Why Study Research Project Proposal

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					TEACHING

INDEPENDENT STUDY

CONDUCTING RESEARCH
AT HURLEY MEDICAL CENTER


Welcome to Hurley Medical Center and the Research Center. Undertaking research is
an important component of any academic program. But prior to conducting your
research, please read this material carefully. Generally—research is divided into four
phases: planning, implementation, evaluation, and dissemination. We encourage you to
devote adequate time to the first phase. Careful planning will ensure success in the
subsequent phases of your work.


First….why am I doing this?

      I am a curious, critical thinker.
      The experience may be beneficial to my career in medicine.
      The study findings may help advance knowledge in the area.
      It is a program mandate.

Stated reasons for undertaking research activities in an academic setting are
generally either altruistic in nature—with the investigator embracing the hope of
making some significant contribution to the field of medicine and/or gaining
recognition for their educational program or institution—or individual in nature—
with the investigator seeking to advance his/her career and/or for personal
satisfaction or enjoyment.

The Hurley Research Center embraces the following objectives for the conduct of
studies:
    To contribute to the advancement of medical therapeutics
    To enhance Hurley’s reputation as the area’s leading medical and
       research center
    To offer physicians and other key health care team members the
       opportunity to grow in their pursuit of scholarly activities
    To provide patients additional treatment opportunities and/or innovative
       therapies

RESEARCH CENTER MISSION STATEMENT
We are dedicated to assisting our physicians and other key staff in conducting
significant project work. This directive is based upon the tenet that patient care is
enhanced by the conduct of research—thus serving to support the institution’s
commitment to Clinical Excellence – Service to People.



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How do I get started?

There are recommended steps to follow in developing and conducting your
research. You may seek advice or guidance from the Hurley Research Center
staff at any time in this process—but it is BEST to seek help early in the process.
Careful planning will reduce the likelihood of making critical errors—and thus
result in better work!


What are the steps in conducting research?

      Identify your topic or area of study.
      Form a study team.
      Review the relevant literature.
      Formulate a study question.
      Select an approach or study methodology.
      Write your study proposal draft.
      Submit your study plan for approval.
      Go . . . . . .

Step one
Identify area of study: Where do ideas come from?

      Observation
      Consultation
      Collaboration
      Reading

In working with patients each day, you make critical observations about their
medical history—or their response to treatment—or the impact of demographic or
personal/psychological variables on their progress. Such observations may lead
to research questions. You may consult with teaching faculty to learn of study
ideas. Or you may consult with other members of the health care team to
develop a study idea. Finally, reading articles in medical journals are a great
source of study ideas. At the conclusion of a manuscript—the authors will
generally offer ―future directions for research‖. They challenge their readers to
further their work!

IMPORTANT:
You may rely on the above sources for providing you with potential study ideas—
but you need to target an area that truly interests you! The work associated with
completing a research project will not be enjoyable if you do have a genuine
interest in the outcome of the study.



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Step two
Form study team: Why should I work with others?

      Ideas
      Workload

Forming a study team that includes co-investigators will generally be of benefit to
you. First, these study team members bring their experiences into the group.
They can provide helpful ideas for developing the study question(s) or enhancing
the proposed study methodology. Second—the addition of ―extra hands‖ will
reduce your workload. You can divide key tasks such as patient recruitment,
data collection, or computer data entry. Most research is conducted by teams.

IMPORTANT:
You need to establish or clarify team roles in advance (e.g., principal investigator,
co-investigator or consultant?). Furthermore—a task list should be generated
that specifies expectations for each team member.


Step three
Review the literature: Why is this done?

      Theoretical basis
      New direction
      Add to body of knowledge

Prior to initiating a study, it is of critical importance to conduct a careful, thorough
review of the published literature. The work of other investigators serves as a
guidepost in developing your study plan. Unless you have a strong rationale for
replicating the work of others—it makes little sense to do so. Your study plan
may be similar to other published studies—but will contain a key ―twist‖ which
enables you to make a contribution to the field.


Produce a Bibliography

As you identify key articles, place copies in a folder or notebook. In addition, you
should maintain a typed reference list or bibliography.


