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 Table of Contents  
Year : 2019  |  Volume : 31  |  Issue : 2  |  Page : 167-170

Integral elements of a research protocol

1 Oral Medicine and Radiology, Government College of Dentistry, Indore, India
2 Centre for Dental Education and Research, AIIMS, New Delhi, India

Date of Submission31-Dec-2018
Date of Acceptance16-Apr-2019
Date of Web Publication24-Jun-2019

Correspondence Address:
Dr. Prashanthi Reddy
Government College of Dentistry, Indore
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Source of Support: None, Conflict of Interest: None

DOI: 10.4103/jiaomr.jiaomr_220_18

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The research is conducted in accordance to a protocol that illustrates each essential part and the manner in which it is carried out. The research proposal outlines the key aim and provides numerous benefits to the researcher. There are numerous integral elements of a research protocol which ensure that the protocol is accurate, concise and provides adequate information about the study, ensures it is ethically sound, illustrates the need and the hypothesis of the study. The methodology explains the study design, procedures, and techniques used to achieve the proposed objectives. It defines the variables and demonstrates in detail how the variables will be measured, whereas the analysis plan and the statistical tests to determine the significance helps in rejecting or accepting the null hypothesis. Referencing is an extremely important aspect of the research protocol. A protocol with appropriate hypothesis, clear methodology, no typographical error, and easy readability is bound to create an impact on the existing and future literature.

Keywords: Research design, research methodology, research protocol

How to cite this article:
Reddy P, Bhadauria US. Integral elements of a research protocol. J Indian Acad Oral Med Radiol 2019;31:167-70

How to cite this URL:
Reddy P, Bhadauria US. Integral elements of a research protocol. J Indian Acad Oral Med Radiol [serial online] 2019 [cited 2022 Oct 6];31:167-70. Available from: https://www.jiaomr.in/text.asp?2019/31/2/167/261084

   Background Top

Research is a quest for knowledge through diligent search or investigation or experimentation aimed at the discovery and interpretation of new knowledge.[1] Historical aspect of origin of research paper dates from 1665. The research is conducted in accordance to a protocol which illustrates each essential part and the manner in which it is carried out. The research proposal outlines the key aim and provides numerous benefits to the researcher as it lays down the structure if constructed in an appropriate manner. The distinct importance of the protocol also lies in the fact that once it is formulated it ideally should not be modified or altered during the progress of the trial. In order to ensure if by any chance the protocol is likely question or threaten the integrity, a pilot study must be done.

   Ethical Considerations Top

The Declaration of Helsinki forms a benchmark for ethical considerations. The research protocol must adhere to ethical backgrounds and guidelines and must not be conducted in accordance to the declaration. The protocol must take into consideration the participant's right and the information must be provided on the informed consent. The reason for conducting research, its justification, the risk associated, potential complications, confidentiality, and the right to withdraw from the study must be explicitly mentioned and explained.[2] The protocol must be reviewed and monitored by an Institutional Review Board that ensures that the risks are negligible and are worth any potential benefits. The committee ensures that the research protects the rights of all participants. The board must initially approve and periodically review the research.

   Integral Elements of a Research Protocol Top


The title of a protocol should be accurate, concise, and provide adequate information about the study, the target population, study setting, and the study design of the article. Preferably, the title should be kept within 12–15 words and provide information about the research in a concise manner. For example, a study with a title esthetic dentistry only indicates the focus of the study and does not provide any extensive idea about it. An excessively long title may provide comprehensive detail, however, limits the readability.

   Introduction (Background) Top

The background should be concise and refer to the subject straightforwardly. The background should explicitly mention about the need of the present with an extensive background search highlighting the positives, negatives, and the limitations of the previous studies quoted. The literature review should logically lead to the statement of the aim of the proposed project and end with the aims and objectives of the study. The research question should be described precisely and concisely. The definition of the problem should be clear.[2] Good research protocols begin with a crisp introduction and generates interest of the readers from the start. A research protocol with a lengthy introduction will hinder the readers in extracting the appropriate findings.

Aim and Objectives

The aim 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.[2] It is usually advised to have a single aim for a research protocol; however, in few cases there are primary and secondary aims. The objectives should be (SMART objective): Specific, Measurable, Achievable, Relevant and Time based.[3] The secondary objectives 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 on the study and avoid the collection of any unnecessary data and hence organize the study in clear and distinct stages. The aim and objectives of the study emerge from study questions/hypothesis.[2]

A good research protocol usually comprises a single aim, which is generally the title of the study. The objectives of such a protocol are aligned in a manner that they lead to aim in a concise manner.

