IRB Review involves the following terms:
Adverse Events - an event of any form that leads to a negative experience for the participant or subject of research or other people or elements in their environment (e.g., family members or ecological system)
Anonymous - participants that are anonymous to the research study have no identifying information provided to any member of the research project at any point in time
Confidential - confidential research includes projects that will at some point collect identifying information about participants, even if the information will not be shared or linked to responses
Conflict of Interest - a researcher’s financial or commercial interest that may mislead their interpretation of research findings
Debriefing - a process where the researcher discusses with the participant(s) of the study the events that took place during the study and any adverse events that may have occurred during the study, often at the conclusion of the study
- In cases where deception was used, debriefing should include sharing the true nature of the study.
Deception - withholding from the participant(s) information about the true nature of a procedure or treatment involved in a study.
Demographic - a defining characteristic of an individual or group of individuals
- Common demographics include, but are not limited to, gender or sex, race or ethnicity, age, and socioeconomic status.
Ethnographic Study - a study that includes the observation of participants or subjects in their natural environment
- The researcher documents behaviors or events that occur during the observation as well as information relevant to other cultural dimensions such as tools, photographs or other artifacts.
- Researchers may be engaged with participants or subjects during the process and may include interviews or other method of collecting information.
Exclusion/Inclusion criteria - any characteristic or other qualifier that allows an individual to participate in a study (inclusion) or does not allow them to participate (exclusion)
Experiment - a study in which participants or subjects of research are randomly assigned to the groups/conditions that are being compared and the independent variable is manipulated
Focus Group – a group of participants involved in research that more in-depth questions
- Typically, the questions, or a series of prompts to generate discussion, are created prior to conducting the focus group.
Generalizable Knowledge - knowledge that could be applied to populations outside of the sample served by the covered entity is considered generalizable
This definition can vary. At Cabrini, we consider this to be research that extends outside the classroom which is being disseminated to a population other than course students or faculty.
Examples of activities that are considered generalizable include (but are not limited to):
- Local or national conference presentations
Examples of activities that typically are not generalizable include (but are not limited to):
- Oral histories that are designed solely to create a record of specific historical events
- Service or course evaluations, unless they can be generalized to other individuals
- Services or concepts where it is not the intention to share the results beyond Cabrini or any agency supporting the research
- Classroom exercises used solely to fulfill course requirements or to train students in the use of particular methods or devices
- Quality-assurance activities designed to continuously improve the quality or performance of a department or program where it is not the intention to share the results beyond the Cabrini community
Note: if research is part of normal educational practices, interventions, or assessment, IRB approval is not required unless it involves populations that are protected and material is sensitive or impact is risky/unknown.
If the educational environment is manipulated and intervention is not part of normal practice, we recommend obtaining IRB approval.
Interview - a research process in which the researcher asks a series of questions to the participant(s), verbally (for instance, in person, over the phone, virtually)
Typically, specific questions are created prior to conducting the interview.
Observational Study (or naturalistic observation) - a study that includes the observation of participants or subjects in their natural environment
- Typically, observational studies do not involve the researcher interacting with the participants or subjects.
- The researcher documents behaviors or events that occur during the observation without the organism knowing they are being observed.
- An outline of such behaviors or events that are anticipated to be observed may be documented prior to performing the study.
Psychological and/or Physical Harm
Research studies, particularly psychology studies, can put participants in situations that may make them feel uncomfortable in order to learn about their reaction to a situation.
The result can be psychological harm that can manifest itself through worry, anxiety (warranted or unwarranted), or feeling upset, depressed, embarrassed, shameful, or guilty.
This could also result in the loss of self-confidence.
- If you are collecting information from participants about upsetting and/or disturbing events, there is a potential for you to upset or disturb your participants.
- Asking information about painful experiences, sexual trauma, etc., could at minimum upset the participant and may bring other psychological issues to the surface.
- In some studies, considering a physical risk is relevant.
- If you ask your participants to exert themselves beyond their resting state and/or there is a possibility for injury as a result of participating in the study, this risk should be described in the consent form and information should be provided as to what care the participant has access to if they become injured.
- For some studies, it might be necessary to exclude participants whose health conditions increase the likelihood of injury.
- Other types of harm could include legal, social, and/or economic harm.
Protected Populations and Sensitive Participants - active participants that fall within the following categories are considered protected and at‑risk:
- Minors (age <18 years)
- Educationally or economically disadvantaged persons
- Fetuses or abortuses
- Incarcerated persons
- Pregnant women
- Persons committing illegal behavior
- Mentally disabled persons
IRB protocol involving these populations should be considered expedited or full.
Quasi-experiment - a study in which participants or subjects of research are grouped and comparisons are made between the groups
- Participants/subjects are not randomly assigned to the groups/conditions that are being compared.
Random Selection of Sample - the selection of participants or subjects of research that is done in such a way that all participants or subjects have an equal chance at being selected for the study
Risk - the potential for adverse events to occur during the research process
This might include physical or emotional discomfort or damage.
Sample - a subset of the population used in research meant to represent a particular group of people or demographic at large
- Samples are randomly selected when participants in the sample all have equal chance of being chosen for the study.
- When not all members of the general population of interest were equally likely of being chosen, the selection process is not random.
Surveys and Qquestionnaires - documents that contain items (e.g., questions, activities, readings) that elicit a response for participants
- The responses are typically documented on the paper or electronic version of the survey or questionnaire.
Voluntary - participation in a research study that is by the participant’s choice and not influenced by incentives or compensation, or coercion for their participation