NLDB - Announcements

First Announcement : "NLDB provides access to any biospecimen type (serum, plasma, fresh or frozen tissue, FFPE, CSF, etc.) and any specific associated data (clinical history, medical follow-up, etc.) in any disease" Second Announcement : "Seats are available for training in Biobanking, Immunohistochemistry (IHC), Immunofluorescence (IF), molecular pathology techniques & molecular techniques" Please Contact : +91 9958368439, Email : mallick.koustav@gmail.com

English Consent Form

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Informed Consent English NDB Click Here
What are Biobanks?

A biobank (“bank of life”) is a place that stores blood and other human tissue samples donated by patients or healthy donors for research in cancer or other serious diseases. These biospecimens are commonly annotated with information about the patient/donor from whom the biospecimen was taken, including data about their medical conditions and background. However, one of the top priorities of biobanks is to protect the privacy and sanctity of the donor's personal and medical information.

Participation in this endeavour is voluntary. You are being asked to donate urine, blood and/or surgical tissues and or other biological materials for future research. If you agree with this, blood/tissue/other biospecimens will be collected, processed and stored along with relevant clinical information in biobank. These stored biospecimens are used in research in India and abroad for various studies to learn more about diseases. It will help to seek answers regarding causes of diseases, treatment, and genetic information.

What are Biospecimens?

Biospecimens are materials such as urine, faecal, blood, tissue, cells, DNA, RNA, and protein taken from the human body. When these samples are properly processed and stored at biobank along with a written consent it is known as biospecimens.

Things to Think About

The choice to let us use/ keep the left over blood/tissue/other biospecimens from your surgery for future research studies within and outside the country for an unlimited amount of time is up to you. No matter what you decide to do, it will not affect your medical care.

If, however you change your mind in future and you wish to withdraw your consent for storage of the samples and health information and wish that they can be destroyed, you may do so at anytime without penalty, loss of benefits to which you are entitled. The withdrawal of your consent for your samples to be used in future research has to be performed by writing to the biobank Investigator/ Manager.

In the future, other researchers may need to know more about your health. The institution where you are treated may give them reports about your health, but it will not give them your name, address, phone number, or any other information that will let the researchers know who you are.

Your blood/tissue/other biosamples will be used only for research and will not be sold. The research done with your blood/tissue/other biosamples may help to develop new products/commercial products in the future. You will not be personally entitled to commercial gains which are made from the study of the donated tissues and you will have no legal rights to any discovery or invention that either directly or indirectly results from the use of the biospecimens, and informatics.

Where does tissue come from?

Whenever a biopsy (or surgery) is performed, the tissue that is removed is examined under the microscope by a trained doctor to determine the nature of the disease and assist with the diagnosis. Your tissue will always be used first to help make decisions about your medical care. After all tests have been done, there is usually some left over tissue. Sometimes, this tissue is not kept because it is not needed for the patient’s care. Instead, a patient can choose to have the tissue kept for future research. People who are trained to handle tissue and protect the donor’s rights make sure that the highest standards are followed. Your doctor has agreed to help collect tissue from many patients. Many doctors across the country are helping in the same way. If you agree, only left over tissue will be saved for research. Your doctor will first use whatever tissue is needed for your care.

Why do people do research with biosamples?

Research with blood/tissue/other biosamples can help to find out more about what causes certain diseases, how to prevent them, and how to treat them. Research using tissue can also answer other health questions.

How do researchers get the biosamples?

Researchers from universities, hospitals, and other health organizations conduct research using tissue. They contact the NLDB and request samples for their studies. The NLDB reviews the way that these studies will be done, and decides if any of the samples can be used. The NLDB gets the biosamples and health information about you from your hospital, and sends the tissue samples and some information about you to the researcher. The NLDB will not send your name, address, phone number, social security number, or any other identifying information to the researcher.

What type of research will be done with my biosample?

Many different kinds of studies use blood/tissue/urine/fecal/swap/other biospecimens. Some researchers may develop new tests to find diseases. Others may develop new ways to treat or even cure diseases. In the future, some of the research may help to develop new products, such as tests and drugs.

Some research looks at diseases that are passed on in families (called genetic research). Research done with your blood/tissue/other biosamples may look for genetic causes and signs of disease. Even if your blood/tissue is used for this kind of research, the results will not be put in your health records.

Will I benefit from the research using my biosamples?

