WRIGHT STATE UNIVERSITY INSTITUTIONAL REVIEW BOARD
ANNUAL PROGRESS REPORT
Form IRB - Cont. Rev. [2012/03]
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RESEARCH INVOLVING HUMAN SUBJECTS - CONTINUING REVIEW QUESTIONNAIRE
INSTITUTIONAL REVIEW BOARD
Must be filled in: HSP #
Principal
Project
Investigator:
Title:
Federal Regulations mandate that all human subject protocols receive continuing review and approval not less than
once per year. In order to comply with this updated policy on research involving human subjects (OPRR Reports,
Number 95-01), sufficient information must be collected to allow the IRB to conduct a "substantive and meaningful"
review. Therefore, in order for the WSU-IRB to comply with this and other directives and, hence, to grant continuing
approval of your protocol, the following information/documents are required: a completed continuing review
questionnaire, a summary of previous protocol activities and future project plans, and, if subjects are still being accrued,
copies of all Informed Consent documents, surveys and/or questionnaires currently being used. In addition, if there have
been any changes made to the original proposal, this must also be submitted.
See instructions at end for returning completed form.
The appropriate Board/Committee cannot proceed with the request for action on this protocol unless all items have been
adequately addressed and this form contains the investigator's signature. If a question does not apply to your protocol, so
indicate (e.g., "Not Applicable" or "N/A").
If you do not respond to this questionnaire, we will assume the project is not currently active, the protocol will be placed
in the inactive file, and the IRB will be so notified.
The information in this petition may become publicly available either through the Ohio Open Records Act or through
open meetings.
Respond to all four sections first:
I. Dates covered by this progress report:
Previous 12 months
Other period as described:
A. Enter last continuing review approval effective through date
II. Is this project currently active?
Yes
No
B. Is this study a retrospective record/chart review?
Yes
No
B. If not currently active, indicate the termination date of your project:
III. Is this project currently open to subject recruitment?
Yes
No
*
If No, please indicate the date closed to recruitment:
IV. Do you wish to continue this protocol?
Yes
No
If Yes, please complete the attached project summary (Item V) and return to Research and Sponsored Programs.
Attach copies of the appropriate informed consent and other relevant document(s).
IRB - Cont. Rev. (2012/03)
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NOTE: If the current approval period has lapsed, no research data from subjects collected after the approval expiration
date and prior to a new approval date can be used in your research.
*NOTE: For studies that have been closed to recruitment, check here to indicate that there are no changes or adverse
events that need to be reported to the IRB ; it is not necessary to complete Item V.
V. PROJECT SUMMARY
A. Have there been any changes in leadership, responsibility, or major personnel?
Yes
No
If Yes, then fully describe:
If new personnel have been added, has the required CITI training been completed?
Yes
No
N/A
B. Briefly summarize the study objectives and procedures, include applicable treatment regimens: (attach
additional page(s) if required)
1.
Objectives:
2.
Procedures:
C. Concisely summarize any changes in Objectives, Procedures, Investigator’s Brochures, and/or Informed
Consent Documents that have occurred during the previous period. Provide documentation of IRB approval of
these items. If applicable, provide details of any changes (e.g., status of, treatment with, use of) in:
Investigational New Drugs (IND), Investigational Devices (ID), experimental surgery, and biohazard usage.
Include a summary of any reports of protocol deviations/violations since the last review. Attach additional
page(s) if required. If no changes, enter “none.”
D. Research Subjects:
1.
Group
List each group, arm, cohort, etc., if applicable, including control groups, on separate lines. If only one
group, description would be “All.”
NUMBER OF SUBJECTS
(at all sites for which your are the
PI)
This
Total
Next Period
Period
Accrual to (anticipated)
Date**
AGE RANGE OF SUBJECTS
(at all sites for which you are the PI)
This
Period
Next Period
(anticipated)
GENDER
(of subjects to date)
%
Male
%
Female
IRB - Cont. Rev. (2012/03)
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** If the accrual of subjects has been lower than anticipated over the past year, explain how this will impact the ability to
complete the protocol's research objectives:
2.
Was the subject population representative of the population base from which subjects could be selected
with respect to:
a. Gender representation?
Yes
No
If No, explain:
For VA studies only: Number of Males ________ Number of Females ________
b.
Yes
Minority representation?
