cihsr.in€¦ · Web viewA critical review lays a strong foundation for your research. So spend time, identifying all earlier work, using various internet and other resources. Critical

Christian Institute of Health Sciences & Research 4th Mile, Dimapur, P.B. No. 31, P.O. ARTC. Nagaland – 797115. Ph: 03862-242555 www.cihsr.in

Preparing Research Protocols for the IRB

A Step-by-Step Guide for Thesis Guides and Researchers

*Note: All sentences marked in Italics are “Frequently Asked Questions” in the CIHSR- IRB

1. Justification and need for this research: Introductiona. The most important qualification of your research is that it is relevant to our

country especially the northeast region.b. The other considerations are that it is urgent, significant and feasible with the

resources available, ethically acceptable and replicable in other settings. c. Often the reviewers are interested in what is already known on the topic, and

what your research will add. Extensive use of internet sources such as PubMed, Scholar google, Cochrane reviews will provide the latest scientific journal articles on the key words of your research. Copy/paste the abstracts of relevance into a separate folder, which you can then sort and use as needed.

d. You need to mention only the best recent work in the Introduction (about 5-10), keeping the others for the section on critical Review of Literature. The essential details of earlier work includes the surname(s), objective(s), location, period, sample sizes, major findings and any recommendations. The Vancouver style of citation in the text and in listing in the end is preferred, using serial numbers in order of appearance. This introduction must mention possible lacunae/limitations of earlier work and hence the need for further research. The section logically leads to the problem identification and objectives. Do not make the introduction too elaborate or rambling so that the focus of your research is lost and the reviewer will be confused or worse, misunderstand your research. Usually 1-2 pages should suffice.

2. Title:a. A good title enhances the face value of your research and identifies the major

objective; it must be brief but informative. b. The titles in your review of literature will be helpful to decide avoiding

identical titles used by other investigators. Have the best tentative title to begin with which you can finalize later.

c. Include place and region of study based on the population you wish to study. (Example only Dimapur, or Nagaland , or Northeast region)

d. Avoid the usage of the term “clients”, patients or participants are more appropriate terms.

e. Make the title more appropriate such that the reader does not think that the patients were mostly locals and thus generalize it to Nagaland.

3. Review of literature

Compiled by Dr. P S S Sundar Rao, Consultant Biostatistcs & Research Methods and Dr Rohan Ramesh, Consultant, Community Health, CIHSR (Version1: 01_05_19)

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a. Don’t list every article as an inventory. Group them if you can, mention the strengths and limitations of each article, identify the deficiencies or lacunae which you will correct or go beyond in your research. Otherwise, the reviewer may feel that when so much work has already been done, why repeat ? Ethically, this is not acceptable.

b. A critical review lays a strong foundation for your research. So spend time, identifying all earlier work, using various internet and other resources. Critical review is not just criticism but an objective analyses of earlier research. The more thorough your review, the better. Do not neglect work done in India and quote only foreign studies and textbooks.

c. Recent published scientific journal articles are preferred and make full use of internet resources such as PubMed, Embase, Scholar google, SSRN, ERIC, etc.

d. All those mentioned here must find a place in your list of references. e. You can use free reference manager softwares like Zotero or Mendeley for this

purpose.f. Vancouver style is the most preferred citation style

4. Scope and significancea. Mention here who will benefit from the findings of this research such as the

communities in which this research is done, respondants, parents and families, research organizations, policy makers, etc.

b. The wider the audience, the greater will be the scope and reach of he research, and increases the significance and relevance. This section will appeal to the Ethical committee.

c. Kindly provide details of what are the possible interventions that could be implemented in the department after the completion of the study.

5. Objectives:a. This serves as a Lighthouse for the research and the most important part of a

Research Protocol. Hence, much thought is needed to formulate them in a manner that reflects the title and aims of the research project. There could be a general objective and several (not more than 4 or 5) specific objectives arising out of the general objective.

b. Objectives are outcomes expected from this research and should be stated as such, viz.,Specific, Measurable, Attainable, Relevant and Time-bound(SMART). There use words such as determine, estimate, compare, correlate ,etc., and not words such as Understand, Study, Find, Appreciate, etc which are not measurable

c. Be careful when you use prevalence and Incidence know the differenced. Use the word determinants, associations correlations instead of etiology in

observational studiese. Risk factors can be determined only in case control and cohort studies.

6. Case definition:a. Kindly provide the standardized definition of the condition to be studied in terms

of diagnostic criteria. This ensures that you don’t include participants that are actually not the disease condition your interested in.


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b. How will you include or exclude cases based on the case definition?

7. MethodologyThis section establishes the validity of your research, so think carefully how you wish to implement your research to accomplish the objectives.

a. Study design:There are several types of study designs, so choose the best. The study design generally falls under 4 categories:

i. Cross-sectional, where each subject is observed/interviewed/measured only once

ii. Longitudinal, each subject observed/measured more than once, retrospectively, or looking back from the outcome to the supposed cause/exposure. Originally called Retrospective studies, the modern terminology refers as Case-Control studiesLongitudinal, each subject observe/measured more than once, prospectively, or looking forward from exposure to outcome. Originally called Prospective studies, currently they are termed Cohort studiesAll the above are non-experimental, namely no intervention by the researcher.The fourth study design is specifically called experimental or interventional/supplementation or simply a ‘trial’, as the term experimental ay not be ethically acceptable.

