Petition for Approval of Medical Research Limited to CHART/ELECTRONIC MEDICAL RECORD
REVIEW (or Review of Publically Available Datasets) for which Consent Will NOT be Obtained
Office of Research and Sponsored Programs (RSP)
201J University Hall
Wright State University
Dayton, OH 45435
(937) 775-2425 – Voice / (937) 775- 3781 - Facsimile
The attached petition is to be used when requesting review for approval of medical research protocols
involving human subjects by the Wright State University Institutional Review Board (IRB). Please TYPE
and SIGN before submitting. Copies should be individually stapled, clipped or banded, with no covers. If
you have any questions concerning the petition or meeting dates, please contact the IRB Coordinator at 7754462.
Hospitals may have additional pre-screening requirements for submission of protocols. Please consult the
hospital research office for further guidance.
The information requested in this petition is necessary and must be on file for inspection by authorized individuals.
Therefore, the appropriate Board/Committee cannot review this petition unless all the questions have been adequately
addressed. When submitting your application, follow the INSTRUCTIONS below.
The information in this petition may become publicly available either through the Ohio Open Records Act or through
open meetings. For additional information, see the signature page.
INSTRUCTIONS
Expedited Review (this includes the majority of research limited to chart review):
Research activity involving no more than minimal risk to the subject may be eligible for expedited review.
Submit all documents to the IRB Office, Attention: Jodi Blacklidge, c/o RSP.
 One single-sided typewritten original (petition and supporting documentation) with original signatures of principal
investigator, co-investigator(s) and, for a student PI, the faculty advisor
 1 double-sided collated copy of all documents, including the petition. Do not include the instruction pages with
your submission.
 Supporting documents (as appropriate for study):
o Protocol summary (max of 4 double-spaced pages)
o Agency or Hospital permission documents (if required)
o Data collection form(s). A complete list of all data (including PHI data) that will be abstracted from the
patient medical record must be provided)
 1 copy of the CV/Biographical Sketch for the PI and all key personnel
Exempt Research:
Chart Reviews may only be approved as exempt as long as no identifiable patient information (protected health information) is
being recorded during the study. If data can be linked to the subject via a code, then the study may not be approved as Exempt.
 Submit one single-sided typewritten original (petition and supporting documentation) with original signatures of
principal investigator, co-investigator(s) and, for a student PI, the faculty advisor
Chart Review petitions will be reviewed by the Chair of the IRB and authorized designees. If your
study does not meet the criteria for Expedited Review or Exempt designation, the IRB Office will
provide with you with information about Full Board Review.
RSP/IRB-1 (3-2016)
Petition for Approval of Medical Research Limited to CHART REVIEW (or Review of
Publically Available Datasets) for which Consent Will Not be Obtained
Wright State University Office of Research and Sponsored Programs
Date:
For RSP use only
IRB Assignment Number: _________________________
Title of Research Project:
PRINCIPAL INVESTIGATOR INFORMATION:
Principal Investigator
Academic Title
Phone
Department
Fax
Address
E-mail
Contact person to receive study correspondence. Include name & phone
no.
Contact E-mail
Position (check one):
Faculty:
1.
Student/Resident:
Staff
Other (specify):
Indicate the names of other investigators participating in the research. If a student is listed as principal
investigator, specify a faculty advisor. If study-related healthcare decisions are to be made and the PI does not
have a license to practice medicine in Ohio, a qualified clinician must be listed. Indicate academic titles, if any,
for all investigators.
(WSU only) Check here to indicate that Principal Investigators/Advisor (exempt protocols) or all
investigators/advisor (expedited and full board) have completed the required human subjects protection training
offered by Collaborative Institutional Training Initiative (CITI) through Wright State University—see
http://www.citiprogram.org/ and IRB Policy P.5. (found in the IRB Charter at
http://www.wright.edu/rsp/IRB/irb_charter.html).
(Other institutions) Check here to indicate that Principal Investigators/Advisor (exempt protocols) or all
investigators/advisor (expedited and full board) have completed the required human subjects protection training
offered by Collaborative Institutional Training Initiative (CITI) through another institution. Please attach a copy
of the CITI report for each investigator listed on the study.
RSP/IRB-1 (3-16-16)
Page 1
List the names of all other investigators and key study personnel who will be involved in the conduct of this
research. For every name include each person’s academic/professional title and their proposed role in the study.
2.
