Confidentiality of Records and HIPAA Authorization

While we will make every effort to keep information we learn about you private, this cannot be guaranteed. Other people may need to see the information. While they normally protect the privacy of the information, they may not be required to do so by law. Results of the research may be presented at meetings or in publications, but your name will not be used.

The federal Health Insurance Portability and Accountability Act (HIPAA) require us to get your permission to use health information about you that we either create or use as part of the research. This permission is called an Authorization. We will use your research record, completed study questionnaires, related information from your medical record, and printouts from the polysomnography assessments.

We will use your health information to assess your:

  • medical and psychiatric status
  • response to treatment

Health information will also be used to report results of research to sponsors and federal regulators. The data we obtain may be audited to make sure we are following regulations, policies and our study plan.

Upenn Medical Center policies allow you to see and copy the information obtained during the investigation. You may not access this information until after the study ends. If you have never received a copy of the UPenn Medical Center HIPAA Notice, please ask the investigator for one.

To meet regulations or for reasons related to this research, the study investigator may share a copy of this consent form and records that identify you with the following people: the Department of Health and Human Services, and the University of Pennsylvania.

If you decide to take part, your Authorization for this study will not expire unless you cancel (revoke) it. The information collected during your participation will be kept indefinitely. You can always cancel this Authorization by writing to the study investigator. If you cancel your Authorization, you will also be removed from the study. However, standard medical care and any other benefits to which you are otherwise entitled will not be affected. Canceling your Authorization only affects uses and sharing of information after the study investigator gets your written request. Information gathered before then may need to be used and given to others. For example, by Federal law, we must send study information to the FDA for the drug and device studies it regulates. Information that may need to be reported to FDA cannot be removed from your research records.

As stated in the section on Voluntary Participation above, you can accept or decline this consent/authorization and not be part of the study. You can also tell us you want to leave the study at any time without canceling the Authorization. By accepting this consent form, you give us permission to use and/or share your health information as stated above. If you meet criteria for a specific study you will be asked at that time to provide written consent.

I understand the advantages and disadvantages of completing these forms online.