Writing a research protocol 2011Document Transcript
WRITING A RESEARCH PROTOCOL2.1. IntroductionAfter proper and complete planning of the study, the plan should be written down as aresearch protocol. Therefore the protocol is the detailed plan of the study. Theprotocol is a requirement for all research purposes, not necessarily for graduatestudies. 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 ones 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 hasstarted 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 candiscredit 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 usedand how the data will be managed and analysed. It should highlight how ethical issueshave been considered, and where appropriate, how gender issues are being addressed.2.3. Protocol formatThe 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. Researchers 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 summaryThe summary should be concise and should summarize all the elements of theprotocol. It should stand on its own, and not referring the reader to points in theprotocol.2.7. IntroductionThis is equivalent to the introduction in a research paper. It puts the research protocolin 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 cant 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. Methods2.8.1. 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 manufacturers 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 researchers 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. ReferencesReferences should be identified in the text of all sections of the protocolaccording to the instructions of the teaching institution on citation of references inT/D. The protocol should end with the relevant references cited by the researcher inall sections of the protocol.