CONSENT FORM & HIPAA RESEARCH AUTHORIZATION ADDENDUM
For Research Approved by the
National Cancer Center Institute’s Central Institutional Review Board (NCI CIRB)
SUNY Downstate Medical Center
University Hospital of Brooklyn
Brooklyn, NY 11203
Research Study Name:
Principal Investigator:
Introduction
You are being asked to participate in a research study that was approved by the National Cancer Institute Central Institutional Review Board (NCI CIRB), which is a committee established to review and approve Research to ensure that it will be conducted in accordance with all federal, institutional, and ethical guidelines. This addendum provides additional information for you to consider.
You will be provided the following information during the informed consent process, using forms approved by the NCI CIRB:
ü the purpose of the research,
ü the expected duration of your participation in the research,
ü the procedures that will be followed,
ü any procedures which are experimental,
ü any reasonably foreseeable risks, discomforts, or benefits,
ü whether there are any potential beneficial alternative procedures or treatments, and
ü how your privacy and confidentiality will be protected and who will see your information.
Your participation in this research is voluntary, and you will not be penalized or lose benefits if you refuse to participate or decide to stop. However, any information collected about you prior to withdrawal must remain in the records, when required by the government regulations or approved by an Institutional Review Board.
Where applicable, the investigator must also tell you about:
ü any available compensation or medical treatment if injury occurs
ü the possibility of unforeseeable risks to you or to your child, if you are pregnant or become pregnant,
ü circumstances when the investigator may stop your participation,
ü any added costs to you,
ü what happens if you decide to stop participating,
ü when you will be told about new findings which may affect your willingness to participate,
ü how many people will be in the study,
ü any genetic testing that may take place,
ü whether clinically relevant research results will be returned to you and, if so, under what conditions,
ü whether it is ok to contact you in the future to seek additional information or specimens or to discuss participation in another research study, or
ü the types of specimens or information that will be collected and the time period for which they will used for research.
If you have any questions or problems, whom can you call?
ü The research
ü Research related injury
ü How to withdraw from a study / Dr. Iuliana Shapira
Office: 718-270-1500
Cell: 718-406-4359
Pager 917-218-1591
Dr. Ovadia Abulafia
Office: (718) 270-1900
ü Privacy rights
ü Your rights as a research subject / National Cancer Institute’s Central IRB: (888) 657-3711
SUNY Downstate Medical Center IRB: (718) 613-8480
SUNY HSCB University Hospital Medical Director’s Office:
(718) 270-2401
SUNY HSCB University Hospital Medical Privacy Officer:
(718) 270-7470
What information do we keep private?
Federal law protects your right to privacy concerning Individually Identifiable Health Information (IIHI). There are certain things you need to know. IIHI is any information from your medical record or obtained from this study that can be linked to you and that refers to your mental or health conditions in the past, the present or the future.
In this study, we will keep your IIHI confidential and all data will be kept in a secure, limited access location. We will not reveal your identity in any publication or public presentation of the results of the study.
For this study we will create, use or report the IIHI from your medical records or research records.
The researchers, their staff and the staff of SUNY Downstate Medical Center participating in the research will use your protected IIHI for this research study.
Your IIHI will be shared or viewed with the following persons or agencies for purposes related to the conduct of the research
· The research staff approved by the Institutional Review Board (IRB)
· The SUNY Downstate Medical Center IRB
· The National Cancer Institute Central IRB
· The sponsor(s) of this study, when applicable
· The Federal agencies that supervise the way research is conducted, such as the Department of Health and Human Services Office for Human Research Protections, the Food and Drug Administration, the National Institute of Health or other government agencies
· The Data Safety Monitoring Board that reviews the safety of this study
· The Institutional Review Board of SUNY Downstate Medical Center and the applicable DMC officials and staff who supervise the way research is done and run the business operations
· Your insurance company
· Collaborating research sites, if applicable
As required by law, your IIHI may also be shared by the research team with the relevant agency to:
· Report suspected child abuse or neglect
· Report certain communicable diseases
· Report a possible threat or harm to yourself or others
· Comply with a court ordered subpoena or other Federal/ State law.
