Guidelines for Biomedical Research

Dr. Naveed Zafar Janjua
Chief Research Officer, PakMediNet

Although there are specific principles behind every research but every project or study is unique in its situation and requires special attention for its design and execution.

Quality of any research study depends on how well both design and execution phases of the project are accomplished. There is a positive relation ship between the research protocol and overall quality and acceptance of the resulting research study [1].

A research protocol is roadmap that guide and investigator from conceiving an idea to publishing results. To be brief every study should be planned. An unplanned study according one of my teachers is a fishing expedition.

Planning is done before the conduct. How ever before you plan to do some thing you must know what you want to do i.e., `idea`, a thought that can be your own or generated in some one else mind.

This idea is transformed in to a research question that you want to answer.

Now before just jumping into planning look for the things other have done, i.e., literature review. It is very important and essential component that tells you what other has done and how they have done. If question conceived by you is already answered, there is no need of doing this because it will not add any thing new to the existing literature.

Now the idea you have conceived should be phrased and formulated in the answerable scientific research question. It should not be too big or ambiguous.

Methodology of any study is based on the way research question is posed and designed is also guided by this.

When you have a good protocol, operational plan and budget to conduct study you can do a good study.

It is excellent that protocol is reviewed by those who are expert in research methodologies (Epidemiologist) and some person in the relevant field.

The components of a Research Protocol

  • A descriptive title
  • The name, titles, degrees, addresses and affiliations of the investigators and co-investigators
  • Introduction & Background
  • Literature review
  • Justification/ Rationale
  • Study objective and /or research questions
  • Study Methodology
    • Study population and its recruitment
    • Study design
    • Study setting
    • Study duration
    • Sample size determination
    • Sampling strategy
    • Variable list
    • Methods of data collection
    • Data collection tools
    • Plan of Analysis
  • Ethical considerations & humane subject protection
  • Quality control
  • Expected benefits from the study
  • Operational plan & budgeting
  • Plan of dissemination of results
  • References
  • Biographical information on investigator and institution

I will elaborate some of these things and for more detail can be found in Textbooks and literature in journals.

Some Components are as follows:

Study title

It should be brief and explanatory. Better to include type of study and setting.

Like `A case-control study of risk factors of acute hepatitis B in Karachi`.

Introduction & Background

Relevant details about the problem. The pathophysiology of the disease, global burden, similar settings and than local (if available)

Literature review

A description about what other in this field in other countries and in your country has done. Literature review should be in depth to identify potential cofounders and effect modifiers and to determine the areas in which knowledge is needed.

Justification/ Rationale

It is very important. It should tell that why you want to do this study. Is there any gap in the existing knowledge that you want to fill? The study has been conducted in other setting and the finding can be different in your setting (but this is not a good justification).

Study objective and /or research questions

It should identify the immediate purpose of study and be very clear. Objective always start with `to` (word of accomplishment)

Like `To identify the risk factors of acute hepatitis B in Karachi`

Study Methodology

It should include the detail description of methods with reasoning.

Study design

Important designs are:

  1. Randomized controlled clinical trial
  2. Cohort Study
  3. Case Control Study
  4. Cross-sectional Study
  5. Case series
  6. Case reports

Details of the designs can be found in any epidemiologic text

Just naming of the design is not sufficient. It should include the details what you want to do, how you are going to recruit subject, how going to follow etc.

Study population and its recruitment

Description of study population. Inclusion and exclusion criteria (Exclusion criteria apply after those who are included in study).

Study setting

Description of the setting whether it is a community or a hospital. In case of hospital what are the important characteristic of this/these hospital which type of patient visit this what is its catchment area, how big it is and what diagnostic and treatment facilities it have. Is it a special centre for some specific disease.

Study duration

If you are mentioning the field work duration specify it

Sample size determination

How and according to what assumptions sample size is calculated. It is very important to detect what you intend to do with adequate power.

Sampling strategy

How sampling will be done; whether is random (type of random sampling) or convenient sampling. How cases and controls will be identified.

Variable list

What variables you want to measure.

Methods of data collection

What method you are going to apply as records, questionnaire and in person interview, mailed questionnaire etc What test you are applying and what is reason for applying this test. Specificity & sensitivity of the test, if some new test is to be applied.

Plan of Analysis

How you are going to analyze your data. For what you are looking for and which statistical method will apply.

Whether you run descriptive analysis or go for hypothesis testing and may be multivariate analysis.

It is better to get help from biostatistician for sample size and data analysis.

Ethical considerations & humane subject protection

This is very important consideration. Now every study should be subjected to ethical review by Institutional review Board.

Ethical consideration include:

Obligations to study subjects

Protection of their interest. Complete information regarding risk benefit for participating in any research study is complete right of every subject; no concealment. Maintaining confidentiality of information obtained from subjects.

Consent form guidelines.

Obligation to society

Avoiding conflict of interest, partiality; communicating finding; data sharing etc.

Obligation to funders or employers

Specifying obligations in contract how research be conducted and it will involve ethical, technical, administrative or legal responsibilities.

Obligations to colleagues

Promoting and preserving public confidence in epidemiologic research while not over and under estimating the epidemiologic methods. Disseminating the study findings.

Quality control

How quality control checks will be introduced and maintained.

Some of the key points are.

  1. Training of data collector
  2. Field testing and pilot sties.
  3. Field editing and final editing
  4. Data entry mistakes checking etc.

Expected benefits from the study

Who will and how benefit from the study

Operational plan & budgeting

Detail time line and budget for the study

Plan of dissemination of results

How the findings will be shared with others.
By some presentations, publishing results in journal etc.

References

References should be quoted in Vancouver style.

Important References

  1. Ott MG. Importance of the study protocol in epidemiologic research. J Occ Med 1991; 33(12): 136-39.
  2. The Chemical Manufacturers Associationís Epidemiology Task Group. Guidelines for good epidemiology practices for occupational and environmental epidemiologic research J Occ Med 1991; 33(12): 1221-29
  3. Tomenson JA and Paddle GM. Better quality studies through review of protocols J Occ Med 1991; 33(12): 1241-43. .
  4. Fowkes FGR, Fulton PM. Critical appraisal of published research: introductory guidelines. BMJ 1991; 302:1136-40.
  5. International Committee of Medical Journals Editors. Uniform requirements for manuscripts submitted to biomedical journals. N Eng J Med 1997; 336(4): 309-16.
  6. Avan BI, White F. Why a research study need a design? JPMA 200;151:197

Books

  1. World Health Organization. Preparing a Research Project Proposal. Geneva 1991.WHO/HRP/PP/1991.
  2. Jan W Kuzma. Basic Statistics for Health Sciences. 2nd edition. Mayfield Publishing Company, Mountain View California 1992.
  3. Hennekens CH & Buring JE. Epidemiology in Medicine. 1st edition. Little brown Company USA 1987.
  4. Friedman LM, Furberg CD, DeMets DL. Fundamental of Clinical Trials. 3rd Edition. Springer 1998.
  5. World Health Organization. Operational Guidelines for Ethical Committee that Review Biomedical Research. WHO Geneva 2000. TDR/PRD/ETHICS/2000.1
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