You and/or your child and/or the individual for whom you serve as a caregiver or legally- authorized representative are being asked to take part in a research study. (For the remainder of the document, where the text says "you", please note that it refers to either you or your child or the person for whom you serve as a caregiver/legally authorized representative.)
The purpose of this research study is to obtain a biological sample (e.g., a blood sample and/or saliva sample and/or urine sample) and personal health information from you to use in future research studies. We are doing this research study because we are trying to find out more about how and why illnesses occur in people. To do this, we will study the biological samples and personal health information from both healthy and sick people. We do not know today what health problems will be important to study tomorrow, so we would like to keep a small amount of your blood, saliva, and/or urine to study in the future.
This sample and your personal health information will be stored in the Indiana Biobank. A "biobank" is a "bank" where samples and information are stored for future research use. The biobank will be used by medical research scientists to study how and why illnesses occur. It will also help in understanding the causes of illnesses and the development of new treatments.
A "biological sample" is usually blood, but can be any body fluid such as saliva or urine. "Personal Health Information" includes such items as your name, age, gender, race, the last four digits of your social security number, and/or your medical information. It can also include data from measurements and tests that you had while participating in another research study or that were done during the course of your regular medical care or doctor visits.
Indiana University School of Medicine and its associated hospitals provide care to the community. For the purposes of this research study, if you are seen at one of these hospitals, your medical record may be accessed to obtain a limited amount of personal health information (including information such as: your medical record number, date of birth, race/ethnicity, and gender) for the purposes of the Indiana Biobank. Information including your medical record number, last four digits of social security number, date of birth, or gender may be used to access your medical record. This information will not be provided to researchers, but will only be used to help link to your information in the electronic medical record.
For the biological sample to be most useful for research, it needs to be linked to your personal health information. "Linked" means that both your personal health information and your biological sample are available at the same time. In other words, this additional information, when linked to your biological sample, will greatly increase the usefulness of your sample for medical research purposes. This is because researchers can compare how a person's biological factors affect his/her health. However, any information that can be used to identify you will only be known to and kept confidential by the Indiana Biobank staff.
NUMBER OF PEOPLE TAKING PART IN THE STUDY:
If you agree to participate, you will be one of 10,000 people per year who will take part in this research. This research project is separate from other research projects in which you may be participating.
DURATION OF YOUR PARTICIPATION:
The sample and related personal health information will be stored in the Indiana Biobank indefinitely. Your permission to allow use of your sample and information for research in the Indiana Biobank, both now and in the future, is provided by indicating below that you understand the conditions of this study and are willing to participate. .
PROCEDURE FOR THE STUDY:
To take part in this study we may collect a blood sample and/or saliva and/or urine sample from you. You may also be asked to donate a blood and/or saliva sample and/or urine sample at multiple times over the course of your medical care.
The amount of blood to be drawn is listed here:
• Less than 12 lbs. and/or up to 30 days old = up to 1ml (1/4 tsp)
• 31 days old up to 2 years old = up to 2mls (1/2 tsp)
• From 2 years old up to 6 years old = up to 5mls (1 tsp)
• From 6 years old up to 12 years old = up to 10mls (2 tsp)
• From 12 years and older = up to 20 mls (1 1/3 Tbsp)
If you are being seen at one of the hospitals, if possible, your blood will be drawn at the same time that you are having blood drawn for another purpose.
There are two ways that we can obtain a saliva sample. When possible, we will obtain a saliva sample by having you spit into a container. To do this, you will be asked to not drink, eat or smoke for approximately 30 minutes prior to giving their saliva sample. You will be asked to spit into a container until the saliva reaches a marked line in the container, which is approximately 2-
3 tablespoons of saliva. You are allowed up to 15 minutes to spit in the vial to achieve the desired amount, but the vial should be closed at 15 minutes.
In some cases, it may not be possible for the person to spit into a container. In these instances, we can obtain a saliva sample using a sponge. To do this, you will be asked to not drink, eat, or smoke for approximately 30 minutes prior to giving the saliva sample. A research coordinator or nurse will place a sponge inside your cheeks and gently move the sponge along your gums and inner cheeks for 30 seconds to soak up your saliva.
Urine will be collected using a urine collection cup.
Personal health information will also be collected about you on a questionnaire or may be obtained from your medical record. There will be no medicines to take, no tests to be performed, and no treatments provided as part of this study. Your sample and personal health information will be used for future research studies. It is not possible to identify all of the ways in which the sample will be used in the future.
You may be asked to complete an optional 3 question survey which is designed to assess the consenting process used for this study.
It is possible that you may be re-contacted to request additional information or a new blood and/or saliva sample and/or urine sample. This is optional and you may decide at that time if you wish to provide this information or sample.
