Alexian Brothers Hospital Network

Alexian Brothers Hospital Network

AMITA Health

Application to Continue (Renew) a Previously Approved IRB STUDY/HDE

At AMITA HEALTH

AMITA Health (ABHN or AMH)IRB#:

Project Title(optional):

Principal Investigator:

Please provide allrequested information/documents pertaining to the above referenced study. All documents and forms are to be typewritten and clearly marked with the project’sIRB #. To download this and other IRB forms, go to You may also obtain IRB forms by calling 847-385-7319.

NOTE: No research-related activities may occur after the protocol expiration date unless the PI contacts the IRB office and the IRB Chairperson (or designee) determines that it is in the best interest of individual subjects to continue during the lapse in IRB approval.

Check the condition that applies to your study:
No subjects have been enrolled at AMITA Health and no additional risks have been identified. This means that no subjects have ever been enrolled at AMITA Health; but that no additional risks have been identified from any site or other relevant source.
No subjects have been enrolled at AMITA Health, but new risks have been identified that pose greater than minimal risk to subjects.
Subjects have been enrolled and recruitment or enrollment of subjects continues. / Study is permanently closed to new subject accrual, but subjects still receive research-related interventions.
Study is permanently closed to new subject accrual, but research activities are limited to data analysis that may require contact with records or specimens linked to privately identifiable health information.
Study is permanently closed to new subject accrual, all subjects have completed all research-related interventions, and the research remains active only for follow-up.
Study is terminated. Skip this form, and complete the Study Termination Form instead.
For IRB Use Only
Qualifies for Expedited Review: N/A
Research was initially reviewed by expedited IRB review
Research was initially reviewed by the convened IRB but deemed by the IRB to be eligible for expedited review
Other / Requires FULL Board Review: N/A
Research was initially reviewed by the convened IRB
Research was initially reviewed via an expedited mechanism but a later amendment increased the risks to greater than minimal.
Review Requirements
  • Completed Continuing Review Form (6 pages)
  • 2 Copies of Current Informed Consents (not needed if study is permanently closed to accrual):
  • IRB-stamped copy;
  • clean copy to be stamped with new expiration date
  • Updated Conflict of Interest Form (not required for HDEs)
  • Attachments, if applicable:
  • Summaries of unanticipated problems, adverse events, protocol deviations/violations, including the Adverse Event Cumulative Log
  • Summary of subject complaints and withdrawal of subjects
  • Summary of change to risks or potential benefits

I. Principal Investigator/ Contact Information
Principal Investigator: / E-mail Address:
Phone/pager: / Fax:
Mailing Address:
Coordinator/Contact Person: / E-mail Address:
Phone/pager: / Fax:
Mailing Address:
II. Study Status
Enrollment/Recruitment has not started / Projected date of study completion:
Active enrollment / Projected date of study completion:
Enrollment closed and participants are receiving study intervention
Participants receiving drugs/devices
Participants receiving other research-related procedures (including protocol-specified testing)
Participants were consented since last continuing review before enrollment closed / Date closed:
Enrollment closed. Research open for collection of follow-up (including survival, if applicable) data and data analysis only
Participants were consented since last continuing review before enrollment closed / Date closed:
III. Subject Enrollment
1. Target enrollment at AMITA Health
2. Number of subjects enrolled at AMITA Health since the study was initiated
3. Number of subjects enrolled at AMITA Health since the last continuing review
4. Numberof participants accrued who are under 18 years of age
5. Number of non-English speaking subjects enrolled
6. If non-English speaking subjects have been enrolled indicate the manner in which informed consent was obtained (e.g., translated consent form)

QUESTIONS IN SECTIONS IV-VII APPLY TO THE CURRENT APPROVAL PERIOD -- it is not necessary to repeat information submitted with a previous continuing review application.

