Institutional Ethical Committee (IEC) form

Evaluation of awareness on Human papilloma

virus vaccine and polycystic ovarian disease
(PCOD) and its effects on mental health among
college students in Tiruvallur.
1 Title of the Proposed Research

Name of the Principal

2 Investigator N. Jaishiya Devi

3 Name of the Co-investigators Dr.Ganesh R, Dr. Selvamani B, Dr. Sasikala M

4 Source(s) of Funding Nil

Expected Duration of the 3 months

5
Project

6 List of documents annexed 1. Research Protocol (see page 3 for guidelines) Yes

2. Informed Consent format Yes

3. Patient Information Sheet Yes

4. Investigator’s Undertaking (if an agreement is with No

another organisation)

• To assess the awareness on

human papilloma virus vaccine
• To assess the awareness on
polycystic ovarian disease
(PCOD)
• To assess the impact of PCOD
on the mental health
Objectives of the Proposed
Research
7

At the end of the study the students will be aware of

8 Benefits of the proposed
Research - the risk factors of cervical cancer
- Importance of regular Pap smears and HPV tests
 for early detection
- Need for HPV vaccination for prevention
- Potential impact on sexual health and relationships
- Importance of lifestyle changes and medical
management for symptom control
Understanding these can empower individuals to
take proactive steps for their reproductive and
overall health

List anticipated risks (injury,

9 harm, pain etc) for the

Volunteers involved in this
Project. Nil
10 Confidentiality of the Patient Records
Confidentiality protocols are strictly followed.

No
11 Conflict of interest

Specific ethical issues

12 No
identified by investigating team

Adherence to Regulatory Guidelines. (Write

13 yes /no/NA) on the right column
National Ethical Guidelines for Biomedical
a Health Research involving
Human participants, ICMR, 2017 Yes
Guideline for Good Clinical Practice E6(R2),
ICH
Yes
Harmonised Guideline, 2016

Other, specify No

Signature of the Investigator

14

15 Signature of the Co-investigators

Annexure 1: Research Protocol: (1page)
Title: Evaluation of awareness on Human papilloma virus vaccine and polycystic ovarian disease
(PCOD) and its effects on mental health among college students in Tiruvallur.

Background:. For the prevention of PCOD and Cervical cancer, which improves health and
lifestyle, young females must be aware of PCOD and the HPV vaccine. But the level of awareness
they possess remains unknown.

Aim:. The study aims to assess the awareness about HPV Vaccination and PCOD and also its
impact on their mental health

Study Type: Online Questionnaire type

Study Design: Cross sectional

Inclusion Criteria: Female College students of age 18 and above in Tiruvallur

Exclusion criteria: Those who have not given consent to participate

METHODOLOGY: A set of 20 self-constructed validated questions will be given to

female college students in Thiruvallur of age 18 and above through google forms as a
questionnaire containing two components a. Knowledge on PCOD and HPV Vaccine (HPV
infection, cervical cancer, ideal age, side effects, vaccine administration) b. Signs and symptoms of
PCOD (menstrual flow, mood swings, headache, sleeping disorder). Before the commencement of
the study ethical committee approval will be obtained. Informed consent will be obtained from
each participant. Pilot study will be conducted to check for the feasibility of the study and to
calculate the sample size. The questionnaire which is fully responded will be collected and
analyzed using SPSS (Statistical Package for Social Sciences) software version 20. through
descriptive statistics. After obtaining the data, in order bring full awareness to the participants,
awareness pamphlets on PCOD and HPV will be mailed to them.

Proposed Statistics : Descriptive statistics

Annexure 2: Informed consent

Why do this study? – To assess the awareness about HPV Vaccination and PCOD and also its
impact on your mental health .

What will participation involve? – At the end of the study the students will be aware of
- the risk factors of cervical cancer
- Importance of regular Pap smears and HPV tests for early detection
- Need for HPV vaccination for prevention
- Potential impact on sexual health and relationships
- Importance of lifestyle changes and medical management for symptom control

Understanding these can empower individuals to take proactive steps for their reproductive and
overall health

How long will participation take? – The entire procedure will last approximately 10 minutes

As an informed participant of this experiment, I understand that:

My participation is voluntary and I may cease to take part in this survey at any time, without
penalty.
I am aware of what my participation involves.

There are no risks involved in the participation of this study.

All my questions about the study have been satisfactorily answered.

I have read and understood the above, and give consent to participate:

Participants Signature: __________________________________ Date:__________

I have explained the above and answered all questions asked by the participant:

Researchers Signature:__________________________________ Date:__________

Annexure 3: Patient information sheet
Patient Information Sheets submitted to the IEC should include:

1. Study title: Evaluation of awareness on Human papilloma virus vaccine and polycystic ovarian
disease (PCOD) and its effects on mental health among college students in Tiruvallur.

2. Invitation paragraph

You are being invited to take part in a research study. Before you decide it is important for you to understand
why the research is being done and what it will involve. Please take time to read the following information
carefully and discuss it with others if you wish. Ask us if there is anything that is not clear or if you would
like more information. Take time to decide whether or not you wish to take part.

Thank you for reading this.

3. What is the purpose of the study?

At the end of the study you will be aware of
- the risk factors of cervical cancer
- Importance of regular Pap smears and HPV tests for early detection
- Need for HPV vaccination for prevention
- Potential impact on sexual health and relationships
- Importance of lifestyle changes and medical management for symptom control
Understanding these can empower individuals to take proactive steps for their reproductive and
overall health

4. Why have I been chosen?

As you are a female who are at risk of getting PCOD

You have been chosen to participate in this study

5. Do I have to take part?

It is up to you to decide whether or not to take part. If you do decide to take part you will be given this
information sheet to keep and be asked to sign a consent form. If you decide to take part you are still free to
withdraw at any time and without giving a reason. A decision to withdraw at any time, or a decision not to
take part, will not affect the standard of care you receive.

6. What will happen to me if I take part?

There will be no impact on you. Your answers will act as a resource for the study.

7. What do I have to do?

You should answer truly to the questions asked in the questionnaire.

8. What is the drug or procedure that is being tested?

No drugs are tested.

9. What are the alternatives for diagnosis or treatment?

No alternatives.

10. What are the side effects of any treatment received when taking part?
 No side effects.
11.What are the possible disadvantages and risks of taking part?

No disadvantages and no risks.

12. What are the possible benefits of taking part?

It helps

13. What if new information becomes available?

NA
14. What happens when the research study stops?

The study does not stop as it is self-funded.

15.What if something goes wrong?

If you are harmed by taking part in this research project, there are no special compensation arrangements. If
you are harmed due to someone’s negligence, then you may have grounds for a legal action but you may
have to pay for it. Regardless of this, if you wish to complain, or have any concerns about any aspect of the
way you have been approached during the course of this study, the normal National Health Service
complaints mechanisms should be available to you.

16. Will my taking part in this study be kept confidential?

All information which is collected about you during the course of the research will be kept strictly
confidential. Any information about you which leaves the hospital/surgery will have your name and address
removed so that you cannot be recognized from it.

17.What will happen to the results of the research study?

The results will be published online once the study is completed without revealing the patient information.

18.Who is organising and funding the research?

Self-funded
19. Who has reviewed the study?

Institutional Ethical Committee- PDCH

20.Contact for Further Information

Contact: Ms. Jaishia Devi- 9360443087

Thank you for being a part of this study.

The Patient Information Sheet should state that the patient will be given a copy of the
information sheet and a signed consent form to keep if requested.