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RESEARCH CONSENT FORM

Protocol Title:

Study Protocol No.: [Please include the SKIMS protocol number only]

Principal Investigator: MR. MOHAMMAD AYUB DAR, LECTURER MMINSR,

Applicant: Bushra Mushtaq, Msc. Nursing , 8491047022

A Study To assess the effectiveness of progressive muscle relaxation technique on

the stress among ist year bsc. Nursing student ,MMINSR
,Soura,Srinagar,Kashmir 

• PURPOSE OF STUDY To identify the selfitis among adolescents of selected higher

secondary school.
• To identify the relationship of selfitis with self esteem among the adolescents of selected
higher secondary school .
• To find association of selfitis and self-esteem with their selected demographic
variables .i.e gender ,type of family , income of the family, residence.

PROCEDURES
 I WILL TAKE WRITTEN CONCENT FROM THE EACH PARTICIPANT IN WHICH EACH
DETAIL WILL BE PROVIDED .
 THE TWO QUESTIONAIRES WILL BE PROVIDED :
 SELF –ESTEEM SCALE FOR MEASURINGT THE LEVEL OF SELF –ESTEEM IN THE
PARTICIPANTS.
 SELFIE SELF STRUCTURED QUESTIONAIREFOR MEASURING THE NUMBER OF
SELFIES TAKEN AND POST ON THE SOCIAL NETWORKINGS.
 THE DATA WILL BE COLLECTED UNDER TOTAL CONDUCIVE AND COMFORTABLE
ENVIRONMENT.

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WHAT ARE MY RESPONSIBILITIES IF I TAKE PART IN THIS RESEARCH?
I will assure the total confidentiality of the information and I will make sure the there is no breech in
information from my side.

POTENTIAL RISKS/DISCOMFORTS:
There are no projected risks or discomforts anticipated for this survey .If you are un comfortable
answering any questions you are able to withdraw from the survey at any time, in which case your
answers will not be recorded . Your participation is completely voluntary.
POTENTIAL BENEFITS
The benefit of this study will give insights on whether the level of self-esteem plays a factor in the
practices of selfies . Factors such as number of selfies taken and posted ,.

ALTERNATIVES TO PARTICIPATION
It is totally voluntary participation and if you don’t want to participate ,you can easily withdraw.
COSTS TO PARTICIPANTS
There are no such costs involved in the study.
PAYMENT TO PARTICIPANTS
The participants will be provided a small refreshment ,as a part of reinforcement for involving in the
study

CONFIDENTIALITY AND ACCESS TO RECORDS

There is no assess to the participants personal information or records ,No previous records will be
checked. Only the information based on present questionnaire will be taken.
RIGHT TO WITHDRAW
Each participant has the right to withdraw any time if the participant is not comfortable in any question

CAN I BE REMOVED FROM THE RESEARCH?

As this is survey if the subject is not addicted to selfie taking, then the participant can be
removed as self-esteem is to be checked for participant whose selfies taking is high.
STATEMENT FROM SKIMS DEEMED UNIVERSITY CONCERNING RESEARCH
RISKS (Minimal Risk Studies)

SKIMS is committed to providing participants in its research all rights due them under State and Central
law. You give up none of your legal rights by signing this consent form or by participating in the research
project. This research has been reviewed and approved by the Institutional Ethics Committee (IEC).
Please call the Institutional Ethic Committee (IEC) if you have questions about your rights as a research
participant.

The research described in this consent form has been classified as minimal risk by the IEC of the Sher-i-
Kashmir Institute of Medical Sciences Srinagar (SKIMS). The IEC is a group of scientists, physicians,
experts, and other persons. The IEC’s membership includes persons who are not affiliated with SKIMS
and persons who do not conduct research projects. The IEC’s decision that the research is minimal risk
does not mean that the research is risk-free. You are assuming risks of injury as a result of research
participation, as discussed in the consent form.

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If you are harmed as a result of the negligence of a researcher, you can make a claim for compensation. If
you have questions, concerns, complaints, or believe you have been harmed through participation in this
research study as a result of researcher negligence, you can contact members of the IEC to ask questions,
discuss problems or concerns, obtain information, or offer input about your rights as a research
participant. The contact information for the IEC-SKIMS is:

Institutional Ethics Committee SKIMS

Dean’ Office, Room 1108, 1st Floor, Administrative Block,
Sher-i-Kashmir Institute of Medical Sciences Soura, Srinagar
Ph: +01942 403018, 01942 401013 ext.2345

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 EMAIL: iec@skims.ac.in

STATEMENT FROM SKIMS DEEMED UNIVERSITY CONCERNING RESEARCH

RISKS (Greater than Minimal Risk Studies)

SKIMS is committed to providing participants in its research the rights due them under State and Central
law. You give up none of your legal rights by signing this consent form or by participating in the research
project. This research has been reviewed and approved by the Institutional Ethics Committee (IEC).
Please call the Institutional Ethics Committee (IEC) if you have questions about your rights as a research
subject.
Participating in research may result in an injury, as explained above. If you suffer an injury directly
related to your participation in this project, SKIMS will help you obtain medical treatment for the specific
injury and provide referrals to other health care facilities, as appropriate. SKIMS will not provide you
with financial compensation or reimbursement for the cost of care provided to treat a research-related
injury or for other expenses arising from a research-related injury A Study To Find Relationship
Between Self-Esteem Levels And Number Of Selfies Take And Post By The
Adolescent’s Of Higher Secondary School,Soura,Srinagar,Kashmir . The study staff
can give you more information about this if you have a study injury.

