MEMORIAL HOSPITAL OF RHODE ISLAND IRB
APPLICATION FOR APPROVAL OF A NEW HUMAN SUBJECT RESEARCH PROJECT
MHRI IRB #
I. TITLE OF RESEARCH PROJECT: 2010-2015 Brown/MHRI Family Medicine Residency
Curriculum Evaluation Project
II. PRINCIPAL INVESTIGATOR: Roberta E. Goldman, PHD
MHRI-BASED RESPONSIBLE INVESTIGATOR (if different from PI):
CO_INVESTIGATORS: Gowri Anandarajah, MD, Melissa Nothnagle, MD, Fadya El
Rayess, MD, MPH; Rabin Chandran, MD, Arnold Goldberg, MD
PRINCIPAL CONTACT: Name:_Roberta Goldman__ Institution: __MHRI____________
Address/City/State/Zip: _MHRI/CPCP___________
Tel: _729-2924__
Fax: _729-2494__
E-Mail __roberta_goldman@mhri.org_
III. LOCATIONS WHERE STUDIES WILL BE PERFORMED: MHRI family medicine
residency
IV. WILL THIS PROJECT INVOLVE INSTITUTIONS OTHER THAN MHRI OR
RESEARCHERS WHO ARE INDEPENDENT OF MHRI? NO
IF SO, IDENTIFY BELOW EACH INSTITUTION/INDIVIDUAL AND STATUS OF IRB
REVIEW FOR EACH (This may be skipped for multi-site clinical drug or device trials)
Institution/Individual
Indicate IRB review status for the Instit/Individ (e.g., N/A,
approved, pending, application not yet submitted, etc.)
V. APPROXIMATE DATES OF RESEARCH:
VI. SOURCE OF FUNDING: HRSA
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FROM:
April 2011
TO: July 2015
Principal Investigator/Responsible Person Signature
I certify that I accept responsibility for the scientific conduct and design of the project. I assure that research staff
assigned to this project has sufficient time and resources to conduct and complete the research. I have determined
that the resources necessary to protect participants are present before conducting the research study and I agree to
provide the required administrative reports if this application is approved and activated. I will conduct the study
identified above in the manner described in this application and any materials submitted herewith. If I decide to
make any changes in the procedure, I will obtain approval by the IRB prior to making the change. If a participant is
injured, or if any problems occur which involve risk or the possibility of risk to participants, I will immediately
report such occurrences to the Memorial Hospital of Rhode Island IRB office.
_________________________________________
Signature of PI
__________________
Date
_________________________________________
Signature of MHRI-Based Responsible Person
__________________
Date
Department approval Signature(s) indicates that the individual(s) certifies that the application is true and complete
to the best of their knowledge and the individual(s) below has reviewed the research proposal to ensure its scientific
merit and adequacy and that it meets the standards of the Department. Approval also certifies that the investigator is
authorized to use departmental resources to conduct this research project.
_________________________________________
Signature of Dept. Chief/Chair
__________________
Date
Approved by the Committee on the Use of Human Subjects in Research:
____________________
Date of Review/Approval
______________________________
Date Contingencies Satisfied (or N/A)
______________
Renewal Interval
Signature of Chairperson/Designee
Date Signed
_______________
Date of Expiration
VII. TRAINING
A) Please identify below all key research personnel who will be involved in conducting this study and provide
information on their training in human research protection:
Name
Roberta Goldman
Fadya El Rayess
Gowri Anandarajah
Melissa Nothnagle
Judith Walker
Rabin Chandran
Arnold Goldberg
Training documentation
previously submitted?
X
X
X
X
Training documentation
enclosed?
X
forthcoming
X
B) Protocol-Specific Training: Rhode Island requires documentation that personnel have been trained in the
procedure(s) they will perform. Check appropriate boxes below or describe how research personnel have
been trained in the protocol and their specific responsibilities in the conduct of the trial and how ongoing
training will be conducted
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Sponsor to provide training to research staff
X Principal Investigator or designate to personally provide training to research staff
Other, please describe ______________________________________________________
Research Description Regulation: 45 CFR 46.111(1)(a).
1. Nature and Purpose of Proposed Studies
a.
Study Abstract: The abstract must provide a clear and concise overview of the proposed work, and should
address the following: Background, Objectives/Hypotheses, Specific Aims, Study Design and Study
Procedures. Summarize the proposed research in language that can be understood by a non-scientist.