iii. Trials could be broadly classified as Therapeutic, where one deals with illness seeking relief or as Prophylactic, where one deals with susceptible persons preventing illness. Both these trials can be done in a health care setting and known as Clinical Trials, or in the communities and are known as Community Trials. Well established international guidelines such as ‘CONSORT” are available to follow in the case of experimental studies. Everyclinical/community/experimental study where intervention with a new drug or method is used must be registered in the national clinical trial registry (ICMR) and given a trial number, without which the results cannot be published in any scientific journal.

b. Sample size: Without Sample size number determined by a scientific formula based on the study design the IRB will not accept the proposal . Most studies are based on a small number (sample) taken from a defined target population. Therefore, you must define your target population by stating the criteria for inclusion and exclusion.

i. Kindly find an appropriate study to estimate sample size calculation.ii. And mention the study in the sample size calculation.

iii. If you cannot find an appropriate study you can use secondary data for the MRD or conduct a pilot study with 10-20 participants to determine the sample size. And provide the results under this section in the IRB form.

iv. Include a drop out rate of 10-20% if you anticipate a high level of attrition in follow up.Depending on the sampling unit, individual or group(cluster), the listing of all these units will constitute the sampling frame from which you choose a sample- simple, stratified, systematic, multistage, etc. For any study, an unbiased,


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representative sample of sufficient size is mandatory for validity, and therefore the sampling process must be clearly stated. Sample size cannot be arbitrarily determined but be based on variability, degree of precision required and acceptable type 1 and type 2 errors. The complement of type 2 error is called the Power of the study design to detect a specified difference.

c. Tools: One a proper sample is chosen, you have established the external validity of your study. You then have to think about the internal validity based on the data collection tools, manner of collecting the data, organizing or managing the data, particularly in terms of computerization, and finally analyses.

i. Make Sure you use standardized tools whenever possible with permission from the original developer.

ii. Please mention how are you going to validate a tool which you are going to test for the first time.

iii. If you are using hard ware or a diagnostic tool please mention how will you standardize the measuring process and how the tool will be validated so that it shows accurate results.Ex: Kindly provide standardized methods of anthropometric measurements that will be used in this study. Kindly mention frequency and methods used to standardize the equipment that will be used in the study.

iv. Mention who will administer or use the tools and how will you train them for the same.

v. Mention the names and the models of the devices and why they are chosen for the study purpose.Methodology establishes the scientific basis of the research and undergirds the validity of the study findings and conclusions. Hence, adequate thought is needed and consultation with a qualified biostatistician and other experts is essential. Review of earlier research is also of great importance.

d. Data management and data analysesi. The methodology will describe how the data will be collected, the tools used for

measurement or observation, manner of recording, and the research proforma/questionnaire that helps in orderly collection of data that are also easily computerizable. Every data collection tool must be subjected to pilot studies to establish its reliability (consistency, reproduceability) and validity(accuracy) apart from other considerations such as convenience, size, etc.

ii. Data collected are best entered onto computer spreadsheets such as Microsoft Excel, Access or Epi info, edited/cleaned for errors, missing data, correct format, etc. Such data entry and management are best done simultaneously with data collection, and not postponed till the collection is over, when any quality checks are impossible.

iii. There are plenty of statistical software available for data analyses such as Stata, SAS, SPSS, R, Epi-Info and so on, but the computer cannot decide for you what analyses are needed ! This is your responsibility, and the computer is merely a slave.


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8. Questionnaire/Proforma:

a. Include a unique study ID number for each participant. This usually placed, at the right hand corner, which will serve as the Reference number maintaining the anonymity and serving as a link.

b. Include a check box of screening questions at the beginning with out which you cannot recruit this participant.

c. Divide the questionnaire into smaller sub divisions/sections (Example: Participant details, Socio demographic details, Investigations, Knowledge, attitude sections)

d. Terminology- Please use appropriate words that lay people can understand in the questionnaire.

e. Include all the potential confounding factors that are associated with the outcome variable (Eg: co-morbidites)

f. Kindly use numerical in continuous variables (Ex: Age, Hb in gm%, CD4 count, height, weight) and try not to pre-group the variables to make it multiple choice type questions. The variables can be grouped during analysis by the statistical software.

g. Translate and back translate the questionnaire into the local language you wish to communicate in/

h. Make a note of the number of participants that are refusing to participate in the study and probable reasons why.

i. Use open ended questions if you wish to explore more reasons behind a particular behavior you wish to study (Ex: Why did you not go to the hospital for treatment after you were diagnosed with cancer?)

j. Investigations: Do not add any additional investigations that the patient needs to pay, if it’s only for the purpose of the study.

k. Be economical in the space used, be selective and collect only such data that are relevant for the study, as collection of every item takes time and must be accurate

9. Information sheet/Consent form:a. Use the headings provided in the standardized format mentioned in the IRB Form.b. Kindly provide the information sheet and Consent form in English and the local

language anticipated to be used (Ex: Hindi, Nagamese)c. Please mention in detail how will you maintain confidentiality

10.Detailed diagrammatic Algorithm of the study:a. Kindly ensure that this is “detailed”.b. Describe all the processes in “detail” especially the recruitment process.

Example: What happens to the recruitment process if its not appendicitis? Would he be still included in the study?, At what point in the patient’s admission

would you recruit the participant for the study?, How the patients will be consulted without additional charge if the patient needs

a referral just for the sake of the study like fundoscopy?


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Who will administer the informed consent? When will you review the repeat ECG.

11.Publication plans:a. Please note that only the genuine contributors can be represented in the study.b. Other contributors can be mentioned in the acknowledgement.


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cihsr.in€¦ · Web viewA critical review lays a strong foundation for your research. So spend time, identifying all earlier work, using various internet and other resources. Critical