28th August, 2022

To,
The Member Secretary
Institutional Review Committee. (IRC)
B.P Koirala Institute of Health sciences, Dharan

Subject: Resubmission of Thesis Protocol

Respected Sir,
I am pleased to submit my thesis protocol titled “EPIDEMIOLOGICAL STUDY OF
ROAD TRAFFIC CRASH AMONG MOTORIZED TWO-WHEELER RIDERS IN B.P.
KOIRALA INSTITUTE OF HEALTH SCIENCES, DHARAN, NEPAL.” in the form of
hard copy as well as soft copy (PDF) for ethical clearance and approval to conduct the
study. The suggestions and modifications as below.

1) Suggestion: Three co-guides are assigned from the same department. Justify
it.

Justification: Three co-guides are assigned in my research thesis titled

“Epidemiological study of road traffic crash among motorized two-wheeler
riders reputed to B.P. Koirala Institute of Health Sciences, Dharan, Nepal”
from SPH and Community Medicine. My thesis title is related to the study of
epidemiological factors on Road Traffic Crashes rather than the clinical
factors. The availability of co-guides from the other departments and their
busy schedule and their assignment of guides and co-guides was discussed
among our faculties in the department. However, any needed suggestions
and advice would be welcome and duly sought from other departments and
they will be duly acknowledged.

2) Title: in BPKIHS modify as reputed to BPKIHS or admitted to BPKIHS

Modification: Title of the study has been modified as Epidemiological study of

road traffic crash among motorized two-wheeler riders reputed to B.P. Koirala
Institute of Health Sciences, Dharan, Nepal.

3) How previous data of 450 will entail a sample size of 600? Clarify it.

Justification: As the data collection method is census method, and all the
 victims (rider and pillion) involved in the Road traffic crashes that fulfil the
inclusion criteria will be involved, the cases are estimated with the previous
hospital record rather than the previous studies. Because of the limitation of
the study period data collection time will be less than one year.

4) How data is collected if the victim is unconscious or unable to do? Clarify it.

Justification: If the victim is unconscious or unable to respond the

accompanying visitor or witness will be interviewed or I will wait until the
victim gains his or her consciousness. Also, I am aware of some degree of
interviewer bias that can occur though this.

5) How would you find the prevalence from this study as mentioned in outcome
measures as target population is in community?

Justification: The health outcome of the injured person will be found during
the hospital stay within the study period or will be found by home visit in the
community if required. This study will identify the health outcome such as
recovery, mortality, disability, etc. This study will not identify the population at
risk for Road traffic crashes.

6) Provide space for legal representative for illiterate participants in informed

consent form.

Modification: Space for legal representative for illiterate participants has been
added in page no. 50.

All required documents as suggested are enclosed with this application in desired
format and numbers.

Looking forward to hearing from you.

Yours Sincerely,

…………………
Dr Ranjit Kumar Makaju
Junior Resident (2021 Batch)
School of Public Health & Community Medicine, BPKIHS, Dharan