FUNDING INFORMATION:
Indicate the category of the sponsor (if applicable):
Industry (other than pharmaceutical)
State Government
Pharmaceutical Company
Non-Profit Organization
Internal Grant Program
Other (specify)
No Funding
Local Government
Federal Agency
Provide the name(s) of any and all sponsors of this research checked above:
3.
FINANCIAL INTEREST DISCLOSURE:
For researchers affiliated with Wright State University: The PI and all key personnel must submit a disclosure of
Significant Financial Interest annually to RSP. The disclosure statement must be current at the time of IRB
submission. Please see http://www.wright.edu/rsp/coi.html for additional information about completing the
electronic disclosure form.
a.
Does the PI or his/her spouse or dependent children have an ownership interest (stock or equity) in the sponsor
of this study or have they received direct compensation (not through WSU or Premier Health) from the sponsor
in the past 12 months?
Yes
No
If yes, please provide the name and contact information for the individual who has the financial interest:
b.
Do any of the study investigators or key study personnel (including all spouses and dependent children) listed
above have an ownership interest (stock or equity) in the sponsor of this study or have received direct
compensation (payment not through WSU or Premier Health) from the sponsor in the past 12 months?
Yes
No
If yes, please provide the name and contact information for the individual who has the financial interest:
c.
Do the PI, study investigators or any key study personnel (including their spouses and dependent children) have
any financial interests that are related or could appear to be related to the drug, device, technology, equipment
or software tested or utilized in this study?
Yes
No
If yes, please provide the name and contact information for the individual who has the financial interest:
d.
Does this study involve intellectual property that is owned by the University, the PI or other WSU faculty or
staff members?
Yes
No
If yes, please provide the name and contact information for the individual who has the financial interest:
RSP/IRB-1 (3-16-16)
Page 2
PROTOCOL INFORMATION
Attach a concise description summarizing the following areas:
 Purpose of research
 Background and hypothesis
 Procedures
 Risks
 Potential benefits
 Inclusion and exclusion criteria
[Note: submit a MAXIMUM of 4 double-spaced pages; descriptions exceeding this limitation will be
returned for re-writing.]
4.
Please check which of the following applies to the research:
Chart review*
Review of public dataset without identifiers***
Other (describe)
*Note: For chart reviews or retrospective studies, copies of the data collection instruments must be
provided. **For public datasets without identifiers, a copy of the data review form must be provided.
RISK ASSESSMENT:
5.
Does the study involve any risk to the subjects other than a potential breach of confidentiality?
Yes
No
If yes:
a. Indicate where these risks are described in the protocol and consent form/cover letter.
b. Are the risks/discomforts reasonable in relation to anticipated benefits (if any)?
Yes
c. Indicate how risks to subjects have been minimized where possible.
No
CONFIDENTIALITY AND PRIVACY:
Any data which contains subject/patient identifiers, or which can be linked to a subject/patient identifier, must be
kept confidential.
6.
Will any information collected during this study contain information that can identify the subject?
Yes
a.
No
If yes, please indicate which of the following will contain subject identifiers such as name, medical record
number, social security number, date of birth, address or other information that might be categorized as
protected health information. Check all that apply to the study:
Study Data with subject identifiers
Study data without subject identifiers, but which can be linked via a unique code to the subject identity
Other (please describe):
b.
If the answer to 6 (above) is yes, please describe the specific steps that will be taken to insure that the study
data will remain confidential. This includes where the data will be stored, and how access will be restricted
to only those authorized to review it.
Please note:
a. For student researchers, all study data containing subject identifiers may not be stored on student
computers or at a non-WSU campus/hospital location.
RSP/IRB-1 (3-16-16)
Page 3
b.
c.
d.
In general, any data containing personal/identifying information should not be stored on thumb
drives, portable computers or personal computers.
Hospitals have specific requirements for data storage. Consult with the hospital research office for
specific requirements
If any identifiable study data containing protected health information will be transmitted
electronically, describe how the data will be encrypted, password protected, and sent only through
secure channels. The need to perform electronic transmission of protected health information
must be justified in the study protocol.
8.
Have adequate safeguards been taken to protect against identifying, directly or indirectly, any individual subject
in any report of the research project?
Yes
No If No, provide further information.
9.
Is identifiable medical information (Protected Health Information or PHI) being recorded as part of the chart
review? This includes information that can be linked back to the subject identity via a code.
Yes
No Refer to
http://www.wright.edu/rsp/IRB/Policies/P_19%20Using%20Protected%20Health%20Information%20In%20Re
search.docx for a list of PHI.
If yes, a waiver of the HIPAA privacy rule must be requested. Complete responses to each of the following
questions is required to grant this waiver.
a.
