RESEARCH COMMITTEE APPLICATION
All research projects initiated or conducted at Providence Hospital or Providence Park Hospital must be approved by
the Research Committee for funding and scientific merit. If a project involves medical records (chart) reviews, surveys,
human participants, or animal experiments, then additional forms must be completed and submitted to their
appropriate committees (see items 2 & 3 in the instructions below). For more information please contact the Research
Department. A list of contacts is found below.
The RC meeting is held on the first Wednesday of each month at 7a.m.
The IRB meeting is held on the first Wednesday of each month at 8 a.m.
Role
Vice-President,
Research
Associate Medical
Researcher
Animal Research
Technician
Lead, Research
Department
IRB Coordinator
Contact
Phone
David Svinarich, PhD
586-753-0270
Nancy Jackson, PhD
248-849-3302
Milessa Decker, LVT,
LAT
Frances Williams, MBA,
MPH
Nicole Bolda
248-849-3077
248-849-5326
248-849-8889
Email
David.Svinarich@stjohn.org
Nancy.Jackson@stjohn.org
Milessa.Gilsdorf@stjohn.org
Frances.Williams@stjohn.org
Nicole.Bolda@stjohn.org
1. To be considered for review and approval at the next Research Committee meeting (held the first Wednesday
of each month), Research Applications (an electronic file and a copy with all the appropriate signatures), must
be received in the Research Department Office by the 10th day of the preceding month.
2. Studies involving human tissues and/or review/collection of protected health information must include a
complete Institutional Review Board (IRB) Application as well, and
3. Time-sensitive requirements, i.e. dates for abstract deadlines, meetings, etc. in Section 3.
4. Prior to application submission, resolve questions regarding research design, data collection and statistical
analysis, availability of technical instruments, time and task summary, and budget development in fulfilling this
study (Sections 5, 6 and 7). Please acquire REQUIRED signatures in Section 7.
5. Applicants will receive e-mail notification within 5 days of the Research Committee's decision.
6. After approval of a research project, changes to the budget will require submission of a Research Committee
Amendment form and approval by the Research Committee.
7. Studies that remain inactive for 12 months will be closed. If any changes are made to this project, please notify
the Research Office at (248) 849-3324.
8. PLEASE SEE SECTION 7 FOR ALL SIGNATURES REQUIRED BEFORE SUBMITTING THIS
APPLICATION.
Note about application: Click on gray boxes, section will expand when text is added.
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APPLICATION FOR RESEARCH
For Department Use Only:
Providence Hospital
Department of Patient Care Research
Southfield, Michigan
Protocol Number:
Date Reviewed:
Date Approved:
Date Expires:
1. Title of Project:
2. Investigator Contact Information:
Principal Investigator(s):
Department/Specialty:
Email, Telephone; Pager Numbers:
(1)
(1)
(1)
(2)
(2)
(2)
Co-Investigator(s)/Pathologist(s):
Department/Specialty:
Email, Telephone; Pager Numbers:
(1)
(1)
(1)
(2)
(2)
(2)
(3)
(3)
(3)
(4)
(4)
(4)
3. Dates of Project:
(a) Estimated starting date:
Estimated completion date:
(b) Prospective abstracts: (Name of Meeting)
(Abstract Deadline Date)
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4. Summary of Proposal:
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1. Type of Study:
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Basic Science Laboratory
Animal#
Other
Chart Review*
4
Survey*
Human*
*Requires an IRB Application Form
#Requires an Animal Care Committee Application Form
2. Brief Summary of Proposal:
(a) Project Background: BRIEFLY SUMMARIZE relevant aspects from the scientific literature that support the
implementation of this study.
(b) Project Rationale: BRIEFLY SUMMARIZE the rationale or reason to study this issue.
(c) Purpose of Study and/or Hypothesis: BRIEFLY SUMMARIZE
(d) Anticipated Outcome: BRIEFLY SUMMARIZE
(e) Importance/Relevance: BRIEFLY SUMMARIZE the importance or relevance of the information acquired
from this study.
