OMB Control Number: 0925-0216 Expiration Date: 10/2016
Public reporting burden for this collection of information is estimated to average 15 or 10 minutes per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to: NIH, Project Clearance Branch, 6705 Rockledge Drive, MSC 7974, Bethesda, MD 20892-7974, ATTN: PRA (0925-0216). Do not return the completed form to this address.
We thank you for participating in the Framingham Heart Study. Your clinic appointment is scheduled for at .
You should bring slippers and if you choose, bring your own robe. In order to perform certain tests, we ask that you NOT eat after 8:00 P.M. the previous evening. You may have water, decaffeinated black coffee or tea (no creamer, milk or sugar) that evening and again in the morning before your appointment. A urine sample will be collected when you arrive.
Please do not wear jewelry because of the Bone Density Scan.
Please take any prescription medications, as you normally would.
Using
the enclosed
MEDICATION
BAG,
please
bring
all prescription
and nonprescription
medications
you currently
take
or have
taken
in the
past month
in their
original
containers.
PLEASE BRING THIS LETTER WITH YOU TO THE CLINIC. If you need help
If you have any questions, please call Maureen Valentino, Project Coordinator at
(508) 935-3417 locally and for long distance at (800) -536-4143
Doctor’s Name Doctor’s Address & Phone #
Hospitalizations,
Emergency
Room
Visits,
or
Day
Surgery
Since
Your
Last
Clinic
Visit
Date Reason Hospital Name & Address Doctor’s Name
Date Reason Doctor’s Name
RESEARCH SUBJECT'S AUTHORIZATION
FOR RELEASE OF HEAL TH IN FORMATION FOR RESEARCH PURPOSES
Name of Research Study: Framingham Heart Study
IRB Number: H-32132
Subject's Name: ------------- Birth Date: --------- We want to use your private health information in this research study. This will include
bot h information we collect abo ut you as part of this study as well as health information abo ut you that is stored in your medical record. The law requires us to get your authorization (permission) before we can use your information or sha re it with others for research purposes. You ca n choose to sign or not to sign this authorization. However, if you choose not to sign this authorization, you will still be able to take part in the research study. Whatever decision you make abo ut this research study will not affect your access to medical care.
Section A:
I authorize the use or sharing of my health info r mation as described below: Who will be asked to give us you r health information:
Who will be able to us e your health information for research:
We may also be asked or required by law to sha re your health information with the following people if they request it. Once we give it to them, your information is no longer protected under the federal Privacy Rule. However, its use and further disclosures remain limited as stated in your Info rmed Consent Form as part of BUMC Institutional Review Board oversight.
Other governmental agencies that oversee research
Research Priva cy Authorization ;
page 1 of 3
IRB APPROVAL DATE : 01/16/2013
Section B: Description of information:
(l)If you choose to be in this study, the research team needs to collect information about you and your health. This will include information co llected during the study as well as information from your existing medical records
from through _
Your health information will be used and sha red with othe rs for the following
s tudy- related purpose(s):
Data Analysis of Results
Specific description of info rmation we will collect:
Face sheet
Discharge Summary
ER Reports
Ad mission Notes
Progress Notes
Operative Reports
Pathology Reports
Echocardiograms
X-Rays
EKGS
EEGs -
CT Scans
MRI/MRAs
Mammograms
Lab Reports
Consults
Cardiac Catheterization Reports
Exercise Tolera nce Tests
Nursing Home notes
Notes Near Time of Death
Arteriography
PA gram
Other: For example Venous Ultrasound, V/Q Scan etc.
Research Privacy Authorization;
page 2 of 3
IRB NUMBER: B-32132
IRB APPROVAL DATE: 01/16/2013
Section C: General
Ex pi ration:
This authorization expires at the end of the study
Right To Revoke:
You may revoke (take back) this authorization a t any time. To do this, you must ask
us the Framingham Heart Study for the names of the Privacy Officers at the inst itutions where we got your heal h info rmation. You must then notify those
Privacy Officers in writing that you want to take back you r Authorization. If you do,
we will still be permitted to use and share the information that we obtained before you revoked your authorization but we will only use and sha re your information the way the Info rmed Consent Form says.
If you revoke this a uthorization, we may still need to share your health information if you have a bad effect (a dverse event) during the research.
Your Access to the Information:
You have the right to see your medical records, but you will not be allowed to review
your Framingham Heart Study research record until after the study is completed.
I have read this information, and I will receive a signed co py of this form.
Signature of research subject or personal re presentative Date
Printed name of personal re presentative: -------------------
Relationship to research subject: ----------------------
Please describe the personal represe ntative's authority to act on behalf of the subject:
Research Privacy Authorization;
page 3 of 3
IRB NUMBER: H-32132
IRB APPROVAL DATE: 01/16/2013
OMB No=0925-0216
File Type | application/vnd.openxmlformats-officedocument.wordprocessingml.document |
Author | William P. Castelli, MD |
File Modified | 0000-00-00 |
File Created | 2021-01-23 |