WRITING A RESEARCH PROTOCOL

2.1. Introduction

After proper and complete planning of the study, the plan should be written down as a

research protocol. Therefore the protocol is the detailed plan of the study. The

protocol is a requirement for all research purposes, not necessarily for graduate

studies. The reasons for writing a protocol are:

2.1.1. A written protocol forces the investigator (s) to clarify his (their) thoughts and

to think about all aspects of the study plan. Usually the plan in one's mind is

not as clear and logical as one would hope, and the gaps and flaws are easier

to recognize and correct when the plan is written on paper.

2.1.2. A protocol is a necessary guide if a team (not a single investigator) is working

on the research as it will guide persons involved in conducting the research.

2.1.3. The protocol can be studied by anyone (a person or a body) for critical

appraisal or whose official and / or ethical approval is required.

2.1.4. A protocol is an essential component of a research proposal submitted for

funding.

Once a protocol for the study has been developed and approved, and the study has

started and progressed, it should be adhered to strictly and should not be changed.

This is particularly important in multi-center studies. Violations of the protocol can

discredit the whole study.

2.2. Characteristics of a well-written protocol:

A well-written protocol can be judged according to three main criteria:

2.2.1. The research protocol should properly address the research question (s) and

the aim of the study; the aim should indicate the general direction of the study.

2.2.2. The protocol should clearly show the relationship of the research to the field

of study of the student.

2.2.3. The protocol must justify the need for the particular research. It must convince

others that a problem exists and that the work in this area or field is inadequate

(incomplete, poorly done, or not done) and that further research is necessary.

2.2.4. The protocol must show that the researcher is qualified and equipped to do the

work and tackle the problem or research question.

The protocol should outline the rationale of the study, its objective, the method used

and how the data will be managed and analysed. It should highlight how ethical issues

have been considered, and where appropriate, how gender issues are being addressed.

2.3. Protocol format

The research protocol is generally written according to the following format:

2.3.1. Research (project) title.

2.3.2. Research summary:

2.3.3. Introduction.

1. Research question / the problem and the aim of the study.

2. Rationale.

3. Objectives.

2.3.4. Methods.

2.3.5. References.

2.4. The title2.4.1. Choosing a good title is essential for writing a good protocol as it is the first

thing to help the reader understand the nature of the study. The title should be

brief and descriptive. However, titles that are too short may lack important

information. A good title is one that has the most important words at the

beginning. The candidate should avoid or limit the use of ambiguous or

confusing words.

2.4.2. Breaking the title into a title and subtitle (everything which occurs after a

colon or a question mark in the title) should be considered when it has too

many words.

2.4.3. Abbreviations should not be used in the title.

2.4.4. The title may need to be revised after completion of writing of the protocol to

reflect more closely the sense of the study.

2.4.5. It should be written on a separate page (title page).

2.5. Title page

This should contain the following information in order:

2.5.1. Name of the University, College and Department written at the upper left

corner of the page.

2.5.2. The title, written in capital and bold letters (font 16).

2.5.3. Protocol identification, written in capitals (font 14):

2.5.4. Researcher's full name, with his degree (s) and specialty along with his

signature.

2.5.5. Academic title and name of supervisor (s), as tentatively assigned by the

head of the department, with the degree (s) and specialty, and institution (if

different from that of the researcher) along with his signature.

2.5.6. Date of submission of the protocol.

2.6. Research summary

The summary should be concise and should summarize all the elements of the

protocol. It should stand on its own, and not referring the reader to points in the

protocol.

2.7. Introduction

This is equivalent to the introduction in a research paper. It puts the research protocol

in context.

2.7.1. The research question / problem and the aim of the study should be

succinctly stated and backed up by a justification statement (rationale). The

secret in writing the research question and aim is clarity and brevity. In fact

every thing elses is built on writing a clear brief question.

2.7.2. The justification statement (rationale) should give evidence coupled with

reasoning that the specific research work arises out of needs and that it could

fill in gaps in knowledge or add to substantive or theoretical understanding.

It should be phrased in a way or another to answer the questions why the

research needs to be done, and what will be its significance or relevance to

the field of the study. A brief description of the most relevant studies on the

subject should be provided to support the rationale of the study and to allow

the reader to understand the context in which the problem exists.

