Module 4

The Informed Consent Process

Youtube link to lecture

The video lecture can be downloaded from here.

Informed consent researchers – Module 4 – Dr Shaza Abbas

Case Study

Knowledge, attitudes and perception of water pipe smoking (Shisha) among
adolescents aged 14-19 years
Proposal Summary
Water pipe smoking has been in practice for the last 400 years. Its origins are traced back to the
Indian subcontinent. It was observed that in the last century a decline was seen and its use was
mostly confined to older men in rural areas. Recently a global resurgence was seen in water pipe
smoking, including our own country, where it is commonly known as “Shisha” among the young
generation. The reasons accredited to this trend are certain misconceptions that water pipe
smoking is not hazardous to health, since the tobacco is filtered through water before inhalation;
nicotine content is less than that of cigarettes and addition of fruit flavorings make it healthier.
Another factor adding to its popularity is its portrayal as a symbol of modernization of our
cultural heritage.
As compared to cigarette smoking, scientific studies of medical sequel are scarce, but available
data suggest that they are similar to those associated with cigarette smoking including lung and
bladder cancers, impaired pulmonary functions, coronary heart disease, infertility, tobacco
dependence and so on. Feature unique to water pipe smoking is its association with infectious
diseases caused by pipe sharing and its manual preparation.
The extent to which water pipe smoking has penetrated our society is difficult to decipher since
very little work has been done on it. A recent survey conducted in high socio- economic schools
of Karachi reported that shisha is gaining popularity among the young generation as it is easily
available in the restaurants, hotels and shisha cafes and also as compared to cigarette smoking it
is readily acceptable and has become part of social gatherings. Hitherto an inseparable part of
villagers evening, the hookah is now heading towards cities.
Therefore, assessing the need to address this emerging health risk it is proposed that a study
should be conducted to evaluate the young generation regarding their knowledge, awareness and
perceptions about water pipe smoking. This study, to be conducted among adolescents of 14-19
years based in different educational institutions of Karachi will be part of our public health
education strategy for controlling the emerging epidemic of water pipe smoking. Awareness
sessions will be conducted for the students along with parental and peer counseling regarding the
hazards of water pipe smoking. Literature and handbills will be distributed during the sessions to
highlight the severity of this problem. Articles will be published in youth magazines and
newspapers to impart health education regarding the perils of water pipe smoking to the general
public and also awareness programs will be broadcast through Radio stations to captivate a
greater audience.
If funded our proposed research project will be a milestone in creating awareness about the
health hazards associated with water pipe smoking and may help in reducing the menace of
shisha afflicting our youth.
RATIONALE:
In Pakistan, extensive work has been done on cigarette smoking but specific literature on water
pipe smoking is scarce. The increasing trend of smoking water pipe among youth is mostly
attributed to lack of knowledge and the misconceptions regarding its use. Therefore we propose
to do a survey on Knowledge, Attitude and Perceptions of Water pipe smoking (Shisha) in
adolescents of Pakistan. Then based on its results we propose to arrange focus group discussions
in Educational Institutions and conduct awareness programs through different media.
OBJECTIVES:
• To determine the factors related to the frequency of water pipe smoking among
adolescents (15-19 years)
• To assess the Knowledge, Attitude and Perception regarding water pipe smoking
• To compare the relationship of water pipe smoking with cigarette smoking.
• To impart education regarding health hazards associated with water pipe smoking
METHODOLOGY:
Study design:
This will be a cross-sectional survey of adolescents aged 14-19 years studying at different
educational institutions of Karachi. The educational institutions will be divided into three strata
on the basis of socio-economic status (upper, middle, lower) of Karachi. Upper socio-economic
status is defined as schools having a monthly fee structure above 4000 Pakistani rupees, middle
socio-economic status is defined as schools having a fee structure between 1000-4000 Pakistani
rupees and lower socio-economic status is defined as schools having a fee structure of below
1000 Pakistani rupees. For each stratum, the institutions will be selected by convenience and
then from each institution proportionate number of students aged 14-19 years will be selected
randomly. In order to assess the impact of health education messages, it is proposed to do a posttest
in randomly picked 40% of the pre-tested sample population three months after initiation of
the education sessions held in different educational institutions.
Target Population:
All students of age range 14-19 years studying in various educational institutions of Karachi.
Study Population:
All students of age range 14-19 years studying in selected institutions of Karachi. A complete list
of these institutions is available at Directorate of Schools and Colleges.
Sample Size:
The sample size was calculated with estimation that 25% adolescents from the upper class, 10%
from the middle class and 2% from the lower class indulge in shisha smoking. Keeping equal
number in each group, at 95% confidence interval and power of 80%, a sample size of 162 was
obtained. A total of 200 participants from each stratum will be selected keeping in view the nonresponse
and invalid responses in the completed questionnaires. For post-test, 240 from these
600 participants will be asked to complete the same questionnaire.
Data collection Instrument:
A pretested self administered questionnaire will be used for data collection. The questions will
be mostly close ended. The questions will include information such as knowledge of water pipe
smoking, water pipe use frequency, cigarette smoking status, current age, age of initiation of
water pipe smoking, and age of initiation of daily cigarette smoking, awareness regarding health
hazards related to water pipe smoking.
Sampling Method:
Multistage sampling in five strata of Karachi will be used.

