Writing a research proposal is probably one of the most challenging and difficult task as research is a new area for the majority of postgraduates and new researchers. The purpose of this article is to summarize the most important steps and necessary guidelines for producing a standard research protocol. Academic and administrative success of any project is usually determined by acquiring a grant for the related field of research. Hence, the quality of a protocol is primarily required to achieve success in this scientific competition. Keywords: Academia, Grant, Higher Education, Researcher Clinical research is conducted according to a plan (a protocol) or an action plan. The protocol demonstrates the guidelines for conducting the trial. It illustrates what will be made in the study by explaining each essential part of it and how it is carried out. It also describes the eligibility of the participants, the length of the study, the medications and the related tests. A protocol is directed by a chief researcher. The health of the participants’ will be regularly checked by members of the research team to ultimately ensure the study’s safety and effectiveness. [Table/Fig-1] outlines the key aims of the protocol.
[Table/Fig-2] outlines the key benefits of the protocol. Benefits of the protocol.
The key points of the proposal should include justification for the need of the project and a detailed plan for the investigation [1,2]: What is the question? (Hypothesis) What is it to be investigated?
Drafting the protocol correctly will increase the likelihood that the conclusions drawn from the research are scientifically sound. Recommendations and suggestions should be sought from colleagues and experts so that researchers can develop their plans. However, once the study is launched, the protocol should not be altered during the progression of the study or trials. If the changes during progress of study are minor, then that part of the study should be excluded from the analysis. Unless unexpected complications occur during the conduct of the trial, it is advisable to reconsider and rewrite the protocol where the whole process is started again provided that the original research topic is still considered to be relevant. If complications are anticipated, it is suitable to run a pilot study, to check the feasibility of the study and find answers to the potential areas of the trial. Clinical trials must be approved and monitored by an Institutional Review Board that ensures that the risks are negligible and are worth any potential benefits. It is an independent committee that consists of physicians, dentists, statisticians, and members of the community. The committee ensures that clinical trials are ethical and that the rights of all participants are protected. The board must initially approve and periodically review the research. Components of a Research Protocol: The topics that should be covered in a protocol are shown in [Table/Fig-3] [3,4]. The components of the protocol.
Protocol writing allows the researcher to review and critically evaluate the published literature on the interested topic, plan and review the project steps and serves as a guide throughout the investigation. The proposal is an inevitable document that enables the researcher to monitor the progress of the project [5]. 1) Title of the Study: Title of proposal should be accurate, short, concise, and identify [2,6]. What is the study about, Who are the targets, Where is the setting of the study and When it is launched, if applicable- It should make the main objective clear, convey the main purpose of the research and mention the target population. Carry maximum information about the topic in a few words; it is a good practice to keep the title to within 12-15 words. It should convey the idea about the area of research and what methods are going to be used in a compact, relevant, accurate, attractive, easy to understand, and informative way. 2) Administrative Details: The following administrative details and a protocol content summary should follow the title page:
3) Project Summary: The summary should be distinctive, concise and should sum up all the essentials of the protocol. 4) Introduction (Background): The background to the project should be concise and refer to the subject straight forwardly. In writing the review, attention should be drawn to the positives, negatives and limitations of the studies quoted [7–9]. Introduction is concluded by explaining how the present study will benefit the community. The literature review should logically lead to the statement of the aims of the proposed project and end with the aims and objectives of the study. The review should include the most recent publications in the field and the topic of the research is selected only after completing the literature review and finding some gaps in it. Introduction should briefly answer the importance of the topic, the gaps/lacunae in the literature, the purpose of the study and benefits for the society, from the study. The research question should be described precisely and concisely. It is going to be the basis of designing the project. The definition of the problem should be clear so that a reader can straight forwardly recognize the real meaning of it. 5) Study Objectives (Aims): The aims should be explicitly stated. These should be confined to the intention of the project and they should arise from the literature review. State the goal you need to achieve. The study aims or objectives emerge from the study questions/ hypothesis. They are answers to what are the possible responses to the research question or hypothesis under analysis and measure. Aims should be logical and coherent, feasible, concise, realistic, considering local conditions, phrased to clearly meet the purpose of the study and related to what the specific research is intended to accomplish. For example, to evaluate knowledge level regarding dental caries in primary school children in KSA (this is not detailed). The following should be added: Causes, treatment, preventive measures, etc. The objectives should be (SMART objective): Specific, Measurable, Achievable, Relevant and Time based [10]. Specific Aims: Details of each objective that will finally lead to the achievement of the goal should be stated. Specific aims one by one should be listed concisely. It is good practice not to include too many aims in the study (2-5 best); too many objectives often lead to inaccurate and poorly defined results. Furthermore, aims should be achievable, realistic and specific with no general and ambiguous statements. They should be stated in action verbs that illustrate their purpose: i.e., “to determine, to compare, to verify, to calculate, to reduce, to describe, etc.” Secondary Objectives (Optional): These are referred to as ancillary and minor objectives that could be studied during the course of the study. The formulation of objectives helps to focus the study and to avoid the collection of any unnecessary data and hence organize the study in clear and distinct stages. Hypothesis: It is a statement based on sound scientific theory that recognizes the predicted correlation between two or additional assessable variables [11]. It is always developed in response to the purpose statement or to answer the research questions posed. Furthermore, hypothesis transforms research questions into a format amendable to testing or into a statement that predicts an expected outcome. Types of hypothesis statements:
Aims should be logically linked and arranged according to the tested hypothesis statement. Example:
The statement of the problem should provide a summary of exactly what the project is trying to achieve.
