- Institutional Review Board (IRB)
- Institutional Review Board (IRB)
- IRB Review
- Expedited Review
IRB review applications under Expedited Review will be reviewed by two IRB reviewers.
All studies which satisfy the following criteria and do not satisfy the criteria for Exempt Review must be submitted for Expedited Review:
- The research activities (or remaining research activities) present no more than Minimal Risk to Human Subjects.
A study is considered to pose no more than Minimal Risk to the subjects when the probability of harm or discomfort that the subjects might experience in the research is not greater in and of themselves than those ordinarily encountered in daily life and in routine interaction with others.
- Identification of the subjects or their responses (or the remaining procedures involving the identification of subjects or their responses) will NOT reasonably place them at risk of criminal or civil liability or be damaging to their financial standing, employability, insurability, reputation, or be stigmatizing unless reasonable and appropriate protections will be implemented so that risks related to the invasion of privacy and breach of confidentiality are no greater than Minimal Risk.
- Research involving materials (data, documents, records, or specimens) that have been collected for any purpose, or will be collected solely for non-research purposes.
- Collection of data from voice, video, digital, or image recordings made for research purposes.
- Research on individual or group characteristics or behavior.
- Research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies.
- Continuing review of research previously approved by the convened IRB where (i) the research is permanently closed to the enrollment of new subjects; (ii) all subjects have completed all research-related interventions; and (iii) the research remains active only for long-term follow-up of subjects.
- Continuing review of research previously approved by the convened IRB where no subjects have ever been enrolled at a particular site and neither the investigator nor the IRB at a particular site has identified any additional risks from any site or other relevant source.
- Continuing review of research previously approved by the convened IRB where the remaining research activities are limited to data analysis.
A minimum of 15 working days is required for the decision by the IRB. However, when the decision is made, the IRB will seek to inform the applicant at the earliest possible date.
Your application for IRB review under Exempt From Full Review should contain:
- Duly filled Application Form
- Attachment of research protocol and supplementary materials (questionnaire, stimuli and/or interview questions, etc.)
- Proof of Completion of the Research Ethics and Compliance course.
- Copies of your research protocol and instruments might include, but not limited to:
- The list of interview questions you will be asking your participants or representative set stimuli that your participants will see
- Separate and complete lists of interview questions if you will be interviewing different groups (e.g., managers and employees) and tailoring the interviews accordingly
- Description of procedures for all study conditions, including the control condition
- Copies of all questionnaires or instruments
- Copies of your consent form, a script for oral consent which explains why consent is necessary, and a copy of the handout you will give to participants telling them how to contact you and the IRB if they have any questions. A separate video or photo consent form, if necessary. Translations of materials into the language of the participants, if your participants will be using a language other than English.
- An explanation of how the confidentiality of participants will be maintained.
*All attachments and supplementary materials containing identifying information of investigators should be submitted as .doc. Files. The IRB will attempt to remove or mask identifying information about the investigators to enable a double-blind process in the ethics review.
Providing information at this level of detail is necessary so that the Committee can make an informed decision about potential risks to participants. Insufficient information provided may result in clarifications needed or a deferred decision.