DESCRIPTION: You are invited to participate in a research study on diabetes. diabetes, including factors that may affect the development and progression of …
SAMPLE CONSENT FORM
For Prospective Collection of Medical Information/Data
DESCRIPTION: You are invited to participate in a research study on
diabetes From the information collected and studied in this project we
hope to learn more about diabetes, including factors that may affect the
development and progression of this condition
PROCEDURES: With your permission, we would like to collect health
information about you, including information about your general health
height, weight, blood pressure, results from blood tests, medications,
physical exam results related to medical treatments and care you receive
We would like to collect this information about you after each medical
visit you have for as long as you are treated at a Stanford Clinic or
hospital This study does not involve any treatment; just the collection
and study of medical information
RISKS AND BENEFITS: There are no anticipated risks associated with this
study You will not receive any direct benefit from participation We
cannot and do not guarantee or promise that you will receive any benefits
from this study
TIME INVOLVEMENT: Your participation in this study will not require more
time from
you other than for the initial visit where this study is
explained to you If you agree to participate, we will collect your
medical information from your medical record after each visit, which does
not involve any direct participation by you
PAYMENTS: You will not be paid to participate in this study
PARTICIPANTS RIGHTS: Your decision whether or not to participate in this
study will not affect your medical care If you have read this form and
have decided to participate in this project, please understand your
participation is voluntary and you have the right to withdraw your consent
or discontinue participation at any time without penalty or loss of
benefits to which you are otherwise entitled Your identity will not be
disclosed in any published and written material resulting from the study
Authorization to Use Your Health Information for Research Purposes
Because information about you and your health is personal and private, it
generally cannot be used in this research study without your written
authorization If you sign this form, it will provide that authorization
The form is intended to inform you about how your health information will
be used or disclosed in the
study Your information will only be used in
accordance with this authorization form and the informed consent form and
as required or allowed by law Please read it carefully before signing it
What is the purpose of this research study and how will my health
information be utilized in the study?
The purpose of this project is to study the causes and incidences of
diabetes and your medical information will be used to see what factors may
affect the development and progression of diabetes
Do I have to sign this authorization form?
You do not have to sign this authorization form But if you do not, you
will not be able to participate in this research study
If I sign, can I revoke it or withdraw from the research later?
If you decide to participate, you are free to withdraw your authorization
regarding the use and disclosure of your health information and to
discontinue any other participation in the study at any time After any
revocation, your health information will no longer be used or disclosed in
the study, except to the extent that the law allows us to continue using
your information eg, necessary to maintain integrity of research If
you wish to revoke your authorization
for the research use or disclosure of
your health information in this study, you must do so in writing Please
provide the written withdrawal to Dr Investigator at 1215 Welch Road,
Stanford University, Stanford, CA
What Personal Information Will Be Used or Disclosed?
Information relating to the treatment and care you receive for your
diabetes results from blood tests, physical examination results and
medications
Who May Use or Disclose the Information?
The following parties are authorized to use and/or disclose your health
information in connection with this research study:
The Protocol Director The Stanford University Administrative Panel on
Human Subjects in Medical Research and any other unit of Stanford
University as necessary
Research Staff working on this project
Who May Receive or Use the Information?
The parties listed in the preceding paragraph may disclose your health
information to the following persons and organizations for their use in
connection with this research study:
The Office for Human Research Protections in the US Department of
Health and Human Services
When will my authorization expire?
Your authorization for the
use and/or disclosure of your health information
will expire on December 31, 2100
________________________________
Signature of Participant
______________
Date
Contact Information:
Questions, Concerns, or Complaints: If you have any questions, concerns or
complaints about this research study, its procedures, risks and benefits,
or alternative courses of treatment, you should ask the Protocol Director,
Dr Investigator, 123-4567 You should also contact her at any time if you
feel you have been hurt by being a part of this study
Independent Contact: If you are not satisfied with how this study is being
conducted, or if you have any concerns, complaints, or general questions
about the research or your rights as a participant, please contact the
Stanford Institutional Review Board IRB to speak to someone independent
of the research team at 650-723-5244 or toll free at 1-866-680-2906 You
can also write to the Stanford IRB, Stanford University, Stanford, CA 94305-
5401
The extra copy of this consent form is for you to keep
________________________________ ________________
Signature of Adult Participant
Date
Source:safeguard.net