Hypothesis is a statement based on sound scientific theory that recognizes the predicted correlation between two or additional assessable variables; in simple words, it is the supposition arrived at from observation or reflection.[4],[5] 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.[2]

A null hypothesis states no actual relationship between variables (H0 or HN). It may be read as there is no difference between the groups to be compared and no relationship between the exposure and outcome under investigation. The final conclusion of the investigators will either keep a null hypothesis or reject it in support of an alternative hypothesis. It does not essentially mean that H0 is accurate when not rejecting it as there might not be an adequate proof against it.[6]

An alternative hypothesis is a statement that suggests a potential outcome that the researcher may expect (H1 or HA). This hypothesis is derived from previous studies where an evident difference between the groups to be compared is present. It is recognized only when a null hypothesis is rejected. Practically, hypotheses are stated in the null form, because they have their inferential statistics. Such hypotheses of no difference will be challenged by researchers and the result of the statistical testing gives the probability that the hypothesis of no difference is true or false.[6]

For example, while understanding the efficacy of a new product as compared to the current one, the null hypothesis will state no difference in the efficacy of the new product when compared to the current product.

   Materials and Methods Top

The methodology explains the study design, 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.[7] The selection of a research strategy is the core of a research design and is probably the single-most important decision the investigator has to make.

Descriptive Study

When an epidemiological study is not structured formally as an analytical or experimental study, i.e. when it is not aimed specifically to test hypothesis, it is called descriptive study; it allows formulation of hypothesis and is the first phase of an investigation. Both qualitative and quantitative technique may be used, including questionnaire, interviews, observation of participants, and service statistics. The types of descriptive studies include case report, case series, cross-sectional studies, surveillance, and ecological descriptive study. The case report is the descriptive report of a disease/condition or syndrome in a patient which is quite rare, unique, interesting, whereas the case series is based on reports of a series of cases of a specific condition or a series of treated cases with no specific allocated groups. The cross-sectional studies imply the collection of data on, as the term implies, a cross section of population. They provide prevalence rate at a particular point in time (point prevalence) or over a period of time (period prevalence). Surveillance is another type of descriptive study which can be thought of watchfulness over a community, whereas when the unit of observation is an aggregated (e.g. family, school) or an ecological unit (village, town, country) the study becomes ecological descriptive study.[1]

Analytical Study

When we establish a relationship between risk factor (etiological agent) and an outcome (disease) it is termed as analytical. The basic approach of analytical studies is to develop a specific, testable hypothesis and to design the study to control any extraneous variables that could confound the relationship between the studied factor and the disease. The types include case–control study, multifactorial case–control study, cohort studies, and analytical cross-sectional studies.

Case–control study/retrospective study is the commonly used analytical strategy in epidemiology. It is designed primarily to establish the causes of diseases by investigating associations between exposure to risk factor and occurrence of disease. Data are analyzed to determine whether exposure was different for cases and controls. The basic steps in a case–control study include: selection of cases and controls, matching, measurement of exposure, and analysis and interpretation. When the several exposure factors in the same study are investigated, it is done through a multifactorial case–control study.

Cohort studies start with the risk, then look for the outcome. A cohort is a group of people who share a common characteristic or experience within a defined time period. In a prospective cohort we start with exposed and unexposed groups and wait for the outcome. In retrospective cohort both exposure and outcome have already happened, but groups are still made based on exposed or unexposed. In a combination of retrospective and prospective cohort, the cohort is identified from past records, and is assessed of date for the outcome. The steps include selection of study subjects, obtaining data on exposure, selections of comparison group, follow- up, and analysis. In the analytical cross-sectional studies, the investigator measures exposure and disease simultaneously in a representative sample of the population.[1]

Experimental Studies

Experiment is an important step in establishing causality; it is often neither feasible nor ethical to subject human beings to risk factors in etiological studies. Experimental strategies are used extensively for testing new drugs or intervention programs. The experimental studies consist of randomized and nonrandomized controlled trials. The research strategy, by which evidence of effectiveness is measured, is the randomized, controlled, clinical trial. A randomized controlled trail consists of drawing up a protocol, selecting reference and experimental group, randomization, manipulation or intervention, follow-up, and assessment of outcome. The two main designs of randomized controlled trial consist of parallel and cross-over designs. In nonrandomized controlled trial there is no randomization, the degree of comparability will be low, and chances of spurious result are higher than where randomization had taken place.[1]

