Ohio University
Institutional Review Board
Project Amendment/Revision Form
Federal regulations require IRB approval prior to implementing proposed changes to
research projects. Such changes include any change to the originally approved proposal,
including, but not limited to changes in number of participants, changes in
recruitment/research procedures, and changes in supporting documents (consent form,
debriefing form, questionnaires, advertisements, etc.)
Please complete this form, and attach all revised documents or supporting information.
Proposal #
10E158
Proposal Title
Email
6/15/2010
COMPARISON OF OSTEOPATHIC MEDICAL SCHOOL
CURRICULA IN TEACHING CLINICAL REASONING
Principal Investigator Information
Name
Amanda Kocoloski
Address
Date
Department OU-COM Department
of Family Medicine
Grosvenor Hall 333
ak322306@ohio.edu
Phone
(740)704-5743
Study Status
Active (currently in progress)
Project on Hold (pending approval of this amendment)
X
Project not yet started (no participants enrolled)
Closed to new participant entry (data analysis/intervention occurring)
1. Describe the proposed changes and why they are being made.
In lieu of giving participants the Tarascon Primary Care Pocketbook, 3 rd
edition (valued at approximately $14) as compensation, we would like to
provide them with lunch during the DxR® Clinician training session, and give
them $15.00 cash for completion of the study. This proposed change would
help with logistics of scheduling the training session since the prospective
participants have a very full schedule during this time, and giving cash as
compensation will be easier to administer and track from the accounting
perspective than a book.
Office of Research Compliance, Rev. 04/2009
Page 1 of 8
2. Describe how, if at all, the proposed changes affect the risks of the study.
N/A
3. Describe how, if at all, the proposed changes affect the benefits of the study.
The benefits of the study (lunch during the training session and $15.00 cash
as opposed to a book) will be different than originally proposed, but they will
be of approximately equal monetary value and the changes will help with
scheduling and accounting.
4. Does the revision affect the consent/assent document(s)?
Yes
X
No
a. If yes, will any participants need to be re-consented as a result of the
changes? If so, please describe process to be used. Include two copies of
the revised consent/assent documents, one with changes highlighted, and
one without highlighting.
No participants will need to be re-consented.
Principal Investigator Signature
Date
Advisor Signature
Date
If new investigator is added, a revised page 1 of the project outline form, a signed signature page
of the Project Outline Form, and proof of training is required.
Please note that approval of an amendment does not change the expiration date of the study.
Please return this form to:
Office of Research Compliance, Rev. 04/2009
Office of Research Compliance
117 Research & Technology Center
Ohio University
Athens, OH 45701-2979
Page 2 of 8
Ohio University Consent Form
Title of Research: Comparison of Osteopathic Medical School Curricula in Teaching
Clinical Reasoning
Researchers: Amanda Kocoloski, MS III, Gordon Marler, MS III, Grace Brannan, PhD,
and Nicole Wadsworth, DO, Trish Sexton, DHEd
You are being asked to participate in research. For you to be able to decide whether you
want to participate in this project, you should understand what the project is about, as
well as the possible risks and benefits in order to make an informed decision. This
process is known as informed consent. This form describes the purpose, procedures,
possible benefits, and risks. It also explains how your personal information will be used
and protected. Once you have read this form and your questions about the study are
answered, you will be asked to sign it. This will allow your participation in this study.
You should receive a copy of this document to take with you.
Explanation of Study
This study is being done to investigate the effectiveness of different medical school
curricula in developing clinical reasoning. Ohio University College of Osteopathic
Medicine and Kirksville College of Osteopathic Medicine have approved this study, and it
will be conducted under their supervision. Your participation in this study is completely
voluntary, and you have the right to refuse to take part. Your acceptance or refusal to
participate will not affect your academic future in any way.
