Methods of Research And Research Protocols

Submitted to: Dr. Olegario Clemente

Submitted by: Kristina Corazon L. Robles 41-DGD

METHODS OF RESEARCH AND RESEARCH PROTOCOLS

Definitions of Research Careful, critical, disciplined inquiry, varying in technique and method according to the nature and conditions of the problem identified, directed toward the clarification or resolution of a problem (Good,p.464) A careful investigation or inquiry especially through search for new facts in any b ranch of knowledge. (Advanced Learners Dictionary of Current English) The process of gathering data or information to solve a particular or specific problem in a scientific manner (Manuel and Medel) In simple terms, research is the pursuit of truth with the help of study, observation, comparison and experiment, the search for knowledge through objective and systematic method of finding solution to a problem, the systematic approach concerning generalization and the formulation of a theory.

Objectives of Research The principal purpose and goal of research is the preservation and improvement of the quality of human life; to discover answers to questions through the application of scientific procedures. The purpose of research is to serve man, and the goal is the good life. Good and Scates

Characteristics of a Research Systematic- It follows an orderly and sequential procedure that leads to the discovery of truth, solution of a problem, or whatever is aimed to be discovered Controlled- All variables except those that are tested are kept constant Empirical- All procedures employed and the data gathered are perceived in the same manner by all observers. Analytical- There is critical analysis of all the sata used so that there is no error in their interpretation Objective, unbiased, & logical- All the findings and conclusions are logically based on empirical data and no effort is made to alter the results of the research Employs hypothesis- This is to guide the investigation process. Employs quantitative or statistical methods- Data are transformed into numerical measures and are treated statistically to determine their significance or usefulness. Original work Done by an expert- The researcher uses valid and carefully designed procedures, valid data-gathering instruments, and valid data. Accurate investigation, observation and description- All conclusions are based on actual evidence Patient and unhurried activity-This is to ensure accuracy. Requires an effort-making capacity- Research involves much work and time Requires courage- Research requires courage because the researcher oftentimes undergo hazards, discomforts and the like. At times the researcher encounters public and social disapproval. Also, disagreements with colleagues may arise

Classifications of research HISTORICAL process of selecting the area or topic to write the history about, and collecting data about the events that occurred in it; It describes the present situations in terms of past events. COMPARATIVE- comparison of peoples experience of different societies. Either between times in the past or in parallel situations in the present DESCRIPTIVE- relies on observation as a means of collecting data; distortions in data can occur in biased questions in interviews, questionnaires, etc. CORRELATION- describes the statistical measure of association or the relationships between two phenomena. Relational- investigates the possible relationships between phenomena Prediction- carried out in research areas where correlations are already known; attempts to predict possible outcomes EXPERIMENTAL Relevant conditions are isolated and controlled so as to observe the effects when the conditions are manipulated. Types: o Pre-experimental: unreliable assumptions are made despite the lack of control over variables o True experimental: rigorous check of the identical nature of groups before testing the influence of a variable on a sample under controlled circumstances o Quasi experimental: Not all conditions can be fulfilled but the shortcomings are identified o Correlation and ex post facto: cause and effect relationships between two sets of data

THE SCIENTIFIC METHOD One of the characteristics of research is systematic. It follows the scientific method which includes the following steps 1. 2. 3. 4. 5. 6. 7. 8. 9. Determining the problem Formulation of hypothesis Doing the library search (Related Literature) Designing the study Developing the instruments for collecting data Collecting the data Analyzing the data Determining implications and conclusions from the findings Making recommendations for further research

The Research Problem The elements of a research problem are aim, purpose, subject matter or topic, place or locale, period or time, and population or universe. Answers questions starting with why, what, where, when, and who or from whom EXAMPLE OF A PROBLEM: To determine the status of teaching science in the high schools of Province A during the SY 2012-2013 TITLE: The teaching of Science in the High Schools of Province A as perceived by the science teachers and students during the SY 2012-2013

Hypothesis A hypothesis is a tentative conclusion or answer to a specific question raised at the beginning of the investigation. It is an educated guess about the answer to a specific question Formulated from the specific questions upon which they are based Serves as a basis for determining assumptions, relevance of data, and for the explanation or discussion about the data gathered

Related Literature Composed of discussions of facts and principles to which the present study is related These materials are usually printed and found in books, encyclopaedias, professional journals, magazines, and other publications.

