Application to the

University of Hyderabad Institutional Ethics Committee

For Approval of a Research Project

Basic Information
1. Title of the Project KNOWLEDGE, ATTITUDES AND PRACTICES OF NURSES AND
PARAMEDICS IN INFECTION PREVENTION AND CONTROL IN
COVI 10 SECTIONS OF DISTRICT HOSPITAL HISAR

2. Name of the Applicant Renu Bala

3. Principal Investigator Renu Bala

3.1.Affiliation School of Medical Sciences University of Hyderabad

(Department, Institute)
3.2. Address Shakti Neuroscience centre barwala road Hisar
3.3. Contact No 7876110100
3.4. Email renusnsc@gmail.com

4. Co-Investigator 1 Prof. B.R.Shamanna

4.1. Affiliation School of Medical Sciences University of Hyderabad

(Department, Institute)
4.2. Address C-170, Old Life Sciences Block, Science Complex
University of Hyderabad, Gachibowli, Hyderabad -
500046
4.3. Contact No T@ 040-2313 5473/6679 5473
4.4. Email brsmd.uoh@nic.in; brsham@uohyd.ac.in

5. Co-Investigator2
5.1. Affiliation
(Department, Institute)
5.2. Address
5.3. Contact No
5.4. Email
6. Co-Investigator*
6.1. Affiliation
(Department, Institute)
6.2. Address
6.3. Contact No
6.4. Email
7. Application Date 13.10.2022
*Additional box may be added, if space is inadequate
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 Outline of Proposed Research
1. Background:
Infection-related diseases are still the one of the main cause of death in India according to the 1011-2017
health profile acquired by the World Health Organization statistics. The burden of disease in India includes
HIV, TB, Malaria, other infectious diseases and respiratory infections. Expansion of the infection prevention
and control movements occur due to the increase in infection occurrences in the country.
Infectious patients are admitted into hospitals and therefore hospitals have become common settings for
transmission of diseases. In hospitals, infected patients are a source of infection transmission to other
patients, health care workers and visitors(Sydnor & Perl, 2011). Nosocomial infection, also known as
hospital-acquired infections is one of the leading causes of death and has much economic cost due to
increased hospitalization and prognosis (WHO, 2015).
A research problem is an area of concern in which there is a gap in the knowledge base needed for nursing
practice (Burns & Grove 2011:146). The researcher has observed that nurses do not apply infection
prevention and control measures in the hospital setting which is required to ensure patient safety. Lack of
knowledge, attitude and practices in infection prevention and control contribute to high rates of hospital-
acquired infections (Jain, Dogra, Mishra, Thaku and loomba, 2012 & Hayeh and Esena, 2013).
Uncontrollable nosocomial infection contributes to prolonged stay, morbidity and mortality which put stress
on health care economics of the country (Mishta, Banerjee & Gosain, 2014).

2. Aims and Objectives:

AIM
In order to address the research question, the aim of the study is to determine the
knowledge, attitudes and practices of nurses regarding infection prevention and control
within Multispecialty hospitals of Hisar.

OBJECTIVES
Based on the aim, the following objectives have been set for the study to determine:

• the knowledge of nurses in infection prevention and control within covid 19 section
of district hospital in Hisar.

• the attitude of nurses in infection prevention and control within covid 19 section of
district hospital at hisar

• the practices of nurses in infection prevention and control within covid 19 section
of district hospital of hisar.
• To make recommendations to the risk program and policies of covid 19 section of
district hospital hisar.

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 3. Hypothesis (as applicable):

4. Research category (Quantitative, Qualitative, Mixed, Applied, Basic etc) and

Research/Study Design: (Ex: Qualitative – Exploratory)
A descriptive quantitative design was proposed to determine knowledge, attitudes and
practices of nurses regarding infection prevention and control within Multispeciality
hospitals of Hisar

5. Methodology:

Study Area:

The study setting was the clinical environment of a Private/Charitable hospitals in

hisar. The clinical environment of the hospital consisted of general wards, surgical
ward, gynaecology, postnatal, maternity, special baby care, intensive care, casualty,
and theatre, and multidrug resistance, orthopaedic and psychiatric unit

Institutions of collaboration: Private and charitable hospitals

Study/Performance Sites: Hisar

Target Respondents& Age group + Gender (clearly mention vulnerability): Nursing

Female Staffs of age group 25 to 35 yrs of age .

Sampling process and sample size: from 156 target Nursing Staff , 70 are selected

Risks, Benefits, Safety & Other Controls

1. What are the potential risks involved? State any potential or known hazards of the
procedure listed in the methodology and how does the investigator intend to overcome this
aspect.
No Potential or known hazards of the procedure involved.

