Use one or more of the following forms to submit a protocol to the Human Subjects Committee (IRB) at College of the Holy Cross. All completed forms should be sent electronically to firstname.lastname@example.org. No handwritten forms will be accepted
If you think your project could be considered exempt from IRB oversight, complete the Application for Exemption from IRB Approval and send it to the above e-mail.
Otherwise, a complete application must include the Cover sheet and Protocol Guide for New Protocols. Once all parts of the protocol are complete and signed, send them electronically to the above e-mail. You will be notified once the protocol has been approved, both by e-mail and with a signed letter of approval. If the protocol must be reviewed by the full Committee, you will be notified of the date that the Committee will meet to consider the protocol. Before that date, you may be asked to clarify certain points of concern by Committee members.
Approvals granted through expedited review (without a full Committee meeting) are indefinite in duration. You need only keep the Committee informed of progress and changes affecting the management of human subjects. Approvals granted through full Committee meetings have a maximum term of 365 days, and must be renewed before that term has elapsed, using a Continuation Form.
Several weeks before the expiration of the initial (and subsequent) approvals, complete the Continuation Form and all applicable components as noted on the form. In particular note how many of the originally approved subjects have been used and whether the original number remains sufficient for the needs of the project. Changes to the protocol may also be requested at this point, using a Modification Form.
This form is used to request changes to the originally submitted protocol, owing either to evolution of your thinking about the project or issues that arose when implementing the original protocol. It can be submitted either in conjunction with a Continuation Form or independently.
Final Report and Termination Form
The protocol must remain approved or exempt for as long as data are being analyzed for the project. Once that process is concluded, you need to submit a notice of termination within a month of the end of the project to the Human Subjects Committee. Protocols for a student’s thesis should not be formally terminated until after the defense of the thesis. Filing a Termination Form with the Human Subjects Committee constitutes a final report.
Informed Consent Form
The form should be tailored to the protocol itself in such a way as to inform the likely subjects of the purposes of the research, the procedures they are being asked to participate in, and any risks and benefits they will experience that might influence their willingness to participate voluntarily. It should be in language that can be readily understood by the subject population and should be in a form that presents the subject with arguments both supporting and opposing their decision to participate. A template is available, the Informed Consent Form, which can be modified to address the issues of your particular protocol. Keep in mind the guidelines given on the website of the Office of Human Research Protections. Depending on the kind of human subjects the protocol involves, you may need to have separate forms for adults and for children (and their parents or guardians), and for protocols involving minimal risk or minor risk.