Explain why the research cannot reasonably be conducted without the waiver of authorization.
b.
Explain why the research cannot reasonably be conducted without access to and use of identifiable
health information.
c.
Briefly but completely describe the PHI (Protected Health Information) for which use and/or
disclosure has been determined necessary.
d.
Describe the reasonable safeguards to protect identifiable information from unauthorized use or redisclosure.
e.
Describe the reasonable safeguards to protect against identification, directly or indirectly, any
patient in any report of the research.
f.
Describe the plan to destroy the identifiers at the earliest opportunity, consistent with the research.
If there is a health or research justification for retaining identifiers, or if the law requires you to
keep such identifying information, please provide this information as well.
g.
Provide written assurance that identifiable information will not be reused/disclosed to any other
person or entity, unless such use is required by law, for oversight of the research study, or for
other research permitted by law.
STUDY SITE RESOURCES:
10. You may either answer the following questions or attach a separate page (check here if a separate page is
attached)
a.
State where you will be conducting the research study (e.g. Wright State University (WSU), Veterans
Administration (VA), Good Samaritan Hospital (GSH), Miami Valley Hospital (MVH), etc.). Include
the address for any site not affiliated with WSU
WSU
DCOP


VA
GSH
MVH
Atrium
Other
Name of site(s):
If other than WSU, Dayton Clinical Oncology Program (DCOP) or hospital facility,
describe the facility where the study will be conducted
RSP/IRB-1 (3-16-16)
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
b.
Please check here to indicate that permission has been received to perform research
at non-WSU sites (documentation must be submitted)
Are any personnel other than the PI involved in this research?
Yes
No
If yes, how will the PI ensure that all research staff for the study are adequately informed of the
research-related duties and functions?
c.
If previously collected deidentified data is being used in the research (for example, publicly
available datasets), briefly describe the source (leave blank if non-applicable)
RECRUITMENT:
11. Briefly describe the inclusion criteria for this chart review. Include the date range for the charts to be reviewed.
12. Approximately how many charts will be reviewed for this study?
WAIVER of INFORMED CONSENT:
13. If there will not be a consent document used in the study then a waiver of consent must be requested by
answering the following questions. A waiver can be granted only if the answer to all of the following questions
is “Yes”.
a.
The research involves no more than minimal risk to the participants.
b.
The waiver or alteration will not adversely affect the rights and welfare of the participants.
c.
The research could not practicably be carried out without the waiver or alteration.
d.
The research is not subject to FDA regulation.
e.
That for any person for whom consent has not been obtained, whenever appropriate, additional
pertinent information will be provided after participation.
Yes
No
N/A
Yes
Yes
No
Yes
Yes
No
No
No
SIGNATURES AND CERTIFICATIONS
By signing and submitting this application, the Principal Investigator agrees that he/she:
1.
2.
3.
4.
5.
6.
7.
8.
Accepts responsibility for the scientific conduct of the project, that the scientific portion of the protocol is
original and contains no false, fictitious, or fraudulent statements or date. Signature certifies that all listed
investigators have reviewed the proposal and that the research will be conducted in full compliance with WSU
policies and federal regulations.
Has provided the IRB with all the information on the research project necessary for its complete review.
Will submit progress reports to the IRB for review in a timely manner in order to obtain appropriate continuing
review to maintain the approval status of the protocol.
Will submit all changes in the study to the IRB for review and approval before implementing those changes.
Will submit anticipated problems (including adverse events) to the IRB for review in a timely manner.
Will not put this research project into effect until final IRB approval is received.
Has completed the required modules in the CITI training program, which can be found at
http://www.citiprogram.org/ (see also IRB Policy P.5.)
Has completed the electronic Significant Financial Interest Disclosure form (for researchers with Wright State
University affiliation (e.g. faculty appointment)
Signature of Principal Investigator
RSP/IRB-1 (3-16-16)
Date
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All other Investigators and/or Faculty Advisor listed on the cover of this petition (if any) must sign to acknowledge
their participation in this project:
Signature of Faculty Advisor
Date
Signature of Co-Investigator
Date
______________________________________
Signature of Co-Investigator
Date
Signature of Co-Investigator
Date
______________________________________
Signature of Co-Investigator
Date
Signature of Co-Investigator
Date
______________________________________
Signature of Co-Investigator
Date
Signature of Co-Investigator
Date
______________________________________
Signature of Co-Investigator
Date
Signature of Co-Investigator
Date
______________________________________
Signature of Co-Investigator
Date
RSP/IRB-1 (3-16-16)
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