Ana G. Méndez University System - Sistema Universitario Ana G

Study Title:
Investigator’s Name:
Mentor’s Name:
This consent may contain words or terms that you do not understand. Please, ask the investigator in charge
or any designated study staff to explain any word or information that you do not clearly understand. You
may take a copy of this consent to your home in order to consult with your family members or friends and
decide whether to participate or not in this study.
I. Introduction
You have been invited to participate in a research study. Before you decide to participate in this study,
please read carefully this consent. Make all questions necessary to assure your comprehension of the study
procedures, including risks and benefits.
II. Study Purpose
III. Study Participants
IV. Procedures
V. Risks
VI. Study Benefits
VII. Participant’s Incentive
VIII. Privacy and Confidentiality
Your identity will be protected (explain how it will be protected) . All identifiable information or
data will be managed confidentially as established by the HIPAA law. To comply with this statement, the
following security measures will be taken in account
. Only
will have access to data and
information. This consent sheet may be a way to identify the participant. However, the data will be stored
for a period of
. Once the study is concluded the following measures will be taken
The results obtained in this research may be published in scientific magazines or presented in medical
meetings, but your identity will not be divulgated. The information may undergo revision by the Ana G.
Mendez University System (AGMUS) Human Research Protection Board (IRB). The AGMUS IRB is a
group of people who independently reviews the research study following federal regulation requirements.
Your information will be kept as confidential as possible by law. Your authorization is valid for the
duration of the study, unless you decide to withdraw from it first. You may cancel this authorization any
time desired.
IX. Harm Compensation
In case of any physical lesion or injury caused as a result of your participation in this research
study, you will receive medical treatment, free of any cost, in a Hospital designated by each
primary institution:
Universidad Metropolitana and Campuses- Rio Piedras Medical Center Emergency Room
Universidad del Este and Campuses- University of Puerto Rico Hospital in Carolina
Universidad del Turabo and Campuses- HIMA Hospital in Caguas
In case of suffering any mental lesion as a result of your participation in this research study, you
will be provided of an initial evaluation available at your correspondent University. If necessary,
you will be referred to your primary health professional for treatment.
The Ana G. Mendez University System does not provide payment options or other types of
compensation for possible harm related to your participation in this research. For example,
salaries, time wasted or suffering. You will not receive any type of economic compensation.
However, you are not resigning to your legal rights by signing this consent.
X. Voluntary Participation
Your participation in this study is voluntary. You may choose not to participate without any penalty. If you
decide to participate, you may withdraw from the study at any time without penalty or loss of benefits.
During your participation in this study, the Principal Investigator (PI) or your representative can request for
you to withdraw.
XI. Contact Person for Information
If you have any additional questions regarding this study, your participation or if you understand that you
have suffered a lesion in your participation in the study, you may contact:
If you have any questions about your rights as a study participant, you may contact:
The Office of Regulatory Compliance
Telephone: (787) 751-0178 ext. 7195-7197
E-mail: [email protected]
XII. Consent
I have read the information in this consent or it has been read to me in an adequate way. The content of this
study has been explained to me and all questions were answered and clarified.
By signing this consent, I accept to participate in this study and also certify that my participation is
voluntary and informed.
Print Participant’s Name
Participant’s Signature
Print Investigator’s Name
Investigator’s Signature
*If the participant is a minor (under 21 years of age) the consent must be signed by a parent or legal authorized
representative, except in those cases where the Investigation is considered of high risk (45 CFR 46.408)(b).
Print Parent’s Name
Parent’s Signature
Print Representative’s Name
Representatives’s Signature