Vellore Institute of Technology, Vellore

Diagnosis of diseases from serum samples

Consent / Authorization Form
If you are the legally authorized representative for a person who may take part in this study, p ermission from you is required and the assent (agreement) of your relative or ward may be re quired. When the word you" appears in this consent from, it refers to the person for whom y ou are the legally authorized representative. When the word us"/we appears in this consen t from, it refers to the people involved in the research. Background/Purpose: You are being selected to participate in this research study for no particular reason You will be given enough time to read and understand the information provided in this conse nt and authorization form. Please ask the study staff to explain any words or information that you do not understand. Serum is the liquid part of blood without the clotting factors. Serum is generally used to find any diseased condition as the body will have antibodies for any disease one will be suffering at any time. Participation in this study will involve donating blood. Objectives. The purpose of this research study is to see if you are suffering from Streptococcal infection, . Rheumatoid arthritis and Typhoid Total subjects participating in the study. Ten subjects for each disease are expected to participate in this research study. Study Procedures: If you agree to participate in this study, 10 teaspoons of blood will be drawn by venipuncture, which is a routine procedure used for obtaining blood samples. A needle is inserted into a vei n in the arm and a blood sample is withdrawn. Although one venipuncture is usually sufficien t, a second one may be necessary if the first one is not successful. Your blood will then be allowed to clot and will be later centrifuged at 3000rmp for 5minutes to separate the Serum, which will be tested with different antigen for the above mentioned di seases.

Immunological Research Your blood [may or will] be tested for the above mentioned diseases and the information obta ined [may or will] reveal if you were or are effected with any of the above mentioned disease s. These tests will reveal no other information unrelated to this study. If requested the results of the test of your sample will be discussed with you. Banking Specimens After the research all of the samples will be disposed with respect to bio-hazard waste dispos al protocols. Since there is no commercial application to our research no money will be provided to you

Risks: Blood sampling may cause fainting and some pain and/or bruising at the site on your arm wh ere the blood was taken. Although rare, an infection is possible at the venipuncture site. Benefits: In any medical research study certain benefits may be derived. Such benefits include the poss ibility that you gain knowledge of any unknown disease condition you might be suffering fro m, and that information learned during this study may help others in the future. It is possible that there will be no benefit to you for participating in this study. Voluntary Participation: Your participation in this study is entirely voluntary and you may refuse to participate or disc ontinue participation at any time without penalty or loss of benefits to which you would norm ally be entitled.

Costs/Payments: There are no costs to you for participating in this study. You will not be paid for participating in this study. Questions: If you have any questions about the research, please contact Mr. __________ at ____ & Miss _______ at _________

In Case Of Injury: In the event of illness or physical injury resulting from taking part in this research study, med ical treatment will be provided at University Hospital. You will be responsible for all costs. N o other compensation is offered by Vellore Institute of Technology or us. You have waived a ll of your legal rights by signing this form , any disputes will be handled by us.

Confidentiality of Records and Authorization to Use/Share Protected Health Informatio n for Research: If you agree to participate in this research, identifiable health information about you will be u sed and shared with others involved in this research. For you to be in this research we need y our permission to collect and share this information. Federal law protects your right to privac y concerning this information. When you sign this consent form at the end, it means that you have read this section and auth orize the use and/or sharing of your protected health information as explained below. Individually identifiable health information under the federal privacy law is considered to be any information from your medical record, or obtained from this study, that can be associated with you, and relates to your past, present, or future physical or mental health or condition. T his is referred to as protected health information. Your protected health information will be kept confidential. Your identity will not be reveale d in any publication or presentation of the results of this research. Why is it necessary to use/share your protected health information with others? The main reason to use and share your health information is to conduct the research as descri bed in this consent form. Your information may also be shared with people and organizations that make sure the research is being done correctly, and to report unexpected or bad side affec ts you may have. In addition, we may be required by law to release protected health information about you; for example, if a judge requires such release in a lawsuit, or if you tell us of your intent to harm y ourself or others. What protected health information about you will be used or shared with others as part of this research? We may use and share the results of tests, questionnaires, and interviews. We may also use an d share information from your medical and research records. We will only collect information that is needed for the research. Who will be authorized to use and/or share your protected health information? The researchers participating in the research will use your protected health information for thi s research study. University staff who supervise the way the research is done may have access to your protected health information. The researchers and their staff will determine if your protected health information will be use

d or shared with others outside for purposes directly related to the conduct of the research. With whom would the protected health information be shared? Your protected health information may be shared with: ______________________ Federal agencies that supervise the way the research is conducted, such as the Department of Health and Human Services Office for Human Research Protections, the Food and Dr ug Administration (FDA), the National Institutes of Health, or other governmental offices as required by law. All reasonable efforts will be used to protect the confidentiality of your protected health infor mation. However, not all individuals or groups have to comply with the Federal privacy law. Therefore, once your protected health information is disclosed, the Federal privacy law may n ot protect it.

For how long will your protected health information be used or shared with others? All protected health information will be destroyed by 31 December 2013.

Can you withdraw authorization to collect/use/share your protected health information ? You have the right to withdraw your permission (revoke authorization) for us to use and shar e your health information, by putting your request in writing to the investigator in charge of t he study. This means that no further private health information will be collected. Once autho rization is revoked, you may no longer participate in this research activity, but standard medic al care and any other benefits to which you are entitled will not be affected. Revoking your au thorization only affects uses and sharing of information obtained after your written request ha s been received, but not information obtained prior to that time. Even after you withdraw your permission we may continue to use and share information need ed for the integrity of the study; for example, information about an unexpected or bad side eff ect you experienced related to the study. Can you have access to your health information? At the end of the study, you have the right to see the health information however, your access may be limited while the study is in progress. Consent to Participate In Research & Authorization to Use and Share Personal Health I nformation I hereby give my consent to participate in this research study and agree that my personal healt h information can be collected, used and shared by the researchers and staff for the research s tudy described in this form. ___________________________________________ Signature of Person Obtaining Consent/Authorization __________________ Date

S.No

Name of Candidate

Contact Information

Signature with date