Note: Please use additional space as necessary.
3. References and Supporting Data:
Please provide copies of key literature referenced in part 2 of section 4.
a)
b)
c)
d)
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5. Specific Objectives and Research Plan:
Detailed Plan of Proposed Research:
(a) Specific Objectives of Aims (describe what you wish to test or demonstrate in the study; list
objectives in a logical order.
(b) Experimental Design (define the organization of the experiment(s), population to be studied,
experimental and control groups, number per group, outcome measures, inclusion and exclusion
criteria, dosing regimens, time points, etc.).
(c) Data Analysis (describe the statistical treatment of data, use of blinding or randomization to prevent
bias, power analysis, number of replicates, etc. – access to the statistical software, SPSS, is
available the Research Department). Attach data collection form(s).
(d) Materials and Methods
(d.1) Materials: describe and quantify the reagents, drugs, assay kits, cell types, etc., to be
used.
(d.2) Methods: describe tests and assays needed (define in detail the methodologies to be used in the
course of the study; for the studies involving surgery with subsequent pathologic evaluation of
tissue, consult with a pathologist regarding design and collection of tissue for histological
preparation and evaluation.
(d.3) Time/Task Summary for study procedures: Please complete the following table indicating time
periods for each phase, or procedure, required for achieving study completion.
Procedures & Person who will perform procedure
Dates
1. Experimental set-up; sample collection; assay development
Who:
2. Perform assay or experiments
Who:
3. Analyze data
Who:
4. Prepare abstract and presentation
Who:
Note: Add or replace above listed procedures and time intervals with those appropriate for your study; use
additional space as necessary.
Signature of Associate Medical Researcher
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6. Hazardous Agents:
Hazardous Agents: Name, concentration
[Type of Hazard]
For example: Formalin, 10%
Biological
Chemical
Not Applicable
1.
Radiological
2.
Biological
Chemical
Radiological
Biological
Chemical
Radiological
3.
Biological
Chemical
Radiological
Please list special Handling Precautions, Personal Protection and Disposal Information for each Agent:
Not Applicable
For example: Use formalin in a fume hood, prevent inhalation and skin contact, take to Histology Dept. waste
accumulation for disposal, DO NOT dispose in drains.
1.
2.
3.
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7. Funding and Signatures:
DETAILED ANNUAL BUDGET PROPOSED
Description
Consulting Fees (Pathologist, Statistician, etc.)
Amount
Expendable Supplies (Consult with Associate Medical Researcher)
Technical Services (Clinical, Laboratory, Histology)
Subtotal
25% Indirect Cost (if applicable)
External funding (if any)
Total
Note:
Additional Budgets for subsequent years to be attached.
Substantial changes to the original budget may require re-submission to and reevaluation by the Research Committee.
Total Funding Requested:
Was outside funding sought?
Yes
Funds Requested For First 12 Months:
No
Will drugs or other reagents be donated?
Yes
Sponsor/Funding Information (Company or Foundation Name):
Contact Information (Name):
No
N/A
Telephone Number:
Investigator(s) Assurance Statement
By electronically signing and submitting this form to the Research Committee for initial approval of a research project,
the Investigator(s) acknowledges and certifies the following:
1. I/we certify that the information provided in this application is complete and accurate.
2. I/we agree to conform with all policies of the Research Department and Providence Hospital.
3. I/we agree to submit in writing a detailed status report as required annually on the anniversary of the research
project's approval to the Research Committee.
4.
I/we will conduct my/our research in accordance with the Declaration of Helsinki and the Statement of
Assurance set forth by Providence Hospital.
I/we further certify that the following individuals have reviewed this application prior to submission:
Associate Medical Researcher (Required):
Budget Reviewed By (Required):
Research Director (Required):
Specialty Department Official (Required):
Ph.D. Scientist (If Involved):
Pathologist (if involved):
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