Writing a research protocol 2011

1. 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. 2.2.4. 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 title
2.4.1. 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

3. 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.

4. 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.

5. 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

6. 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.

7. 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.