Sistema Universitario Ana G. Méndez

(Institution)

(Campus)

(School/Department)

CONSENT

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.

  1. 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.

Theresults 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 causedas a result of your participation in this research study, you will receive medical treatment, free of any cost, in aHospital designated by each primary institution:
  1. Universidad Metropolitana and Campuses- Rio Piedras Medical Center Emergency Room
  2. Universidad del Este and Campuses- University of Puerto Rico Hospital in Carolina
  3. 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 Sistema Universitario Ana G. Méndez (SUAGM)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:

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.

[ ] I certify that I have received a signed copy of this consent

[ ]Icertify that a signed copy of this consent was provided, but I am not interested

Print Participant’s NameParticipant’s Signaturemo/day/yr

Print Investigator’s Name Investigator’s Signaturemo/day/yr

*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 Signaturemo/day/yr

Print Representative’s Name Representative’s Signature mo/day/yr

SUAGM_IRB_Consent_Parent/MinorPage 1 of 4

08/2016