HIPAA Authorization Language
(Please note that this is part of the Bronson IRB Informed Consent Template)
Release of Protected Health Information for Research Purposes:
This section explains how your personal health information that is collected for this study may be used. The law lets us use and share health information for research, if you agree to let us do this. If you let us use and share information about you, we will protect it as required by law.
What information are you asking me to release?
The health information that may be used or disclosed (released) for this study includes
[Complete as appropriate; provide a description of information to be used or disclosed for the research project. This may include, for example, all information in a medical record, results of physical examinations, medical history, lab tests, or certain health information indicating or relating to a particular condition]
What will be done with this information?
Your information may be used and shared with others:
§ To carry out and to evaluate the results of this study
§ To make sure the study is correctly performed
§ To meet the reporting requirements of government agencies or for legal actions
Who may use or share your protected health information for this research study?
By signing this document you are giving permission to [covered entity] to use and share your health information for this research.
This information may be shared with: [complete as appropriate-see examples below]:
§ The Research team including the Principal Investigator, study coordinator, research nurses, and all other research staff; Do not list names because they may change over the course of the study; instead list them by title or category only]
§ Research teams at other institutions (if a collaborative project)
§ Sponsor of the study and/or its agents
§ Contract Research Organization
§ Outside Laboratories
§ Data Analysis, Data Coordinating Centers
§ Study Safety Monitors
§ Drug Safety Monitoring Board
§ The medical staff who are taking care of you
Others who may see your health information during this study include:
§ The Bronson Methodist Hospital Institutional Review Board and their staff;
§ Agencies of the federal, state, or local government. This includes the Food and Drug Administration (FDA), Department of Health and Human Services (DHHS) and the Office for Human Research Protection.
If the information is shared with others and leaves [Institution], we cannot promise that others will keep it private. The information will be shared only if necessary.
If the results of this study are published, or presented at medical meetings, you will not be identified in any way.
How long will this authorization last?
[List a specific time period, at the completion of the research project, or state that you do not know when the information will no longer be used therefore the information will be kept for an indefinite length of time]
What happens if I do not give authorization or want to stop a previous authorization?
You can refuse to release your personal health information for this study. If you
decide not to permit the release of your information:
§ You will not be able to take part in the study.
§ Your medical care outside of this study will not change
§ Your medical care benefits will not change
You can change you mind and decide to withdraw your consent for the release of this information. You can stop collection of the information for study purposes by contacting the PI, preferably in writing, at [PIs name, phone number, and address]. If you decide to withdraw your consent for the release of this information:
§ We will stop collecting your medical information, and
§ Any information that was collected before you withdrew your consent will be used and seen as described above.