PROCEDURES
Your consent and authorization will be obtained by participating researchers who have been approved by the CSMC IRB to obtain consent. We ask for your consent and authorization to allow the Biobank to do the following:
1. Forward any remaining tissue samples to the Biobank for future research after all tests necessary for clinical purposes have been completed on your tissue. Tissues removed as part of the standard of care, which are not needed for diagnosis purposes and would otherwise be discarded, may also be collected for research under this protocol.
2. Use your past, present and future remaining tissue samples for research.
3. Obtain no more than 4 additional tablespoons (50 ml) of blood during blood draws that are needed for the treatment of your illness or that are part of your procedure. The frequency of this additional collection will be no more than every other month. If blood cannot be drawn during a routine clinical draw, research blood may be collected by an extra needle stick.
4. Provide a urine sample with your blood draw.
5. Obtain noninvasive samples that do not involve puncture of the skin or any other entry into the body. These samples may include hair and nail clippings, teeth that have fallen out naturally, saliva, placenta, amniotic fluid, dental plaque, mucosal and skin cells, sputum, stool, sweat and breath.
6. Obtain protected health information (PHI) from your medical records maintained by CSMC. As noted in the next section, your name and other identifying information will not be directly linked to your biological samples, to maximize the protection of your health information. We may collect any information from your medical records, including laboratory reports, x-rays and other radiology exams, hospital/medical records, doctor/clinic records, pathology reports, other information related to the course of your treatment (diagnosis, demographics e.g. age, gender), and genetic data that can be used to establish paternity (determine who is the father of an individual). We will not include information pertaining to your psychological well-being, illegal activity or sexual preferences, if this information existed in your medical records. If you sign this consent/authorization form, you are giving the Biobank permission to continue to collect your health information from your future medical records at CSMC indefinitely.
7. Contact you in the future to obtain health information that is not captured through your medical records, for example to better understand details of your diet.