Consent:
The proposal is being submitted to the Ethics Review Committee of Ziauddin Medical
University for approval. The certificate of the committee will be submitted for you perusal when
the project is approved as the meeting of the committee will be held in the next month.
• Written consent will be taken from authorities of institutions where the survey will be
conducted.
A. Informed verbal consent will be taken from students who agree to participate in the survey.
B. For data sharing (if requested by other institutions or organizations) all identifying code / numbers will be removed.

POLICY IMPLICATION:
• Health education sessions will be conducted in order to increase the awareness regarding health hazards
of water pipe smoking among adolescents.
• Parental counseling sessions will be done regarding the hazards of water pipe smoking.
• Information education and communication (IEC) material will be distributed highlighting
• the hazards of water pipe smoking in general public and articles will be published in magazines and
newspapers.
• Awareness programs regarding the health hazards of water pipe smoking will be

CONSENT FORM:
Survey to assess attitude and perceptions of youths regarding water pipe smoking (shisha)
Informed Consent
I ____________________________________ s/o, d/o, w/o
____________________________________ understood that I am being asked to allow my
students to voluntarily join this research as a subject for the sake of obtaining scientific
information for the above study.
My students’ role in the study
I understand that my students will be asked a few questions regarding his/her perceptions and
attitude regarding water pipe smoking. No physical examination is required.
Compensation
I have been told that there will be no monetary or other reward for my student’s participation.
Withdrawal
I understand that even after signing the consent form my student can refuse to participate in the
entire study or any part of it, at any time and that my student will in no manner be penalized for
that.
Confidentiality
I understand that my student’s participation in the study will be kept confidential and that the
results of this study will be used for adolescents counseling to increase the awareness regarding
the health hazards of water pipe smoking and to reduce the incidence of water pipe smoking
among adolescents.
The results will be disseminated in a manner that ensures anonymity of the participants.
Contact
I have been told that if I have any questions regarding my student’s participation, I can contact
Dr.Qudsia Anjum and Dr.Farah Ahmad at phone #021-5862937 ext. 208 at Ziauddin Medical
University, Clifton Karachi –75600 during office timing.
I hereby confirm that I have read and understood whatever has been stated above and based on
the same, I voluntarily give consent that my students can participate in the study. (questionnaire
attached)
Authority’ s Signature: ____________________

Discussion and questions
• Is the description of the informed consent process well described?
• Are the consent forms included? (see consent form checklist for assessment)
• Will informed consent be obtained from appropriate individuals?
• Will it be necessary to assess the comprehension of the potential subjects?
• Will consent be obtained from the subject’s legally authorized representative?

*Please let your reflections/questions/comments related to the cases for discussion in the box bellow.