ࡱ > > @ = [ bjbj *. ΐ ΐ 8 / $ S $ # w w ( z z z 3# 5# 5# 5# 5# 5# 5# % *( 5# z z z z z 5# J# & z v 3# z 3# V ! @ " `q p ! # p# n # " x ( ` ( " ( " z z z z z z z 5# 5# * ^ z z z # z z z z ( z z z z z z z z z : PROTOCOL TITLE:
PROTOCOL NUMBER:
PRINCIPAL INVESTIGATOR:
The word you means both the person who takes part in the research, and the person who gives permission to be in the research. This form and the attached research informed consent form need to be kept together. The words we and MEEI mean the Massachusetts Eye and Ear Infirmary.
What is the purpose of using and sharing my protected health information?
We are asking you to take part in the research study described in the attached informed consent form. We need to be able to collect, use and share your protected health information in order for you to participate in this research study.
What protected health information about me will be collected, used and shared with others during this research study?
For you to be in this research study, we need your permission to collect, use and share health information that identifies you, (your health information) which may include one or more of the following:
Demographic information, such as, but not limited to, your name, date of birth, address and other contact information such as telephone, fax, or e-mail address, gender, insurance information and Social Security number,
The results of medical tests, questionnaires and interviews, and
Information from your medical record, including your medical record number.
We will only collect, use and share information that is needed for the research.
Who will use or share protected health information about me?
We may use and share your health information with:
People at MEEI who conduct, supervise, administer, or otherwise help with the research, such as, but not limited to, physicians, researchers, research support staff, the MEEI Human Studies Committee, and MEEI staff who are involved in the administration of the research,
Other researchers and their support staff outside of MEEI, and
People outside of the MEEI who:
Administer,
Oversee or regulate,
Pay for, or
Work with us on the research.
Other external entities who provide services to support the research, such as, but not limited to, laboratories and data analysis companies.
Some of these people may share your health information with someone else. If they do, the same laws that MEEI must obey may not apply to those people, and may not protect your health information.
For how long will protected health information about me be collected, used or shared with others?
If you sign this form, we will collect, use and share your health information until the end of this research study, which may be after your direct participation in the research project ends.
Your health information may also be useful for other studies. We can only use the health information collected for this research study again if the MEEI Human Studies Committee gives us permission. This Committee may ask us to talk to you again before using or sharing the health information collected for this research study for other research purposes. However, if we meet certain requirements established by law, the Committee may also let us use and share your health information collected for this research study for additional research without talking to you again.
Health information collected as part of the research study that is also kept in your medical record for treatment and billing purposes will be maintained, used and disclosed in accordance with the policies and procedures of MEEI, and laws and regulations applicable to medical records. As a patient of MEEI, and not as part of this research study, you will receive a copy of the MEEI Notice of Privacy Practices which explains how MEEI may use and disclose health information kept in your medical record.
Can I change my mind?
If you change your mind later and do not want us to collect, use or share your health information, you need to send a letter to the researcher listed on the attached informed consent form. The letter needs to say that you have changed your mind and do not want the researcher to collect, use and share your health information. In this case, we may continue to use and share the information we have already collected about you, but we wont collect any further information about you for the research study.
Summary of privacy rights:
If you sign this form, you are giving us permission to collect, use and share your health information. If you decide not to sign this form, you cannot be in the research study. You need to sign this form and the attached informed consent form in order to participate in the research study. Whatever decision you make about this research study will not affect your access to medical care.
If you have any questions, please ask the researcher. The researcher will give you a signed copy of this form.
SIGNATURE, DATE, AND IDENTITY OF PERSON SIGNING
The health information about ________________________ can be collected, used and shared by MEEI for the research study described in this form and the attached informed consent form.
SIGNATURES:
___________________________________ DATE: _____________
Subject
OR, if applicable, signature of parent or individual authorized by the subject to make health care decisions:
___________________________________ DATE: _____________
Parent/Court-appointed Guardian/Health Care Proxy
Print Name: _____________________ Relationship: ____________
Massachusetts Eye and Ear Infirmary
243 Charles Street
Boston, Massachusetts 02114-3096
RESEARCH HIPAA AUTHORIZATION FORM
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