Please limit your response to 350 words
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Background: The Department of Family Medicine was recently awarded a five year grant to
“Train Family Medicine Residents for Leadership in Underserved Health Care: PatientCentered Medical Home, Self-Directed Learning, Innovation and Scholarship. The scope of the
grant requires input and participation from the department’s core faculty and residents. This
application addresses the proposed evaluation research that we will conduct for the five content
areas of this curriculum development grant: Patient-Centered Medical Home; Cultural
competence and health disparities; scholarly development; self-directed learning; and
leadership. The evaluation will entail a mixed methods design, involving qualitative interviews
with some closed-ended questions included. Faculty interviews will explore teaching practices
and teaching experiences regarding the 5 content areas. Interviews with residents will explore
learning experiences and preparedness in the same areas.
Objectives: To provide baseline, process and outcome assessments of faculty and residents’
knowledge, attitudes and practices when teaching or learning about the 5 content areas of this
project:
Design: Open-ended, semi-structured interviews will be conducted and analyzed using
qualitative methods. In addition, some closed ended questions will be included in the interviews.
Data will also be collected as process evaluation regarding residents’ progress in the PatientCentered Medical Home and Scholarly Development rotations.
Inclusion criteria: family medicine faculty based at MHRI who are directly involved in
teaching FM residents; family medicine residents
Study Procedures: Semi-structured interviews will be conducted with up to 30 core faculty
members of the Brown FM Residency, and with 13 residents in each of the classes of 2011,
2013, and 2014. (See attached interview scripts). For the latter two classes, baseline and followup interviews and rotation evaluations will be conducted. Interviews will be conducted by Drs.
Goldman and El Rayess, and Ms. Walker. Qualitative data will be analyzed using qualitative
content analysis procedures; quantitative data will be analyzed using basic statistical procedures.
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Investigational drugs and/or devices Regulation: 21 CFR 312 and 812
2. a. Does this study entail the use of any drugs?
Yes XNo
If YES, complete 2 b-f
b. Does this study constitute a clinical trial of one or more drugs?
Yes
If YES, indicate the study phase:
Phase I
Phase II
Phase III
c. List Drug(s) to be used
Name
Alternate name
(e.g. generic)
‡.
,I.e.,
FDA Approved
Drug?
Yes
No
Yes
No
Yes
No
No
Phase IV
IF FDA approved,
On label or off label?‡
On
Off
On
Off
On
Off
IND#
attach verification*
will the study-related use of the drug be outside its FDA approved indication?
*IND# verification may be documented by a letter from the sponsor, a letter from the FDA, or
inclusion of the IND# on the Sponsor generated protocol.
d.
Will the Pharmacy Department be responsible for the storage, dispensing, handling, and disposal of
investigational and FDA-approved drugs/ biologics?
Yes No If NO, please identify person(s)
responsible, describe storage, dispensing, handling, and disposal of investigational and FDA-approved
drugs/biologics. Include a description of the procedures for inventory control and documentation.
e. Does the PI hold the IND for the use of this investigational drug(s)?
Yes
No
f. Has the study been registered on clinicaltrials.gov or as otherwise required by law?
Yes
No
3. Does this study include the use of investigational device(s) or a device approved by the FDA but
being used for a different indication than FDA approval indicates?
Yes
No
If Yes, complete supplemental application (found at the end of this application)
4A. For each Subject Type, please indicate one and only one of the following eligibility codes:
“T” means eligible and specifically targeted for participation.
“E” means eligible to participate but not specifically targeted.
“I” means ineligible.
Subject Type
Adults >64
Eligibility Code
(“T”, “E” or “I”)
E
Adults 18-64
Adolescents 13-17
E
I
Children 2-12
I
Infants <2
Embryos or fetuses
Pregnant women
Prisoners
Healthy Volunteers
I
I
E
I
E
Subject Type
Residents/interns/
Students/trainees
Decisionally impaired
Economically
Disadvantaged
Educationally
Disadvantaged
Physically disabled
Acute illness (describe)
Chronic illness (describe)
MHRI Employees
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Eligibility Code
(“T”, “E” or “I”)
T
I
E
I
E
E
E
T
4B. For Clinical Studies:
a. What is the routine standard of care for the patient population being studied?
b. Identify all procedures and/or interventions included in this project that would be done for
diagnostic or treatment purposes even if the subjects did not participate in this research?
c. Will the experimental treatment(s) present increased risk over standard of care for this patient
population?
Yes
No
Explain.
d. Will subjects be withdrawn from routine care for the purpose of this study?
If yes, provide rationale:
Yes
No
e. Will the participants be responsible for costs associated with any portion of the research study?
For example, will they need to pay for standard of care interventions and/or medications, their
clinic visit co-pays, drugs not part of the study,?
Yes
No If yes, please explain. This information must also be made clear in the ICD.
