Malimu research protocol

RESEARCH PROTOCOL
Dr Malimu
MUHAS
Dar es Salaam

What is research?
 Research is a quest for knowledge through
diligent search/investigation/ experimentation
 Research aims at the generation and
interpretation of new knowledge
 Research plays a very important role in the
efforts to maintain health and combating
diseases.

Health Research-02
 Research helps us to create new
knowledge and develop proper tools for
the use of existing knowledge.
 Research enables health care providers to
diagnose and treat diseases, and provides
evidence for policies and decisions on
health and development.

What is a research protocol/proposal?
 A research proposal is a short document that
highlights you’re a topic and the method to
use to formally study something related to the
topic in an effort to either confirm or test a
theory or to add to a scarce or non-existent
body of academic literature
 Is a document that asks a specific question or
questions that a research effort will attempt to
answer.

Why a Research Protocol?
 When you write a proposal it is usually for a formal
health related research effort assigned either as
part of your academic work such as a research
paper or as part of your degree completion such as
for an undergraduate dissertation, thesis or doctoral
dissertation.
 The quality of your research proposal is critical to
the future success of your final research effort.
 What you provide in the proposal is what you will be
expected to follow as you carry out your research
and prepare your finished product

Major components of a research protocol/
proposal
 Summary
 Investigators and institutional affiliation
 Introduction/Background
 Rationale/Justification
 Hypothesis/Research Questions
 Methodology (including activities)
 Plan of activities
 Budget and budget justification
 References
 Research instruments

How to get started?
 The first step in preparing a research proposal is to
prepare a rough draft. Start by writing preliminary
answers to the following questions:
 What is the tentative title? (The title may change as your
research progresses)
 Why do you want to do this research? (What do you think
you will be able to say when your research is complete?)
 What steps will you have to take to accomplish what you
want to do? Can you put those steps into sequential order?
 What resources will you need to conduct the study?
 What assistance from other people will you need? eg skills
of a supervisor, other staff members.
 Will Ethics Approval be required?

Title and investigators
 Name and title of the investigator (s) who is
(are) responsible for conducting the
research
 Name(s) and address(es) of the affiliated
Institutionsinvolved in the research

Introduction
 Nature of the problem
 Why the issue/problem is important
 How your research would contribute to
the solution of the problem

Introduction
 The introduction of your research proposal should draw
the reader into your topic. Introduce your topic, support it
with current literature
 Introduction should provide relevant information,
potentially including statistics that indicate the
burden/enormity of the problem.
 The research proposal should also present a modest
literature review citing existing research that supports
both your topic and the relevance of a proposed study
 State what is missing from current literature that your
formal research effort will provide
 Provide your specific goals and objectives for the
research effort and state the research question you seek
to answer.

Introduction
 Knowing there is a solid research base
from which to draw is critical to your
success.
 Remember, only sources with academic
credibility can be used.
 After your literature review, you should
follow with a statement of need
(Rationale)

Important Questions in the Introduction
QUESTION PURPOSE OF INFORMATION
What is the public health issue? Orientate the reader by giving some
general background to the topic
Why is the issue important? Justify your research by explaining to
the reader why this is an important
area of research
What do we know about the topic in
general?
Provide the reader with a context for
your research by giving a brief
summary of past research
What are some of the weaknesses in
our knowledge about the topic?
Justify your research by showing gaps,
weaknesses etc.
What are you going to do about these
gaps?
Give the reader a general statement
about the purpose of your research

Rationale
 The Rationale specifies the reasons for conducting the
research in light of current knowledge.
 It should include a well documented statement of the
need/problem that is the basis of the proposed study, the
cause of this problem and its possible solutions.
 It should answer the question of why and what: why the
research needs to be done and what will be its relevance.
 The magnitude, frequency, affected geographical areas,
ethnic and gender considerations, etc of the problem
should be followed by a brief description of the most
relevant studies published on the subject
 This is a short section on your proposal where you will
state the specifics of what you intend to study and why.

Goals and Objectives
 Goals are broad statements of what the
proposal hopes to accomplish.
 Goals create a setting for the proposal.
 Specific objectives are statements of the
research question (s).
 Objectives should be simple (not complex),
specific (not vague), and stated in advance
(not after the research is done).
 After statement of the primary objective,
secondary/specific objectives may be
mentioned.