Characteristics are: o o o o o Must be as recent as possible Objective and unbiased Relevant to the study Genuinely original and true facts Sufficient enough to give insight to the study

Sampling Design must contain the size of the population, the study population, the margin of error and the proportion of the study population used, the type of technique of sampling used (pure random, systematic random, stratified random, cluster sampling, or a combination), actual computation of the sample, and the sample

Collection of Data Data- collection of numbers, quantities, facts, or records, used as bases for drawing conclusions or making inferences 1. o o o o o o 2. o o o o Primary data- are gathered from primary sources Individual persons, organized groups or organizations Established practices such as marriage, religious rites, legal system, economic system, democracy, system of morals, etc. Documents in their original forms such as the Constitution, laws, orders, proclamations, treaties, contracts, census, etc. Living organisms such as animals, fowls, and other lower forms of living things. Man-made material things Natural objects and phenomena Secondary data Books including dictionaries, encyclopaedias, almanacs Articles published in professional journals, magazines, newspapers, and other publications Unpublished masters theses and dissertations, and other studies Monographs, manuscripts, etc

Methods of obtaining data In any form of research, you will be required to either count things and/ or talk to people. We can broadly classify research methods using this distinction. These two types of research method and their output data are classified as: o QUANTITATIVE - concerned with quantifying things asks questions such as how long, how many or the degree to which. seeks to quantify data & generalise results from a sample of the population may also measure the incidence of various views and opinions in a chosen sample for example or aggregate results. QUALITATIVE concerned with a quality of information attempts to gain an understanding of the underlying reasons and motivations for actions establishes how people interpret their experiences and the world around them provides insights into the setting of a problem, generating ideas and/or hypotheses

QUANTITATIVE METHODS Quantitative methods are research techniques that are used to gather quantitative data which can be sorted, classified, measured. o Quantitative survey o Secondary data collation and analysis o Statistical analysis Quantitative survey o a popular method of collecting primary data. o The broad area of survey research encompasses any measurement procedures that involve asking questions to respondents. o useful means of gathering data from businesses, community organisations and residents o It is important to understand what format of survey you are looking to undertake. There are broadly two survey formats that you may use and it is important to understand which you are using: Cross-sectional surveys are used to gather information on a population at a single point in time. (e.g. a questionnaire that collects data on peoples experiences of a particular event.) determine the relationship between two factors (e.g. impact of a program of activity on the level of benefits) Longitudinal surveys gather data over a period of time. This would allow analysis of changes in the population over time and attempt to describe and/or explain them. The three main types are trend studies, cohort studies, and panel studies Surveys can be delivered in a variety of ways: postal surveys telephone surveys email/internet surveys street surveys/administered surveys

Secondary data collation and analysis refers to the review of existing information and may involve the manipulation of statistical data. differs from primary research techniques in that the researcher does not collect the data directly and cannot control the actual data collected, but can bring to bear new insights through interpretation or presentation. useful for contributing to the analysis and commentary throughout a research report.

What types of data sources are there? There are a number of different types of secondary information. Some of the most common types are identified as follows: Official statistics - This refers to national data sets relating to issues such as population, employment and unemployment and businesses. Much of this information can be acquired from the Office for National Statistics Other statistics - A wide range of other types of numerical data can be drawn on for evaluation purposes. e.g. project monitoring information of beneficiaries, funding information, service data.

Statistical analysis a mathematical method of interrogating data. This is done by looking for relationships between different sets of data. There are two types of statistics: Descriptive statistics: numerical summaries of samples (what was observed); Inferential statistics: from samples of populations (what could have been or will be observed).

