Research Authorization Form for the Use and Disclosure of Protected Health Information
New YorkMedicalCollege
RESEARCH AUTHORIZATION FOR THE USE AND DISCLOSURE OF
PROTECTED HEALTH INFORMATION
Name of Patient/Subject: ______Med Record#______
DOB: ______Subject Study ID #:
Titleof Research Project:
Name of Principal Investigator:
Information about you and your health (Protected Health Information) is personal. We want to protect the privacy of that information. Protected Health Information may include your name, address, phone number, photograph, date of birth. We must obtain your written permission before we may use or disclose your protected health information for research purposes. This form provides that permission. It will help us make sure that you are properly informed of how this information will be used or disclosed. Please read the information before signing this form.
Who may have your protected health information?
Any of the following may have your protected health information:
New YorkMedicalCollege
WestchesterMedicalCenter
Westchester Institute for Human Development
Your doctor’s private office
What information may be used or disclosed?
The research record and information relating to the study protocol
Any medical records held by the researcher or the researcher’s private practice or related to services at a New YorkMedicalCollege affiliated hospital.
Any information showing that you have had an HIV-related test (providing you gave permission for such a test) or have HIV infection, HIV-related illness, or AIDS. Any information showing that you might have been exposed to HIV OR currently have or have had, a mental health condition.
Other information not addressed above that is required by the study (specify):
Who may receive, use or disclose your protected health information?
Your protected health information may be shared with:
The Principal Investigator, sub-investigator(s) and research team
Any health care provider who provides service to you in accordance with this study.
Authorized members of a New YorkMedicalCollege affiliated hospital’s workforce, who may need to access your information in the performance of their duties (for example: to provide treatment, to ensure integrity of the research, accounting or billing matters, etc.); and
People who represent the New York Medical College Institutional Review Board (IRB) and Office of Research Administration
In addition to the individuals mentioned above, your health information may also be shared with the following:
The study sponsor:
People and organizations working with the sponsor to conduct the study, to analyze the data, or to monitor the study (specify to the extent possible):
The U. S. Food and Drug Administration (FDA), and/or the U.S. Office for Human Research Protection of the US Department of Health and Human Services.
Other cooperating research sites (specify):
Any parties not included above (specify):
Why is your health information being used or disclosed for this research?
In this research, your health information will be collected and used to conduct the study, to monitor your health status, to measure the effects of drugs/devices/procedures, to determine the research results. It may possibly be used to develop new tests, procedures and commercial products. The study sponsor may add your study data to research databases so that it can design better research studies in the future, develop other therapies for patients, or gain a better understanding of disease.
When will this permission end?
Your health information will be kept indefinitely and this authorization will not expire.
Can you cancel this permission?
Yes. You can cancel your permission at any time in writing to:
Principal Investigator:
Address:
If you cancel your permission, we will stop collecting your health information for the study. You will not be able to continue participating in the study. The study doctors will be able to use the information already collected. Information already sent to the study sponsor cannot be withdrawn.
Can you see and copy your research records?
You may ask to see and copy your health information related to the study, but you may have to wait until the end of the study to see your study records so that the study can be conducted properly. You may also ask the researcher to correct any study related information about you that is wrong.
Do you have to sign this authorization form?
No. If you decide not to sign this form you will not be allowed in the research study. If you do not sign, it will not affect your ongoing treatment, or health plan coverage
Will your protected health information remain confidential?
While we will make every effort to maintain confidentiality of information we obtain about you, it cannot be absolutely guaranteed, in part because the study sponsor, their staff or other research sites may need to look at the information. While they normally protect the privacy of the information, they may not be required to do so by law.
Will you receive a copy of this form?
Yes. You will be given a copy.
Notice Concerning Mental Health and HIV-Related Information
If you are authorizing the release of Mental Health or HIV-related information, you should be aware that the recipient(s) is prohibited from re-disclosing any Mental Health or HIV-related information without your authorization unless permitted to do so under federal or state law. You also have a right to request, from the Principal Investigator, a list of people who may receive or use your Mental Health or HIV-related information without authorization. If you experience discrimination because of the release or disclosure of Mental Health or HIV-related information, you may contact the New York State Division of Human Rights at (212) 480-2522 or the New York City Commission of Human Rights at (212) 306-5070. These agencies are responsible for protecting your rights.
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Signature of Subject or Legally Authorized Representative
Printed Name of Subject or Legally Authorized Representative
Date
Legally Authorized Representative’s Relationship to Subject
HIPAA 05/27/08Page 1 of 3