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Informed consent to participate in
Research of Mr. X and authorization to collect, use and share health
information
Information to consider before participating
in the research study
Title: Evaluation and comparison of
the effectiveness of a fourth-generation rapid HIV test to the conventional
ELISA technique
Overview: Through this document,
you are being requested to be a part of the research study. This document
contains vital information that would help you form a decision that whether
or not you would like to be involved in the research.
Research Authority: The research
study is headed by Dr. X, who is a Post Doc. in Molecular Medicine from the
University of Ohio and is the principal investigator for the research study.
The research would be conducted in the Biotechnology laboratory of Michigan.
Mr. A and Ms. B are also involved in the project who are Post Doc from the
University of Michigan in Molecular Medicine and are led by Dr. C, who is the
Head of the Department of the Human Genetics Department of University of
Michigan.
Study Details: The research study would
be conducted in Michigan and would be funded by the National Institute of
Health. The primary objective of the research study would be to evaluate the
effectiveness of the fourth generation HIV testing technique against the
conventional ELISA technique. The fourth generation technique has been
studied to be extremely specific and twice more specific compared to the
ELISA technique. The technique has successfully passed through animal trials
and this research forms the first time when the testing would be done on
human biological samples of blood, urine and saliva.
Participants: You are requested to
be a part of the research study because you are eligible in terms of the
following parameters:
You belong to the age group that comprises
of the highest reported case HIV/AIDS
You are a healthy individual
You fall under the target community
that has the highest prevalence of HIV/AIDS as per global statistics
Voluntary Participants:
Benefits, Compensation and Risk:
Confidentiality:
Reason for Participation:
Procedure:
Total Participants:
Voluntary Participation/ Option for
withdrawal:
Added Benefit:
Involved Risks:
Remuneration:
Involved expenditure:
Reimbursement in case of injuries:
Privacy:
What if a novel information becomes
available?
Query addressal:
Authorization to use and disclose HIPAA
language:
Consent to Take Part in
Research and Authorization for the Collection, Use and Disclosure of Health
Information
It is up to me to decide whether I want to agree to allow my blood/tissue
to be used and stored for future research. I understand that I do not have to
agree to the use and storage of my blood/tissue in order for me to take part
in the study that has been explained to me. I agree to the choice(s)
initialed below.
_______ I agree to provide blood for use in this research project.
_______ I agree to provide blood for use in future research.
I freely give my consent to take part in this study and authorize that my health information as agreed above, be collected/disclosed in this study]. I understand that by signing this form I am agreeing to take part in research. I have received a copy of this form to take with me. _______________________________________________________________ Signature of Person Taking Part in Study Date [Authorization] Statement of Person Obtaining Informed Consent and Research Authorization I have carefully explained to the person taking part in the study what he or she can expect from their participation. I confirm that this research participant speaks the language that was used to explain this research and is receiving an informed consent form in their primary language. This research participant has provided legally effective informed consent. _______________________________________________________________ _______________ Signature of Person Obtaining Informed Consent Date ________Mr. Alexis_______________________________________________________ Printed Name of Person Obtaining Informed Consent |