You need to know that some of the individuals or groups mentioned above who may receive your health information may not be required by Federal privacy laws to protect your IIHI. They may share your information with others without your permission if permitted by the laws governing them. For example, the sponsor does not have the same obligations as your research team and may no longer protect your IIHI.
Some IIHI that is obtained in this study cannot be shared with you during the course of the research. However, this information can be shared with you at the end of the study.
You have a right to refuse to sign this form. While your health care outside the study, the payment for the health care and your health care benefits will not be affected if you do not sign this form, you will not be able to participate in the research described in this form.
One of the following boxes must be checked:
If this box is checked, the researchers will NOT obtain specimens for genetic testing.
If this box is checked, the researchers will obtain specimens for genetic testing, and the following applies:
After the genetic tests have been completed, we would like to be able to contact you in order to get more information from you that may be needed for this research and/or to explain the results of this research study. Under New York law, you must provide your consent to such future contact. The risks of allowing us to contact you are that we may have information that causes some emotional distress, but the benefits are that we may have information that could help you in your medical planning and decision-making.If you allow us to contact you in the future, we will not disclose your medical information, including any results of genetic tests done as part of the research study, to any member of your family for clinical, research or any other purpose, without your further specific written informed consent. If we do think that your family members could benefit from knowing any information we have received about you during this research study, we may ask you for permission to contact them, and would explain our reason for wanting to do so. But we will contact no one (other than you yourself) unless and until you specifically tell us to do so.
Please indicate below whether we have your permission to contact ONLY YOU in the future:
_____ (initials) The researchers may contact ONLY YOU in the future to obtain or share information related to genetic testing.
_____ (initials) The researchers may NOT contact you in the future to obtain or share information related to genetic testing.
One of the following boxes must be checked:
If this box is checked, the research DOES NOT involve storing specimens for research purposes
If this box is checked, the research involves storing specimens for research purposes, and the following applies:
The samples will be stored for an indefinite period of time.
The samples will be stored until they can no longer be used.
The samples will be stored until: (state the specific date, condition, or period for when specimens are destroyed, as approved by the NCI CIRB)
One of the following boxes must be checked:
If this box is checked, the research DOES NOT involve HIV Information.
If this box is checked, the research involves HIV Information, and the following notice applies:
Notice Concerning HIV-Related Information: If you are authorizing the release of HIV-related information, you should be aware that the recipient(s) is prohibited from redisclosing any HIV-related information without your authorization unless permitted to do so under federal or state law and any release pursuant to this Research Authorization is required to inform the recipient of this limitation. You also have a right to request a list of people who may receive or use your HIV-related information without authorization, as well as a list of any disclosures made pursuant to this Research Authorization. For more information about HIV confidentiality, call the New York State Department of Health HIV Confidentiality Hotline at 1-800-962-5065; for more information regarding federal privacy protection, call the Office for Civil Rights at 1-800-368-1019. You may also contact the NYS Division of Human Rights at 1-888-392-3644.
One of the following boxes must be checked:
If this box is checked, the researchers will NOT obtain video/audio records of you.
If this box is checked, the researchers will obtain video/audio records of you for the purposes of the research, and the following applies:
Only the research staff approved to be on this study may have access to the recordings. These recordings will be stored in a locked cabinet and will only be used for the research. The recordings/files will only be kept for as long as they are needed for this research. The recordings will be destroyed or stored as indicated below, after all the necessary information is collected from them:
Once the study is ended, the recordings will be destroyed
The recordings may be stored for archival purposes, and used only for the purposes approved by the NCI CIRB.
How can you withdraw from the study?
