IRB: Frequently Asked Questions
How do I determine whether I need to submit an IRB protocol?
All research involving human participants should be approved by the IRB prior to data collection; however, there are many data-collection or data-analysis activities that do not meet the criteria for research or human participants. Check the Definitions page to determine whether your proposed activity fits the criteria.
I want to collect data in class to determine whether a teaching method is effective. Does this require IRB review?
Data that are collected for quality-control or quality evaluation reasons do not qualify as research. Instructors are permitted to engage in activities within the classroom that they believe will promote learning, and are permitted to measure the outcomes or effects of these activities without IRB review. However, an instructor might subsequently want to describe these activities or outcome data in a professional presentation or publication--at which point the measures become part of research rather than instruction, and thus do require IRB review and approval.
I want my students to conduct demonstration research projects so they can learn about research methods or statistics. Does this require IRB review?
Classroom demonstration projects for the purpose of instruction and learning do not require IRB review or approval. However, if those projects produce data that may contribute to generalizable knowledge (e.g., get submitted for presentation or publication), the study qualifies as research and require IRB review and approval.
For my capstone project, I want to interview faculty members to write about their experiences integrating faith and scholarship. Does this require IRB review?
Oral histories and journalistic activities do not require IRB review or approval. They are about individual persons or events and are not intended to be generalized to other people or events. However, case studies, focus groups, and interviews with individuals on attitudes, opinions, or behaviors that are intended to generalize to other people do meet the criteria for research and do require IRB review and approval.
I have an approved research protocol. How do I add some students as research assistants?
Members of the research team should be listed on the original Research Protocol Application. Changes to the research team, including new investigators (faculty, staff or student) or removal of members of the research team (e.g., students who graduate) should be submitted by email to firstname.lastname@example.org, together with documentation of appropriate CITI training for each new member of the research team. Submit a revised Informed Consent form if the personnel amendment alters the approved form. The IRB must review and approve personnel changes before those personnel can begin working on the study.
I have an approved research protocol, but want to make some changes. How do I amend my protocol?
Your approved protocol is your contract with the IRB: You have indicated exactly what you will do, and the IRB has approved only the procedures you described. In most cases, it is easy to get approval for changes in the procedure, unless those changes alter the risk to participants; however, you must get IRB approval before deviating from the approved protocol. To submit a protocol amendment, edit the approved Research Protocol Application, highlighting in some way all changes, or append a statement describing the proposed changes (e.g., increasing participant numbers, changing recruitment procedures or populations, altering research procedures). Submit the amendment request to email@example.com.
My research appears to qualify as exempt, so can I begin the study without IRB review?
All activities that meet the definition of research with human participants requires IRB review and approval before the study can begin. Exempt does not mean “does not require review” but rather “exempt from annual review after approval.” The IRB determines whether a protocol meets the criteria for exempt versus expedited versus full-board review.
Do all studies require participants to sign an informed consent form?
Participants should typically be informed of study details and should consent to be included in the study, but this does not necessitate a signed consent form. Indeed, investigators can request a waiver of documentation of consent if the study meets specific criteria (see IRB Application Procedures page). Online surveys may use “click here if you consent to participate” and phone interviews may involve verbal consent, for example; a waiver of documentation of consent is required anytime participants will not physically sign a paper consent form. In rare cases, research may necessitate a request for waiver of consent or alteration of consent (see IRB Application Procedures page for more information).
Are there special rules for focus groups?
When participants are tested in a group, the consent form needs to state that the research team cannot ensure confidentiality of responses. Although focus-group members should be encouraged to treat discussions as confidential, the investigators can only guarantee their own compliance with this requirement.
What is “third-party information”?
Suppose a researcher interviewed students about their classroom experience, and the students reported information about Dr. Prof’s behavior. Unless Dr. Prof has consented to be included in the study, this would be considered third-party information and cannot be used in the research. Similar instances would include when family members are asked to report on a focal individual’s attitudes or actions without that person’s knowledge or consent, or athletes asked about the recruitment actions of a specific coach. If the information is private and individually identifiable, then the third party is considered a human subject. The investigators must either redact that information from the data, inform and consent the third party, or request and receive a waiver of consent.
Can a student submit a research protocol as principal investigator without a faculty PI?
No, all Covenant College research proposals must include at least one faculty or staff member who accepts responsibility for supervising the student investigator(s).
What is an “adverse event” and what do I do if one happens?
In preparing the Research Protocol Application, investigators must describe the risks of participation. An adverse event is any unexpected occurrence during the course of an approved research protocol that either causes physical or psychological harm, or increases the risk of physical or psychological harm, or results in a loss of privacy and/or confidentiality to a research participant or others (such as family members). Examples of adverse events include, but are not limited to: a participant in study becomes nauseous or experiences an injury; a member of the research team loses a USB drive that contains identifiable project data; a participant experiences unexpected psychological distress (e.g., begins to cry) when describing an incident; a researcher accidentally discloses in conversation that a mutual acquaintance visited the lab to participate in a study. Adverse events must be reported immediately to the IRB via firstname.lastname@example.org . The IRB will investigate and determine corrective actions.
What does it mean when the protocol application says I need to justify my research population (e.g., if you are testing a vulnerable population) and my sample size (i.e., expected number of people you will test)?
“Justify” doesn’t just mean explain or describe; rather, you need to state how you know that your population or sample is the appropriate one. For instance, how did you estimate the number of participants that you will need for the study? How do you know that number is adequate to achieve the goals and scientific/societal benefits you have described? How do you know that it isn’t too many participants—more than you need to achieve the objectives of the project, so that you are multiplying the (even minimal) risk unnecessarily. You might justify your sample size on the basis of personal experience with studies of similar designs, on published work by others who used similar research designs, on the basis of disciplinary convention, using power analysis or a similar statistical procedure, or in other ways. Note that convenience (e.g., “I propose to test 30 participants, because there are 30 students in the class”) or practical considerations may be important, but they typically are inadequate as justifications. Similarly, if your research proposes to test children, prisoners, pregnant women, individuals with diminished decision-making or mental capacities, or individuals who are vulnerable for reasons of economic or educational disadvantage), you must justify why this specific population is appropriate for the study and what additional protections will be provided.
What if I have concerns about whether a researcher is engaged in unapproved research, or is appropriately following approved research procedures?
Questions, concerns, or reports of suspected noncompliance should be reported to email@example.com or directly to a member of the IRB. This information can be submitted anonymously, but all such reports must be submitted in writing. The IRB will investigate suspected noncompliance and will determine whether corrective action is required.