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This guidance is intended for students who are conducting research that may be unsure about the IRB process and whether they need to submit their research to the IRB.

What is considered research by the IRB?

The defines research as "a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge."

Does my project qualify as human subjects research?

Please use our decision chart to help you determine if your project meets the definition of human subjects research and if an IRB application is required before you begin working on your project.

If you have reviewed the decision chart and are still unsure whether to submit an application to the IRB, please reach out to the IRB at irb@bowdoin.edu.

Examples of Human Subjects Research activities:

• Conducting a survey
• Changing a participants’ environment
• Collecting blood
• Interviewing
• Administering a psychological test
• Collecting data
• Conducting a focus group
• Testing a new educational technique
• Using secondary data sets with private information

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My project is human subjects research! Now what?

The next step is to take :

• Principal investigators, faculty advisors, staff members, students, or guests of the college planning to participate in a research project involving human subjects must receive training in Human Participant Protection.
• This training is available at no cost for any researcher not otherwise trained in these areas. All members of the research team must complete training before submitting their protocol and participating in human subjects research.
• Register with CITI and complete the Social and Behavioral Research course. The IRB website has step-by-step instructions.
• Feel free to take other supplemental courses that you find interesting or helpful!

How do I submit to the IRB?

You submit your research through the IRB’s online application system, .

Things to keep in mind:

1. Planning: make a plan research plan with your faculty advisor.
2. Cayuse: Send an email to irb@bowdoin.edu to request an account. Once an account has been created, you can begin an initial protocol application. 
3. IRB Review: The IRB review will begin when the protocol has been completed and submitted. Give yourself plenty of time for the review process—at least 3 weeks in advance of the anticipated study start date.
4. Revisions: It is routine for the IRB to return your protocol application for revisions at least once during the review process.
5. Approval*: You can start your project!

* Research may not begin before it is approved. This includes the recruitment of subjects.

For more information, visit Protocol Submission and Review Process.

Role and Responsibility of the Faculty Advisor

This information should be shared and discussed with your faculty advisor prior to protocol submission.

What is the faculty advisors role in student led research?

1. The faculty advisor shares with the student the responsibility for the ethical conduct of the research.
2. The advisor is responsible for ensuring that the research activities involving human subjects are reviewed and approved by the IRB before they are initiated.
3. The faculty advisor is expected to take an active role in student research activities and provide supervision for the duration of the project. 
4. The faculty advisor must review, approve and certify the all submissions to the IRB.

What are the responsibilities of the faculty advisor in student led research?

1. Be informed. Contact the Research Compliance Manager to discuss policies and procedures for obtaining IRB review before the initiation of research activities. Faculty advisors are expected to be familiar with institutional requirements for the conduct of human subjects research. 
2. Complete the required CITI training for human subjects research. Faculty advisors are expected to be familiar with ethical and regulatory requirements. 
3. Know what must be reviewed. Determine when a student lead research project contitutes human subjects research and requires IRB review. If the faculty advisor is unsure, it is their responsibility to reach out to the Research Compliance Manager for guidance.
4. Assist students with the IRB process and protocol submission. When proposed activities constitute research with human subjects, it is the responsibility of the faculty advisor to determine what the requirements are for submission to the IRB, help the student to understand the IRB process and assist students in preparing and reviewing materials to be submitted to the IRB via . 
5. Educate students on the role of the IRB and the importance of research review. Take an active role in the review process and assist students when presented with questions and comments from the IRB committee and/or Research Compliance Manager.
6. Oversee changes. Ensure that before a change is implemented to an approved protocol that it is approved by the IRB. All changes must be reviewed and certified in by the faculty mentor.
7. Maintain ethical standards. Faculty advisors ensure that projects are conducted to the highest ethical standards and that students understand and implement these ethical standards in the conduct of their research.
8. Report any adverse events or other research-related problems to the IRB as soon as possible. Incident reports can be accessed and submitted to the IRB through . 
9. Ensure that continuing review requirements are satisfied, if applicable. The PI will be notified if a continuing review must be submitted annually.
10. Ensure that the study is closed at the conclusion of the study. Once the study is complete, including data ananlysis, please submit a closure form via .