APPLICATION FOR IRB APPROVAL FOR STUDY DESIGNS OTHER THAN

INTERVENTIONS, DIAGNOSTIC TESTS AND OBSERVATIONAL STUDIES

CHRISTIAN MEDICAL COLLEGE, VELLORE

(Please complete Sections I to III and submit with all supporting documents)

Section I

Fluid Research Funding/External Funding (delete as appropriate)

If for external funding, please provide name of funding agency and the application for
submission in the funding agency’s format, in addition to this application.

1. Title of Research
Hazard identification and risk analysis (HIRA) in critical care units of Christian Medical College
(CMC), Vellore.

2. Title of Study (for lay public):

Descriptive study to perform HIRA in critical care units (CCU) of Christian Medical College (CMC),
Vellore.

3. Acronym if any
HIRA – Hazard Identification and Risk Analysis
HVA - Hazard Vulnerability Analysis
CCU – Critical Care Units.
CMC - Christian Medical College

4. Name of the Principal Investigator: Mrs. Sheeba Paul

Designation: Junior Lecturer in Nursing
Department of Principal Investigator:
Emergency Department
Medical and Surgical Nursing Specialty - IV
College of Nursing, CMC, Vellore
Employment Number: 90166
Address for communication (including telephone and fax numbers and email id):
College of Nursing, CMC, Vellore
Phone No. 0416 3077004
Email ID: sheebapaul25@gmail.com

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5. Name of Guide and address
Mrs. Jeyalinda Christopher
Professor and Acting Head,
Department of Medical Surgical Nursing Specialty - IV,
College of Nursing, Christian Medical College,
Vellore-632004
Employment Number: 70691

6. Name and Designation of Co-Investigator(s), Employment Number and Address :

Nil

7. Department of Institution where the research will be carried out

Selected Critical Care Units
CMC, Vellore

8. Duration of the Scheme: 2 months

9. Source/s of Monetary or Material Support: College of Nursing Research Fund

10. Permission letter from the HOU & HOD of each unit/department involved in the study
(if medical, nursing or allied health students or nurses are involved in the study, a permission
letter from the appointing authority has to be enclosed).
Permission from Dean, College of Nursing and Nursing Superintendent, Nursing Services,
CMC, Vellore will be obtained before commencement of the study

11. Objectives and aims of study

1. To identify the hazards in selected Critical Care Units.
2. To perform risk analysis of the hazards in selected Critical Care Units.

12. Summary of the proposed research scheme (250 words)

For any hospital to be successful, it has become essential to identify the hazards and to assess its
associated risks that are acceptable. The presence of vulnerable environmental factors places the
hospitals particularly critical care units at a greater risk for disaster. HIRA provides a systematic
and objective approach in recognizing hazards, associated risks and its potential impact to the
system. The present study is intended to identify the hazards and its risk in various critical care
units of Christian Medical College and subsequently endorse to develop an emergency response

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plan and provide recommendations to reduce the risk which will enhance patient safety and
hospital safety. In addition it will facilitate smooth functioning of the system in times of disaster.
A piloting will be done in Emergency Department to check the feasibility of the study.

13. Present Knowledge and relevant bibliography (Is there a justification for this study based
on a detailed literature review or other sources of evidence? Please provide details)