When to use? Descriptive statistics -if you want to summarise some data into a shorter form Inferential statistical- when you are trying to understand a relationship and either generalise or predict based on this understanding. Statistical analysis, through a range of statistical tests, can give us a way to quantify the confidence we can have in our inferences or conclusions.

What to consider in Statistical Analysis: Variables- are measured on an ordinal, interval, or ratio scale Inference- (conclusion) is a generalization with calculated degrees of certainty Confidence & Significance o The confidence interval is an interval estimate of a population parameter, this is the plus-orminus figure reported in. (e.g. newspaper or television opinion poll results) o Significant means probably true, and not important. The findings of your research may be proved to be true but this does not necessarily mean that the findings are important.

Statistical tests Parametric tests include Mean, Standard Deviation, t test, analysis of variance (ANOVA), Pearson correlation, regression (linear and non linear);

Non-parametric tests include Median, interquartile range, Spearman correlation, Wilcoxon test, Mann-Whitney test, Kruskal-Wallis test, Friedman test.

Parametric tests Mean - more commonly called the average Standard Deviation - measures the spread of the data about the mean value; useful in comparing sets of data, which may have the same mean but a different range. t test - assesses whether the means of two groups are statistically different from each other; appropriate whenever you want to compare the means of two groups. Parametric tests Analysis of variance (ANOVA) used to test hypotheses about differences between two or more means, however when there are more than two means, analysis of variance can be used to test differences for significance without increasing the error rate (Type I). Pearson correlation common measure of the correlation between two variables. A correlation of +1 means that there is a perfect positive linear relationship between variables. A correlation of -1 means that there is a perfect negative linear relationship between variables. Regression (linear and non-linear) - used for the modelling and analysis of numerical data; can be used for prediction (including forecasting of time-series data), inference, hypothesis testing, and modelling of causal relationships. Non-parametric tests Median - is the middle of a distribution: half the scores are above the median and half are below the median Interquartile range - (IQR) is the distance between the 75th percentile and the 25th percentile. It is essentially the range of the middle 50% of the data. Spearman correlation - used to test the direction and strength of the relationship between two variables. In other words, its a device to show whether any one set of numbers has an effect on another set of numbers. Wilcoxon test - compares two paired groups of data. It calculates the differences between each set of pairs, and analyses the list of differences. Non-parametric tests Mann-Whitney test used to assess whether two samples of observations come from the same distribution, testing the null hypothesis that the probability of an observation from one population exceeds the probability of an observation in a second population. Kruskal-Wallis test used to test equality of population medians among groups, using a one-way analysis of variance by ranks. Friedman test - compares three or more paired groups.

Data Analysis Qualitative methods are generally associated with the evaluation of social dimensions. o provide results that are usually rich and detailed, offering ideas and concepts to inform your research. o Can tell how people feel and what they think, but cannot tell you how many of the target population feel or think that way as quantitative methods can.

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Social surveys/questionnaires Interviews Discussion Groups Workshops Observation Visual Techniques

Questionnaire surveys o o o can be used in a wide range of settings and to gather a variety of different types of information. A small-scale qualitative survey may be conducted to explore in more detail the findings of qualitative research. Social survey - less statistical rigour is required, where sample sizes are not as large, and with results not expected to be significant of the wider population.

Interviews Conducting interviews is an interpersonal process and as an investigator you must be very aware of your own behaviours and assumptions in the context. Interviews are not neutral social spaces and you must be respectful and maintain app ropriate boundaries often used to obtain the interviewees perceptions and attitudes to the issues

How to analyze the data: Thematic generation - identifying and drawing upon common themes across the interviews; Citation - directly quoting parts of the interview in the main body of the report. Discussion groups (also known as focus groups) are an example of a technique widely used in political circles to road test policies. A discussion groups consists of a number of individuals you invite to discuss their views on a particular topic, typically involving between 6 and 12 people, which is conducted specifically to get a group of peoples views on a subject.