4C. Provide a list of inclusion/exclusion criteria. You may add a page if necessary, or reference
where this information can be found in the research plan.
Inclusion: Faculty in the Brown/MHRI family medicine department who teach in the residency;
family medicine residents in each of the classes of 2011, 2013, and 2014
4D. What is the proposed number of subjects to be enrolled: At this site? Up to 69
_NA____
At all sites?
5. Describe possible benefits of the proposed study to the individual subject.
Residents and faculty may feel satisfied to have the opportunity to comment on their experiences
teaching and learning in this residency. They will be able to speak in their own words about
what they see as the pros and cons of the new curricula, and to assess their own preparedness
regarding the 5 topic areas of the curriculua development project.
6. Risk and Safety Considerations:
A) Please describe the anticipated risks that will be associated with participation in the proposed study. As used
here, the term “risk” includes the possibility of any harm - physical, psychological, sociological or other - as a
consequence of any activity which goes beyond the application of those established and accepted methods
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necessary to meet his/her needs.
Risks to participants are minimal in this study. For residents, we are having a new employee,
the project coordinator, conduct the interviews. In this way they will not be interviewed by a
faculty person or anyone in a position to evaluate the resident. Nevertheless, some residents
may feel uncomfortable answering particular questions. The residents will be informed that
they may skip questions they do not wish to answer. Given that the interview is qualitative,
they will also be able to include only that information that they voluntarily offer. Faculty will
be interviewed by faculty members on the project team. However, questions will be worded
to minimize any discomfort among the interviewees, and both faculty and residents are
accustomed to self-evaluation exercises in the academic environment.
Studies that present greater than minimal risk should include a data safety monitoring plan (DSMP) for monitoring
subject safety. Acceptable plans for monitoring subject safety include a description as to how unanticipated problems
and adverse events are evaluated with respect to subject risk and frequently include criteria that would be used to
prematurely stop the trial for safety reasons. Large multi-site trials will often include the use of a Data Safety Monitoring
Board (DSMB). Smaller local trials may include one or more professionals who may or may not be involved with the
study to review unanticipated problems, including adverse events that may occur.
Definition of Minimal Risk (from 45 CFR 46.102(i)):
Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not
greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine
physical or psychological examinations or tests. Studies that include the use of investigations drugs, devices, or
psychological interventions are considered to present greater than minimal risk. The possibility that research may
invade the privacy of individuals or result in a breach of confidentiality may present a risk of serious harm to
subjects (e.g., as when the researcher obtains information that would, if disclosed by the researcher, jeopardize
subjects’ jobs or lead to their prosecution for criminal behavior).
If the study poses greater than minimal risk, please complete items b. and c.
B) Please specify what measures have been incorporated to minimize risk, (e.g., inclusion
/exclusion criteria based upon safety considerations, by using procedures already being
performed on the subjects for diagnostic or treatment purposes, and testing performed for
subject safety monitoring are often incorporated into research protocols to minimize risk
to subjects). Describe here or provide page number reference in protocol or other
accompanying document.
Please see response to part A of this question.
C) Is there a plan to monitor subject safety?
Yes
No
If “yes”, please describe here or provide page number reference in protocol or other
accompanying document. If “no”, justify why not.
7A. Please indicate how you will identify and recruit potential subjects by marking all of the
following that apply. Provide additional information that would facilitate the IRB’s review.
___ Practitioner with clinical relationship with subject(s) will consent subject(s)
___ Practitioner with clinical relationship with subject(s) will obtain subject’s written consent to
forward contact information to researchers.
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___ Practitioner with clinical relationship with subject(s) will inform subjects about study and
how to contact researcher(s).
___ Will search electronic medical record for patients who fit some to all of the eligibility criteria
Personnel who will perform the search: ____________________________
Electronic record system to be searched: ___________________________
Search criteria to be used: _______________________________________
___Will review paper medical records for patients who fit some or all of the eligibility criteria
Personnel who will perform the search: ____________________________
Location/custodian of the record: _________________________________
___Subjects will self-identify by responding to promotional announcements and advertisements
Provide additional information that would facilitate IRB review.
We are not including patients. All subjects will be faculty and residents in our
department. We will inform faculty and residents at regularly-scheduled departmental
meetings that we are conducting this curriculum evaluation study, and invite them to
participate. We anticipate that all or most individuals who meet the eligibility criteria
will agree to participate, as we have conducted numerous educational evaluation
studies in this department and faculty and residents are usually interested in
participating. Participation, however, is voluntary, and refusal to participate will in no
way impact the employment or performance evaluation of faculty and residents.
7B. Please describe how and by whom potential subjects will be contacted after they are
identified.