You can withdraw from the study or withdraw this authorization for the use or reporting of your IIHI. You have to write to us to withdraw. Please write to:
Dr. Iuliana Shapira
SUNY Downstate Medical Center
450 Clarkson Avenue
Brooklyn, NY 11203
If you withdraw, we will stop collecting and accessing your IIHI, but we will collect and report any adverse event (bad effect) that you had in the study. Your IIHI collected before you withdraw your authorization will still be used and reported.
If you withdraw your authorization, you can no longer be in the study.
Will it cost me money to be in this study?
You will not be charged for procedures, tests performed and for any drugs, devices, or biologics given to you for participating in this study if they are being done only for research.
While participating in this study, there are certain procedures, tests and/or drugs that may be given to you as part of usual medical treatment for your medical condition, but are NOT free of charge. We will bill your insurance provider for these costs. However, if your insurance provider decides that you are responsible for paying any of these costs, such as copayments and deductibles, we will bill you.
The SUNY Downstate Medical Center makes no commitment to provide free medical care or payment for any unfavorable outcomes resulting from participation in this research. Medical services will be offered at the usual charge. However, you are not precluded from seeking to collect compensation for injury related to malpractice, fault, or blame on the part of those involved in the research, including the hospital.
You should know that your insurance provider may refuse to pay any study-related costs for a number of different reasons. For example, if the insurance provider believes that the treatments are not medically necessary and/or are not proven effective for your condition, the insurance provider may deny payment.
You may consult with a financial counselor or reimbursement specialist to explain the costs and the insurance and reimbursement issues. The research investigator may help you find out in detail what portion, if any, of the study-related procedures your insurance will cover for your participation in the study.
If you have Medicare, you may visit the Center for Medicare and Medicaid Services website at https://www.cms.gov/Medicare/Coverage/ClinicalTrialPolicies/index.html for further information about Medicare Clinical Trial Polices. If you do not have internet access, please use any public library or ask a family member to help you.
CONTACT INFORMATION: Before signing this form, please provide your contact information:
Address:______
______
______
______/ Telephone:
______(daytime)
______(evening)
**Email Address (optional):
______
** Your e-mail address will not be used for insecure communications of IIHI.
Consent and Authorization
By signing this consent form you accept that you read this form, or had it read to you. You agree to be in the study and authorize the use and reporting of your individual identifiable health information (IIHI) as explained in this form. You will not be giving up any of your legal rights by signing this consent. We will give you a copy of this form and of DMC’s Notice of Privacy Practice.
Signatures
______Print the Name of the Research Participant / ______
Signature of the Adult Research Participant
I have read this form and all of my questions about this research have been answered to my satisfaction. (A child does not sign this form)
By signing, I acknowledge that I have read the consent and accept all of the above and volunteer to participate in this research study. My contact information is provided above. / ______
Date Signed
Time:
____:____am/pm
(hh:mm)
______
Print Name of Interpreter
(Applicable when the person authorizing the research has limited English proficiency) / ______
Signature of Interpreter (if applicable)
I have provided interpreter services to convey all of the information on this form to the person authorizing the research. I have assisted the investigator explaining the research study and have assisted in answering all questions to the satisfaction of the subject. I am satisfied that the research participant understands this information and is voluntarily participating in this study. / ______
Date Signed
Time:
____:____am/pm
(hh:mm)
______
Print Name of Impartial Witness / ______
Signature of Impartial Witness
I was present during the entire consent process. The person authorizing the research voluntarily consented to this research and all questions were answered. The consent process was adequate and the information was accurately convened. / ______
Date Signed
Time:
____:____am/pm
(hh:mm)
______
Print Name of Investigator Obtaining Informed Consent / ______
Signature of Investigator Obtaining Informed Consent
In addition to advising the person authorizing the research about any appropriate alternatives to research participation, I have offered an opportunity for further explanation of the risks and discomforts which are, or may be, associated with this research, and to answer any further questions. / ______
Date Signed
Time:
____:____am/pm
(hh:mm)
DISTRIBUTION: