Tamil and Telugu families required for important research.

Why does the Tamil and Telugu populations need more research?

 Although there is a lot of research being undertaken to help to study cardiovascular disease in many Asian populations, the Tamil and Telugu populations have not had enough research, and we aim to redress this imbalance.

 What is in it for you?

 In addition to contributing to a database of Tamil and Telugu research, you will also all have a full cardiovascular set of blood tests and other heart investigations, and we will ensure that you are informed of any abnormal results.

The study needs Tamil and Telugu trios, ie father, mother, and offspring. This research is a collaboration with the prestigious 1000 Genomes Project, the first project to sequence the genomes of a large number of people, to provide a comprehensive resource on human genetic variation. As with other major human genome reference projects, data from the 1000 Genomes Project will be made available quickly to the worldwide scientific community through freely accessible public databases, and help with understanding variations in both health and disease. We at Imperial are contributing Tamil and Telugu populations to this research.

In practical terms this will involve a brief research questionnaire, measurements of height weight waist hip blood pressure, ECG, blood and urine samples. We estimate father, mother, offspring (so a medical student and his or her parents would form a typical “trio”) assessment to take around 45 min. If we can be assembling the students we can liase re timings and will be prepared to do assessments at weekends etc.

If you have either Tamil or Telugu ancestry, and are willing to take part, please get in touch with Professor Jaspal Kooner (j.kooner@imperial.ac.uk) or Dr. John Chambers (j.chambers@imperial.ac.uk) .

Fuller details from the ethics form that you may like to read first are given below.

 

 

LOLIPOP Ancillary Study: 1000 Genomes Project.

Participant Information Sheet

Version: 2

Date: 2nd September 2011

 

Introduction

Thank you for taking part in the LOLIPOP study. We are pleased to be collaborating with the

1000 Genomes Project. This is an international collaboration aimed at producing an

extensive catalogue of genetic variation. The genomes of about 2,500 unidentified people

from about 25 populations will be analysed and will be made freely and publicly available to

researchers worldwide. The LOLIPOP study will be participating in this project since it will

help with the analysis of our results. We are inviting participants in the LOLIPOP study who

have South Asian ancestry to donate a sample for the 1000 Genomes Project.

We would like to invite you to participate in the 1000 Genomes Project. This will involve:

(1) blood samples and material taken from the blood samples, which will be kept in a

repository and distributed to researchers for use in future projects; and

(2) Data from the study of the samples, which will be kept on scientific databases

available over the Internet. The resource will be used in many future studies related

to health and disease. Researchers in several countries are working together to

develop this resource, including the LOLIPOP leadership at Ealing Hospital NHS

Trust and Imperial College London.

 

Several agencies are sponsoring the project. You can learn more information about the

organization of this project at http://www.1000genomes.org.

In order to take part, you must:

• be willing to give an additional sample of blood so that researchers can read out all of

your genetic information from it (a process called “sequencing”);

• be willing to have a “cell line” made from the blood sample that will make it possible

for researchers to get an unlimited amount of genetic material from the sample for a

long time— maybe forever;

• be willing to have all of your genetic information (without your name or other

traditional identifying information, such as address and birth date) put in scientific

databases available on the Internet;

• be willing to have many researchers around the world study the genetic material and

data from the sample for a long time, and to have the information they learn put in

scientific databases on the Internet.

We will not provide your name or any medical information to the 1000 Genomes Project.

Researchers who study the material and data from the samples will be told only the sex of

each donor and which ethnic or geographic group the donor came from.

If you think you might want to be part of this project, please read the rest of this form and

take as much time as you need to ask questions.

 

The decision about whether to participate or not is completely up to you.

If you decide not to sign this form, it will not affect your medical care or your participation in

the main LOLIPOP study.

 

What is the purpose of this research?

Genes are the basic “instruction book” for the cells that make up our bodies, and are made

out of DNA. The DNA of a person is more than 99% the same as the DNA of any other

unrelated person. But no two people have exactly the same DNA except identical twins.

Differences in DNA are called genetic variations. They explain some of the physical

differences among people, and partly explain why some people get diseases like cancer,

diabetes, asthma, and depression, while others do not. Such diseases may also be affected

by factors like diet, exercise, smoking, and pollution in the environment, which makes it hard

to figure out which genes affect the diseases. Most genetic variations are found in people

across the world. But there are differences among groups in how common some genetic

variations are.

The purpose of the 1000 Genomes Project is to find most of the genetic variations that exist

in people. We will do this by studying the DNA in blood samples collected from many people

whose ancestors were from various parts of the world, and then putting all of this information

in scientific databases on the Internet.

These scientific databases will be kept for a long time, and many future researchers around

the world will use them to help find genes and genetic variants related to health and disease.

The scientific databases we develop for this project will not include any medical information,

but they will still be useful to help future researchers learn about health and disease. In the

future, for a disease (such as diabetes), researchers will study different sets of samples—

some from people who have the disease and some from people who do not, and look for

areas in the DNA where the patterns of variation differ between the two groups. This will give

them a clue that those areas might contain genes that affect the disease. They will then use

the scientific databases we develop for this project to look at the genetic variants in those

regions, to help figure out which genes might affect the disease. They can then study how

the genes work and eventually find better ways to prevent, diagnose, and treat the disease.

Researchers will also use the scientific databases to learn more about how different people

respond to different drugs, and about how traits (like long life), or behaviours (like addiction),

differ between people. Other future studies that use scientific databases and the samples

themselves will help researchers understand even more about human genetic variation and

other important biological questions.

 

What will you ask me to do if I want to participate?

We will first ask you a few questions to determine whether you are eligible to give a sample.