They will be contacted by telephone by the departmental secretary to arrange a time
and place for the interview. They will then be met at the scheduled interview time and
location by Judy Walker, who will conduct the interview.
8A. Where, when and by whom will informed consent be obtained? (Describe how subjects will
be approached and the physical location where, or the medium by which, the consent
discussion will take place)
Informed consent will take place in person. The interviewer (Judy Walker) will
explain the consent form prior to beginning the interview, answer any questions the
potential participant has, and request the potential participant’s written signature.
8B. Will any person(s) other than the primary subject, for example, a parent, spouse, caregiver,
clinician, etc., be involved either in the consent process or in the actual conduct of the
research study? G Yes
X No
If the answer to 8B is “Yes,” please describe the involvement of all such persons.
(Please note that, in all studies involving subjects who are decisionally impaired, or at material risk of becoming
decisionally impaired during the course of the study, a caregiver and/or authorized representative capable of
providing a legally effective informed consent will have to participate in the informed consent process and sign
the informed consent document.)
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8C. How much time and opportunity will subjects be provided to consider whether or not to
participate?
Faculty and residents will hear about the study at various points prior to the scheduling
of their interviews. At the time they are contacted by the departmental secretary, they
can agree to be scheduled for an interview, or they can refuse completely, or they can
request to have more time to think about whether they want to participate.
8D. Are there special issues in this study where there is a possibility of coercion or undue
influence or transient impairment (e.g. recent pain medication, age, ICU inpatient) during
the consent process?
Yes
No If Yes, please describe, what steps will be taken to minimize this possibility.
It is possible that faculty or residents may feel compelled to participate simply
because they are in this department. We will take care to explain to all potential
participants that participation is voluntary, and that they also can participate and still
decline to answer certain questions. We will not have any residents interviewed by
someone who is responsible for their performance evaluation.
8E. Will this study screen and/or enroll participants or legally authorized representatives that
speak a language other than English? Yes
No If Yes, describe and complete next question.
If English is not the subjects’ native language, will the consent form be translated into their
native language? If not, will you use the short form and how will translation be provided?
8F. Informed consent is an ongoing process that continues throughout the course of the research
project. How will you ensure that research participants remain informed about the study
and continue to agree to participate in this research study after initial informed consent has
been obtained?
Researchers will answer any questions from participants regarding the study at any
time and will provide updated information regarding the study, particularly any new
risks associated with study treatment or procedures, as it becomes available and
ensure that participants are aware that they have the right to be removed from the
study at any time.
Not applicable because:
one time interaction
no consent is obtained
Other (describe) ____________
9. Privacy and Confidentiality
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a. What measures will you take to protect privacy during the recruitment and consenting process, including
access to private information? (E.g. first contact with potential subjects comes from individuals who are
already known to them through routine care; conducting discussions in private areas)
The departmental secretary will inform each faculty person and resident either by email
or telephone that they are being asked to be in the study. The potential participant will
then have the opportunity to respond, in confidence, on the telephone or by email about
whether he/she wants to participate or not.
b. Please describe the steps taken to:
 assure confidentiality of subject data;
 protect the identifiers/links to identifiers from improper use or disclosure;
 Store research data

Protect confidentiality of sensitive data and protected health information (e.g. coding or
removal of identifiers as soon as possible, limitation of access to data, protection of computer-based
data systems, etc.). If links to identifiers are used, please describe the coding mechanism, whether the
code is derived from subject information, and how and where the mechanisms for re-identification
will be maintained.
Please describe here or provide page reference to accompanying document if applicable
As we have with all of our previous studies involving residents and faculty, we will
maintain the interview data in the strictest confidence. There will be no
protected health information collected in this study, however participants’
personal opinions about their learning or teaching in this department may be
viewed as sensitive data. We will audio record the interviews, and keep the
recordings and typed transcripts in password-protected computer files. Any
paper versions of the interview data will be kept in a locked cabinet. Only the
interviewer will have access to the recordings. Only the project team will have
access to the typed transcripts. The recordings will be typed by a professional
typist. Each participant will be accorded a code number, and no data will be
saved in the same location as personal identifiers. A master list of code
numbers and names will be kept in a locked location.
At a minimum, PHI and identifiable data must be stored in locked cabinets behind locked doors.
c. Will the research data include sensitive health information and/or private data, such as Social Security
number (SSN), illegal behavior, (E.g. drugs, abuse etc)?
Yes
No if yes, provide the rationale for
why these data are needed:
d.
Will the study involve the use (including access) or disclosure of individually identifiable health
information? )
Yes
No
If “yes” the study will require that (1) the consent form(s) incorporate required HIPAA; (2) subjects sign a
stand-alone authorization (HIPAA) form; and/or (3) the IRB waives the HIPAA authorization requirement.