STORAGE and ACCESS:
The sample that is collected will be labeled so that it can be linked to your personal medical information obtained from the questionnaire or your medical record. The sample will be stored in a secure, protected place belonging to and managed by the Indiana Biobank. To minimize
the risk of loss of confidentiality, the sample will be registered and processed by an experienced technician. No personal health information will be recorded on the sample itself. Rather, a
barcode label will be placed on the tubes containing the sample. The barcode will not have your name or any personal health information on it. The barcode is a secure, confidential way to link your sample to your personal health information.
The Indiana Biobank will be maintained and accessed only by authorized staff managed by the Indiana Biobank. Biological samples and health information in the Indiana Biobank will be made available only to medical researchers who have agreed, in writing, to follow all applicable laws and regulations regarding the use of human biological materials. The researchers will include federally funded researchers and researchers at a variety of organizations, such as universities and drug companies. The researchers will not know that the blood and health information came from you. Researchers will not be able to ask for a specific subject's information or blood sample.
Information in the Indiana Biobank will not be used for treatment purposes. Results of any research involving the Indiana Biobank will not be shared with you.
RISKS OF TAKING PART IN THIS EFFORT:
The physical risks associated with participation in this study are related to the blood draw. The process of drawing blood may cause bleeding, bruising, pain, lightheadedness, and/or some minor swelling around the area of the needle stick. Occasionally, an infection or bleeding may develop where the needle was placed in the vein. To minimize these risks, the blood specimen will be obtained by experienced technicians.
Another risk of your participation is the possible loss of confidentiality of personal and medical information. DNA, which contains the code that identifies you as a person, can be taken out of the sample. Every person's DNA is unique. Therefore, it could be used to identify you. Because genetic studies (involving the study of DNA) may be performed on your sample, it is possible that such a loss of confidentiality may reveal information that might affect your life course, employability, or insurability. Although there can be no absolute guarantee of security, every precaution will be taken to ensure that your sample and personal health information are maintained in a highly secure place and that no unauthorized person has access to your information. Since we cannot know the exact questions that will be studied by researchers in the future, we cannot tell you what specific studies will be performed on your sample.
Some de-identified data may also be provided to a government health research database for broad sharing to approved investigators. This information will be de-identified and will not contain any identifiers such as name, date of birth, address, and telephone number. There is a slight risk that there could be a breach in the security of this database system resulting in the access of information. Safeguards at the government health database are in place to minimize this risk.
BENEFITS OF TAKING PART IN THE EFFORT:
This is a research study and participation in it will not provide any direct benefit to you. The benefit of research using your sample and personal health information is to the general community and includes understanding the cause of a wide variety of illnesses and health conditions including, but not limited to, cancer, diabetes, arthritis, osteoporosis, and infectious diseases. This research is invaluable for preventing, treating, and curing future diseases.
Every effort will be made to keep your personal health information confidential. In order to protect your confidentiality we will ensure that:
1. Databases containing information obtained from the questionnaire will be maintained and accessed only by authorized staff managed by the Indiana Biobank.
2. Organizations that may inspect and/or copy your research records for quality assurance and data analysis include groups such as the study investigator and his/her research associates, the Indiana University Institutional Review Board or its designees, the study sponsor, and (as allowed by law) state or federal agencies (specifically the Office for Human Research Protections (OHRP).
3. Any published results from research on your sample will not identify you.
4. The Indiana Biobank will release your sample and medical information for research purposes only when a researcher has received approval from the Indiana Biobank Steering Committee. Researchers will receive only de-identified samples and data.
This research follows the Genetic Information Nondiscrimination Act (GINA), a federal law which generally makes it illegal for health insurance companies, group health plans, and most employers to request the genetic information we get from this research and discriminate against you based on your genetic information. For more information about GINA, you may wish to visit this website: http://ghr.nlm.nih.gov/spotlight/the-genetic-information-nondiscrimination-act-gina
ALTERNATIVES TO TAKING PART IN THE EFFORT:
The alternative to participation in this research is to not give a blood and/or saliva and/or urine sample or personal health information to the Indiana Biobank. This will not affect your participation in other research studies you are involved in or obtaining your medical care.
There is no cost to you for participating.
There is no compensation provided for participation. Donating a sample is an act purely to aid future medical research.
In the event of physical injury resulting from your participation in this research, necessary medical treatment will be provided to you and billed as part of your medical expenses. Costs not covered by your health care insurer will be your responsibility. Also, it is your responsibility to determine the extent of your health care coverage. There is no program in place for other monetary compensation for such injuries. However, you are not giving up any legal rights or benefits to which you are otherwise entitled. If you are participating in research which is not conducted at a medical facility, you will be responsible for seeking medical care and for the expenses associated with any care received.
CONTACTS FOR QUESTIONS OR PROBLEMS:
For questions about this study or an injury resulting from this study, you should contact the Principal Investigator, Dr. Anantha Shekhar, at (317) 278-6969. Additionally, you can contact Brooke Patz at 317-278-5939. If you cannot reach the researcher during regular business hours (i.e. 8:00AM-5:00PM), please call the Indiana University Human Subjects Office at
317/278-3458 or 800/696-2949.