Methodology
 Highlight the specific method (phenomenological, general
qualitative, quantitative, mixed method, etc.) including
reasons why you have chosen this approach.
 Published sources should be cited as your rationale.
Once this is established, you should briefly mention who
will comprise your participant base and how you will solicit
participants.
 Discuss what instruments will be used if any, why they
were chosen or if you created one, etc.
 Mention how data will be collected, compiled and
analyzed.
 Each of these sections should represent their own section
heads of your proposal.

Study design
 The scientific integrity of the study and the credibility of the study data
depend substantially on the study design and methodology.
 The design of the study should include information on the type of
study, the research population or the sampling frame, and who can
take part (e.g. inclusion and exclusion criteria, withdrawal criteria
etc.), and the expected duration of the study
 For example, a study may be described as being a basic science
research, epidemiological or social science research, it may also be
described as observational or interventional; if observational, it may
be either descriptive or analytic, if analytic it could either be cross-
sectional or longitudinal etc. If experimental, it may be described as a
controlled or a non controlled study.

Study instruments/tools
Instruments are tools by which data are collected.
They include:
 Questionnaire and interview schedules
 Preparation, pre-coding and pre-testing of questionnaires;
 Plan for interviews and call-backs;
 Preparation of instructional manual;
 Training of interviewers
Other methods of observation:
 Medical examination
 Laboratory tests
 Screening procedures
 Design of recording forms

Plans of activities
 Organisation of study and data collection in order
to minimise the possibility of confusion, delays, and
errors;
 Organisation and training of the data-collecting
team and definition of responsibilities;
 Logistic support for data collection;
 Plans for test or feasibility studies, including pre-
testing methods; and
 Plans for collaboration between different
institutions, if applicable.

Plan of activities
 Your proposal should provide a brief time table, presenting
estimated times for completion of the major stages of your
research effort. For example:
 Development of research proposal     1 Week (March 1 – 7, 2010)
 Prepare survey instrument   1 Week  (March 8-15, 2010)
 Seeking ethical approval 6 weeks (March 16-April 29, 2010)
 Recruit participants       2 Weeks   (May 1-15, 2010)
 Data collection 8 weeks (May 16-July 14, 2010)
 Data entry and analysis 8 weeks (August 1-September 30, 2010)
 Report writing 4 weeks (October 1-28, 2010)
 Include all the major steps and times associated with
completing your research effort.

Data management and statistical
analysis
 Plans for analysis should be incorporated
into the research proposal.
The description should include:
 Design of analysis form;
 Plans for processing and coding data, by manual
sorting or computer programme; and
 Choice of statistical methods to be applied to
each hypothesis

Ethical Considerations in Health
Research
 Provisions to protect the privacy of the subjects and
to maintain the confidentiality of the data.
 Anticipated risks to the subjects. This includes any
potential risk of social harm (e.g. emotional distress,
loss of confidentiality, stigmatization) economic harm
(e.g. loss of employment, professional standing or
reputation within the community) and legal risks (e.g.
disclosure of illegal activity, negligence or abuse) as
well as physical side effects (physical injury resulting
from participation in the study)
 Summary of the benefits, if any, for the subjects
and/or the study community
 Informed consent

Expected outcomes
 The protocol should indicate how the
study will contribute to advancement of
knowledge, how the results will be
utilized, not only in publications but also
how they will likely affect health care,
health systems, or health policies

Dissemination of Results and Publication
 The protocol should specify not only
dissemination of results in the scientific
media, but also to the community and/ or the
participants, and consider dissemination to
the policy makers where relevant.
 Publication policy should be clearly
discussed- for example who will take the
lead in publication and who will be
acknowledged in publications, etc

Budget and budget justification
 The budget section should contain a
detailed item-wise breakdown of the
funds requested for, along with a
justification for each item.

References
 A reference list of all citations must be
provided

Curriculum vitae
 The CV of the Principal investigator
and each co-investigators should be
provided.
 In general each CV should not be
more than one page, unless a
complete CV is specifically requested
for.

Summary
 Like the abstract of a research paper, the
project summary, should be no more than
300 words and at the most a page long
 Provided preferably on a separate page, it
should summarize all the central elements of
the protocol, for example the rationale,
objectives, methods, populations, time frame,
expected outcomes and expected budget
cost.

An iterative research strategy

Malimu research protocol

More Related Content

What's hot (20)

Viewers also liked (15)

Similar to Malimu research protocol (20)

More from Miharbi Ignasm (18)

Recently uploaded (20)

Malimu research protocol