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 _
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: FROM: April 2011 TO: July 2015
VI. SOURCE OF FUNDING: HRSA
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.
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Signature of PI Date
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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.
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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
/ Training documentation previously submitted? / Training documentation enclosed?Roberta Goldman / X
Fadya El Rayess / X
Gowri Anandarajah / X
Melissa Nothnagle / X
Judith Walker / X
Rabin Chandran / forthcoming
Arnold Goldberg / 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
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
Background: The Department of Family Medicine was recently awarded a five year grant to “Train Family Medicine Residents for Leadership in Underserved Health Care: Patient-Centered 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 Patient-Centered 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 follow-up 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.
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 No
If YES, indicate the study phase: Phase I Phase II Phase IIIError! Bookmark not defined. Phase IV
c. List Drug(s) to be used
Name / Alternate name (e.g. generic) / FDA Approved Drug? / IF FDA approved,On label or off label?‡ / IND#
attach verification*
Yes No / On Off
Yes No / On Off
Yes No / On Off
‡.,I.e., 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
/ Eligibility Code(“T”, “E” or “I”) /
Subject Type
/ Eligibility Code(“T”, “E” or “I”)
Adults >64 / E / Residents/interns/
Students/trainees / T
Adults 18-64 / E / Decisionally impaired / I
Adolescents 13-17 / I / Economically Disadvantaged / E
Children 2-12 / I / Educationally Disadvantaged / I
Infants <2 / I / Physically disabled / E
Embryos or fetuses / I / Acute illness (describe) / E
Pregnant women / E / Chronic illness (describe) / E
Prisoners / I / MHRI Employees / T
Healthy Volunteers / E
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? Yes No
If yes, provide rationale:
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 At all sites? _NA____
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 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.
___ 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