PROJECT:  RESEARCH PROJECT
TASK 2 WITH AN EXAMPLE
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Objective: To construct the following sections of a research protocol


 
  Hand in by Monday July 28th

Aims, Objectives, Methods

The problem statement needs to be rewritten as a concise statement of aim or aims  (not too many).

The the aim statement gets unpacked into a set of discrete and more concrete objectives which set tasks to be done by measurement in the study methods section.

The methods section or a study protocol follows the standard pattern and includes the following headers:

population studied
study group sampled
study design
measurement methods which follow the objectives focussing on:
                 the definition of variables to be measured including exposure,
                         outcome, confounding and effect modifying variables
                 sampling methods for exposure measurements if any
                 analytic  methods
                 statistical methods
ethical considerations which include
                The researcher must ensure confidentiality in respect of patient information,
                      information about the institutional setting of research (company, health facility)
                      and identification of staff working in this setting.
                The informed consent form must be in all first languages used by the subjects.
                      They must be informed  in the consent/document /patient information sheet that
                      
their participation in the study is entirely voluntary and that if they refuse to
                      participate or withdraw from participation at any time, there will be no prejudice to
                      the quality of services received by them including clinical management and care.   
                Permission has been obtained from the institution or health authority with jurisdiction
                      over the site of research, including a letter to this effect  if possible.
               The investigator has the right to publish findings and disseminate these appropriately.
               The final responsibility for  ethical and effective research conduct   lies with the
                       principal investigator or supervisor.
                Conflicts of interest are made explicit.

   

 

Learning activities:   

A SIMPLER EXAMPLE:  A CASE CONTROL STUDY TO DETERMINE THE FACTORS ASSOCIATED WITH NEEDLE-IN-FINGER INJURIES IN THE WESTERN CAPE CLOTHING INDUSTRY

A MORE COMPLEX EXAMPLETHE NERVOUS SYSTEM EFFECTS OF OCCUPATIONAL  EXPOSURE ON WORKERS IN A SOUTH AFRICAN MANGANESE SMELTER

 

References:

The critical appraisal checklist is useful to follow and to assess whether  you are progressing with your project in such a way as to include all the necessary methodological steps.

Section B.  Epidemiological research methods and protocol development.  In "Epidemiology:  A manual for South Africa."  Eds Katzenellenbogen JM, Jubert G, Abdool Karim SS.  Oxford University Press, Cape Town 1997, pages 49-100.

Evaluation: 

Steps 1 through 6 will count 3 marks each (3x6 = 18), the final report 3 marks, and the final presentation oral 3 marks. This gives a total of 24 marks.

Marks will be allocated as follows:

3 = Complete, 2 = Progress, 1 = Markedly incomplete, 0 = no hand-in

                                                                                                                      


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