What are the expectations of the IRB when I submit my proposal?
The main expectation is that the proposal be presented in a thorough and professional manner. For student researchers, faculty must sign off that the study was carefully reviewed and meets the faculty member's standards. The researchers must address all questions in the appropriate form. All potential subject protections must be anticipated and described.
Few proposals are approved on the first submission. It is more likely for a proposal to be approved with modifications. The most common reason for non-approval is lack of appropriate human subjects' protections: not enough is being done to protect subject identity or to protect the subject from physical or psychological harm. A conversation with the IRB chair is always suggested for new researchers or those with questions.
How is my proposal reviewed?
In the policies and procedures, you will see a detailed check list that indicates the levels of review for proposals. We have three basic levels: full review, expedited review, and exempt from review. Full review is required for studies of vulnerable populations or those that exhibit greater than minimal risk. Expedited review is required for minimal risk studies. Exempt from review is a category basically of anonymous surveys and program reviews. The level of review is determined by the researcher and affirmed by the IRB committee.
How do I know if the research I am conducting in a class does not need to be reviewed?
As indicated in the IRB policies and procedures, research conducted as part of a class does not require IRB review if it is a normal part of the students course work, has a primary goal of developing research skills, is closely supervised by the faculty member, and is not anticipated to result in public dissemination. Please contact the IRB chair if you are not sure if your study fits in this category.
How can I best maintain confidentiality for study participants?
Anonymity, or the inability to determine the identity of a subject participant, is always a best practice in protecting the confidentiality of participants. In some studies, however, anonymity is not possible. This is particularly noted in studies where the researcher wants to follow-up with a participant at a later time or connects two sources of data to the same participant. In this case, the IRB recommends maintaining a separate and secured code list of participant names and code numbers. Once the data have been entered into a database, the code lists are shredded.
What do I need to consider if I am going to compensate the study participants with money or gifts?
The researchers must be aware that incentives are taxable and must be reported to the CSB or SJU business office. This process will require that participants fill out a specific form (1099) so the business office can process the payment and withhold the appropriate tax. Researchers must present in the research proposal a provision for protecting the identity of subjects by separating all business office forms, payments and budget numbers from the subject data. It is critical to ensure that the subjects' identity and research findings are not identifiable through the study budget or business office forms.
Research Using Web-Based Surveys
Web-based surveys require careful scrutiny in order to protect the anonymity or confidentiality of subjects. These surveys need to have a provision for excluding research subjects who are under the age of 18. The researcher must provide specific, detailed information about the type of information that is collected AND the underlying technology being used to collect the data. For example, does the program/software/survey technology collect any electronic identifying information? Does the survey involve collecting any information that is regarded as private or could be harmful to the participant if revealed? How does the program/software/survey technology provide a means for preventing multiple survey completions by subjects? How does the program/software/survey technology prevent "hacking" into the data base?