Q: What is an IRB (Institutional Review Board)?
A: An administrative body established to protect the rights and welfare of human subjects recruited to participate in a research study conducted under the auspices of the institution with which it is affiliated. The role of the IRB is to ensure the protection of human participants in a research study.
Q: What is and what *isn’t* research?
A: This is can be a complicated question to answer. Research under IRB regulations (as specified under the ‘Common Rule’ issued by the Office of Human Research Protections, U.S. Dept. of Health and Human Services) is defined as a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. A class project that is not intended to be published or presented is not likely to be considered research. However, a class project that you wanted to work on later or eventually publish would be treated as research. Be sure to ask the Research Officer if you are not sure.
Q: What is human subjects research?
A: Any systematic investigation that is designed to develop or contribute to generalizable knowledge, and which involves living humans about whom an investigator obtains information through intervention or interaction or obtains identifiable private information, qualifies as human subjects research.
The ‘Common Rule’ also tells us that:
Generalizable knowledge refers to information that expands the knowledge base of a scientific discipline or other scholarly field of study and can be expressed in theories, principles, or statements of relationships that can be generally applied to our experiences. Activities designed to contribute to generalizable knowledge are those designed to draw general conclusions, inform policy, or generalize findings beyond a single individual or an internal program. The information is collected to share with others in a discipline and is created to make a broad statement (conclusion) about a group of people, procedures, programs, etc.
An intervention can include physical procedures by which data are gathered (e.g., venipuncture) and manipulations of the subject or subject's environment for research purposes.
Interaction includes communication or interpersonal contact between the researcher and subject.
Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). Private information that is individually identifiable (i.e., the identity of a participant is associated with the information or may readily be ascertained by the investigator) constitutes research involving human subjects.
Q: Do research projects conducted by students need IRB approval?
A: Yes. Studies conducted by students need IRB approval, if the project fits the definitions of "research" and "human participants.” If the project is to be used in classroom setting only to teach research methods, the project may not constitute human participant research. However, this means that at no point during or after the conclusion of the course can the results or the data be used for publication, presentation, or other research purposes. Therefore, students should discuss these limitations with their instructor or faculty advisor so that they can determine whether IRB review is necessary.
Q: How do I know if I have to submit my proposal to the IRB?
A: Not all interactions with human beings or data collected from humans are considered research under IRB rules. If your project is not considered research, you do not need to submit an application to the IRB office (see the “research” question above). If your project is considered research under IRB rules, you must submit an application to the IRB. Applications must be submitted to the IRB for review and approval before subject recruitment or data collection begins. This includes proposed research involving existing secondary data and previously collected human fluid and tissue samples.
Q: I’m just doing a survey. Do I have to submit my proposal to the IRB?
A: If the study using the survey meets the definition for research with human participants, yes, you doe have to submit the proposal to the IRB. Written approval from the IRB must be in place before any interventions or interactions with human participants (including recruitment) actually begin.
Q: Can a person be exempted from completing the human ethics training?
A: No. Everyone at KHSU-KansasCOM who may be a researcher or a research assistant or who wishes to submit a proposal for IRB review is required to have completed CITI human ethics training within the past two years. Even persons who have been trained in human ethics elsewhere through another institution or those who have served on IRBs are required to have completed CITI human ethics training within two years.
Q: I’m doing a case study. Do I need to submit that to the IRB for review?
A: No. Single Case Reports or Case Series Reports consisting of three or fewer cases because these activities do not meet the federal definition of research subject to IRB review. This condition is true so long as the subject’s identity cannot be discerned and does not involve at-risk or special populations or vulnerable adults.
Q: What is the difference between Exempt, Expedited, and Full board review?
A: There are three categories of review, Exempt, Expedited and Full Board which are defined by federal regulation. Depending on the risk/benefit ratio of the study, one of these three levels of review will be assigned. An Exempt status means that the IRB Chair has determined that a project is exempt from federal regulation. Expedited reviews are typically used to approve minor revisions to previously approved projects or for projects from a specified list of activities that present only minimal risks to the participants. Expedited does not mean that a review will be given priority or given less time. Full Board (Convened) reviews are the most intensive and require approval by a quorum of the IRB.
Q: What does "exempt" mean? Does this mean I don't have to submit an application for review?
A: Exempt is a status granted by the IRB and is not determined by the researcher, so yes, you must submit an IRB proposal. Studies that meet the definition of regulated research under the Common Rule may fit within one or more categories of “exempt” research. The status affects how the IRB reviews the proposal rather than how the researcher submits the proposal.
Q: When can I start data collection for my study?
A: You cannot begin participant recruitment, data collection, or data analysis until you have received written approval from the IRB to do so. A memo will be sent to the Primary Investigator via e-mail when your project has IRB approval.
Q: How long will it take for me to obtain approval to do my study?
A: That depends on several factors including the type of study and the population of participants you intend to recruit. The length of time required for review varies by classification (exempt, expedited, or full review). For applications requiring full board review, you should allow at least 4-6 weeks for review and approval of your study.
Q: Can the IRB approve a project retroactively?
Q. I am a professor teaching a research seminar and some of the projects will involve students interviewing subjects. Do these projects require an IRB review?
A. No IRB review is needed for required student projects that are only for a class, i.e. not for presentation or publication. However, no data that was obtained by this class project may be used for future publication, unless an IRB was submitted and approval granted prior to the student classwork activity.