If you agree to participate, you will be asked to complete a simulated patient case
using the computer-based program DxR® Clinician. With your permission, a review of
your performance prior to beginning medical school and on the DxR® Clinician will be
performed under the guidance of Dr. Wadsworth, Assistant Dean of Pre-Clinical
Education OU-COM or Dr. Sexton, Associate Professor of Family Medicine at KCOM. The
specific information that will be accessed is the following: MCAT score and GPA prior to
entering medical school and performance on the DxR® Clinician prior to beginning
clinical rotations.
You should not participate in this study if you are a student in the PCC track at OUCOM, or if you have spent more than two years completing the first two years of medical
school.
Your participation in the study will last until you have completed the DxR® Clinician
simulated case at the conclusion of your second year of medical school.
Risks and Discomforts
No risks or discomforts are anticipated.
Benefits
This study is important to science/society because it will provide information
regarding the differences between two different preclinical curricular styles in the
development of clinical reasoning in osteopathic medical students. The information
Office of Research Compliance, Rev. 04/2009
Page 3 of 8
gained will be of benefit to both OU-COM and KCOM, as well as other osteopathic
medical schools, in their ongoing curricular development.
Individually, you may benefit from use of the DxR® Clinician because it will provide
valuable, standardized feedback regarding clinical decision-making. This information
is particularly useful to preclinical students about to begin their clerkships, where
they will be involved with patient care on a daily basis.
Confidentiality and Records
Your study information will be kept confidential by the use of an interim identifier.
You will be assigned a random numerical code, and then your name will be removed
from the data and the code will be used instead. The matching of each participant’s
name and numerical code for the OU-COM students will be kept in passwordprotected computer accessible only to Nicole Wadsworth, project advisor and PreClinical Assistant Dean of OU-COM. The KCOM data will be protected in this way as
well by Trish Sexton, Associate Professor of Family Medicine at KCOM. Only
anonymized data will be used for analysis.
Additionally, while every effort will be made to keep your study-related information
confidential, there may be circumstances where this information must be shared with:
* Federal agencies, for example the Office of Human Research Protections, whose
responsibility is to protect human subjects in research;
* Representatives of Ohio University (OU) or KCOM, including the Institutional
Review Board, a committee that oversees the research at OU.
Compensation
As compensation for your time/effort, you will receive lunch during your DxR®
Clinician training session, and $15.00 cash when you complete the study
requirements. Since the funding is provided by Ohio University, you will be required
to provide your name and address when you receive the $15.00 cash. This personal
information will be made available to the Ohio University Finance office for
accounting purposes.
Contact Information
If you have any questions regarding this study, please contact Amanda
Kocoloski MS III, at (740)704-5743.
If you have any questions regarding your rights as a research participant, please contact
Jo Ellen Sherow, Director of Research Compliance, Ohio University, (740)593-0664.
By signing below, you are agreeing that:
 you have read this consent form (or it has been read to you) and have been
given the opportunity to ask questions and have them answered
 you have been informed of potential risks and they have been explained to
your satisfaction.
 you understand Ohio University has no funds set aside for any injuries you
might receive as a result of participating in this study
 you are 18 years of age or older
Office of Research Compliance, Rev. 04/2009
Page 4 of 8


your participation in this research is completely voluntary
you may leave the study at any time. If you decide to stop participating in the
study, there will be no penalty to you and you will not lose any benefits to
which you are otherwise entitled.
Signature
Date
Printed Name
Version Date: [06/18/2010]
Office of Research Compliance, Rev. 04/2009
Page 5 of 8
Ohio University Consent Form
Title of Research: Comparison of Osteopathic Medical School Curricula in Teaching
Clinical Reasoning
Researchers: Amanda Kocoloski, MS III, Gordon Marler, MS III, Grace Brannan, PhD,
and Nicole Wadsworth, DO, Trish Sexton, DHEd
You are being asked to participate in research. For you to be able to decide whether you
want to participate in this project, you should understand what the project is about, as
well as the possible risks and benefits in order to make an informed decision. This
process is known as informed consent. This form describes the purpose, procedures,
possible benefits, and risks. It also explains how your personal information will be used
and protected. Once you have read this form and your questions about the study are
answered, you will be asked to sign it. This will allow your participation in this study.
