INDIANA UNIVERSITY HEALTH BLOOMINGTON INSTITUTIONAL REVIEW BOARD (IRB)
CONTINUING REVIEW
OPEN TO ENROLLMENT
IRB STUDY NUMBER:
Please type only in the gray boxes. To mark a box as checked, double-click the box, select “checked”, and
click “OK”. Please see the Continuing Review/Closeout Form Instructions for more information.
SECTION I: INVESTIGATOR INFORMATION
Principal Investigator:
Name (Last, First, Middle Initial):
Phone:
E-Mail:
Additional Study Contact:
Name:
Phone:
Project Title:
Sponsor/Funding Agency:
Sponsor Type:
Federal
Internally Funded
Funding Status:
Pending
E-Mail:
Sponsor Number:
Federal Pass-Through
Funded
State
Industry
Not-for-Profit
Unfunded
N/A
SECTION II: CURRENT STUDY STATUS
ONGOING – OPEN TO ENROLLMENT
Date study was initiated:
Projected date of completion:
(Select one below)
Enrollment of new participants or review of records/specimens continues
No participants have been enrolled to date. Please explain, then skip to Section V:
Please check here if the study is currently suspended (temporarily) and indicate the reason(s)
for the suspension:
SECTION III: SUBJECT SUMMARY
Check here if your study utilizes records or specimens versus human subjects. When the form asks for
the number of subjects, document the number of records/specimens that have been reviewed or
collected.
Check here if the IRB has approved a waiver of consent for your study. When the form asks for the
number of subjects consented, document the number of records that have been reviewed or the
number of individuals enrolled.
06/24/2014
RR 403-E
1
1. Subject Summary Table
On-Site
Since last Total number of subjects CONSENTED
IRB review
Total number of subjects who FAILED SCREENING (e.g. found
ineligible to participate)
Total number of subjects who have WITHDRAWN from the study
Since
beginning
of study
Total number of subjects CONSENTED
Total number of subjects who FAILED SCREENING (e.g. found
ineligible to participate)
Total number of subjects who have WITHDRAWN from the study
Number of ACTIVE subjects
Number of subjects who have COMPLETED the study
If necessary, please provide further explanation regarding the subject summary:
2. Withdrawal. Have any subjects withdrawn from the study since the last IRB review?
No
Yes, state the reasons for withdrawal:
3. Justification for Study Continuation. Have subjects accrued in the study since the last IRB review?
Yes
No. Justify study continuation:
4. Vulnerable Populations. Are any of the subjects who have consented or enrolled in the study members
of a vulnerable population?
No.
Yes. Has the IRB previously approved enrollment of these subjects?
Yes. Continue to Question 5.
No. You must submit an amendment to the IRB to request the inclusion of these
subjects. Subjects in the following vulnerable populations were enrolled without IRB
approval.
Children
Pregnant Women and Human Fetuses
Prisoners
Economically/Educationally Disadvantaged
Cognitively Impaired
Students
06/24/2014
RR 403-E
2
5. Short Form Consent. Were any subjects consented using the short form written consent document?
No.
Yes. Please describe the circumstances of each subject enrolled, including language in which the
consent process was conducted:
Is there a reasonable possibility that additional subjects who speak this language could
be enrolled?
No.
Yes. Please submit a translated version of the IRB-approved consent document for
review and approval by the IRB.
6. For studies employing waivers of assent:
a. State the number of assent waivers that were employed since the last IRB review:
b. Explain the circumstances surrounding each assent waiver employed:
SECTION IV: ETHNIC/RACIAL REPORTING REQUIRED FOR FEDERALLY-SPONSORED STUDIES
Ethnic Category
SUBJECT ACCRUAL
Females
Males
Unknown or
Not Reported
Total
Hispanic or Latino
Not Hispanic or Latino
Unknown (Individuals Not Reporting
Ethnicity)
Ethnic Category Total of All Subjects*
Racial Categories
American Indian/Alaska Native
Asian
Native Hawaiian or Other Pacific Islander
Black or African American
White
More Than One Race
Unknown or Not Reported
Racial Categories Total of All Subjects*
If ETHNIC and RACIAL category totals are not equal, please explain:
1. Have there been any unexpected problems recruiting participants, especially subjects in a particular
category (including children and women)?
No.
Yes. Please explain:
2. Is this study conducted at, funded by, or recruited from the VA?
No.
Yes. In the table below, please indicate the total number of VA subjects enrolled in the study and
indicate in which categories those subjects fall and how many represent each category indicated.
06/24/2014
RR 403-E
3
Total number of VA subjects:
Children:
Cognitively Impaired:
Economically/Educationally Disadvantaged:
Pregnant Women and Fetuses:
Prisoners:
Students:
SECTION V: STUDY SUMMARY OF EVENTS
1. Since the last IRB review, did any unanticipated problems, including adverse events, protocol
deviations, or subject complaints, or noncompliance occur that required prompt reporting to the IRB?
No.
Yes. Were these events reported previously to the IRB and VA, if applicable?
No. Please explain why these events were not previously reported:
Yes. Provide a summary of these events:
Check here if the summary is attached.
