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05.Review Exemption Form

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Abia Afroze
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21 views

05.Review Exemption Form

Uploaded by

Abia Afroze
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
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Review Exemption Application Form

1. Principal Investigator’s Name:

___________________________________________

2. Department:

___________________________________________

3. Title of Project:

________________________________________________________________________
________________________________________________________________________
_______________________________________________________________

4. Names of other participating staff and students:

________________________________________________________________________
__________________________________________________________________

5. Brief description of the project:

The title of the dissertation is “ AN AUDIT OF POST OPERATIVE COMPLICATIONS OF ELECTIVE


AND EMERGENCY ABDOMINAL SURGERY ACCORDING TO CLAVIEN DINDO CLASSIFICATION - AN
OBSERVATIONAL STUDY “. The primary aim of the study is to categorise the post operative com-
plications of all open - minor and major and laparoscopic abdominal surgery using the Clavien
Dindo classification. The objective is to record the post operative complications all open - mi -
nor, major and laparoscopic abdominal surgery in elective and emergency cases following which
the complications will be categorised according to the Clavien Dindo classification and then a
recommendation for the appropriate management based on the Clavien Dindo grading will be
made. My hypothesis is Clavien Dindo classification is an accurate method to grade complica-
tions of open - major, minor and laparoscopic abdominal surgery. I will be including all patients
above the age of 18 who are admitted requiring open - major, minor and laparoscopic abdomi -
nal surgery (elective and emergency ) across all departments.
The procedure followed will be all patients who are 18 years of age and above who will undergo
elective and emergency abdominal surgery which can be both laparoscopic or open will be se-
lected for the study. Their clinical details, investigations, whether any optimisation is required or
not and their comorbid conditions will be recorded. A record of which procedure the patient has
undergone will be noted. Any further change in the course of management, anaesthesia/
surgery , if any will be recorded. The post surgical complications, if any , will be categorised
based on the Clavien Dindo classification in order to appropriately recommend early surgical, ra -
diological , high dependency care needed for the patients.

6. State reasons why exemption from ethics review is requested?

1. The dissertation “AN AUDIT OF POST OPERATIVE COMPLICATIONS OF ELEC-


TIVE AND EMERGENCY ABDOMINAL SURGERY ACCORDING TO CLAVIEN
DINDO CLASSIFICATION - AN OBSERVATIONAL STUDY ” as mentioned in the
title is an observational study. No intervention will be attempted by the principal inves-
tigator.
2. The information for the study will be collected from pre-existing records of the patient
which is maintained by the treating surgeon and team.
3. As this study poses no threat to the patient and under is ICMR 2017 is categorised as
“LESS THAN MINIMAL RISK”, I request an exemption from the ethics review.

Principal Investigator’s signature______________________________ Date: _________

Forwarded by the Head of the department:

Name: ___________________________ Signature: __________________ Date: ________


Official Use only

Recommendations by the IHEC Member Secretary/Additional Member Secretary:

□ Exemption

□Cannot be exempted, Reasons_______________________________________________

□ Discussion at full board

Signature of the Member Secretary/Additional Member Secretary:


_____________________________Date: ________

Final Decision:

□ Exemption

□ Cannot be exempted, Reasons ______________________________________________

□ Discussion at full board

Signature of the Chairperson: ___________________________________Date: ________

Final Decision at Full Board meeting held on


______________________________________________________________________________
______________________________________________________________________________
_____________________________________________________________________

Signature of the Chairperson: ___________________________________Date: ______

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