Page 10 - Standard Operating Procedures (SOPs)

ANNEXURE - C
FORMAT FOR SUBMISSION OF A RESEARCH PROPOSAL FOR
ETHICAL APPROVAL

• Project Title :

• Summary :

• Introduction: (Introduce the subject. Provide full background information. Cite
literatures that are specific to the topic of the research proposal. Information should be
completed to prove that the research proposal is based on a sound scientific footing.)

• Objectives: (List the general and specific objectives of the proposed study and state
clearly the question that is being posed or the hypothesis being tested.)

• Rationale: (Describe the relevance of the proposed study to national health
priorities and relationship of the objectives to existing scientific knowledge on the
subject. Cite relevant literature and refer to related studies done in our country or
elsewhere.)

• Methodology: (Describe the design of the study and methodology in sufficient
detail to enable assessment of how they will contribute towards achievement of the
stated objectives and to permit proper appraisal of the budget. Plan for data analysis
should be included if relevant and important. This section should contain details of the
research methods. Enough detail should be given to evaluate whether the methods are
already tested and feasible. The following scheme is suggested: Factors in study
(variables), Study Population, Sampling, Statistical basis of the sample size,
Procedures, Methods of Data Collection, Pretesting, Data Interpretation, Statistical
Analysis (Correlation, Significance Test, Coefficient of Variation, Evaluation
Methods, wherever applicable).

• Utilization of Results: (Describe in brief how you perceive that the results from this
study may contribute to health development of the Country.)
• Facilities : (Resources, equipment, chemicals, subjects (human, animal) etc.
required for the study):
o Facilities Available :
o Additional Facilities Required :

• Approval / Forwarding of the Head of Department / Institute / IRB.

• Flow Chart: (Describe sequence of tasks within time frame).
• Ethical Implications: (Think very carefully about possible ethical implications and
put views. Consult BMRC's Guidelines for Ethical Review of Projects involving
Human Subjects).
• References: Vancouver style to be followed. e.g.- Can Med Assoc J 1995; 152(9):
1459-1465.

SOP OF BMRC ETHICAL GUIDELINE Page 9