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 5 – US Based Collection of Personal Health Information
(PHI) from Covered Entity (Johns Hopkins Affiliated Covered Entities (JHH, JHCP,
Bayview, HCGH, etc.) or other Covered Entity)
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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”, “Adults with Condition”, “Cases”, “Controls” etc.
[Greeting]. I am from [Johns Hopkins School/Department] 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.
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.
[ 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…].
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.] When we share your information with other
researchers, we will ask them to use the same protections.
<<Always include the following sentence.>>
People at Johns Hopkins who are involved in the study or who need to make sure the study is
being done correctly will see the information.
<<Include one of the following two paragraphs depending on whether this is a single-center,
multi-center or sponsored study.>>
<<For single-center non-sponsored studies>>
People at Johns Hopkins may need to send your information to people outside of Johns
Hopkins (for example, government groups like the Office of Human Research
Protections) who need to make sure the study is being done correctly.
Page 1 of 2
Oral Consent Script 5_US_PHI from Covered Entity_10Jun2015
IRB Office Use Only
DO NOT USE TO ENROLL
PARTICIPANTS
Approval date:
Approved consent version No.:
(Once approved, IRB logo goes here)
<<For multi-center or sponsored studies>>
People at Johns Hopkins may need to send your information to people outside of Johns
Hopkins (for example, government groups like the Food and Drug Administration) who
are involved in the study or who need to make sure it is being done correctly. If the study
has a sponsor, people at Johns Hopkins will send your information to that sponsor.
These people will use your information for the purpose of the study.
We will collect information about you until the end of the study unless you tell us that you have
changed your mind. If you change your mind and don’t want your information used for the study
anymore, you can call The Johns Hopkins School of Public Health Institutional Review Board at
410-955-3193. Just remember, if we have already used your information for the study, the use
of that information cannot be cancelled.
We try to make sure that everyone who needs to see your information uses it only for the study
and keeps it confidential - but, we cannot guarantee this.
[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 contact info] about
your questions or problems with this study.
May I begin?
Page 2 of 2
Oral Consent Script 5_US_PHI from Covered Entity_10Jun2015