2. Since the last IRB review, did any protocol-related adverse events, subject complaints, or protocol
deviations occur on-site that did not require prompt reporting to the IRB?
No.
Yes. Provide a summary of these events:
Check here if the summary is attached.
3. Is there a data safety monitoring plan for this study?
No. This study is minimal risk (exempt or expedited).
Yes. Does the plan include a data safety monitoring board?
No.
Yes. Please provide the most recent monitoring report if it has not already been provided
to the IRB or explain why one cannot be provided:
4. Based on the above information, do you feel the validity of the data is affected?
No.
Yes. Explain:
5. Based on the above information, do you feel there is an increase in risk to subjects or others or in the
frequency or severity of adverse events, protocol deviations, problems, complaints, etc. since the last
IRB review?
No.
Yes. Explain:
06/24/2014
RR 403-E
4
SECTION VI: SUMMARY
1. Describe the progress of the research, including any preliminary observations and information about
study results or trends:
If no progress description is provided, please explain why:
2. Have subjects experienced any direct benefit(s) from their participation in the study?
No.
Yes.
Please explain:
3. If any recent literature has been published or presented by you or others since the last IRB review, has
it demonstrated a significant impact on the conduct of the study or the well-being of subjects?
N/A. There has not been any recent literature published or presented since the last IRB review.
No.
Yes. Attach a copy or explain:
4. Have there been any audits from federal agencies conducted since the last IRB review that identified
unanticipated problems involving risks to subjects or others or noncompliance?
No.
Yes. Attach the report(s).
5. Do you believe the risk/benefit ratio has changed based on all of the information provided on this form
and any attachments?
No.
Yes. Explain:
SECTION VII: CO-INVESTIGATOR UPDATE
This submission does NOT include additions or removals to the Investigator List. Proceed to section
VIII.
This submission includes additions or removals to the Investigator List. The updated Investigator List is
attached.
The following investigators are being added to the current Investigator List:
The following investigators are being removed from the Investigator List and will no longer be
participating in this research:
06/24/2014
RR 403-E
5
SECTION VIII: REQUIRED ATTACHMENTS
All current study documents must be included with your continuing review submission. Please check the
appropriate boxes as they apply to your study.
Assent, dated:
Number of assent documents:
Authorization, dated:
Number of authorizations:
Clinical Investigator’s Brochure, dated:
Protocol, dated:
Recruitment materials (please list and
date):
Request form(s) for vulnerable
population(s) (please list and date);
Expedited Research Checklist, dated:
Study Information Sheet, dated:
Surveys, questionnaires (please list and
date):
Summary Safeguard Statement or HUD
Form, dated:
Test Article Supplement, dated:
Other (please list and date):
HIPAA & Recruitment Checklist, dated:
Informed Consent, dated:
Number of consent documents:
Investigator List, dated:
Medical Device form, dated:
Include the following documents, as applicable:
Publications, if you answered YES to VI.3 above
Audit reports, if you answered YES to VI.4 above
Summaries, if you indicated in Section V that summaries are attached
DSMB report, if the study includes a DSMB and you are submitting the most recent DSMB report
Interim findings, if there are any to report
Multi-center trial reports, if there are any available
NOTES:
 No changes to previously approved study documents are allowed at the time of continuing review
unless requested by the IRB.
 Incomplete submissions will result in a processing delay, which could result in study expiration.
 VA Requirements: For studies conducted at the VA, utilizing VA funding or VA patients, you must provide
a copy of the approved continuing review form to the VA Research Service office.
SECTION IX: INVESTIGATOR STATEMENT OF COMPLIANCE
By submitting this form, the Principal Investigator assures that all information provided is accurate.
He/she assures that procedures performed under this project will be conducted in strict accordance with
federal regulations and Indiana University Health Bloomington policies and procedures that govern
research involving human subjects. He/she acknowledges that he/she has the resources required to
conduct research in a way that will protect the rights and welfare of participants and that he/she will
employ sound study design which minimizes risks to subjects. He/she agrees to submit any change to the
project (e.g. change in principal investigator, research methodology, subject recruitment procedures, etc.)
to the Board in the form of an amendment for IRB approval prior to implementation.
06/24/2014
RR 403-E
6
SECTION X: IRB APPROVAL
For IU Health Bloomington IRB Office Use Only
Type of review:
Full Board
Expedited, Category:
STATUS OF STUDY: ONGOING - Open to Enrollment
This continuing review has been reviewed and approved as meeting the criteria for IRB approval as
outlined in 45 CFR 46.111(a) by the Indiana University Health Bloomington IRB. Based on the criteria for
determining the frequency of continuing review and the level of risk, this study will expire on:
___________________. If the study is not re-approved prior to that date all research activities must cease
on that date, including enrollment of new subjects, intervention/interaction with current participants, and
analysis of identified data.
Authorized IRB Signature:
IRB Approval Date:
Printed Name of IRB Member:
For IU Health Bloomington IRB Office Use Only.
Recorded in the Minutes of:
This form must be electronically signed by the Principal Investigator or designee. The electronic signature
certifies that the information provided above is accurate, current and complete.
06/24/2014
RR 403-E
7