Committee for the Protection of Human Subjects
Short Form Oral Consent Process and Form
Non-English Speaking Participants or Non-native Speakers
Investigators are strongly encouraged to recruit and include all segments of our community in research, including
individuals whose primary language is not English. Participants who do not understand English should be presented with
a consent document written in a language understandable to them.
The Stevens’ IRB and OHRP encourage the use of a full consent form translated into the participant’s language
whenever possible.
However, with the prior approval of the IRB, federal regulations permit the use of a short form consent process (45 CFR
46.117(b) (2) and 21 CFR 50.27(b) (2)).
The IRB determines if use of the short form consent process is appropriate and can be approved.
If a non-English speaking participant is initially consented for a study through an approved short form process, to the
extent the study includes ongoing interventions or interactions with the participant, investigators will assess the
feasibility of translating the full English consent into the participant’s language whenever possible.
A description of the process used to obtain the short form consent should be provided in the "consent background" of
the protocol application. The IRB expects the investigator to have an understanding of the short form process as follows:
 If the Person Obtaining Consent is not fluent in the participant's language, an interpreter must be present to
assist in the consent process
 The interpreter must be fluent in English and the language of the participant. A family member may be the
interpreter only if the participant has declined use of the interpreter provided by the investigator.
 If the participant agrees to take part in the study, the following signatures are required:
o Short Form (translated):
i) Participant or participant's legally authorized representative [LAR]
ii) Witness *
o Summary Form (English):
i) Person obtaining consent
ii) Witness *
 The participant should be given a copy of both the translated Short Form and the Summary Form
* The witness may be the interpreter, study staff, a family member, or other person conversant in both English and the
participant’s language.
45 CFR 46.117(b) (2) - A short form written consent document stating that the elements of informed consent required by §46.116
have been presented orally to the subject or the subject's legally authorized representative. When this method is used, there shall
be a witness to the oral presentation. Also, the IRB shall approve a written summary of what is to be said to the subject or the
representative. Only the short form itself is to be signed by the subject or the representative. However, the witness shall sign both
the short form and a copy of the summary, and the person actually obtaining consent shall sign a copy of the summary. A copy of
the summary shall be given to the subject or the representative, in addition to a copy of the short form.
Created: August 2012
Review/Revision History:
Consent to Participate in Research
You are being asked to participate in a research study. The title of the study is:
__________________________________________________________________________________________________
__________________________________________________________________________________________________
__________________________________________________________________________________________________
Before you agree, the investigator 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.
Where applicable, the investigator 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.


If you agree to participate, you must be given a signed copy of this document and a written summary of the
research.
If you have any questions, concerns or complaints about this research study, its procedures, risks and benefits,
or alternative courses of treatment, you should:
o ask the Protocol Director, ___________________________________________
o contact him/her now or later at ______________________________________
If you are not satisfied with the manner in which this study is being conducted, or if you have any concerns, complaints,
or general questions about the research or your rights as a research study subject, please contact the Stevens
Committee for the Protection of Human Subjects at 201.216.5280 and speak to the CPHS coordinator. You may also
submit written comments to: The Office of Sponsored Projects, Stevens Institute of Technology, 9 th Floor Howe Center,
Hoboken, New Jersey 07030
Your participation in this research is voluntary, and you will not be penalized or lose benefits if you refuse
to participate or decide to stop.
Signing this document means that the research study, including the above information, has been described
to you orally, and that you voluntarily agree to participate.
_______________________ ____________ _______________________ ____________
Signature of participant
Date
_______________________________________________________________________
Signature of witness
Date
(e.g., staff, interpreter, family member, or other person
who speaks both English and the participant’s language)
ALL RESEARCH PROJECTS THAT ARE CARRIED OUT BY INVESTIGATORS AT STEVENS INSTITUTE OF
TECHNOLOGY ARE GOVERNED BY REQUIREMENTS OF THE UNIVERSITY AND THE FEDERAL GOVERNMENT.
ANY QUESTIONS REGARDING MY RIGHTS AS A RESEARCH SUBJECT MAY BE ADDRESSED TO THE STEVENS
COMMITTEE FOR THE PROTECTION OF HUMAN SUBJECTS AT 201.216.5280.
Created: August 2012
Review/Revision History:
Created: August 2012
Review/Revision History: