Genetic Information Nondiscrimination Act Notice
TempleUniversity Institutional Review Board
Genetic Information and why it is special
During the course of this research study, which is described by title in the study-specific document attached, your genetic informationwill be collected, stored and/or analyzed as described in the Informed Consent Document. It is important for you to know the specific risks of genetics research and how you are being protected from these risks. Genetic information is different from other health information because it could be used to predict future health problems of you and/or your relatives. This information may be of interest to health insurance companies, life insurance companies, and disability insurance companies or your employer who couldpossibly use this information against you. For that reason, genetic information is considered separate from Personal Health Information which is defined on a separate HIPAA Authorization document.
How your information will be used and your rights
You should know that you have consented for your genetic information to be used in the way and for the purpose described in the attached study-specific document. Storing your specimens containing the genetic information and use in future research may be considered. You should know that current and future research is overseen by a committee called the Institutional Review Board (IRB) which works to protect the rights and welfare of research participants. The IRB may require that you be re-contacted and ask for your consent to use your specimens in a specific research study. Refusal to consent at that time will not impact on your care or result in the loss of any benefits to which are you are entitled. Also, any blood, body fluids or tissue specimens obtained for this genetics study may contribute to significant scientific or medical breakthroughs. By signing this document and participating in this study, you waive the right to seek compensation for developments made using your genetic information.
Protection of your genetic information
By signing this authorization form, you give TempleUniversity, TempleUniversityHospital and Temple University Clinical Faculty Practice Plan, the principal investigator and/or any sponsors named in the attached study-specific document permission to collect, store and/or analyze your genetic information. It is important for you to know that the recipients, and their agents or representatives, will take all reasonable efforts to maintain your genetic information in confidence, and to use appropriate safeguards to prevent further use or disclosure by those not authorized to use or disclose your genetic information. To further protect you, the GINA law was passed to keep your genetic information from being used against you. GINA stands for the Genetic Information Nondiscrimination Act which bans health insurance providers and most employers from requiring or requesting your genetic information. The law prohibits health insurers from using genetic information to decide coverage, rates or preexisting conditions. Also, employers with more than 15 employees cannot hire fire or make promotion decisions based on your genetic information.
Limitations of GINA
While GINA does help to protect you, you should know that certain information from your specimens is not protected by GINA. This includes blood counts, cholesterol tests, and liver-function tests. GINA also does not protect against analysis of proteins in your body that are related to a disease, disorder or condition that a doctor could find and use to diagnose a condition. Your health insurance company may increase your premium based on a blood test that shows that you have a preexisting disease. GINA will not protect your genetic information from being used against you by life insurance, disability insurance and long-term care insurance companies. Also, GINA does not apply to employers with fewer than 15 employees. Individuals who are or will be working for such employers are not covered by GINA protections. These limitations may affect your risk of participatingin this research.
The status of GINA and protection of your genetic information
GINA protects you as described above as of May 21, 2009 for discriminatory practice in health coverage and as of November 21, 2009 for employers with more than 15 employees.
Version: May 2009
STUDY-SPECIFIC DOCUMENT
1. RESEARCH STUDY: ______
______
2. PRINCIPAL INVESTIGATOR:______
______
3. RECIPIENTS:Sponsor:
Sponsor Agents:
TempleUniversity:
______
______
Other(s):
______
4. EXPIRATION DATE:
Signature of PatientDate
Printed Name of Patient
Signature of Personal Representative of the PatientDate
Printed Name of Personal Representative of the Patient and Relationship to Patient
Signature of Person Collecting AuthorizationDate
Printed Name of Person Collecting Authorization
Version: May 2009