey, it may not be feasible to complete a full written informed consent process where the participants sign their consent to participate in your research. You will find that these exceptions are very few and also that the extent of the exception is often limited. In the case of an anonymous survey for example, participants should still be informed in a way that they can make a decision to participate or not participate, even if you do not ask for their signature to both verify and focus the consent process. Why is there such a strong emphasis on informed consent and its documentation? The Informed consent process is the primary way you as a researcher show respect for persons. Through it, you give potential participants an informed opportunity to voluntarily choose to participate or not participate in your research. Here is the form to use to request an exception.
Making a Successful Submission
Once you have selected the right basic form, which is either the General Request for Exemption Determination or the New Study Application for Review, you will find it provides information that organizes your submission process. Here is some general advice:
EXEMPT RESEARCH Research determined through an IRB sanctioned request for exemption to fit within specific categories of minimal risk research that are articulated in federal regulations. Once a research study is determined to be exempt, data collection may begin, which is why it is said to be exempt from IRB review.
HUMAN SUBJECTS Individuals whose physiologic or behavioral characteristics and responses are the object of study in a research project. Under the federal regulations, human subjects are defined as: living individual(s) about whom an investigator conducting research obtains: (1) data through intervention or interaction with the individual; or (2) identifiable private information.
MINIMAL RISK A risk is minimal where the probability and magnitude of harm or discomfort anticipated in the proposed 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. For example, the risk of drawing a small amount of blood from a healthy individual for research purposes is no greater than the risk of doing so as part of routine physical examination.
RESEARCH A systematic investigation (i.e., the gathering and analysis of information) designed to develop or contribute to generalizable knowledge [Federal Policy 45 CFR 46.102(d)].
RESEARCH REVIEW COMMITTEE A standing committee at Alverno delegated by the Alverno IRB to conduct determinations of exemption of research from IRB review. When located within a School at Alverno (e.g., School of Nursing), the Committee also ensures that student research conforms to the School’s educational policy for protecting human subjects.