If No, explain:
No
For VA studies only: Number of Subjects from Minorities*: __________
*Minorities defined as (1) Asian American (2) Black (3) Hispanic (4) Native American (including
American Indian, Alaskan Native, and Native Hawaiian) or (5) Pacific-Islander American
c. For VA studies only: Number of Vulnerable Population Subjects*: ______________
*Defined as groups of persons whose range of options is severely limited, who are frequently subjected
to coercion in their decision making, or who may be compromised in their ability to give informed
consent.
3.
Have any subjects withdrawn from study during this reporting period?
Yes
No
If Yes, indicate how many and reason(s):
4.
Are you aware of any breach in confidentiality? (e.g., unauthorized access to medical record(s))
Yes
No
If Yes, describe:
E. Adverse Events - Clinical/Treatment/Intervention studies: [if the study is conducted at multiple sites, please
include national trial information as well. If previously reported to the Board, reference the reporting dates.]
1.
Have there been any unexpected toxicities or problems involving risks to subjects locally?
Yes
No
If Yes, please summarize these unexpected toxicities or problems, the number of occurrences, and indicate
if they required consent document changes, particularly in the “risks” section. If risks are affected, describe
how they are minimized and reasonable in relation to expected benefits. If available, attach copies of data
safety monitoring reports.
2.
Were there major (e.g., severe or life threatening) toxicities locally?
Yes
No
IRB - Cont. Rev. (2012/03)
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If Yes, please summarize all local major toxicities, the number of occurrences, and indicate if they required
consent document changes.
3.
Have there been any deaths on study (from any cause) locally?
Yes
No
If Yes, list each local death separately and the apparent cause.
4.
Has there been a change from the initial risk-potential benefit assessment based on findings of the study to
date?
Yes
No
If Yes, describe completely.
F.
Negative Reactions:
Have there been any unexpected/unusual negative responses as a result of subject recruitment? (i.e., angry
letters, phone calls, threats of legal action)
Yes
No
If Yes, describe:
G. Briefly summarize study findings to date. Include any findings described in relevant recent literature, any
interim findings, and any relevant multi-center trial reports. If findings to date are not available, explain why
not.
H. Comment briefly about plans for the next twelve months:
I.
Revisions/Amendments/Modifications:
1.
Are there revisions/amendments to the protocol, consent form(s), questionnaires, etc. that are included with
this renewal (including any new information that may change the risk/benefit ratio)?
Yes
No
If Yes, provide a brief description below and highlight the changes on the document(s) to be reviewed.
2.
Will the revisions/amendments change the scope or research objectives of the protocol?
Following are examples of actions considered to change the scope or research objectives:
A change in the specific aims approved at the time of award (funding).
A change from the previously approved use of human subjects.
Shifting the emphasis of the research from one disease to another.
IRB - Cont. Rev. (2012/03)
Yes
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No
N/A
If Yes, provide sufficient information/documentation to allow the IRB to review and approve prior to
initiation.
3.
Will the revisions/amendments change risks to subjects?
Yes
No
N/A
If Yes, provide sufficient information/documentation to allow the IRB to review and approve prior to
initiation. In particular, describe how risks are minimized and reasonable in relation to expected benefits.
J.
Provide a listing of all publications, presentations and reports that have resulted from this work since the last
review. If none, so state.
Check if this protocol includes proprietary/confidential information. Provide a statement and any relevant documentation.
(Note: The IRB cannot act on a request for consideration of confidentiality without appropriate justification and relevant
documentation. For further information concerning what constitutes proprietary or confidential information, you may contact
the Wright State University Office of General Counsel (775-2475).)
INVESTIGATOR'S STATEMENT:
As PRINCIPAL INVESTIGATOR, I acknowledge that I have complied with reporting requirements for adverse events
and unanticipated problems as stated in the WSU IRB Guidelines; that I will submit any proposed procedural
modifications to the IRB for its review and approval and, except where necessary to eliminate apparent immediate
hazards, no such modifications will be put into effect without prior Institutional Review Board (IRB) approval; that
unless otherwise directed by the IRB Chairperson, I will renew this application with the IRB no less than annually; that
the research project is being conducted in compliance with the IRB's understanding and recommendations; that the IRB
is provided all the information on the research project necessary for its complete review; and that this research project
will not be put into effect until final IRB approval is received.
_____________________________________________________________
Signature of Principal Investigator [not required if submitted electronically]
Date
Instructions for returning form via e-mail
When form is completed, you can add any additional documents (e.g., consent form, surveys, questionnaires) to the end
by using Insert File command (i.e., select Insert menu, then File, then tell Word what file you want to insert). Select
Save As from File menu and save the completed document with a filename that matches the HSP number and has a .doc
extension (e.g., 1234.doc).