IMPORTANT:
Your reference list or bibliography is not complete until you finish writing your
study findings. It is a ―dynamic‖ document. Routinely recheck the literature to


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determine if a relevant article has been published—then add this to your
holdings.
Step four
Formulate study question: What is a “good” question?

      Simple
      Specific
      Important

Seasoned investigators sometimes say that a central purpose of conducting
research is to enable us to ask better questions. As referenced above in step
three, investigators use the knowledge forwarded by others in deciding on which
direction to follow. Elaborate or complex study questions are fraught with the
potential to lead nowhere. It is generally best to keep your study question simple
and specific. Of course we also strive to pose a question that will produce
information of value to the medical community and our patients.

PITFALLS

Study questions with the following characteristics will most likely result in a failed
project:

   o   Weak scientific rationale
   o   Complex
   o   Vague
   o   Post hoc ―creation‖


IMPORTANT:
It is essential that the hypothesis or study question is developed prior to (―a
priori‖) or in advance of the initiation or conduct of the project work. Otherwise
the risk of bias is too high—and will threaten to invalidate your work.



Step five
Select an approach: How do I decide?

      Research Center staff
      Faculty members

Unless you have several years experience in the planning and management of
research projects, it is essential that you seek consultation when developing your
study methodology. You may have achieved a well-formulated study question,
but if your study plan is flawed—you will not be able to answer the question (or
others will not ―trust‖ your answer). You may seek guidance from Research staff


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or faculty physicians. In the Research Center we maintain a Research Directory
that may help link you with a faculty member who shares an interest in your
targeted topic for study.


IMPORTANT:
Methodology establishes or determines both the internal and external validity of a
study. As emphasized in the introduction of this manual—careful planning is
essential.


Step six
Write your proposal draft: What information do I need to include?

      Introduction
              Statement of the problem
              Review of the literature
              Study rationale
      Methods
              Setting and subjects
              Hypothesis
              Study design
              Procedures
              Measures
              Plan of analysis
      References

A study proposal consists of three sections: Introduction, Methods, and
References. (Later—once you have completed your work—you will also write
the Results and Discussion sections.) If you follow the above outline—your
proposal will be complete!

Regarding your references, please remember to be thorough in your review of the
published literature.

Writing tips:

   o   Read
   o   Reflect
   o   Write
   o   Revise

After completing your reading of the literature—devote time to ingesting the
material. (You may wish to reread some of the articles.) Then you can tackle the
task of writing down your ideas. Many of us find writing to be difficult or
burdensome. We suggest that you initially do not worry about the ―quality‖ of


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your writing or writing style. Simple begin writing. Of course, it is important that
you follow the general outline provided above. Later—and with the assistance of
your program director or others—you may begin revising your initial writing.


IMPORTANT:
Depending on the nature of your proposed study—the proposal draft may only be
a few pages in length or it may consist of several pages. But regardless of the
length of this document, it needs to be clear and well organized. If another
investigator wished to replicate your work—the study proposal should be written
such that he/she could use it as their ―map‖.


Step seven
Submit plan: Do I need approval?

      Residency program director or designee
      Research Center director
      IRB

You are advised to first discuss your ideas with your educational program
director. Since your work will most likely be used to satisfy a program mandate
or research requirement, it is best that your director provide you with the initial
guidance. But you also need to receive early guidance from the Research
Center director. You should schedule an appointment soon after meeting with
your program director. The Research Center director will advise you as to
whether or not you need to seek approval from the Hurley Institutional Review
Board (IRB).


IMPORTANT:
You will need to complete a FORM 201 – PROTOCOL ASSESSMENT
CHECKLIST. All studies/projects—prospective or retrospective—will require this
step. The Research Center director will provide you with needed guidance in
completing this form.

IMPORTANT:
If it is determined that you need to seek IRB approval for your study, you may be
subject to a fee for this review. (Please refer to FEE SCHEDULE FOR INVESTIGATIVE
RESEARCH STUDIES.) However, you may be eligible for a waiver of this fee.
(Please refer to APPLICATION FOR W AIVER OF IRB FEES.) All student and resident
projects are free from any fees.




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FINAL NOTE


In any research endeavor—our concern for the welfare of the patient or subject
is always our first priority. As an investigator, you have the responsibility to
conduct your study in accordance with established ethical principles. Any
violation of such principles will result in serious consequences and/or penalties.




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