OHR-8-S
12/17/2014
IRB Control #__________
Thomas Jefferson University
“Short” Informed Consent Document for Human Subjects Research
Principal Investigator:
Telephone:
Co-Investigator(s):
Telephone:
Medical Title:
Lay Title:
You are being asked to participate in a research study. Before you agree, the investigator must
tell you about:
(i)
the purposes, procedures, and length of the research;
(ii)
any procedures that are experimental
(iii)
any expected risks, discomforts, and benefits of the research;
(iv)
any alternative procedures or treatments; and
(v)
how your confidentiality will be maintained.
Also, when necessary, the investigator must tell you about:
(i)
any available compensation and medical treatment if injury occurs:
(ii)
the possibility of unexpected risks
(iii)
reasons that the investigator may stop your participation;
(iv)
any costs that will be your responsibility;
(v)
what happens if you decide to stop participating;
(vi)
when you will be told about new findings that may affect your willingness to
continue your participation; and
(vii) how many people will be in the study.
If you agree to participate, you must be given a signed and dated copy of this document and a
written summary of the research.
You may contact ___________ at __________ any time you have questions about the research.
You may contact the Office of Human Research at 215-503-8966 if you have questions about
your rights as a research participant.
Your participation in this research is voluntary, and you will not be penalized or lose any
benefits if you refuse to participate or decide to stop participation.
Signing and dating this document means that the research study, including the above
information, has been described to you orally, and that you voluntarily agree to participate.
_____________________________________
Printed Name of Participant
_____________________________________
Signature of Participant
Date
_____________________________________
Printed Name of Witness
_____________________________________
Signature of Witness
Date
IRB Control #__________
OHR-8-S
12/17/2014
HOW TO USE THE SHORT FORM OHR-8-S
The OHR-8-S (“short form”) should be submitted to the IRB with a summary script of what will
be presented orally to the subject or legally authorized representative in the consent interview.
The summary script should cover all pertinent elements of informed consent referenced in the
short form. When using the short form, a witness who is not associated with the research study
must be present. This person can be a family relation of the subject.
The subject or legally authorized representative and the witness should sign and date the short
form. The witness and the person obtaining consent (the PI, co-I or a key personnel) should sign
and date the summary. Copies of the signed and dated short form and summary should be given
to the subject or legally authorized representative
If the study also involves collection of protected health information (PHI), the OHR-8H verbal
consent to obtain PHI also must be used in tandem with the short form and summary statement.