• We will ask you where your grandparents were born, and what language they

spoke. Tell us if you are unsure, because the samples should be from people whose

grandparents mostly came from Andhra Pradesh, Tamil Nadu (India) & Sri Lanka.

• We will ask you whether any of your relatives already gave samples for this project.

We need to collect samples from people who are not closely related to each other, so

we do not want to include more than one member from a family.

If we find that you are eligible to give a sample, we will then draw about an additional 20ml of

blood from your arm at the same time as the blood sample taken for the LOLIPOP study.

What will happen with the sample I give you?

We will send the sample to the Coriell Institute, New Jersey (USA) to be processed and

stored.

 

 

The only information we will include with the sample is your ethnic group, geographic

origins of your grandparents and your gender.

The Coriell Institute will:

• make a “cell line” from the sample so that researchers can get an unlimited amount

of DNA from it for a long time—perhaps indefinitely;

• And send the DNA from the cell line to project researchers in laboratories around the

world.

Over the next 1-3 years, these project researchers will:

• “sequence” the sample, by reading out all of the genetic information in it;

• put all the data in open access (public) scientific databases on the Internet through

which the data can be accessed.

• study the genetic variation data from all the samples;

• and compare individual samples and samples from different ethnic or geographic

groups.

The Coriell Institute will also make the cell lines and DNA from the samples available to

other researchers around the world, so that they can be used in many future studies. These

future researchers may include researchers in universities, hospitals, non-profit groups,

companies, and government laboratories. Such researchers, just like the researchers in this

project, will have to follow all the laws and guidelines that apply to biomedical research.

Future researchers may use the samples to study many other questions, such as how genes

and genetic variants affect the way genes work and the products that genes make (these are

called “gene expression” or “proteomic” studies). Future researchers may also use both the

samples and the scientific databases to study such questions as:

• the biology of DNA;

• how new variations arise;

• how the process of evolution works;

• the composition and size of human groups; and

• how people from different parts of the world are related to each other.

People who do identity testing, such as for paternity testing or law enforcement, may use the

samples and the scientific databases to do general research about patterns of human

genetic variation. Some of the results of that research, and of other future research using the

samples or the scientific databases, may also be put in open access scientific databases on

the Internet. However, it will be hard for anyone to find out anything about you personally

from any of this research because the samples and the scientific databases will not include

anybody’s name or other traditional identifying information (such as address & birth date).

Any future researcher who wants to study your sample will be required to apply to 1000

Genomes Project with a written “Statement of Research Intent.” The 1000 Genomes Project

will review each Statement of Research Intent to make sure that the purpose for which the

sample will be used is consistent with this consent form.

 

Are there any benefits to participating in the 1000 Genomes Project?

You probably will not benefit personally from giving a sample for this project because this

kind of research usually takes a long time to produce medically useful results. However, your

participation will help researchers around the world understand more about human genetic

variation and how it relates to health and disease.

 

What are the risks of participating?

We have already explained the risks involved in taking a blood sample. Although we will not

provide the 1000 Genomes Project with any names or medical information, and we will take

many measures to protect your privacy, we will generate lots of genetic information about

each person whose sample is studied. This information will be put in open access scientific

databases, available on the Internet to anyone who wants to look at it. Although only experts

will know how to interpret this information, there is a small chance that somebody could work

out how to connect you with the information from the sample you give. Currently we believe

this could happen only if somebody knew that you had given a sample to be studied for this

project and:

• got another sample from you, found an expert to test that sample, and then

compared the genetic information from that test with the genetic information in the

scientific databases;

• found an expert to compare the genetic information about you in the scientific

databases with information known to have come from you (or from a family member)

included in some other database developed by someone else for some other

purpose; or

• found an expert to look in the scientific databases for a particular genetic variation

known (or someday found) to be associated with a disease or trait that you have or

carry, that others know about or can see, and that is very rare.

Any of these things would require that the person trying to link the information to you knew

that you participated in the project. For this reason, to minimize these risks, you may wish to

limit the number of people you tell about your participation.

As technology advances, there may be new ways of linking information back to you that we

cannot foresee now. Also, we cannot always foresee the results of research, so new risks

may come up in the future that we cannot predict now. We believe that the benefits of

learning more about human genetic variation and how it relates to health and disease

outweigh the current and potential future risks, but this is something that you must judge for

yourself.

 

How will you protect my privacy?

This has been covered in the main LOLIPOP study information sheet.

 

Are there any risks to my community or group?

The names of the ethnic or geographic groups the samples came from will be included with

the samples and in the scientific databases. In future studies, researchers may find that

certain genetic variations appear more often in people from your group than in people from

other groups, and that these variations are more common in people with a certain disease.

This may make some people look down on your group unfairly. Some people may use the

information from the scientific databases, or from future studies using the scientific

databases, to exaggerate differences between groups for prejudiced or other bad reasons.

Others may use the information to downplay differences between groups, to say that all

people’s genes are about the same, so we don’t need to respect the special concerns of

different groups. Biology does not provide a reason for prejudice, but discrimination does

exist. We will work to make sure that the ethnic or geographic identity of your community is

described as carefully as possible--in the sample collection, in the scientific databases, and

in articles that project researchers write based on this research, but we cannot completely

control how this information is described in publications that others write.

 

Can I change my mind after I decide to participate?

Once you give the sample for the 1000 Genomes Project, it will be impractical for us to

withdraw the sample from the Coriell repository or the derived information from the public

databases.

 

 

How can I find out about the results of the research?

It will probably take a long time for the data from this project to be used to produce healthrelated

information that we will know how to interpret accurately. For this reason we will not

be able to give you individual results from this research. However, you can check the 1000

Genomes Project web site to see what the uses are and eventually what sorts of results

have been found.