You should receive a copy of this document to take with you.
Explanation of Study
This study is being done to investigate the effectiveness of different medical school
curricula in developing clinical reasoning. Ohio University College of Osteopathic
Medicine and Kirksville College of Osteopathic Medicine have approved this study, and it
will be conducted under their supervision. Your participation in this study is completely
voluntary, and you have the right to refuse to take part. Your acceptance or refusal to
participate will not affect your academic future in any way.
If you agree to participate, you will be asked to complete a simulated patient case
using the computer-based program DxR® Clinician. With your permission, a review of
your performance prior to beginning medical school and on the DxR® Clinician will be
performed under the guidance of Dr. Wadsworth, Assistant Dean of Pre-Clinical
Education OU-COM or Dr. Sexton, Associate Professor of Family Medicine at KCOM. The
specific information that will be accessed is the following: MCAT score and GPA prior to
entering medical school and performance on the DxR® Clinician prior to beginning
clinical rotations.
You should not participate in this study if you are a student in the PCC track at OUCOM, or if you have spent more than two years completing the first two years of medical
school.
Your participation in the study will last until you have completed the DxR® Clinician
simulated case at the conclusion of your second year of medical school.
Risks and Discomforts
No risks or discomforts are anticipated.
Benefits
This study is important to science/society because it will provide information
regarding the differences between two different preclinical curricular styles in the
development of clinical reasoning in osteopathic medical students. The information
Office of Research Compliance, Rev. 04/2009
Page 6 of 8
gained will be of benefit to both OU-COM and KCOM, as well as other osteopathic
medical schools, in their ongoing curricular development.
Individually, you may benefit from use of the DxR® Clinician because it will provide
valuable, standardized feedback regarding clinical decision-making. This information
is particularly useful to preclinical students about to begin their clerkships, where
they will be involved with patient care on a daily basis.
Confidentiality and Records
Your study information will be kept confidential by the use of an interim identifier.
You will be assigned a random numerical code, and then your name will be removed
from the data and the code will be used instead. The matching of each participant’s
name and numerical code for the OU-COM students will be kept in passwordprotected computer accessible only to Nicole Wadsworth, project advisor and PreClinical Assistant Dean of OU-COM. The KCOM data will be protected in this way as
well by Trish Sexton, Associate Professor of Family Medicine at KCOM. Only
anonymized data will be used for analysis.
Additionally, while every effort will be made to keep your study-related information
confidential, there may be circumstances where this information must be shared with:
* Federal agencies, for example the Office of Human Research Protections, whose
responsibility is to protect human subjects in research;
* Representatives of Ohio University (OU) or KCOM, including the Institutional
Review Board, a committee that oversees the research at OU.
Compensation
As compensation for your time/effort, you will receive lunch during your DxR®
Clinician training session, and $15.00 cash when you complete the study
requirements. Since the funding is provided by Ohio University, you will be required
to provide your name and address when you receive the $15.00 cash. This personal
information will be made available to the Ohio University Finance office for
accounting purposes.
Contact Information
If you have any questions regarding this study, please contact Amanda
Kocoloski MS III, at (740)704-5743.
If you have any questions regarding your rights as a research participant, please contact
Jo Ellen Sherow, Director of Research Compliance, Ohio University, (740)593-0664.
By signing below, you are agreeing that:
 you have read this consent form (or it has been read to you) and have been
given the opportunity to ask questions and have them answered
 you have been informed of potential risks and they have been explained to
your satisfaction.
 you understand Ohio University has no funds set aside for any injuries you
might receive as a result of participating in this study
 you are 18 years of age or older
Office of Research Compliance, Rev. 04/2009
Page 7 of 8


your participation in this research is completely voluntary
you may leave the study at any time. If you decide to stop participating in the
study, there will be no penalty to you and you will not lose any benefits to
which you are otherwise entitled.
Signature
Date
Printed Name
Version Date: [06/18/2010]
Office of Research Compliance, Rev. 04/2009
Page 8 of 8