Approval date:
(Once approved, IRB logo goes here)
Approved Authorization IRB version No.:
IRB Study No:
Principal Investigator:
Study Title:
JHSPH IRB Study No.:
Date:
This form asks you to authorize the use of your private health information for the research study named above. A separate consent form will describe the study procedures and activities. This form tells you what information about you may be collected in the study, and who might see or use it. Johns
Hopkins has rules to protect information about you. Federal and state laws also protect your privacy.
By signing this form, you give permission for your health information to be used and shared for the purposes described below.
The people working on the study will collect information about you, including
 things learned from the procedures described in the study consent form, and
 other information including your name, address, date of birth, and other details.
The people involved in this study know how important it is to keep your health information private.
Generally, only people on the research team will know that you are in the research study and will see your information. However, there are a few exceptions such as the ones that are listed later in this form.
This Study cannot be done without your permission to give out your health information. You do not have to sign this form. The part of Johns Hopkins being asked to share your health information does not condition treatment, payment, benefit eligibility or enrollment activities on the signing of this form. However, if you do not sign this form, Johns Hopkins will not use or share your health information for this study. If you do not sign this form, you may not join the Study.
1.
<<Researcher: Insert the name of the covered entity or entities that will be providing the PHI. >> may share your health information with researchers at the Johns Hopkins Bloomberg School of
Public Health. << Researcher: If applicable, include the following sentence. >> They may also share your health information with <<Researcher: Insert the name of any collaborators or other entities that will be receiving the PHI from the covered entity (i.e. researchers outside of JHSPH, data coordinating centers who will be receiving the PHI, etc.). >>
2.
The information is needed to carry out the above Study. <<Researcher: You may add more here about why you need the information. >>
1
<<Insert some sort of document control identifier – version number/date>>

Approval date:
(Once approved, IRB logo goes here)
Approved Authorization IRB version No.:
IRB Study No:
3.
Your information that will be shared with the researchers includes: <<Fill in the types of information to be collected (i.e. name, address, phone number, birth date, diagnosis, medical history, etc.). >>
4.
The information that will be shared from your health records also will include:
<<Researcher: Select what information is needed for the above study. Delete the remaining bullet points.>>
 Entire medical record from <<insert name of provider(s)>>
 Information related to (specify) ________________________________________
 Information for the period from __________to __________________
 Other (specify) ___________________________________________
5.
In addition to the research team involved with this Study, other people at Johns Hopkins may see or give out your information. Examples include people who review research studies, their staff, lawyers, or other Johns Hopkins staff. People outside Johns Hopkins may need to see you information for this study. Examples include government groups (such as the Food and Drug
Administration), safety monitors, other hospitals in the study and companies that sponsor the study.
6.
We will use and disclose your information only as described in this form and in the Johns Hopkins
Notice of Privacy Practices; however, people outside Hopkins who receive your information may not be covered by this promise. We try to make sure that everyone who needs to see your information keeps it confidential – but we cannot guarantee this.
7.
<< Include the following provision if applicable; otherwise delete provision 7 in its entirety. >>
As a part of this Study, the research team may need to see your health care records from your other or your future health care providers.
<< Researcher: Select only one of the following two alternatives. >>
The research team will ask these other health care providers to give them ANY information about your health status or your health care.
<< OR >>
The research team will ask these other health care providers to give them information about your health status or your health care involving << Researcher: specify any particular type of health information that is appropriate. >>
<< Optional: >> You will be asked to give the researchers a list of other health care providers that you use.
You authorize your other or future health care providers to share your health information and records with the researchers as indicated above.
2
<<Insert some sort of document control identifier – version number/date>>

Approval date:
(Once approved, IRB logo goes here)
Approved Authorization IRB version No.:
IRB Study No:
8.
Your permission to use and share your health information has no time limit.
You may cancel your decision to share your health information at any time by sending a letter that includes your contact information, the study number and name of the principal investigator to:
Johns Hopkins Bloomberg School of Public Health
Institutional Review Board Office
615 North Wolfe Street, Room E1100
Baltimore, Maryland 21205-2179
Email: irboffice@jhsph.edu
Phone: 410-955-3193; Fax: 410-502-0584
If you cancel, you may not be able to stay in this Study. The School of Public Health will share your cancellation with the people at Johns Hopkins that are supplying your information to the research team as soon as possible. Once the School of Public Health tells these people that you cancelled, no new information will be collected about you. If you cancel, the research team will still be allowed to use the information that they already collected.
FOR ADULTS AND CHILDREN CAPABLE OF GIVING CONSENT
Participant’s Signature Date
FOR ADULTS NOT CAPABLE OF GIVING CONSENT
Signature of Surrogate/Guardian/Health Care Agent for Participant
____________________________________________
Relationship to Participant
Date
FOR CHILDREN NOT CAPABLE OF GIVING CONSENT
Signature of Parent Date
Signature of Legal Guardian (when applicable) Date
N OTE : A COPY OF THE SIGNED AUTHORIZATION MUST BE KEPT BY THE PRINCIPAL INVESTIGATOR ; A COPY MUST BE GIVEN TO
THE PARTICIPANT ; AND IF APPROPRIATE A COPY OF THE SIGNED AUTHORIZATION MUST BE PLACED IN THE PARTICIPANT ’ S
MEDICAL RECORD .
3
<<Insert some sort of document control identifier – version number/date>>