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/toolsInstruments 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

Thank you & Enjoy your Day