Completed applications will be submitted to the IRB Chair ([email protected]), via email. For student research projects, the application must be submitted by the faculty advisor.
Regardless of the type of application you are submitting, you must ensure that participants understand the nature of the study and agree to participate. Not all studies require written informed consent; however, expedited and full reviews must have a written consent form. Further information on the consent form and the elements of informed consent are located at the informed consent link. An informed consent template is also provided.
Many research protocols that meet the definition of research in the federal regulations may be in one of the categories that are exempt from formal IRB review. The CSB/SJU IRB policies require that researchers who believe their study meets exempt criteria must submit an IRB application using the Exempt Form (Form 2). The application will be reviewed by the IRB chair to verify that the study meets the exempt criteria.
Most research with children, prisoners, and other "vulnerable" populations does NOT qualify for exemption. Research that may be considered exempt includes:
- Surveys that are done in a completely anonymous manner
- Research that has been already approved by another institutional review board (documentation of this approval is required by the IRB, submit to the committee chair)
- Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as (1) research on regular and special education instructional strategies, or (2) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods
- Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified
Click here for a comprehensive list of research categories that are exempt from formal IRB review. When completing Form 2 for Exempt Research, researchers must identify which category fits their research, making it eligible for exemption.
If the research does not meet the criteria for exempt status, the application will undergo either expedited or full review.
Research that is not exempt but involves no more than minimal risk may qualify for expedited review. The Federal Register (2018, Title 45, Subtitle A, Subchapter A, Part 46) defines minimal risk as "the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations." If you believe that your study meets the criteria for expedited review, submit an IRB application using the Expedited Review Form. A subcommittee will review the application within two weeks of submission.
Click here for a detailed description of research categories that may qualify for expedited review.
If the research does not meet the criteria for exempt status or expedited review, the application will undergo full review.
Full review at a convened meeting of the IRB is required for research that involves more than minimal risk and most research that involves vulnerable populations. If you believe that your study requires full review, submit an IRB application using the Full Review Form. The IRB holds convened meetings on the 2nd and 4th Wednesdays of the month when school is in session to review these applications. To ensure review at a particular convened meeting, an application must be submitted to the IRB Chair at least two (2) weeks prior to the meeting.
Categories of research that typically require full review include:
- Activities that include stress at greater levels than that of daily life.
- Deception that significantly misrepresents the research and may involve more than minimal discomfort to participants. If deception is used in the study, a debriefing will need to be described in the research protocol.
- New or experimental drug research.
- Research that includes the collection of identifiable information of a highly sensitive nature (for example, sexual orientation or behavior, alcohol and drug use, immigration status, illegal activities, etc.).
- Research with vulnerable populations (children, pregnant women, homeless, prisoners, individuals with impaired decision-making ability, etc.).
International research creates unique challenges for researchers in terms of cultural appropriateness of research and local/national regulatory structures. The general guidelines for IRB review of international research remains the same as for research conducted in the US. However, some additional information will be required.
For assistance with preparing your IRB proposal for International Research, please see the following documents:
- Additional Documentation or Explanations that May be Required for International Research
- Checklist for International Research
Research with Vulnerable Populations:
Who are considered vulnerable populations?
Vulnerable populations include: children (in some instances), prisoners, individuals with impaired decision-making ability, non-English speakers, English Language Learners, economically/educationally disadvantaged individuals. Conducting research with vulnerable populations raises important concerns about cultural sensitivity, possible coercion, and privacy/confidentiality.
Children are defined as individuals under the age of eighteen (18) years. Research with children will be reviewed only if (1) the procedures do not present greater than minimal risk, (2) a plan is developed for obtaining informed consent from at least one legal representative (guardian), and (3) a plan is developed for obtaining assent from children ages seven (7) and older.
Studies involving prisoners will not be reviewed and approved by the IRB; these will be referred to the appropriate state or federal agency that oversees that prison system.
For assistance with preparing your IRB proposal for research with vulnerable populations, please see the following documents:
If you have received prior IRB approval for a study you are conducting, and need to make changes to the study, you will need to submit a Project Revision Form. Federal regulations require IRB approval before implementing proposed changes. Changes that need prior approval include changes to the protocol, consent form, or any supportive materials.
Continuation of Research
Approval of the research extends for one year from the date of the initial approval letter. Continuation of the protocol beyond the one year approval requires submission of the Renewal/Extension of Research Form.