Course Approval Process
How to Use the Course Approval Process for Research Conducted in a Class
When a faculty member is teaching a class in which students conduct research with human subjects and the research does not fit into one of the categories of research do not need to be reviewed or approved by the IRB, the research may be eligible to be reviewed under the Course Approval process.
The research must meet certain criteria to use this system (e.g., minimal risk, no vulnerable populations, all participants recruited from CSB/SJU community, etc.).
1) Step 1 – complete the checklist below to ensure that the research projects conducted within the context of your class will meet all required criteria
2) Step 2 – complete the IRB Course Approval Application and submit with the course syllabus
3) Step 3 – submit student research project descriptions and their informed consent forms
4) Step 4 – submit the End-of-Semester Report
NOTE: In subsequent semesters with the same course, Steps 1 and 2 can be skipped if no significant changes are made to the types of projects conducted or the instruction pertaining to research ethics.
Detailed instructions for each step are given below.
Step 1 – Checklist
Research projects must meet all of the following criteria to be eligible for the Course Approval process.
_____ All participants must belong to the CSB/SJU campus community; no off-campus recruitment of participants is permitted [except for anonymous surveys which may be conducted through Facebook or sent through emails, texting, twitter, etc.] and all in-person research must be conducted on the CSB/SJU campuses [except for observation of public behavior].
_____ All participants must be at least 18 years old, and no vulnerable populations can be recruited.
_____ No proposed research projects can pose more than minimal risk to participants.
_____ Projects cannot cause participants to feel physically or psychologically threatened or involve procedures with more than minimal physical pain/discomfort. Acceptable minimal pain/discomfort might be a finger stick to collect a blood samples or the completion of an exercise fitness test, like a VO2max test.*
_____ No personal identifiers [e.g. name, social security number] can be connected to any research data; instead, use codes to match data to individual participants if necessary.
_____ Only non-sensitive information may be collected from participants. Sensitive information that should be avoided includes: history of drug use, sexual history, illegal activities and/or practices, mental health, and medical history.*
_____ No deception about risks or other information that could influence individuals’ willingness to participate is allowed. When it is necessary to obscure the true purpose of the research in order to obtain valid or unbiased results, a debriefing must be provided to explain why this deception was necessary and provide an opportunity for the participants to ask questions.
_____ Research that involves student athletes requires a letter of support from the coach. Consult with the IRB Chair to determine if a letter of support is also required from the Athletic Director.
* questions regarding acceptable procedures, minimal discomfort, or non-sensitive information can be directed to the IRB Chair ([email protected])
_____ The course must include Ethics Training
- All students must complete the CITI online research ethics training course for research involving no more than minimal risk. Students should submit their Completion Reports to the faculty member, who will save them with other documents relevant to the class projects. Students may not begin data collection on their project until their Completion Reports have been submitted. Instructions for accessing the CITI course are available on the IRB website.
- Course time must be allotted to discuss the elements of informed consent, ethical research practices, the role of the IRB, etc.
- NOTE: If the research involves collecting potentially biohazardous samples (e.g., biological fluids such as blood), proper training for handling of biohazardous materials must be included in the course or completed via online training and proof of competency obtained for each student working with the samples. Biohazardous materials, or "biohazards", are infectious agents or hazardous biological materials that present a risk or potential risk to the health of humans, animals, or the environment. Students must also have completed the Hepatitis B vaccination series.
Step 2 – Submit the IRB Course Approval Application and course syllabus
Step 3 – Submit the Student Project Descriptions and Informed Consent Forms
After submitting the IRB Course Approval Application but before starting student research projects:
A project description and the informed consent form for each student research project must be submitted to the IRB Chair before any data collection or subject recruitment can begin.
- The project description should include the following:
- who the participants will be and how they will be recruited
- the procedures to be used
- how risks will be minimized and how confidentiality of the data will be maintained
- an explanation of the debriefing process and how participants may obtain information about the study results
- Each student/team must develop and use an approved informed consent form
Step 4 – Submit the End-of-the-Semester Report
- The students should fill out this End-of-Semester Report Form, which will be sent to the course instructor for comments and approval. (Note: If you don’t have your students do this, you can fill it out yourself, then approve it when it is sent to your email for approval).
- Only one form needs to be filled out per project
- List of instructor-approved project titles
- Names and contact information for students involved with each project
- Identification of any problems that affected the health or wellbeing of participants or jeopardized the confidentiality or anonymity of the data and how problems were handled. If no problems were encountered, simply state that in the report.
- Assurance that informed consent was provided, and that all participants willingly participated in the research projects.