IRB APPLICATION AND RELATED FORMS
Please complete and submit electronically, the application form materials, which consists of the following documents:
- IRB Application Form
- IRB Consent Form Template
- IRB Application and Consent Form Completion Instructions
Full Committee Review Application. For an application that requires a full committee review, the submission, which includes an electronic copy sent to firstname.lastname@example.org , must be in the Office of the Provost no later than two weeks prior to the scheduled IRB Committee meeting . You may contact Sue Costello at 610-499-4211 with any questions. Pages requiring signatures can be scanned and submitted with the electronic copy of the application.
Expedited and Exempt Applications. Expedited and Exempt applications require the submission of an electronic copy of the application forms sent to email@example.com. Pages requiring signatures can be scanned and submitted with the electronic copy of the application.
Expedited and exempt applications can be submitted at any time for committee review. Please see the application review process tab to see if your application may qualify for exempt status.
IRB CONFLICT OF INTEREST FORMS
Conflict of interest arises when an employee, faculty member, or student is involved in a particular matter as part of his/her official duties with an outside organization with which he/she also has a financial interest, or one which is imputed to him/her, i.e., the employee’s spouse, minor children, an organization in which the employee serves as officer, director, trustee, partner, or employee, or a person or organization with which the employee is negotiating for or has an arrangement for prospective employment. Conflicts can be real or apparent.
CHILD/YOUTH ASSENT FORMS
The resources below have been created to help investigators craft consent forms that are appropriate for minors. Please use the following templates to create age appropriate assent forms:
CHANGES TO A PREVIOUSLY APPROVED IRB APPLICATION
The Request for a Change to Approved IRB Application Form is completed whenever there is change to a research protocol approved by the IRB. Any changes to a protocol that has received prior IRB approval must be reviewed by the IRB. Please forward a completed electronic copy of the application to firstname.lastname@example.org.
COMPLETION OF A RESEARCH STUDY
IRB approval to solicit participants is good for one year. The Research Status Form is completed when: (1) the research study has been completed, (2) data collection extends beyond the one year approval date, (3) the study is terminated by the researchers prior to the completion of data collection, or (4) an adverse event occurs resulting in a physical, emotional or psychological injury to a participant.
RESEARCH INVOLVING HUMAN SUBJECTS
Students who wish to carry out research projects involving human subjects may also be required to submit their applications to the IRB Committee. The student must first obtain agreement from such a faculty member to sponsor and supervise the research, and must secure written approval of the protocol from the sponsoring faculty member before submitting it for IRB review.
Classroom research projects DO NOT require IRB review. A classroom project is not considered research when:
(1) the exercise is solely to fulfill course requirements or to train students in the use of particular research methods or devices, AND
(2) the results will never be distributed outside the classroom and/or institutional setting, AND
(3) the project involves minimal risk to subjects, AND
(4) the project does not involve vulnerable populations.
For classroom only research projects, while IRB review is not required, the ethical principles of the Belmont Report still apply. The classroom instructor is responsible for informing students about these principles including the elements of informed consent.
For applications requiring a full IRB Committee review, please allow two weeks following the meeting date for the committee to respond to a first time submission. Incomplete applications or resubmissions will be returned for correction and will not be reviewed until the next meeting .