2. Does this study involve ionizing radiation, hazardous substances, invasive procedures
(including radiological imaging, venipuncture, or any other invasive procedures or intimate
physical examination)? If yes, please justify

ionizing radiation, hazardous substances, invasive procedures not invloved

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3. What are the compensations for Unexpected Risks? NA

4. If there are any novel interventions to be used in the study which is not the medically-
accepted ‘treatment of choice’ within the local context, explain why a novel intervention
is being tested, and what arrangements will be made to switch subjects over to the
‘treatment of choice’ if the experimental intervention is not effective.
No

5. What are the potential benefits to the subjects?

It will create awareness oof Infection control practices applicable at their working areas
6. What are the potential severe adverse events (SAE) anticipated in this proposed study? NA

Type of SAE Likelihood of Occurrence Strategy to reduce occurrence

What will be the likelihood of occurrence and strategies to reduce the occurrence?

7. Please state whether subjects will have to bear any expenses related to medicines or
investigations or travel or if they have to forego their work/pay in relation to participation
or any other costs in relation to the study. State how the expenses would be met. NO

8. Will the subjects receive financial benefit / other material benefit as a result of participation
in this study? Please specify. NA

Consent, Confidentiality
1. How will informed consent be obtained and by whom? (Mandatorily provide a copy of the
participant information sheet and consent form) Attached

2. Is allocation involved in selection of participants i.e. will participants know they are
part of the research? Yes / No, If yes (allocation – random/nonrandom/selected etc),
explain how and why? Yes, Random ,On the basis of age group and their qualification

2. What procedures will ensure the confidentiality of participants? Will the identifiable
information be removed? How will data be stored and for how long?
It will be inform of project and raw data will be stored for 1 yr with the researcher .

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 4. How will results be disseminated? What information will be fed back to the subjects
and/or participating organization?
Feedback will be given through administrator of hospital or in charge

Conflict of Interest/Sponsored/Proprietary Interest

1. Please state any conflict of interest/sponsorship/proprietary interest is involved in the
study and its team? (financial / non-financial) – Provide supportive documents as
annexures. NO

Declaration by the Principal Investigator

I certify that the information provided by me is complete and correct. I understand that as
principal Investigator, I will take full responsibility for the protection of rights and welfare of all
participants/study subjects including the conduct of study and ethical performance of the project.
I agree to comply will all rules and regulations of IEC and University of Hyderabad for the
conduct of the study / trial.
I hereby declare that:
 Qualified personnel according to IEC guidelines will conduct the study.
 No change will be made in the protocol or consent form until approved by the IEC.
 Legally effective informed consent will be taken from Human subjects as applicable.
 Adverse events will be reported to IEC as per ICH GCP/DCGI Adverse event reporting
policy.
 I further certify that the proposed research is not currently being conducted and will not
begin until IEC approval has been obtained.
Sl.No Research Team Signature Date
1 Principal Investigator Renu Bala
2 Co-Investigator 1 Prof. B.R.Shamanna

3 Co-Investigator 2
4 Co-Investigator 3
5 Co-Investigator 4

NOTE: All proposals submitted will be subjected to technical review or specialty

expert sub-committee whetting and those comments will have to be clarified
appropriately before it is taken up for consideration of the IEC.
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 Details of Exemption/Expedited from Full Review
1. Are you requesting for:
a) Exemption from full review – No
b) Expedited Review -No

2. Under which category are you claiming this? Please highlight in the list by encircling.
A. Exemption from Full Review of EC
i. Research on data in the public domain/ systematic reviews or meta-analyses;
ii. Observation of public behavior/ information recorded without linked identifiers and
disclosure would not harm the interests of the observed person;
iii. Quality control and quality assurance audits in the institution;
iv. Comparison among instructional techniques, curricula, or classroom management methods;
v. Consumer acceptance studies related to taste and food quality;
vi. Public health programs by government agencies.

B. Expedited review from EC

i. Involves non-identifiable specimen and human tissue from sources like blood banks, tissue
banks and of left-over clinical samples.
ii. Involves clinical documentation materials that are non-identifiable (data, documents,
records).
iii. Modification or amendment to approved protocol (administrative changes/correction of
typographical errors and change in researcher(s)).
iv. Revised proposal previously approved through expedited review, full review or continuing
review of approved proposal.
v. Minor deviation from originally approved research causing no risk or minimal risk.
vi. Progress/annual report where there is no additional risk, for example activity limited to data
analysis. Expedited review of SAEs/unexpected AEs will be conducted by SAE subcommittee.
vii. For multi-centre research where a designated EC has approved the proposal, a participating
EC may review participating centre specific information and modifications in the study proposal
through full committee meeting/expedited review depending on the importance of local consent
related issues involved specific to the centre.
viii. Research during emergencies and disasters (See Section 12 of ICMR Ethical Guidelines, 2017 -
https://main.icmr.nic.in/sites/default/files/guidelines/ICMR_Ethical_Guidelines_2017.pdf)
3. Justification for claim in Point 2 above: NA

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 Human Research during COVID-19 pandemic times
1. Will you be carrying out this Research during Covid-19 Pandemic times? No

2. If Yes - highlight the steps of how you will take to ensure health/safety/wellbeing/protection
of stakeholders of this research.

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