IRB Office Use Only

Oral Consent Script 2_Int’l Sensitive Info
DO NOT USE TO ENROLL PARTICIPANTS
(Once approved, IRB logo goes here) / Approval date:
Approved consent IRB version No.:

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; include “Johns Hopkins” if appropriate

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:

Study Title:

IRB No.:

PI Version/Date:

[Greeting]. I am from [Johns Hopkins/Collaborating Organization] and would like to talk to you about [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 work because you [explain why]. You do not have to join, it is your choice.

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.] We will/will not share this information with other researchers.

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 not let anyone outside our work see your [answers, health 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.] When we share your information with other researchers, we will ask them to 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 Ethics Committee which approved this study about any problems or concerns at [provide name of EC and telephone number/email address.]

May I begin?

Oral Consent Script2_Int’l Sensitive Info_10Jun2015