10. Will compensation, financial or otherwise, be offered to participants in this project?
Yes
No If yes, please describe the amount, type and timing of payment to participants (e.g.
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parking coupons provided at the time of the visit, voucher for cash to be provided at the time of the
visit, check which will be sent by mail 4-6 weeks after the visit, etc.)
12. If advertisements will be used to recruit subjects, enter here a copy or the text of the
proposed advertisement. This should include: a) name and address of investigator; b)
purpose of the research; c) eligibility criteria (in summary form); d) a straight-forward
description of the benefits to the subject (e.g. payment, free treatment, etc.); e) the location
of the research and the person to contact for further information.
No advertisements will be used for recruitment.
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APPLICATION SUBMISSION CHECKLIST
GENERAL
 A substantive answer has been provided for each question in the application form.
 All protocols, advertising materials, questionnaires, consent forms and minors’ assent forms
accompany the application.
 All standard, well-recognized questionnaires, psychological instruments and other diagnostic
tools to be used are identified by name.
 Copies of non-standard, not-well-recognized questionnaires, psychological instruments and other
diagnostic tools accompany the application.
 The principal investigator and department chair have signed the application.
 The application identifies, and includes the signature of, at least one MHRI-based professional
who will be responsible for the study at this site and who acts as either a principal investigator or
co-investigator.
 Provide an original plus 12 double-sided (where possible), collated copies of all materials to be
reviewed.
CONSENT FORM
 The consent form has been proof-read for spelling, grammar, clarity and typographical errors.
 Discussion on reproductive and pregnancy-related issues appears in bold print.
 Discussion on compensation and/or reimbursement of expenses of subjects appears in the “What
Will Be Done” section, not in the “Benefits” section.
 The consent form clearly describes the nature of any expenses, such as expenses for standard
medical care, that the subject or the subject’s health insurer are likely to incur in connection with
the study.
 If the study involves the retention of subjects’ biological specimens, the consent form incorporates
the requirements set forth in the document appended to the instructions as Attachment G.
Human subjects training:
All investigators and co-investigators are required to have human subjects training certificates on file with
the IRB office. Please remember to attach certificates if not already done previously. Satisfactory
programs of education include the training available at http://phrp.nihtraining.com/index.php as well as
any program of education deemed acceptable by the Brown University IRB or by the IRBs of any of the
Brown-affiliated teaching hospitals.
Revised: 11/09
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If you answered “YES” to question #3 of the main application, please complete these
supplemental questions relating to use of devices.
(If your study does not involve the use of devices, please delete this page before printing)
STUDY TITLE & PRINCIPAL INVESTIGATOR:
a. List Device(s) to be used
Name
FDA Approved Device?
Yes
Yes
Yes
IDE# attach verification*
Medicare
Reimbursement
Category **
A
B
A
B
A
B
No
No
No
*IDE# verification may be documented by a letter from the sponsor, a letter from the FDA, or
inclusion of the IDE# on the Sponsor generated protocol.
**Category A consists of novel, first-of-a-kind technologies. These are innovative devices for which initial
questions of safety and effectiveness have not been resolved and the absolute risk of the device type has not
been established. The FDA has insufficient evidence to determine whether these device types can be safe and
effective. Category A devices remain uncovered by Medicare.
Category B devices are newer generation devices of already proven technologies. Initial questions of safety and
effectiveness of these devices have been resolved. Devices in this category represent evolutionary changes in
proven technologies and will be viewed as potentially reasonable and necessary by Medicare. These devices
may be eligible for coverage and payment.
b. Indicate the risk level of the device(s). Check Non-Significant Risk if you are requesting the IRB
make that determination on either an already approved device or an investigational device.
A non-significant risk device. (Provide documentation from the Sponsor)
A significant risk device.
NOTE: If study device is not approved by the FDA for the specified use and an IDE has not been
obtained, then the IRB must make a determination as to whether this is a significant (SR) or nonsignificant risk (NSR) device. Additional information is available on the ORA website and the
FDA webpage at http://www.fda.gov/oc/ohrt/irbs/devrisk.pdf -It is imperative the sponsor make the
preliminary determination, see section IV (A) of the document in link above.
______
c. Provide a plan for the storage, dispensing, handling, and disposal of investigational and FDAapproved devices. Include a description of the procedures for inventory control and
documentation.
d. Does the PI hold the IDE for the use of this investigational device?
Yes
No
e. Has the study been registered on clinicaltrials.gov or as otherwise required by law?
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Yes
No