Human Subjects in Research Policy
Do I need to submit a form to the Institutional Review Board (IRB)?
Some activities that gather data from human subjects do not require you to submit a form. These include most in-class activities, demonstrations, lab exercises, or other collection of information from students in a DePauw University class that is conducted for demonstration purposes, rather than for the purpose of developing or contributing to a knowledge base. In addition, gathering data for purposes of institutional assessment does not generally require IRB notification/approval. While these activities should be guided by similar principles, they do not come under the purview of the institutional review board.
As a general rule, your project is considered research that requires you to submit a form to the IRB if you are manipulating and/or obtaining data from human subjects and:
- the activity is considered research by your discipline and/or you are gathering data with the purpose of building or contributing to a knowledge base and/or
- you are using invasive procedures and/or your participants are members of a special or protected population (e.g. , participants under 18 years of age, prisoners, in/outpatients, mentally/physically disabled, pregnant women) and/or
- the data collection is for senior thesis projects and/or
- the work is connected to a DePauw University class and gathers data from subjects outside of the class
If you are not certain whether your proposed activity requires the submission of a form, the IRB recommends that you go ahead and submit one.
Which form should I submit?
The IRB has two forms. One is for Category I (Monitored Research), and the other form is for both Categories II and III (Expedited and Full Review Research, respectively). To decide which form to submit you should first decide whether your proposal falls under category I, II, or III.
Category I (Monitored Research)
http://www.depauw.edu/admin/acadaffairs/researchProtocols/irb/documents/IRBmonitored.pdfCategory I research requires only notification, and the form is quite brief. Research described on the form may begin one week after the forms are submitted to Academic Affairs. Category I includes research that involves no more than everyday stress, the use of educational tests or comparison of educational techniques, most field observations, and the study of existing data. [If subjects can be identified, the research must receive an expedited review or full review as described below.] You should use the Category I form if all of the following are true of your research:
- Does not involve a special or protected population (e.g., participants under 18 years of age, prisoners, in/outpatients, mentally/physically disabled, pregnant women)
- Does not involve deception (beyond not informing subjects about every aspect of this study and hypotheses)
- Poses no reasonably foreseeable physical risks to participants
- Poses no reasonably foreseeable stress or discomforts to participants (beyond everyday levels)
- Does not involve private records (e.g., medical and/educational data linked to names)
- Does not probe for sensitive personal information (including disease/disorder/disability status)
- Obtains informed consent from participants (if all other conditions are met there may be cases-field studies, for example-when informed consent is not required; the category I form asks for an explanation/justification in such cases)
- Does not present offensive, threatening, or degrading material
- Preserves confidentiality of participants
- Debriefs participants (there may be exceptional circumstances—field studies—where debriefing is not feasible; the category I form will ask for an explanation/justification in such cases)
Faculty and students whose research meets the above criteria should fill out the Category I form. Please note that students must have a faculty sponsor endorse and sign the form. The faculty member then submits the form to the Office of Academic Affairs.
You may obtain the form from one of the following sources: the Office of Academic Affairs, the IRB chair or other IRB committee member, or download the form from the DePauw web site. Complete the form, and attach any additional information that is requested, and submit the form to the Office of Academic Affairs. This research does not require formal approval; you may begin your research one week after submission of the form. The form will be reviewed by one or more members of the committee, and if the conditions for Category I are not met, the research may be suspended.
Category II (Expedited Review Research) and Category III (Full Review Research)
http://www.depauw.edu/admin/acadaffairs/researchProtocols/irb/documents/IRBfullreview.pdfIf your research does not fall under Category I, it falls under either Category II or Category III. Both categories require the same form (you may obtain the form as described above). On the Category II/III form you will need to designate which category your research falls under.
The primary difference between Categories II and III is the level of stress, discomfort, deception, etc., involved, and the characteristics of your participants. Check the Category II space on the form if your research: does not involve special or protected populations (participants under 18 years of age, prisoners, in/outpatients, mentally/physically disabled, pregnant women), and involves only minimal risk, minimal discomfort, moderate stress, etc.
Complete the form and attach any additional information that is required or requested. Students must have a faculty sponsor endorse and sign the form. The faculty member then submits the form to the Office of Academic Affairs. Two or more members of the committee will review the proposal and you will be notified by the Office of Academic Affairs when the work is approved. This will generally take less than one (working) week and nearly always less than two (working) weeks. Because category II research requires approval you should not begin data collection until you have received notification from the Office of Academic Affairs, based on the recommendations of two or more members of the IRB.
If your proposed research involves:more than minimal risk, minimal discomfort, moderate stress, etc., or involves special or protected populations (participants under 18 years of age, prisoners, in/outpatients, mentally/physically disabled, pregnant women)
then the research falls under Category III, and you should check that space on the form. Complete the form, attach any required or requested information, and submit the form to the Office of Academic Affairs. The full committee will review the proposal and the Office of Academic Affairs will notify you upon approval. This will generally take less than one (working) week and nearly always less than two (working) weeks.
Because Category III research requires approval, you should not begin to collect data until you have received formal approval from the Office of Academic Affairs, based on the recommendation of the IRB.