By signing this Consent Form, you are not giving up any legal rights. If this research project is conducted
in a negligent manner and you are injured as a direct result, you may be able to recover the costs of care
and other damages from the individuals or organizations responsible for your injury.

If you have questions, concerns, complaints, or believe you have been harmed through participation in
this research study as a result of researcher negligence, you can contact member-secretary of the IEC or
the Chairman to ask questions, discuss problems or concerns, obtain information, or offer input about
your rights as a research participant. The contact information for the IEC-SKIMS is given above.

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 Signing this consent form indicates that you have read this consent form (or have had it read to you), that
your questions have been answered to your satisfaction, and that you voluntarily agree to participate in
this research study. You will receive a copy of this signed consent form.

If you agree to participate in this study, please sign your name below.

Please incorporate all signature lines (below) which are applicable to your study and delete all others.
NOTE: The participant and person obtaining consent signature lines are required for all research studies.

___________________________________
_______________ Signature of Parent/Guardian
(When applicable)

Relationship:________________________
Date:______________________________
Date:______________________________

___________________________________
_______________ Signature of Parent/Guardian #2
Investigator or Designee Obtaining Consent (When applicable, as required by State/
Signature Central regulations for permission by
parents’ assent)

_______________ Relationship:________________________

Date:______________________________

___________________________________
Witness*

Date:______________________________

*Witness is optional unless IEC required, participant is illiterate, or unable to sign. It is prudent
to include a witness line, however, in your consent form because you will not know who your
future participants will be and you may find that you will need a witness.

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 GENERAL INFORMATION FOR INVESTIGATORS
(Not to be included in the submitted consent form)

CDSCO GUIDELINES OF INFORMED CONSENT PROCESS IN CLINICAL TRIAL

INFORMATION FOR PROSPECTIVE STUDY SUBJECT

Before requesting an individual’s consent to participate in clinical trial the Investigator

must provide the individual with the following information in a language that is non-
technical and understandable by the study subjects and the same shall be recorded
through audio-visual means.
(A) Essential elements:
1. Statement that the study involves research and explanation of the purpose of
the research

2. Expected duration of the Subject's participation

3. Description of the procedures to be followed, including all invasive procedures

4. Description of any reasonably foreseeable risks or discomforts to the Subject

5. Description of any benefits to the subject or others reasonably expected from

research. If no benefit is expected subject should be made aware of this.

6. Disclosure of specific appropriate alternative procedures or therapies available

to the Subject.

7. Statement describing the extent to which confidentiality of records identifying

the subject will be maintained and who will have access to subject’s medical
records

8. Trial treatment schedule(s) and the probability for random assignment to each
treatment (for randomized trials)

9. Statement describing the financial compensation and medical management as

under:
a. In the event of an injury occurring to the clinical trial subject, such
subject shall be provided free medical management as long as required.

b. In the event of a trial related injury or death, the Sponsor or his

representative, whosoever has obtained permission from the licensing
Authority for conduct of the clinical trial, shall provide financial
compensation for the injury or death.
10. An explanation about whom to contact for trial related queries, rights of
Subjects and in the event of any injury

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11. The anticipated prorated payment, if any, to the Subject for participating in the
trial

12. Subject's responsibilities on participation in the trial

13. Statement that participation is voluntary, that the subject can withdraw from
the study at any time and that refusal to participate will not involve any penalty
or loss of benefits to which the Subject is otherwise entitled

14. Any other pertinent information

(B) Additional elements, which may be required:

1. Statement of foreseeable circumstances under which the subject's participation
may be terminated by the Investigator without the subject's consent.
2. Additional costs to the subject that may result from participation in the study.
3. The consequences of a subject’s decision to withdraw from the research and
procedures for orderly termination of participation by subject.
4. Statement that the subject or subject's representative will be notified in a timely
manner if significant new findings develop during the course of the research
which may affect the subject's willingness to continue participation will be
provided.
5. A statement that the particular treatment or procedure may involve risks to the
subject (or to the embryo or foetus, if the subject is or may become pregnant),
which are currently unforeseeable.
6. Approximate number of subjects enrolled in the study.

Where a subject is not able to give informed consent (e.g.an unconscious person or a
minor or those suffering from severe mental illness or disability) the above information
should be provided to the legally acceptable representative (LAR). If the subject or
his/her legally acceptable representative is unable to read/write – an Impartial
witness (IW) should be present during the entire informed consent process.
The Investigator has the duty to communicate to the subjects/LAR/IW, all the
information necessary for informed consent. There should not be any restriction on
subject’s right to ask any questions related to the study as any restriction on this
undermines the validity of informed consent. Details of such questions if any, asked
by the subject/LAR/IW and his/her understanding on consent are also to be recorded
through the audio video means. The process of signing/putting thumb impression by
the subject/LAR/IW should also be video recorded.

PRINCIPLE OF PRIVACY AND CONFIDENTIALITY

The Investigator must safeguard the confidentiality of trial data, which might
lead to the identification of the individual subjects. Data of individual subjects can be
disclosed only in a court of law under the orders of the presiding judge or in some
cases may be required to communicate to Drug regulatory/ Health authority.

CDSCO: Central Drugs Standard Control Organization (India)

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