IRB Office Use Only
Oral Consent Script 3_US Based Min Risk
DO NOT USE TO ENROLL
PARTICIPANTS
Approval date:
Approved consent IRB version No.:
(Once approved, IRB logo goes here)
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Sections inside brackets should be completed/included, as appropriate.
Keep language at an understandable reading level.
Remove this box and instructions before printing.
<<Insert Name of Consent Document>>
If there are multiple consent scripts, identify each document by the population who will sign it,
for example, “Parents”, “Teachers”, “Cases”, “Controls” etc.
PI Name:
Institution: Johns Hopkins Bloomberg School of Public Health
Study Title:
IRB No.:
PI Version/Date:
[Greeting]. I am from [Johns Hopkins School/Department or Collaborator] and would like to talk
to you about a research study on [topic of the study]. We are working to see if [hypothesis of
study w/out bias as to outcome]. We ask you to join this study because you [explain why]. You
do not have to join, it is your choice. [Your decision will not affect the care you will receive at
(Johns Hopkins or other health provider).]
If you say yes, we will ask you to [describe the study procedures, who will do them, and where
they will happen]. It will take [‘x’ amount of time/visits to your home…].
You may [be uncomfortable answering questions/feel a prick from the needle/have a bruise –
describe risk]. [For questionnaires] You do not have to answer all the questions and you may
stop at any time. There is a risk that someone outside the study will see your information. We
will do our best to keep your information safe by [not writing down your name/using a special
code/locking up the information/etc.] If we share your information with other researchers, they
will use the same protections.
[If the participant may benefit from the study, say “You may <<describe direct personal
benefit>>”; otherwise say “You will receive no direct benefit from this study.”] We will use the
information from you [answers to questions/blood from blood draw – whatever the information
is] to [answer our question/find out about…].
[Address payment/cost to participants.] We will/will not pay you to join this study. [Include as
appropriate: We will pay you back for any travel costs. We will provide food while you are with
us.]
Do you have any questions? You may ask me now, or contact [name and study contact info]
about your questions or problems with this study. You may contact the Institutional Review
Board which approved this study about any problems or concerns at [provide name of IRB and
telephone number/email address.]
May I begin?
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Oral Consent Script 3_Minimal Risk US_17Nov2011