For questions about your rights as a research participant or to discuss problems, complaints or concerns about the research study, contact Indiana University Human Subjects Office at
317/278-3458 or 800/696.2949.
VOLUNTARY NATURE OF PARTICIPATION AND WITHDRAWAL:
Taking part in this effort is completely voluntary. You may choose not to take part at this time. If you decide to participate, but later change your mind, you may withdraw permission to use your biological sample or personal data at any time by contacting the principal investigator, Dr. Shekhar, at the numbers listed below. You should ask for your sample to be discarded and/or your personal identifiers removed. This will be done; however, any research data that has been obtained from your biological sample up until that time will remain part of any research already conducted.
Due to unforeseen circumstances such as flood, fire, earthquake, tornado or electrical failure, your sample may need to be discarded.
COMMERCIAL USE OF HUMAN BIOLOGICAL MATERIALS:
As this is a research institution, biological samples obtained will be used for research purposes. It is possible that an investigator's research may lead him or her to design a product to be sold as a result of his or her work. If so, please know that you will not share in the profits or losses in the sale of these products.
AUTHORIZATION FOR RELEASE OF HEALTH INFORMATION FOR RESEARCH
You have the right to decide who may review or use your Protected Health Information ("PHI"). The type of information that may be used is described below. When you consider taking part in a research study, you must give permission for your PHI to be released from your doctors, clinics, and hospitals to the research team, for the specific purpose of this research study.
What information will be used for research purposes? The PHI that will be used for research purposes may include some or all of your health records. This includes, but is not limited to: information provided by you directly to the Research Team, hospital records and reports; admission histories, and physicals; X-ray films and reports; operative reports; laboratory reports; treatment and test results; immunizations; allergy reports; prescriptions; consultations; clinic notes; and any other medical or dental records needed by the Research Team.
Specific Authorizations: I understand that this release also pertains to records concerning hospitalization or treatment that may include the categories listed below.
• Mental health records • Sexually transmitted diseases
• Psychotherapy Notes • Alcohol / Substance abuse
• HIV (AIDS)
I have the right to specifically request that records NOT be released from my health care providers to the Research Team. However, I understand that if I limit access to any of the records listed below, I may not be able to be in this research study. I will contact the study team if I wish to limit the Research Teams' access to these records:
Who will be allowed to release this information?
I authorize the following persons, groups or organizations to disclose the information described in this Release of Information/Authorization for the above referenced research study: the Prinicpal Investigator and the Research Team, treating providers, and hospitals, clinics or other places where I have received treatment.
Who can access your PHI for the study? The people and entities listed above may share my PHI (or the PHI of the individual(s) whom I have the authority to represent), with the following persons or groups for the research study: the Research Team, IU Institutional Review Board and its designees, Research Sponsor and its representatives, Research Organizations, the Department of Health & Human Services or other US or foreign government agencies as required by law, and to the Food and Drug Administration (FDA) or a person subject to the jurisdiction of the FDA in order to audit or monitor the quality, safety or effectiveness of the product or activity.
The Research Team includes the Principal Investigator, his/her staff, research coordinators, research technicians and other staff members who provide assistance to the Research Team and the Research Sponsor, Lilly Endowment.
Expiration date of this Authorization: This authorization is valid until the research ends and all monitoring is complete.
Efforts will be made to ensure that your PHI will not be shared with other people outside of the research study. However, your PHI may be disclosed to others as required by law and/or to individuals or organizations that oversee the conduct of research studies, and these individuals or organizations may not be held to the same legal privacy standards as are doctors and hospitals. Thus, the Research Team cannot guarantee absolute confidentiality and privacy.
I have the right:
1. To refuse to sign this form. Not signing the form will not affect my regular health care including treatment, payment, or enrollment in a health plan or eligibility for health care benefits. However, not signing the form will prevent me from participating in the research study above.
2. To review and obtain a copy of my personal health information collected during the study. However, it may be important to the success and integrity of the study that persons who participate in the study not be given access until the study is complete. The Principal Investigator has discretion to refuse to grant access to this information if it will affect the integrity of the study data during the course of the study. Therefore, my request for information may be delayed until the study is complete.
3. To cancel this release of information/authorization at any time. If I choose to cancel this release of information/authorization, I must notify the Principal Investigator for this study in writing at: 410 W. 10th Street, Suite 1100, Indianapolis, IN 46202. However, even if I cancel this release of information/authorization, the Research Team, Research Sponsor(s) and/or the Research Organizations may still use information about me that was collected as part of the research project between the date I signed the current form and the date I cancel the authorization. This is to protect the quality of the research results. I understand that canceling this authorization may end my participation in this study.
4. To receive a copy of this form.