Hospitals with large scale population and infrastructure confront extraordinary challenges in
creating a safe environment to the patients. It becomes mandatory for the hospital to provide a
safe and secure environment of healing as well as optimal level of preparedness .An important
step in emergency preparedness is to identify all hazards that may affect the hospital and assess
their associated risks to determine which hazards are most likely to result in disaster. This
approach both satisfies accreditation requirements and also allows for a systematic, targeted
approach to emergency preparedness. (HIRA 2014, Halton health care)
when any disaster strikes the hospital it usually leaves a substantial burden on the
affected population, often resulting in human, material, economic, or environmental losses or
impacts (Ahmadreza et al ,2014). According to global platform 2011 hospitals also represent
enormous investments for any country. Destruction of such facilities results in significant
economic burden. In addition the decline in function of the hospitals and emergency services
during a disaster can enormously affect public morale and a community's social and health
capital.
Rising from these disasters require significant amount of human and financial resources
which can be a huge challenge if the affected population is already struggling economically. But
it’s important to remember that a disaster is typically the product of a hazard and vulnerability
combined. According to Ahmadreza et al, 2014 Hazards that occur in areas with low
vulnerability will not turn into a disaster. In order to minimize the hazards the Sendai Framework
for Disaster Risk Reduction, an international document adopted by UN state members had been
the most encompassing international equate to date on disaster risk reduction.
The Sendai Framework 2015 to 2030 for disaster risk reduction has been recently
adopted by 187 countries including India, emphasizes the need to strengthen functional disaster
risk prevention and reduction measures in critical care facilities, including hospital emergency
departments. (Sendai, 2015). It focuses on substantial reduction of disaster risk and losses in

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lives, livelihoods and health in all aspects including the economic, physical, social, cultural and
environmental assets of individuals, businesses, communities and countries.
There is a growing threat of hazards in critical care units and preparing for such an event
is a challenge considering the diverse nature of its type. Nurses have plethora challenges in
contributing and enhancing disaster risk reduction as professional health personnel. HIRA will be
able to offer the best to greater number of people enabling health care facilities to identify and
reduce the potential hazards. The three highlighted risk questions are:
 Hazard – What can go wrong?
 Consequences – How bad it could be?
 Likelihood – How often it might happen?

HIRA is a systematic process which involves Hazard identification, Risk assessment, Risk
analysis, Monitor and Review

Hazard: Any natural or manmade events that has the potential to cause harm which can lead to
undesired consequences such as injury, illness and adverse health effects to individuals or to
organizations as property or equipment losses.

Hazard Identification: This is the process of examining each work area to evaluate if any
particular situation, item, thing, etc. may have the potential to cause harm.

Risk: The likelihood, or possibility of harm that may occur from an exposure to a hazard.

Risk Assessment: BK Rout et al 2017 states that it is the process of evaluation of the risks
arising from the hazard ,taking into account the adequacy of any existing controls and deciding
whether the risks is acceptable .

Monitoring and Review: This involves ongoing monitoring of the hazards identified, risks

assessed and risk control processes, further reviewing them to make sure that they are working

effectively.

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 Hospitals are required to conduct HIRA annually. It serves as a key step in need

assessment and plan emergency response to disaster subsequently can help the organization to

prioritize planning, mitigation, response, and recovery activities accordingly.

Disasters like natural, technological, and man-made disasters are ultimately becoming

more frequent in our modern society, which is why conducting a standardized hazard

vulnerability analysis is essential in order to establish a robust emergency and disaster

management program. Hazard Vulnerability Analysis tool aids to assess all hazards, their risk of

actual occurrence, as well as the impact on life, property, and business.

This will help to implement effective disaster mitigation policies, and emergency

response programs of the event. As nurses are at the forefront of disaster and serve a critical role

in disaster management conducting HIRA systematically in critical care settings will enable to

prioritize, plan and prepare recommendations to minimize or control disaster.

Bibliography:

1. Hospital safety index: guide for evaluators. Geneva, Switzerland: World Health Organization;

2008. http://www.paho.org/english/dd/ped/SafeHosEvaluatorGuideEng.pdf

2. Sauer, LM, McCarthy, ML, Knebel, A, Brewster, P. Major influences on hospital emergency

management and disaster preparedness. Disaster Med Public Health Prep. 2009

3. "Sendai 2015: a new global agreement on disaster risk reduction | Overseas Development

Institute".ODI. Retrieved 2016-01-13.

