IRB Office Use Only
DO NOT USE TO ENROLL
PARTICIPANTS
Approval date:
Approved consent version No.:
(Once approved, IRB logo goes here)
:
ORAL CONSENT SCRIPT 4– US Based Collection of Sensitive Private
Information (surveys, focus groups, biospecimen collection – no genetics)
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Sections inside brackets should be completed/included, as appropriate,
by the PI.
Remove all boxes and instructions before printing.
Keep language at an 8th grade reading level or lower.
Insert PI name and version number in footer
<<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”, etc.
[Greeting]. I am from [Johns Hopkins/Collaborating Organization] 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 our 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.]
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. [For biospecimens] We will/will not give you the results
of the [identify biospecimen] test. We will only use this information to [insert limits to use
of biospecimen information.] When we share your information with other researchers,
we will ask them to use the same protections.
You may [describe direct personal benefit, if any]. We will use the [answers to
questions/blood from blood draw – whatever the information is] to [answer our
question/find out about…]. We will/will not share the results of the study with you.
People at [Johns Hopkins/Collaborating Institution] who work on the study or who need
to make sure the study is being done correctly may see the [answers to
questions/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.
[Address payment/cost to participants.] We will/will not pay you to help us. [We will/will
not pay you back for any travel costs. We will provide food while you are with us.]
Do you have any questions? You may contact [name and contact info] about your
questions or problems with this work. 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.]
<<Insert PI name and document name and version number >>
Oral Consent Script 4_US Sensitive Info_10Jun2015
IRB Office Use Only
DO NOT USE TO ENROLL
PARTICIPANTS
Approval date:
Approved consent version No.:
(Once approved, IRB logo goes here)
:
May I begin?
<<Insert PI name and document name and version number >>
Oral Consent Script 4_US Sensitive Info_10Jun2015