The justification of the research should be a convincing statement for the need to do it:
6) Methods and Materials: It should describe in detail the ‘Where’, ‘Who’, ‘How’ the research will be conducted. It explains the study design and procedures and techniques used to achieve the proposed objectives. It defines the variables and demonstrates in detail how the variables will be measured. It details the proposed methodology for data gathering and processing. Methodology composes an important part of the protocol. It assures that the hypothesis will be confirmed or rejected. It also refers to a thorough strategy to attain the objectives [13]. The methods and materials are divided into various subheadings: a) Study design (cross-sectional, case-control, intervention study, RCT, etc.): Proper explanation should be given as to why a particular design was chosen (on the basis of proposed objectives and availability of resources). A study design is in fact the researcher’s general plan to acquire the answer (s) to the hypothesis being tested. Here, strategies will be applied to develop balanced, correct, objective and meaningful information [14]. It explains the methods that will be used to collect and analyze data. Proper selection of the study design is important to attain reliable and valid scientific results. Ethics, logistic concerns, economic features and scientific thorough-ness will determine the design of the study. Here, a chief concern is given to the legality of the results including potential bias mystifying issues. Randomized controlled clinical trial is the best to document a causal relationship between an exposure and its outcome [Table/Fig-4]. Suitable research design depends on the purpose of the study.
b) Study population (Study subjects): Where are you going to do the research and who is the study population (why doing research in this place and why selecting this population?). It describes in detail about the study subjects, all aspects of the selection procedure and sample size calculation. Proper definition of eligibility, inclusion, exclusion and discontinuation criteria of the study subjects should be stated. Allocation of subjects to study arms should be explained and described in details bearing in mind the concealment and randomization process [15,16]. c) Sample size: Sample size calculation is recommended for economical and ethical reasons [16–18]. The calculation of the sample size must be explained including the power of the sample. The sampling technique should be mentioned, e.g., randomization that will be used in order to obtain a representative sample for your target population. Each step involved in the recruitment of the study subjects should be described according to the selection criteria (inclusion and exclusion criteria). “Informed consent” should be mentioned (Permission granted in full knowledge of the possible consequences). d) Proposed intervention: Full description of proposed intervention should be given. Here, all the activities and actions should be recorded and thoroughly explained in their order of occurrence.
Involved personnel should precisely define:
e) Data collection methods, instruments used: Data collection tools are:
7) Data Management and Analysis Plan: This section should be written following statistical advice from a statistician. The analysis plan and which statistical tests will be used to check the significance to the research question/hypothesis with appropriate references should be described. Names of variables that will be used in the analyses and the name of statistical analysis that will be performed to assess the outcome should be listed [22–25]. If computer programs are to be applied, it is important to mention the software used and its version. 8) Project Management: Work plan-A work plan is an outline of activities of all the phases of the research to be carried out according to an anticipated time schedule. Proper time table for accomplishing each major step of the study should be defined. Assigning time frame to each step in the trial will be helpful in organizing the structure of the research trial. The personnel (investigators, assistants, laboratory technicians etc.) involved in the study or data collection should be properly trained. 9) Strengths and Limitations: It is important to mention the strengths or limitations of the study, i.e., what study can achieve or cannot achieve is important, so as to prevent wasteful allocation of resources. 10) Ethical Considerations (Issues for Ethical Review and Approvals): It should indicate whether the procedures to be followed are in accord with the Declaration of Helsinki. In any case, study should not start unless approval from ethics committee is received [26]. The following points should be explained:
11) Operational Planning and Budgeting (Budget Summary): Outline the budget requirement showing head wise expenditure for the study-manpower, transportation, instruments, laboratory tests, and cost of the drug. Budget estimate is to be attached in the annexure. All costs including personnel, consumables, equipment, supplies, communication, and funds for patients and data processing are all included in the budget. Each item should be justified. 12) Reference System: Referencing is the regular method of recognizing information taken from other researchers’ work. A proper citation will enable the readers to follow-up any reference of interest. Plagiarism refers to claiming and acquiring someone else’s ideas, an action that is considered a criminal action. Failure to reference an idea that you have found in your research, or to acknowledge the work of other team members in a team assignment falls under the category of plagiarism. Therefore referencing is an extremely important aspect of the research protocol. The two most commonly used citation systems in clinical writing are the Vancouver system and the Harvard system [27, 28]. The choice of referencing system is dependent upon the funding organizations where the research protocol is being submitted. These frequently identify their preferred system of referencing and this should be strictly adhered to. The most common style used in the dental literature is Vancouver style. 13) Annexure: The following annexes are to be attached at the end of the protocol:
The protocol should adequately answer the research question. The research design must be sound enough to yield the expected knowledge. It should provide enough detail (methodology) that can allow another investigator to do the study and arrive at comparable conclusions. Here, the proposed number of participants is reasonably justified and the scientific design is adequately described. Incorporating insufficient elements regarding proposed studies and inadequate explanation for the implication of the problem must be shunned as well as suggesting far more work than can be practically done during the study period. Furthermore, underpowered sample size should be justified, invalid or unreliable instrumentation should be tested and improper statistics should be adequately analyzed. The most difficult stage of conducting a research project is the preparation of a protocol that results in a short yet comprehensive document that clearly summarizes the project. 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