Procedure for Committee Review and Protocol Closure
It is the responsibility of the investigator (faculty member, administrator, or student) using human subjects in a covered research project to submit the appropriate application materials for Committee review according to the following guidelines:
Complete the application form and an appropriate informed consent form.
Submit all completed forms to email@example.com. During the current academic year, the Committee will meet monthly. Application materials must be submitted by 11:00 a.m. on the Wednesday one week prior to the meeting. Expedited and Exempt review will occur on an ongoing basis and can be submitted anytime.
Written responses concerning Committee action and/or approval forms will be sent to the applicant within one week following final action by the Committee.
The Committee reserves the right to consult with the subject matter, medical, or legal experts concerning any projects submitted for review. If expert review of a proposal is deemed necessary by the Committee, a substantial delay in Committee action should be anticipated.
In the event that a project is denied approval by the Committee, the applicant will be notified in writing of the reasons for disapproval and will be given the opportunity to respond in person or in writing.
All research projects that have been approved by the Committee may be subject to further review or disapproval by appropriate officials of the University. Projects that have been disapproved by the Committee may not be subsequently approved by any other University's Officer.
Major changes in the research design and/or procedures following Committee approval must be resubmitted to the Committee as an amended proposal. In addition, progress reports must be submitted at least annually and more often if so specified by the Committee.
Approval of a project does not remove the researcher's legal responsibility for the project. The researcher is expected to retain signed individual informed consent forms for a period of five years. The Committee's approval of a project constitutes only a statement by the Bradley Committee that it believes the rights of human beings will be adequately protected.
Questions concerning application procedures and guidelines should be referred to the Chairperson of CUHSR.
Final Status and Protocol Closure
When a protocol in finished the Principal Investigators have the responsibility of informing CUSHR when a protocol has been completed. This requirement is for any study that initially approved by CUHSR and includes studies approved by full review, expedited review, exempt studies and quality assurance studies.
Investigator should submit a Final Status and Protocol Closure form to the CUSHR office via email to firstname.lastname@example.org at the conclusion of their study. Forms can be found on the CUSHR website. As a reminder, investigators will be notified by CUHSR shortly after to the anticipated time they stated they would be finish with their data collection or at least annually one month before the anniversary of the initial approval. Those studies with Full Committee Review that are ongoing should fill out a Continuing Review form.
Faculty advisors for student research are responsible to ensure that the Final Status and Protocol Closure Report is filed with CUHSR in a timely fashion.
A protocol may be closed when ALL of the following apply:
All subject recruitment and enrollment is complete (i.e., no new subject recruitment or enrollment are ongoing)
All subject specimens, records, data have been obtained (i.e., no further collection of data/information from or about living individuals will be obtained)
No further contact with subjects is necessary (i.e., all interactions or interventions are complete and no further contact with enrolled subjects is necessary)
Analysis of subject identifiable data, records, specimens are complete (i.e., use or access to subject identifiable data is no longer necessary.
The completed Final Status and Protocol Closure form should be submitted it to CUHSR within 30 days of closure of the protocol.
Should a principal investigator terminate employment from Bradley University, he or she must either submit a Final Status form or formally transfer the protocol to another principal investigator via a modification which is reviewed and approved by the CUHSR. In very rare cases, the CUHSR may grant special permission for the departing individual to remain as principal investigator on the protocol. Cases are reviewed on a case by case basis.