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4. Assessment of disaster preparedness among emergency departments in Italian hospitals: a

cautious warning for disaster risk reduction and management capacity Matteo Paganini,

Scandinavian Journal of Trauma, Resuscitation and Emergency Medicine2016

5. Nursing Home and Assisted Living Hazard and Vulnerability Analysis Tool

Type: Planning and Response, Author: American Health Care Association, from Kaiser

Permanente, Year of Publishing: 2014

6. Common Hazards Found in Hospital Environments, By Layla Davis on February 25, 2015

7. Emergency Response Plan: Hazard Identification and Risk Assessment (HIRA) Haltom health

care. 2014.

8. Hazard © 2001 American Society for Healthcare Engineering of the American Hospital

Association One North Franklin, Chicago, Illinois 60606 -9-

9 Hazards Analysis. www.pascocounty.com/odp/ hazard.htm

10. Hospital Accreditation Standards. Joint Commission on Accreditation of Healthcare

Organizations, Oakbrook Terrace, IL, 2001.

15. List of publications of the investigator in the field

.Nil

16. Structured abstract (Structured abstract should be in future tense)

The Christian Medical College is a tertiary hospital with 2888 beds and serves as a level one

trauma Centre. There are more than 15 critical care units which are involved in lifesaving for

vulnerable population. How safe are they in preventing and mitigating disaster effect.

In order to have a effective hospital safety programme, which will prevent functional collapse of

critical care facilities we use HIRA. It is a term that encircles all activities involved in identifying

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hazards and evaluating risk at facilities, and, to make certain that risks to employees, the public,

or the environment are consistently controlled. It’s a process which involves Hazard

identification, Risk assessment, Risk analysis, monitor and review.

CLASSIFY WORK ACTIVITIES

CONSULTATION

IDENTIFY AZARDS

RISK ASSESSMENT

PREPARE RISK CONTROL ACTIVITY PLAN.

IF NECESSARY

IMPLEMENT
-

Most of the patients in critical care settings are dependent which poses incremental risk to
hazards which can result in physical or psychological harm.
Therefore this study is aimed
1. To identify the hazards in selected Critical Care Units.
2. To perform risk analysis of the hazards in selected Critical Care Units.
The study is descriptive and will be conducted in critical care units. The samples will be chosen
using simple random sampling technique once they fulfill the sampling criteria. A widely used
tool to perform HIRA is Hazard Vulnerability Analysis (HVA) which was developed by Kaiser
Permanente. This allows quantitative assessment of probability, impact and risk for different
hazards. The categories for each event and response obtained from Hazard specific scale will be

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represented as frequency and percentage. Associated risk for each possible event will be assessed
through Hazard Vulnerability Analysis tool. The data can be represented graphically using pie
chart and bar chart.
Identification of hazard and the risk assessment in critical care units will enhance patient safety
and hospital safety through emergency response plan. Understanding the importance of risk the
hospital administrators can develop a team for ongoing assessment and formulate control
measures, eliminate or minimize the risk for disaster.

17. Detailed diagrammatic Algorithm of the study

CONSENT WILL BE OBTAINED FROM CONCERNED AUTHORITIES

SIMPLE RANDOM SELECTION OF CRITICAL CARE UNITS

DATA COLLECTION
INTERVEIW, OBSERVATION & AUDITING RECORD

DATA ANALYSIS

RESULTS AND REPORTS

18. Detailed Research Plan:

a) Participant Recruitment
Population: Critical Care Units Of Christian Medical College, Vellore.
Sample: Critical Care Units Of Christian Medical College, Vellore who fulfill the inclusion
criteria

Sampling Technique: Simple Random Sampling Technique

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Sample size: 5 Critical Care Units.
b) Setting
Selected Critical Care Units, of CMC, Vellore
c) Inclusion and exclusion criteria:
Inclusion criteria:
1. Critical care units with more than or equal to 5 bed occupancy in the Main Block
,CMC,Vellore
Exclusion criteria:
1. High Dependency Unit
2. ISSC Block
3. A Block
d) Details of the research
Written permission will be obtained from the college research committee, Medical Superintendent and

Nursing Superintendent. The samples will be selected using Simple Random sampling method. Data will

be collected within two months using observation technique, interviewing process and auditing records

among the critical care units who fulfill the inclusion criteria.