2.7.3. Objectives of the study are needed in order to answer the research question

or meet the aim. They should be specific (not vague) and clearly written.

After stating the primary objectives, secondary objectives may be mentioned.

There is no need to write too many objectives or over-ambitious objectives

that can't be adequately achieved by the research. Objectives are preferably

stated at the end of the introduction having a "subheading". Objectives have

been described by some authors as SMART (specific, measurable,

attainable, realistic, and time-bound).

2.8. Methods

2.8.1. This part of the protocol has to be written in sufficient detail including in-

depth description of the human resources, materials and methods going to be

used.

2.8.2. Methods should follow the stated objectives in a clear and logical manner.

2.8.3. It should include information on:

1. Research design.

2. Setting (place of conducting the work).

3. Expected duration of the study including time for preparation and submission

of the "final" thesis or report.

4. Research participants (subjects): including:

• Selection of the observational or the experimental participants (patients,

controls, laboratory animals, etc….), clearly stating inclusion and exclusion

criteria.

• Description of the source of participants.

• Sampling technique.

• Sample size estimation: sample size should not be too large, or too small

taking into consideration the cost and duration of the study and

inconvenience to participants.

5. Justification for choosing the research design, method of selection of

participants, sampling technique, etc.

6. Instruments, equipments, laboratory devices, kits (giving manufacturer's name

and address whenever possible), drugs, chemicals, vaccines (giving generic

names, doses, routes of administration whenever possible).

2.8.4. This part of the protocol should also describe in sufficient detail:

1. All available resources that are necessary for the work. Both human (who

are to provide materials or access to laboratory or field sites) and non-

human (including laboratory facilities or field sites or both) resources

should be described.

2. The unavailable resources that are going to be provided by the researcher

(in the researcher's institute or other settings).

3. Experimental procedures or laboratory techniques, unless they are well

established procedures which need a brief description with references.

4. Pilot study or preliminary experiments to be done (if applicable).

5. Design of the questionnaire and method of data collection (self-

administered, direct interview, etc…). The questionnaire should be

provided as an appendix.

6. Data management and statistical analysis, including statistical package and

statistical test that will be used, stating the significance level.

7. Ethical considerations.

The protocol must describe the measures that will be undertaken to ensure

that the proposed research is carried out in accordance with the Word

Medical Association of Helsinki on Ethical Principles for Medical

Research involving human subjects. Generally, in experimental

investigations on human subjects, a written approval of the appropriate

human ethics committee (if such a committee exists) and an informed

consent (written in the mother tongue of the participants, using simple

non-medical terms) are required.

In studies involving experiments on animals, researchers should indicate

that the institutional and national guide for the care and use of laboratory

animals is to be followed.

8. Gender issues:

It was only recently that attention was drawn to the importance of

addressing gender issues in research protocols. This was in response to

several areas of concern. It is well known that genetic and hormonal

factors modify the prevalence, behavior, and treatment of diseases of body

systems in men and women. Both biological and gender-related

differences can influence the outcome of the research for men and women.

The researcher have to ensure, where indicated, that clinical trial of

pharmaceuticals, medical devices, and other medical products include

women with their full knowledge and consent and ensure that the resulting

data are analysed for sex and gender differences.

2.8.5. The content of the 'methods' could be divided into logical segments using

'subheadings' covering already mentioned information.

2.9. References

References should be identified in the text of all sections of the protocol

according to the instructions of the teaching institution on citation of references in

T/D. The protocol should end with the relevant references cited by the researcher in

all sections of the protocol.

factors modify the prevalence, behavior, and treatment of diseases of body

systems in men and women. Both biological and gender-related

differences can influence the outcome of the research for men and women.

The researcher have to ensure, where indicated, that clinical trial of

pharmaceuticals, medical devices, and other medical products include

women with their full knowledge and consent and ensure that the resulting

data are analysed for sex and gender differences.

2.8.5. The content of the 'methods' could be divided into logical segments using

'subheadings' covering already mentioned information.

2.9. References

References should be identified in the text of all sections of the protocol

according to the instructions of the teaching institution on citation of references in

T/D. The protocol should end with the relevant references cited by the researcher in

all sections of the protocol.