Workshops a group-based method of research in which there is an emphasis on activity-based, interactive working. The focus is on everyone participating and undertaking the work. Therefore, when using this type of research technique, the researcher acts as a facilitator, rather than leading the discussion or activity

When should it be used? Raising awareness Capturing views and information Building consensus

Developing skills and capacity

Observation consists of a mix of techniques: o informal interviews o direct observation o participation in the life of the group o collective discussions o analyses of personal documents produced within the group o self-analysis o life histories o Notes, diaries and transcripts

Visual techniques Visual techniques in social research offer an interesting, stimulating and interactive approach to gathering information. Visual methods such as drawing, painting, video, photography and hypermedia offer increasingly accessible and popular resources for research. o Cartoon test presented with a picture of a cartoon depicting a specific situation o Completion technique using the cartoon test above, the character is shown thinking or saying something but the sentence is left uncompleted. Participants are given the opportunity to make suggestions to complete the sentence. o Collage/concept boards uses a range of images that can be used to represent or describe the subject for discussion o Ideas board this board invites participants to jot down their ideas on post-it notes o Mind mapping visually representing information in an interesting format without the limits or formality of standard written text. o Money well Participants are given a certain amount of fake money, which they can place on the options displayed. o Graffiti or ideas wall The participants are able to write comments about a research topic or discussion statement. o Photographic research The use of photographs in research can be used to evoke feelings or trigger memories that lead to perspectives and explanations that would not have been unlocked using a more conventional research technique. o Film and video - video cameras are particularly well suited as data gathering technologies for ethnography, participant observation, oral history, life history, etc, preserving things that are not preserved in even the best researchers field notes.

SUMMARY, CONCLUSIONS, & RECOMMENDATIONS SUMMARY- a brief statement about the main purpose of the study, the population or respondents, the period of the study, method used, research instrument, and the design CONCLUSIONS- are inferences, deductions, abstractions, implications, interpretations, general statements, and generalizations based upon the findings

RECOMMENDATIONS- are appeals to people concerned to solve or help solve the problems discovered in the inquiry

RESEARCH PROTOCOL What is a protocol? A detailed plan of a scientific or medical experiment, treatment, or procedure The protocol is the detailed plan of the study. Every research study should have a protocol, and the protocol should be written. Importance forces the investigators to clarify their thoughts and to think about all aspects of the study; is a necessary guide if a team is working on the research; is essential if the study involves research on human subjects or is on experimental animals, in order to get the institutions ethical approval; is an essential component of a research proposal submitted for funding. It should be adhered to strictly and should not be changed. Violations of the protocol can discredit the whole study. If the violations are minor, at least that part of the study should be excluded from the analysis. An additional step is to develop what may be called the operations manual for the study. This will include detailed instruction to the investigators to assure a uniform and standardized approach to carrying out the study with good quality control.

CRITERIA A well-thought out and well-written protocol can be judged according to three main criteria. Is it adequate to answer the research question(s), and achieve the study objective? Is it feasible in the particular set-up for the study? Does it provide enough detail that can allow another investigator to do the study and arrive at comparable conclusions?

Format for the protocol Project title Project summary Project description: Rationale Objectives Methodology Data management and analysis Ethical considerations Gender issues

Expected outcome Budget summary References

Project title The title should be descriptive and concise. It may need to be revised after completion of the writing of the protocol to reflect more closely the sense of the study.

Project summary The summary should be concise, and should summarize all the elements of the protocol. It should stand on its own, and not refer the reader to points in the project description. Summary should be concise but must be sufficient to orient the reader to the main purpose of the study, how it would be conducted and its expected benefits.