It is hoped that the results of research on your blood/tissue/other biosamples and blood/tissues/other biosamples from other patients will provide information that will help other patients in the future. However, there will be no direct benefit to you because your blood/tissue/other biosamples may not be used for some time after you donate it and because research can take a long time. The research that may be done with your blood/tissue/other biosamples is not designed specifically to help you. The benefits of research using blood/tissue/other biosamples include learning more about what causes diseases, how to prevent them, and how to treat them.

Will I find out the results of the research using my biosamples?

Your doctor will give you the results of your biopsy when results are known. These test results will be ready in a short time and will be used to make decisions about your care. Though research involves the test results of many different people, your biopsy result involves only you.

You will not receive the results of research done with your blood/tissue/other biosamples. This is because research can take a long time and uses blood/tissue/other biosamples from many people before results are known. Results from research using your blood/tissue/other biosamples may not be ready for many years and will not affect your care right now, but it may be helpful to people like you in the future.

Why do you need information from my health records?

In order to do research with your blood/tissue/other biosamples. Researchers may need to know some things about you. (For example: What is your race or ethnic group? How old are you? Have you ever smoked?) This helps researchers to answer questions about diseases. The information that will be given to the researcher includes your age, sex, race, diagnosis, treatments, and possibly some family history. This information is collected by your hospital from your health record and sent to the NLDB but without your name or other identifying information.

Risk(s)

There will be minimal risk for you, as only remnant surgical tissue will be collected that is not needed for pathologic diagnosis but has to be removed as treatment. No additional tissue will be removed for the sole purpose of this study hence no reimbursement will be given.

Risks associated with blood and other biosamples

There is no potential risk but slight discomfort or bruising may occur while collection of blood as it occurs in any other blood collection.

How am I protected?

The institution from where you receive your treatment from/ have blood drawn from/ etc will protect your records so that your name, address, and phone number will be kept private, unless otherwise required by law. All information and samples obtained for this study will be assigned a secure code that will not use your name and any other identifying information. The code will be stored in secured database and safeguarded by biobanking staff who will sign Confidentiality Disclosure Agreement.

The NLDB is in charge of making sure that information about you is kept private. The NLDB will take careful steps to prevent misuse of records. Your name, address, phone number and other identifying information will not be associated with your blood/ tissue/biosamples when it is given to the researcher. This would make it very difficult for any research results to be linked to you or your family. Also, people outside the research process will not have access to results about any one person which will help to protect your privacy.

Whom Do I Call if I Have Questions or Problems?

If you have any questions regarding your rights as a participant in this research and/or concerns about the study, or if you feel under any pressure to enroll or to continue/discontinue/withdraw to participate in this study, you may contact or ask more questions about the study at any time, Please contact Dr. Birendra Kumar Yadav, Biobank Manager. nldb.ilbs@gmail.com /Ph.:+91-11-46300000. Ext.24814

For more information, please contact: Dr Chhagan Bihari, Project Investigator, NLDB and Associate Professor, ILBS; Ph.:+91-11-46300000. Ext.16035

A copy of this consent form will be given to you to keep.

Your consent

I confirm, I have read or have had read to me, in language understandable to me, the above information. The content and meaning of this information has been fully explained to me.

I have had time and opportunity to ask any questions that I have about the NLDB biobank and this form, and all my questions have been answered. I have read all pages of this consent forms and risks described.

I understand that NLDB biobank researchers and the Institutional Ethical Committee (IEC) will not need my permission to look at my health records in respect of any further research that may be conducted in relation to it, even if I withdraw. I agree to this access. However, I understand that my identity will not be revealed in any information released to the unauthorized third parties or published.

I understand that my participation is voluntary, that it is not compulsory to take part and that, if I do take part, I may withdraw at any time. I also understand that, if I refuse to take part or if I decided to withdraw, I will not suffer any penalty, loss of rights or loss of other benefits that I have right to receive.

I understand that my biosamples can be used for academic/commercial research studies within and outside the country.

I consent to the collection, processing reporting of my personal and sensitive data for healthcare and/or medical research purposes.

I agree not to restrict the use of any data or results which arise from the study (ies), provided such a use is only for scientific purpose(s).

I agree or I agree to have my child to take part in the above study.

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*Impartial witness is required if the subject is unable to read the consent
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The investigator, or person designated by the investigator to conduct the informed consent process must sign and date form at the same time as the subject
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Date(*)
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Related Links

www.ilbs.in 

www.dbtindia.nic.in 

www.echo.ilbs.in 

www.whocc.ilbs.in

 

 

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