What is an IRB?
IRB is the acronym for Institutional Review Board for Human Participants. Any research institution conduct research with human participants, is required to establish an IRB to review all research that directly or indirectly involves human participants, and to set forth institutional policy governing such research.
The IRB has the authority to review, approve, disapprove or require changes in research or related activities involving human participants. Research reviewed by the IRB may also be subject to other review and approval or disapproval by officials at AUIS. However, those officials may not approve research that has not been approved by the IRB for Human Participants. The IRB primary role is to ensure the protection of human participants as subjects of research at AUIS.
How do I know if I am conducting research with human participants?
According to AUIS IRB, research is defined as “…a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.”
Activities which meet this definition constitute research for this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities.
Human subjects are “…living individuals about whom an investigator (whether professional or student) conducting research obtains
- data through intervention or interaction with the individual,
- identifiable private information.”
Intervention includes both physical procedures by which data are gathered (e.g., venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes (e.g, providing stimuli to gauge reaction and response).
Interaction includes communication or interpersonal contact between investigator and subject (for example, surveys and interviews).
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 must be individually identifiable (i.e., the identity of a participant is associated with the information or may readily be ascertained by the investigator) in order for obtaining the information to constitute research involving human subjects.
In order for your project to be considered human participant research covered by AUIS IRB, the criteria for both definitions must be met. If you are unsure if your project involves research with human subjects, please consult with IRB staff who can provide guidance in making this determination.
When am I required to submit a proposal involving research to the IRB?
All research projects that will involve human participants must be submitted for review and approval before beginning the study. This includes proposed research involving existing data and previously collected human fluid and tissue samples, as well as any advertising or other recruitment procedures.
I am just doing a simple survey; do I need to submit my proposal to the IRB?
Yes, if the study meets the definition for research with human participants, as explained above. Written approval from the IRB must be in place before any interventions or interactions with human participants (e.g., recruitment) actually begin.
I am not collecting any identifying information in my human participant research project. Do I need to submit my proposal to the IRB for review?
Yes, if your research project involves active data collection. US Federal regulations and AUIS IRB policy require that ALL research involving intervention or interaction with human participants, regardless of whether or not identifying information is being collected, must be submitted for review prior to beginning the research study.
However, if your research project involves use of existing information collected from human participants (e.g., secondary datasets, existing biological samples), but there are not any identifiers linking individuals to the data/samples, then the activity may not require IRB review.