Project description Rationale o This is equivalent to the introduction in a research paper. It puts the proposal in context. o It should answer the question of why and what: why the research needs to be done and what will be its relevance. o A brief description of the most relevant studies published on the subject should be provided to support the rationale for the study. Objective(s) o Specific objectives are statements of the research question(s). o Objectives should be simple (not complex), specific (not vague), and stated in advance o After statement of the primary objective, secondary objectives may be mentioned. Methodology- It is the most important part of the protocol. Research design: The choice of the design should be explained in relation to the study objectives. Research subjects or participants: the following questions should be answered: What are the criteria for inclusion or selection? What are the criteria for exclusion? In intervention studies, how will subjects be allocated to index and comparison groups? What are the criteria for discontinuation? Interventions: If an intervention is introduced, a description must be given of the drugs or devices to be used, and whether they are already commercially available, or in phases of experimentation. o For drugs and devices that are commercially available, the protocol must state their proprietary names, manufacturer, chemical composition, dose and frequency of administration. o For drugs and devices that are still in the experimental stage, the approval of the drug regulatory agency in the country is generally needed before implementing the study. Observations: Information should be provided on the observations to be made, how they will be made, and how frequently will they be made.

If the observation is made by a questionnaire, this should be appended to the protocol. Laboratory or other diagnostic and investigative procedures should be described. o For established procedures, reference to appropriate published work is enough. o For new or modified procedures, an adequate description is needed, with a justification for their use. Sample size: The protocol should provide information and justification about sample size. o The basis on which sample size is calculated should be explained in the methodology section of the protocol. o Calculation of sample size has been made easy by computer software programs. But the principles underlying the estimation should be well understood. o

Data Management & Analysis The protocol should provide information on how the data will be managed, including data coding for computer analysis, monitoring and verification. Information should also be provided on the available computer facility. The statistical methods used for the analysis of data should be clearly outlined.

Ethical considerations All research protocols in the biomedical field, particularly if it involves human subjects, must include a section addressing ethical considerations. This includes two components: o The first is a written approval of the appropriate ethics review committee, together with a written form for informed consent, where appropriate. o The second is a special section, preferably in the format of a checklist, to address all possible ethical concerns.

Ethical considerations Approval by ethics review committees o For studies in humans (or involving human biological materials), the protocol must be approved by the local, institutional or equivalent ethics committee and/or national ethics committee. o For animal studies approval is required from the animal welfare committee of the institute or its equivalent. Ethical considerations Informed decision-making o A consent form, where appropriate, must be developed and attached to the protocol. o It should be written in the prospective subjects mother tongue. o The consent form has two parts: a statement describing the study and the nature of the subjects involvement in it; a certificate of consent attesting to the subjects consent. Both parts should be written in simple language so that the subject can easily understand the contents. Ethics checklist o The protocol must describe the measures that will be undertaken to ensure that the proposed research is carried out in accordance with the World Medical Association Declaration of Helsinki on Ethical Principles for Medical Research Involving Human Subjects

o Gender issues

A checklist must address ethical concerns that could be raised about the methodology, including the research design, selection of subjects, the interventions introduced and the observations to be made.

It was only recently that attention was drawn to the importance of addressing gender issues in research protocols. "Ensure, where indicated, that clinical trials of pharmaceuticals, medical devices and other medical products include women with their full knowledge and consent and ensure that the resulting data is analysed for sex and gender differences. -The Commission on the Status of Women It is well known that genetic and hormonal factors modify the prevalence, behaviour and treatment of diseases of body systems in men and women. But what is less known is that culturally evolved gender-related differences in lifestyle behaviour are also powerful determinants of womens health and account for major differences in the disease burden between males and females, probably more than genetic or hormonal factors. Both biological and gender-related differences can influence the outcome of the research for men and women.

EXPECTED OUTCOME This section restates the justification for the study in terms of the anticipated results. It will specify the following points: The implications of the potential results How the results of the study may be useful to the policy makers, community at large and for future research

BUDGET SUMMARY A brief outline of the budget requirement showing head-wise expenditure for the study should be given in this session. (e.g. manpower, logistics, transportation etc.) A detailed budget estimate showing all the expenditures under various heads can be placed in annexure.

References The protocol should end with relevant references on the subject. In this section list of the various references quoted while formulating protocol may be listed in a sequential manner.

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