Protocol Submission and Review Process
Protocols are submitted via the module, an online protocol management software system, accessible through the College’s Okta Single Sign-On (SSO) portal.
To request a Cayuse account or if you are having difficulty signing in to Cayuse, please email irb@bowdoin.edu.
PIs should build time in their research workplan, at least three weeks, for back-and-forth communications between the IRB and the PI in the event there are questions or requested revisions to be made before the protocol can be reviewed.
Human subjects research must be current for all study personnel before the review process can begin.
Research may not begin before it is approved or deemed exempt, and this includes the recruitment of subjects.
Level of review is based on regulations put forth by the Office for Human Research Protections and ºÚÁϳԹÏÍø±¬ÍøÕ¾ College IRB Policy. It is determined after a preliminary review of the protocol by the Research Compliance Manager based on several factors: level of risk to participants, the vulnerability of participants, the level of transparency in study procedures (i.e., is there deception or incomplete disclosure involved), and the procedures involved.
Exempt Review
Protocols are eligible for an exempt review if:
- There is little or no risk to participants
- participants are not vulnerable to coercion or undue influence
- the study intent and procedures are fully disclosed to participants (i.e., there is no deception or incomplete disclosure)
- and the procedures fall into one of the outlined by the OHRP.
An exempt review is conducted by the Research Compliance Manager and/or the IRB Chairperson and is reviewed on a rolling basis.
Expedited Review
Protocols are eligible for expedited review if:
- There is no more than minimal risk to participants (i.e. the probability and magnitude of harm do not exceed those encountered in daily life or during the performance of a routine physical or psychological test)
- the study is not focused on prisoners
- and the procedures fall into one of the outlined by the OHRP.
An expedited review is conducted by the IRB Chairperson or one or more experienced IRB members and is reviewed on a rolling basis.
Full Committee Review (FCR)
All other protocols will be subject to full committee review.
A full committee review is conducted by all members of the IRB. Protocols that require full committee review are conducted on a monthly basis at our regularly scheduled IRB committee meetings. Protocols that are likely to need full committee review must be submitted at least three weeks prior to the meeting at which they will be reviewed. Protocols submitted in less time may not be reviewed until the next scheduled meeting.
The IRB also has the authority to recommend that a protocol receive a higher level of review than that permitted by federal regulations. Please also note that all reviews, regardless of level, take some time. The entire application must be read by one or more individuals, and we frequently need to obtain additional information from the investigator before we can make a final determination.
Research may not begin until the researcher receives an approval letter from the IRB. No contact with potential subjects is to be made prior to approval.
What happens after my protocol is approved?
Modifications to exempt protocols do not require IRB approval unless the modification changes the risk/benefit ratio for participants and/or renders the protocol ineligible for exempt status. If you are unsure whether a modification needs to be reviewed for your exempt protocol, please contact us at irb@bowdoin.edu.
- Continuing reviews are not required for exempt protocols.
Modifications to expedited protocols must be submitted to the IRB for review and approval prior to their implementation.
- Continuing reviews are not required for expedited protocols unless the IRB determines otherwise. The IRB will send the PI of any expedited protocols an annual email reminding them of the terms of their approval.
Modifications to full committee review protocols must be submitted to the IRB for review and approval prior to their implementation.
- Continuing reviews are required for full review protocols. The IRB will send the PI a reminder to complete the continuing review 60 days prior to the study expiration date. If a continuing review is not received and approved by the study expiration data, study activities must halt.
What happens when my study is complete or discontinued?
Closure forms should be submitted for all protocols when the study is complete or discontinued.