IV. Problems, Complications, Subject Withdrawal
Questions in this section apply only to your local site / Yes / No / Date reported to IRB
Did any subjects express complaints about their participation in the study?
  • If yes, describe on a separate sheet the complaints and corrective measures, if any

Did any subjects voluntarily withdraw from the study?
  • If yes, describe on a separate sheet any known reasons for each subject’s withdrawal

Were any subjects prematurely terminated by the investigator from the research for medical or non-medical reasons?
  • If yes, describe on a separate sheet the reasons for each subject’s withdrawal

Was there an unusually high frequency of serious but anticipated (expected) adverse events?
  • If yes, describe this finding on a separate sheet

Did any subject suffer an unanticipated (unexpected) adverse event, serious adverse event, or death?
  • If yes, attach a summary of all such events describing the number, nature and significance

V. Unanticipated Problems / Protocol Deviations
Questions in this section apply to all study sites / Yes / No / Date reported to IRB
Have there been any unanticipated problems (events involving risks to participants or others)?
  • If yes, attach a summary of the problems

Has the profile of adverse events (in terms of frequency, severity, or specificity) changed from previous experience or from protocol expectation?
  • If yes, attach a summary of the changes

Have there been any protocol exceptions, major deviations or major violations?
  • If yes, attach a summary describing the exceptions/deviations/violations

VI. Informed Consent Evaluation
Check the type(s) of consent:
□ Written □ Oral □ Waiver/Alteration □ None
Number of consent forms (e.g., consent, consent addendum, assent):
Did any problems occur in obtaining and documenting informed consent?
  • If yes, explain on a separate sheet
/ Yes / No / N/A
Is the most recent version of the consent form(s) still acceptable?
  • In answering this question, it should be considered whether the document is accurate, complete and in language understandable to subjects, and does not exclude any new information about the study procedures or results that should be disclosed to subjects.
  • If the answer is yes, attach a copy of the current consent form
  • If the answer is no, submit a “Revisions and Amendments” form with the revised consent form(s) with tracked changes
/ Yes / No / N/A
Was any study-related procedure performed prior to obtaining informed consent?
  • If yes, explain on a separate sheet
/ Yes / No / N/A
Have informed consent documents and information pertaining to the identity of subjects been securely stored?
  • If not, explain on a separate sheet
/ Yes / No
Have any significant new findings developed in the course of the study that may relate to the willingness of current subjects to continue participation?
  • If yes, explain on a separate sheet the new findings plans to inform subjects of this information
/ Yes / No
VII. Benefits / Risks
Yes / No / Date reported to IRB
Have participants experienced any direct medical benefits as described in the consent form (if any)?
  • If yes, attach a summary of participant benefits

Has there been any new risk information that would affect this research?
  • If yes, attach a summary of this information

In the opinion of the principal investigator, have the risks or potential benefits of this research changed?
  • If yes, attach a summary description of those changes and the rationale behind the PI’s opinion

RENEWAL SUMMARY

1.Changes & Amendments

Briefly summarize any IRB approved changes or amendments to the protocol or consent form during the prior approval period; include the date of IRB approval. Note: If there are any changes that were not previously reported to the IRB, attach a request for approval of those modifications using the Revisions and Amendments form.

No changes during the prior approval period.

Changes/amendments briefly summarized as follows:

2.Progress Report:

Briefly describe the progress of the research during the last approval period. A separate progress report may be submitted.

No progress made during the prior approval period.

Progress briefly described as follows:

3.Interim Findings:

Briefly describe any significant preliminary observations/interim findings during the last approval period.

No significant interim findings during the prior approval period.

Interim findings briefly described as follows:

4.Literature:

Briefly summarize recent (within the last year) relevant literature from peer reviewed publications (if any exist) and their relevance to your research. Note: Do not merely provide a list of publications without analysis as to significance to the research.

No relevant literature found during the prior approval period.

Brief summary of literature and its relevance to the research as follows:

5.Data and Safety Monitoring

Brieflydescribe the data and safety monitoring plan (DSMP) for this study and who is responsible for monitoring (e.g., principal investigator, commercial sponsor etc.). Attach a copy of the latest report or interim findings generated by the DSMP. If no reports or interim findings have been generated, explain why.

 No DSMP is required for this research.

 Monitoring safety for this research is the responsibility of ______.

 No DSM report has been generated because:

 Brief description of the DSMP is as follows:

6.Conflict of Interest

Attach an updated “Disclosure of Financial Interest” form covering all members of the research team.

(Not required for HDEs)

PRINCIPAL INVESTIGATOR’S ASSURANCE:

I certify the information in this application is complete and correct.

I understand that as Principal Investigator, I have ultimate responsibility for the protection of the rights and welfare of human subjects and the ethical conduct of this research project/HDE. I agree to comply with all AMITA Health IRB policies and procedures, as well as all applicable federal, state, and local laws regarding the protection of human subjects in research.

X

Principal InvestigatorPrinted NameDate

1

Continuing Review Application

Version: rev 1-10, 10-09, 7-09, 6-08, 8-12, 9-15

Top View