ACU IRB # ____________
Date of Approval __/__/____
Date of Expiration __/__/____
Abilene Christian University Institutional Review Board Committee &
Departmental Research Review Panel
Continuing Review Form
Complete the Request and send as an e-mail attachment to orsp@acu.edu. Include any
appendix materials, as applicable, and the signed Investigator assurance/signature form.
Allow up to 3-4 weeks for the requests to be processed. Many members of the committee are
unavailable to review proposals during the summer or holiday months. Submission during the
fall or spring term is highly recommended.
Title of Project:
Protocol #:
Date of Request:
Principal Investigator:
Faculty Advisor (If PI is a student):
Investigator Assurances Form
Department / Affiliation:
Phone:
**Note: Faculty Advisor MUST read and sign the
Degree/Credentials:
Email:
Address or ACU Box:
Point of Contact, if other than PI (Name, phone, email):
Are you requesting an expedited review (please see HHS Chart 9)?
briefly justify qualification for expedited review based on Chart 9:
Were any changes made since the last review?
Yes
If yes, were they all previously approved by the IRB?
Yes
No If yes,
No
Yes
No
Please summarize the approved changes that were made:
Date of Amendment:
Summary of Change:
Date of Amendment:
Summary of Change:
Date of Amendment:
Summary of Change:
Were any unapproved deviations reported to the IRB as noncompliance?
Yes
No
N/A Explain:
(If no and the deviation is serious, please include an
Unanticipated Problems/Noncompliance Report. Serious is defined as adversely affecting
participant safety, increasing risks to participants, or violating participants’ rights and welfare)
Did any of these unapproved changes place participants at a greater risk of harm?
Yes
No
N/A Explain:
####_PI_ContinuingReview_########
ACU IRB # ____________
Date of Approval __/__/____
Date of Expiration __/__/____
What has been done to prevent reoccurrence of unapproved deviations:
You may make very minor changes at this time to include updating study personnel and/or
contact information. Do you wish to include any changes?
Yes
No
If yes, summarize the changes and include any revised forms in the appendix:
Please describe the current status of the study related to enrollment (e.g., have not started
enrolling participants or collecting data/speciments, are actively enrolling participants or
collecting data/speciments, have temporarily or permanently halted/completed enrolling
participants or collecting data/specimens):
Participant Enrollment
How many participants:
Were originally approved for screening
And for enrollment
Have been screened
Have been enrolled
Have completed participation
Have withdrawn/been withdrawn
Please provide a description of each withdrawal, including who initiated the withdrawal
(e.g., participant or PI) and why (e.g., adverse event, non-compliance, no longer met
eligibility criteria, etc.):
Was consent obtained for all enrolled participants, as described in the initial protocol?
Yes
No
N/A Explain:
Did all participants receive a copy of the signed consent form?
Yes
No
N/A Explain:
Are research procedures currently being performed on participants or will they be in the future?
Yes
No
Please summarize the progress on the study:
Have any problems occurred?
Yes
####_PI_ContinuingReview_########
No If yes, please summarize:
ACU IRB # ____________
Date of Approval __/__/____
Date of Expiration __/__/____
Were these previously reported to the IRB?
Yes
No Explain:
Were any of these problems unanticipated and probably related to the research?
Yes
No
N/A Explain:
Were any of these problems serious or did they suggest a greater level of risk than originally
anticipated?
Yes
No
N/A Explain:
Did the occurrence of any of these problems require a revision of the consent form?
Yes
No
N/A Explain:
Have any participants made any complaints about the study?
Yes
No Explain:
Describe any recent literature that has come out since the last review related to this research:
Does the recent literature suggest any new risks or benefits that should be considered?
Yes
No Explain:
Is there any other new information related to the risks and benefits of this research?
Yes
No Explain:
Does the study have a safety monitoring plan?
summary report:
Yes
No. If yes, please provide a
APPENDIX
Identify which items are included in the appendix
Signed Investigator assurance/signature form (required)
NIH Protecting Human Subject Research Participants Training Certificates of
Completion for any new research team members. **NIH Training will be required of
all research team members beginning January 1, 2016. It is highly encouraged
prior to then.
Current Consent Form (required)
Requested Revised Consent Form
Unanticipated Problems/Noncompliance Report Form
Other: ______________________
####_PI_ContinuingReview_########