The hazard Vulnerability Analysis tool will be used by the investigator to assess the hazard vulnerability

risk in selected critical care units.

The collected data will be analyzed to give the research findings.

Methods to minimize bias:

The principal investigator will follow the guidelines of scoring as per the author
recommendation.
e) Potential benefits:
 Determines the probability and risk of events to occur.
 Introduce the hazards identified to the organization.
 Focus can be given to hazards which has higher priority
 Emergency response plan can be developed.
 Formulate measures to eliminate or control hazard.
e) Risks to participants:

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 NA
f) Details of Instruments:
g) A tool which is widely used to perform HIRA is Hazard and Vulnerability Analysis tool (HVA)
developed and revised by Kaiser Permanente in 2017. This allows quantitative assessment of
probability, impact and risk for different hazard categories like
 Natural Hazards such as earth quake, extreme temperature etc
 Technological Hazards such as electric fire , structural damage etc
 Human hazards such as terrorism, Bomb threat etc…
 Hazardous materials events such as chemical spill, radiologic exposure etc
Risk of hazards equals product and severity. The severity is calculated from the difference
between magnitude and mitigation. The cumulative index of the assessment will reveal overall
score for each hazard.
Note that with no probability of occurrence for a given critical care unit is scored as zero, and
therefore will automatically result in a zero for the total score. Listing the hazards in descending
order of the total scores will prioritize the hazards in need of the facilities attention and resources
for emergency planning.
h) Details of data analysis planned:
Descriptive analysis will be used to analyse the data. The categories for each event and response
obtained from Hazard specific scale will be represented as frequency and percentage. Associated
risk for each possible event will be assessed through Hazard Vulnerability Analysis tool. The
relative threat to the facility and relative impact on facility can be represented graphically using
pie chart and bar chart.
j) Name & designation of the statistician involved in your project for Statistical
Analyses:
Ms. Dona Maria Philip.
Junior Lecturer
Department of biostatistics, CMC, Vellore.

19. Enclose proforma for Data collection: Appendix 1

20. Informed Consent Documents: Appendix 2

Publication Plans: (List all potential authors and their likely contributions)

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Author(s) Researc Data Interpretation Prepara Review Guide Technica
Name h collectio and tion of and critical l support
& n conclusion of Manuscri revision
Study & Manusc pt
design analysis ript
Mrs. Sheeba Paul √ √ √ √ √ √
√ √ √ √ √ √

MrsJeyalinda
Christopher

21. Signature of Principal Investigator:

Mrs. Sheeba Paul

22. Signature of Guide/Head of the Department/ Unit:

Mrs. Jeyalinda Christopher
Professor And Acting Head,
Department Of Medical Surgical Nursing Specialty - Iv,
College Of Nursing, Christian Medical College,
Vellore-632004

Section II
APPLICATION FOR APPROVAL FROM ETHICS COMMITTEE OF THE
INSTITUTIONAL REVIEW BOARD OF CMC VELLORE FOR ALL OBSERVATIONAL
(CASE CONTROL, COHORT & OBSERVATIONAL) STUDIES IN HUMAN UBJECTS

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1. Please provide a brief summary of the justification, objectives and methods in lay
language, avoiding technical terms:

A quantitative approach with descriptive design will be used

1. To identify the hazards in selected Critical Care Units.
2. To perform risk analysis of the hazards in selected Critical Care Units
.
2. Please describe what benefits might be reasonably be expected by the participant as an
outcome of participation
The study findings will benefit the hospital by taking preventive and mitigating actions to
disaster events.
3. Please describe what benefits to others or new knowledge might be expected as a result
of this study
Results of study will be helpful for devising strategies to mitigate and reduce the hazards or
develop emergency response plan.
4. Who are to be enrolled?
Not applicable
5. If any vulnerable groups (e.g., pregnant women, children) are to be enrolled, please
provide a justification for their inclusion.
Not applicable
6. Mention how you will ensure that there is no undue inducement for participation of
economically disadvantaged persons among the likely participants in this study.
Not applicable
7. What are the potential risks to participants in this study?
There are no risks associated with this study.
8. Are the risks to participants reasonable in relation to the benefits that might reasonably
be expected as an outcome to the participant or to others, or the importance of the
knowledge that may reasonably be expected to result? Please provide a detailed description
of the above.
Not applicable
9. Regarding informed consent to obtained from research participants or their legally
authorized representative(s):

a. Does the informed consent document include all the required elements? Not applicable
b. Are the participant information sheet and the consent document in language
understandable to participants? (PLEASE PROVIDE WITH THIS SUBMISSION
TRANSLATIONS IN ALL LOCAL LANGUAGES ANTICIPATED TO BE USED).
Only English language is used as it is the official language of the institution.
c. Who will obtain informed consent (PI, nurse, other?) and in what setting?
Not applicable

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d. If appropriate, is there a children’s assent? If yes, please submit a copy of this form.
Not applicable
e. Is the EC requested to waive or alter any informed consent requirement? No
10. Is there provision of free treatment for research related injury? If yes, who will provide
it?
Not applicable
11. Is the study covered by insurance? If yes, please provide insurance documents from an
Indian insurance company.
Not applicable
12. In addition to the overall budget in Section I, please provide details of the following
i) Justification, timing and amount of payments to study participants
Not applicable
ii) Justification, timing and amount of payments to investigators/departments
Not applicable
iii) Any other study related financial or in kind incentives to participants or study staff
Not applicable
13. Please describe the plan for maintaining confidentiality of study participant
information.
The collected data will not be accessible to anyone other than the guide..
14. Please describe the plans for monitoring the safety of participants, reporting and
managing adverse events. If this is an externally funded study with a Data Safety
Monitoring Board, please provide the name and contact information of the DSMB
chairperson.
Not applicable
15. Declaration (to be signed by all investigators)

By signing this form we give our consent to provide our expertise to the project. In addition:

a. We confirm that all investigators have approved this version of the protocol and have contributed
substantially to its development.
b. We confirm that all potential authors are included in this protocol.
c. We confirm that we shall submit any protocol amendments, significant deviations from
protocols, progress reports (if required) and a final report and also participate in any audit of this
study, if required.
d. We confirm that we shall conduct this study in accordance with the Declaration of Helsinki; the
ICMR Guidelines for Biomedical Research in Human Subjects 2006, with any subsequent
amendments; and all applicable laws of the land.
e. We also agree to submit for publication to a peer reviewed journal the complete results of this
study within two years of completion of this study.
f. We declare that we have no conflicts of interest that may affect the conduct or reporting of this
study (OR) we declare the following conflicts of interest below.

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 g. We are aware of the institution’s policies regarding scientific misconduct
(Falsification/fabrication/plagiarism) and agree to abide by them

1. Signature of Principal Investigator

Mrs.SheebaPaul

2. Signature of Guide/Head of the Department

Mrs. Jeyalinda Christopher

Professor and Head,
Department of Medical Surgical Nursing Specialty - IV,
College of Nursing, Christian Medical College,
Vellore-632004

APPENDIX-1

Section A:
1. Name of the ICU :
2. No of beds :
3. No of emergency exit present:
4. No of fire extinguishers :
5. Emergency floor plan :
6. No of admissions /month :
7. No of death / month:

Section B: HAZARD AND VULNERABILITY ASSESSMENT TOOL

(Tool attached as pdf format)

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