Human Research Participants & Institutional Review Boards
The Department and University follow strict federal guidelines governing the use of human research participants, informed consent, data collection, and storage procedures. The Graduate School’s Education Research Institutional Review Board website is a comprehensive and important resource necessary for your success using human participants in your research.
An important part of the research process is the protection of the rights of human research participants. All research involving human participants needs to be approved by one of the campus Institutional Review Boards (IRBs) before any collection of data about the participants begins. This applies to pilot work involving human research participants, as well as regular research projects.
Class related projects involving collection of information about individuals (i.e., projects related to course requirements) do not require IRB review as long as the student will not use the information for any research purpose, ever! If there is some possibility of using the information collected for research purposes, the student needs to work with a faculty member to submit a protocol to the IRB for approval to conduct the project.
To obtain IRB approval for a research activity involving human research participants, a protocol covering the activity must be submitted to the IRB. Only individuals qualified as principal investigators (P.I.) can submit protocols. Students are not qualified to serve as principal investigators, but they can serve as co-investigators. Therefore, students need to work through their advisor or some other faculty member to submit protocols covering student work.
All investigators and staff on a research project involving human research participants need to complete an on-line training program regarding such research. The IRB will not consider a research protocol unless all key personnel have successfully completed this training.
In most cases, the first step for students interested in conducting research with human research participants is to complete the on-line training program. Students are urged to complete this training as early as possible in their graduate program. The training involves a series of tutorials on specific topics, followed by short forced-choice tests on each topic or “module.” When a student has successfully passed the test on each required module, the student is certified and can print off a completion report. Certification needs to be renewed on a regular basis by passing an on-line refresher course. Details of the certification requirements and procedures for completing the training can be found on the Graduate School’s Education Research Institutional Review Board website.
After students have received certification, they are ready to participate in research involving human research participants. Once the details of a study have been fleshed out, the investigators can prepare a research protocol to be submitted to the IRB. For master theses and doctoral dissertations, this step usually occurs after the student has successfully passed a thesis/dissertation hearing.
All protocols need to be initiated by the project’s principal investigator. This means students need to ask their advisor (or another appropriate faculty member) to initiate a protocol and give them access to the protocol. Then, students can work with the P.I. in preparing the protocol and the P.I. will submit the protocol to the IRB (the student cannot formally submit it). The IRB will not take action on a protocol until it has been formally submitted and includes all appropriate information and attachments.
Because research protocols are complex, students are urged to work closely with the P.I. on preparation of the protocol. In addition, students are strongly encouraged to attend a training session that the IRB sponsors. These often occur at the beginning of the academic year or sometimes the beginning of second semester. Training sessions may also occur during one class session of a course. If students have questions about the preparation of a protocol, they can contact their advisor, a current member of the IRB, or an IRB staff person for advice and assistance. Membership of the IRB is listed on the IRB website, which also contains contact information for IRB staff. Students definitely should take advantage of these resources before the protocol is submitted; it is likely to expedite the review and approval process.
In some cases, student research is already covered under an existing IRB protocol. For example, if the student is collaborating with a faculty member on a research project and drawing data from the faculty member’s research, it is possible that the student’s research is part of the work that the IRB has already approved. If the IRB has already approved the research, there is no need to file a new protocol application. However, the student needs to check carefully and directly with the P.I. of the project to determine whether or not a new research protocol is needed.
IRB protocols are complicated and take time to prepare and gain approval. Investigators should count on two months to obtain final approval for a research project.
Remember, no work can begin on a research project until the IRB has given final approval for the project. In some cases, the IRB will approve all procedures but withhold final approval until the investigators have submitted additional documents, such as letters from cooperating institutions and agencies (e.g., school districts from which a study sample is to be drawn) granting permission for the researchers to access their population for a study. Students are advised to read correspondence from the IRB about their research project very carefully to be sure they have a “green light” to begin work.
Occasionally, unanticipated problems arise in the course of research with human participants, or investigators determine that they need to change some aspect of the project. In such cases, the P.I. will need to file a request for Change of Protocol or a report on an Adverse Event or a Deviation with the IRB. It may be necessary to suspend activity on the project until the IRB has taken action on the request or report. Students need to report any problems or unusual circumstances surrounding the project to the P.I. as soon as possible. Failure to follow these procedures can have very serious ramifications for the student and the PI.
Students are urged not to underestimate the amount of time it takes to receive final approval for a research project. In addition to the deliberations of the IRB, many times students need to have a project approved by a school district or specific school staff. For example, many students plan to use subjects from area public schools and need to present their approved protocol to the Madison Metropolitan School District (MMSD) research committee for permission and access to that population. The MMSD committee meets only one time per month to consider requests and presenting a request to MMSD hinges on prior approval from the IRB. Once the MMSD has given approval, the student has to solicit the cooperation of a specific school; obtain a letter from that school granting permission to access a study population within the school; and file the letter with the IRB. If the school requests some modification in the study plan or procedures, the changes may require approval by the IRB, via submission of a Change of Protocol application.