Broward Health Medical Center

Broward Health Coral Springs

Broward Health Imperial Point

Broward Health North

Salah Foundation Children’s Hospital

Broward Health Weston

Community Health Services

Broward Health Physician Group

Institutional Review Board - Human Research Protections

Supplemental Short Form Consent

Use this document when oral translation is required to obtain informed consent

Study Title:

You are being asked to participate in a research study. Before you agree, the investigator involved in this study must tell you about:

(i)	the purposes, procedures, and duration of the research;

(ii)	any procedures which are experimental;

(iii)	any reasonably foreseeable risks, discomforts, and benefits of the research;

(iv)	any potentially beneficial alternative procedures or treatments; and

(v)	how confidentiality will be maintained.

The investigator (researcher) must also tell you about:

(i)	any available compensation or medical treatment if injury occurs;

(ii)	the possibility of unforeseeable risks;

(iii)	circumstances when the investigator may halt your participation;

(iv)	any added costs to you;

(v)	what happens if you decide to stop participating;

(vi)	when you will be told about new findings which may affect your willingness to participate; and

(vii)	how many people will be in the study.

(viii)	when applicable, “A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as	required by U.S. Law. This Web site will not include information that can identify you. At most, the Web	site will include a summary of the results. You can search this Web site at any time.”

(ix) how will your personal and health information be used for research purposes

If you agree to participate, you will be given a signed copy of this document and a written summary of the research.

For questions, regarding your safety and participating in this research contact: Researcher: at

For questions regarding your rights as a research subject, contact Broward Health Institutional Review Board at 954-355-4941. The role of the IRB is to foster ethical treatment of human research participants.

Your participation in this research is voluntary. You will not be penalized or lose benefits if you refuse to participate or decide to stop.

SIGNATURE PAGE

Signing this document, means this research study including the information on page 1 have been explained to me orally in a language I can understand. By signing below, I voluntarily agree to participate in this study. In addition, I voluntarily authorize use and sharing of protected health information for research proposes.

______________________________________________________________________

Signature of Participant / Legally Authorized Representative

________________________________________________ ____________________

Print Name of Participant / Legally Authorized Representative	Date

______________________________________________________________________

Signature of Impartial Witness	(must be fluent in the subject’s own language)

________________________________________________ ____________________

Print Name of Impartial Witness	Date

*TRANSLATOR SIGNATURE IS REQUIRED FOR NON-ENGLISH SPEAKING SUBJECT

__________________________________________________________________________________________

*Signature of Language Translator (required for non-English speaking subject).

__________________________________________________	___________________________

*Print Name of Language Translator	Date

*Investigator may serve as translator

_________________________________________________________________________________________________

Subject must be given a signed copy of this short form and a summary of the research. The actual IRB approved long version consent document(s) serve as the summary of the short form.

Investigator read below

English Supplemental Short Form Revised 02/2015 Page 1 of 2

1. Subject/subject legal representative sign short form document only

2. Impartial witness sign both short form and long version consent(s)

3. Investigator sign long version informed consent document only, unless investigator is also the language translator

4. Provide subject/subject legal representative both copies of signed long version consent and short form documents

5. *Non-English Speaking subject Only-short form document must be translated into subject own language.

Additional translator signature is required.

required

SAMPLE SHORT FORM WRITTEN CONSENT DOCUMENT

Smith, Robin

2015-02-24

NBHD