FAQ's
What is research?
Research means 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 purposes of 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. 45 CFR 46.102(d)
What is a human subject?
Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains
- Data through intervention or interaction with the individual, or
- Identifiable private information.
Do I need to go through the IRB process?
Research includes the collection of data on subjects whose participation in any activity is requested for the purpose of generalizing knowledge. Recruitment measures that involve human subjects for research need to be reviewed by the IRB. The IRB considers data gathering activities not to be within its scope of review if the data is used for non-research purposes, such as institutional evaluation, and/or if it will not result in a presentation or publication. Such activities, including but not limited to course evaluations or alumni surveys, are not typically within the scope of the IRB review. Researchers who are unclear about whether an activity should be reviewed by the IRB are encouraged to consult the IRB through the Office of Research Integrity and Assurance (480) 965-6788 or research.integrity@asu.edu.
When should projects involving human subjects be reviewed?
All research involving human subjects must be reviewed and approved before data collection can occur to assure that subjects are being treated ethically.
When can I start collecting data?
Researchers cannot begin data collection until they have received a written approval letter from the IRB (which will be sent via the Office of Research Integrity and Assurance). All approved projects must be conducted in accordance with protocol submitted guidelines and IRB conditions.
How long will approval take?
IRB approval may take between 1 to 6 weeks after the study is received in the Office of Research Integrity and Assurance. A particular protocol may take longer to process based upon issues such as complexity and completeness.
How often does the IRB meet?
The Social Behavioral IRB and Biosciences IRB each meet approximately once a month. Refer to the meeting schedule for actual dates and times. Applications that are incomplete will not be reviewed until they are complete. Completed applications requiring full board review are due to the Office of Research Integrity and Assurance at least 12 business days before the next scheduled meeting.
What are the types of review and the application process?
1. Full-Committee Review
This type of review is carried out for studies that pose greater than minimal risk to subjects. Researchers should complete either a Social Behavioral Application or a Bioscience Application depending on the area of research. The IRB meets regularly throughout the year. Researchers should refer to the meeting schedule for meeting dates and times. The deadline for submitting complete applications is at least 12 business days prior to the next scheduled IRB meeting. (Please note: that the 12 business day deadline applies to applications reviewed by an IRB Coordinator with no outstanding questions or issues.)
2.Expedited Review
Studies are reviewed by the IRB Chair or a qualified member of the IRB. This type of review is carried out for studies which involve minimal risk to subjects and fit into an expedited review category of research as defined by 45CFR46. Researchers should complete either a Social Behavioral Application or a Bioscience Application depending on the scope of research.
3. Exempt review
This type of review is used for studies that meet exemption categories as defined by 45CFR46. If the study is not found exempt, it will need to go through expedited or full-committee review. Researchers whose studies fall into one of the exemption categories should complete an Application for Exempt Research. Research that falls into an exempt category MUST be reviewed by the IRB before data collection can begin.
What types of studies should be submitted to the Social Behavioral IRB?
The Social Behavioral IRB reviews research in the area of behavioral or social science examining topics such as normal behavior, non-medical issues, opinions, personal and social history, and educational practice.
What types of studies should be submitted to the Bioscience IRB?
The Bioscience IRB reviews research involving invasive procedures (saliva, tissue, urine, or blood samples etc), exercise science, dietary manipulation, human physiology, and studies that evaluate the safety or effectiveness of a medical product or procedure.
Do I need to complete training before conducting human subject research?
All researchers (principal investigators and co-investigators) involved in human subjects research must complete training. At this time, there are two online options. Researchers must complete either the NIH training course or the CITI Training Course. Upon completion of the course, researchers should print two copies of the certificate. Researchers should keep one copy for their records and forward one copy to the Office of Research Integrity and Assurance with the IRB application.
Who can be a Principal Investigator?
The Principal Investigator (PI) must be an ASU staff or faculty member. In the event that the responsible researcher is a student, then the supervisory faculty member/faculty advisor must act as the PI.
What happens if I want to make a change to the protocol after the study is approved?
Submit ANY proposed changes directly to the Office of Research Integrity and Assurance for review and approval by the IRB before implementing them. Use the Modification Form. Examples of such changes include:
- Alteration of study design, methodology, or recruitment methods
- Addition of study participants
- Changes to any instruments, including surveys and interview questions
- Changes to informed consent documents
- Addition/deletion of investigators
- Alteration of Project Title
- Addition of research sites
Changes to exempt studies do not need review unless the change makes the study non-exempt.
Can I do a study for more than one year?
In accordance with federal policy, research can be approved for up to one year. Submit a Continuing Review Form if a non-exempt project is to last longer than the approval period, which is typically one year. The study must be reviewed and re-approved by the IRB for research to continue on an annual basis. In certain cases approval may be for less than one year. For more information about continuing review, please refer to OHRP Guidance.
When is a study complete?
Non-exempt studies are considered complete when data collection and data analysis are complete. Submit one copy of the Close Out Form to the Office of Research Integrity and Assurance within 30 days of study closure.
A researcher from off campus wishes to perform a study that involves collecting data at ASU without an ASU investigator. What type of review is needed?
The only action needed by the research team is to submit the IRB approval from the other institution to the IRB. The IRB will then check to see if there is any obvious problem with allowing the study to proceed. If there are no problems, then the IRB will inform the researcher that he or she may proceed. The ASU IRB provides oversight on projects where ASU faculty, staff or students are collecting or analyzing data. If ASU is used as a recruitment site only, then ASU IRB review is not necessary. For more information, please see OHRP's FAQ about engaged in research.
Are there special application procedures for research projects involving Native American participants?
Researchers should review section IX of the ASU Procedures for the Review of Human Subjects Research that addresses special populations.
Are there special procedures for reporting adverse events?
Researchers should review the Adverse Events Flowchart
Does ASU have any reciprocity agreements?
Arizona State University, Northern Arizona University, and the University of Arizona have established an IRB reciprocity agreement for research projects involving investigators from the three campuses. This agreement simplifies the process of IRB review of collaborative projects by allowing one campus to become the designated IRB for jointly conducted projects. Researchers must submit a "local context" review as well as related materials. For more information contact the Office of Research Integrity and Assurance at 480-965-6788 or send a message to research.integrity@asu.edu.
Are there special application procedures for research conducted over the internet?
Researchers will want to assure that studies are designed in ways in which the rights of subjects are protected. Participation in such projects is voluntary and all recruitment materials and cover letters should reflect that.