A systematic review is the summaries of the world literature on a specific topic that use explicit methods to systematically search, critically appraise, and synthesize the evidence from clinical research, whereas meta-analysis is the retrospective systematic identification, appraisal, and comparison of all clinical studies relevant to a selected topic of interest, using statistical methods to combine and summarize the results from related studies.[1]

Another important component of the methodology is the study population which 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.[8],[9] Sample size calculation is recommended for economical and ethical reasons.[9],[10],[11] Sample size estimation differs for individual studies and varies in accordance with the study design and also the type of randomization or sampling used. Estimation of sample size must also include the power of the sample. Sample size estimation is done using various software or formulas and is aided by either the previous studies or by conducting a pilot study.

A good study highlights all the integral components of the study in methodology. A comprehensive description of the tools should be provided in the methodological section of the protocol. Inadequate explanation of the inclusion, exclusion criteria, sample selection, sample size estimation, and detailed protocol hinders in making it a good research protocol.

A full description of the proposed intervention should be provided along with the data collection methods, and instruments used should also be provided. Data collection tools should include retrospective data (medical records), questionnaires, interviews (structured, semi-structured), laboratory test (literature or personal knowledge should be referenced if established test, or description should be provided in details if not established test), clinical examinations, description of instruments, tools used for data collection, as well as the methods used to test the validity and reliability of the instrument should be provided.[2]

Analysis Plan

The analysis plan and the statistical tests which will be used to determine 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.[2] Inappropriate analysis plan and use of improper statistical measures to determine significance lead to wrong inferences.

Strengths and Limitations

One of the most common findings observed in research protocols is the inability to highlight the limitations of the study. Highlighting the limitations of the study pave path for further evidence-based researches and reduces the wasteful allocation of resources.

Operational Planning and Budgeting (Budget Summary)

Budget summary outlines 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.[2]

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 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. 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.[2]

   Modern Controversy in Dental Research Top

Dental research has been associated with a number of controversies since the start; however, one of the most recent controversies in dental research is to protect human health and the environment from the adverse effects of mercury which is used in dental restorative treatments in some of the countries around the world. To phase out mercury use in a number of products and processes, control measures on emissions to air and on releases to land and water, and the regulation of the informal sector of artisanal and small-scale gold mining.

   Conclusion Top

An increase in the number of research proposals in the last decade has given a new light and scope to the field; however, it is also disheartening to see the lack of integral elements and appropriate methodology in a research protocol. One of the most difficult parts of conducting a research is the preparation and formulation of the research protocol. To create an impact on the existing as well as the future literature, the research project must follow an appropriate structure. The preparation before the start of research protocol is equally or more important than the efforts at the later stages of the protocol.

Financial support and sponsorship


Conflicts of interest

There are no conflicts of interest.

   References Top

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Al-Jundi A, Sakka S. Protocol writing in clinical research. J Clin Diagn Res 2016;10:ZE10-ZE13.  Back to cited text no. 2
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Park's text book of preventive and social medicine. 23rd edn. Bhanot Publishers, 2011; 491-519.  Back to cited text no. 4
Crisp RJ, Burke FJ. Conducting trials. Br Dent J 2005;198:282.  Back to cited text no. 5
Eaton KA, Santini A. Designing a protocol. London: Faculty of General Dental Practice (UK); 2007.  Back to cited text no. 6
Smith MC. Research methodology: Epistemologic considerations. Image J Nurs Sch 1984;16:42-6.  Back to cited text no. 7
Study designs in medical research. 2014. Available at: http://galton.uchicago.edu/~thisted/courses/315/lectures/0297.pdf. Accessed on December 28, 2018.  Back to cited text no. 8
Zodpey SP. Sample size and power analysis in medical research. Indian J Dermatol Venereol Leprol 2004;70:123-8.  Back to cited text no. 9
[PUBMED]  [Full text]  
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Sundar Rao PSS, Richard J. An introduction to biostatistics. 3rd edn. New Delhi: Prentice/Hall of India; 1996.  Back to cited text no. 11

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