Submissions to the IRB

A "new study" or initial submission is a protocol that has not been previously submitted to the IRB. An application will need to be completed and submitted through Cayuse HE.

IRB protocols include the following components:
• Initial Submission  
• Informed Consent Form*
• Assent Form, if recruiting minors*
• Data collection instruments (e.g. questionnaires, surveys)*
• Interview scripts*
• Recruiting tools (e.g. letters, fliers, advertisements)*
• Debriefing document, if needed*
• Recruiting/Research Site permission letter, if necessary
• Reliance Agreement, if your study is a multi-site study (also referred to as IRB of
Record, or Data Agreement)
• CITI Training - Social & Behavioral Research (Basic/Refresher Course) for all members of the research team that will be collecting/handling data

*Written information given to subjects, including consent forms, must be in the participant’s
native language.

For student primary researchers: faculty sponsor(s) must be listed as the studies PI.

Incomplete submissions will be returned without review.

A modification submission is used when changes are being made to a study protocol. For example, changes to procedures/study activities, study populations, consent/assent form or process, instruments used or data collected, recruitment methods or advertising, and changes to the research team (administrative information).

Federal regulations require “prompt reporting to the IRB of proposed changes in a research activity” and “such changes in approved research, during the period for which IRB approval has already been given, may not be initiated without IRB review and approval except when necessary to eliminate apparent immediate hazards to the subject.” (45 CFR 46 103(a)(4)(iii)) 

The investigator must receive approval from the IRB before implementing any proposed changes to the protocol which modify study activities. Changes which do not impact the procedure of the study protocol (such as a change in investigator) may also be reported to the IRB using this form. 

Modifications may be submitted to the IRB at any time through Cayuse HE. 

Renewals are required for all non-exempt research. Depending upon the risks and nature of the study, the IRB may require an alternative renewal schedule. The scheduled renewal will never exceed one year.

Cayuse HE will send a renewal reminder to the PI well in advance of the protocol expiration date. Failure to submit a renewal will result in the study expiring. Once a study expires, all research MUST be stopped, including new participant enrollment, interaction with current participants, and any data collection or analysis. 

To reopen an expired study, please contact the IRB at irb@bowdoin.edu.

A closure is submitted, using Cayuse HE, to the Institutional Review Board (IRB) when all project/protocol-related activities have ceased. Closures should be submitted when enrollment of subjects and collection of data is complete. By submitting this form, the Investigator acknowledges that NO further data collection will take place related to this project/protocol. 

If activities are not complete, and the protocol’s approval is due to expire, a renewal should be submitted instead of the closure submission.  

A reportable incident is submitted, using Cayuse HE, to the Institutional Review Board (IRB) when an event occurs that results in a change in the welfare of the subject(s) or in a change to the protocol procedures. Events that should be reported include (but are not limited to) the creation of conditions that jeopardize the health or well being of subjects, including natural disasters, accidents, and mechanical failures, resulting in actual harm or death to subjects. 

This submission must be completed and submitted to the IRB as soon as possible after the occurrence of an adverse event, and no later than 10 working days from when the investigator becomes aware of the event. 

The Committee will use the submitted information to determine whether or not the risk-benefit ratio continues to be acceptable, and whether or not the protocol activities need to be revised to accurately reflect such events.