IRB Office Use Only
Oral Script 6_General_Instructional
DO NOT USE TO ENROLL
PARTICIPANTS
Approval date:
Approved consent IRB version No.:
(Once approved, IRB logo goes here)
JOHNS HOPKINS BLOOMBERG SCHOOL OF PUBLIC HEALTH
ORAL CONSENT SCRIPT
This is the consent form template for creating your oral consent script. Please
review the companion “Consent Form Instructional Template” for guidance.
Delete this box and all other guidance boxes
Insert an identifier in the footer such as version number and/or date on the first
page
If there are more than one consent form, identify each document by the
population who will sign it, for example, “Adult Controls”, “Parents”, “Teachers”,
“Cases”, “Controls”, etc.
<<Insert Type of Consent Document here>>
Study Title:
Principal Investigator:
IRB No.:
PI Version/Date:
Investigators are expected to write consent forms in simple language. The
preferred reading level in the US is 8th grade. Check the instructional template
for guidance about assessing reading levels.
PURPOSE
You are invited to take part in a research study. The purpose of this study is…
Explain to the subject why s/he is being invited to participate.
PROCEDURES
Briefly describe procedures, where they will take place, and how long the interaction will
last. For questionnaires, be sure to state that subjects may refuse to answer any
question(s) that they do not wish to answer.
Oral Consent Script 6_ General Template_Instructional_10Jun2015
IRB Office Use Only
Oral Script 6_General_Instructional
DO NOT USE TO ENROLL
PARTICIPANTS
Approval date:
Approved consent IRB version No.:
(Once approved, IRB logo goes here)
RISKS/DISCOMFORTS
All research studies have some degree of risk or discomfort. Time burden and
discomfort during interviews using sensitive questions are common risks and
discomforts of minimal risk studies that use an oral consent process. Address the risk of
breach of confidentiality. Explain how you will protect the information and that when you
share it with other researchers, you will ask them to use the same protections.
BENEFITS
Describe any benefit to the participant from the study. If there is no direct benefit to
subject, state that:
“There is no direct benefit to you from being in this study.”
Describe the potential benefit to society in the future as a result of information gathered
in the study.
PAYMENT
Describe any financial or other token of appreciation you plan to give to the participant
from the study. State whether transportation or other costs incurred by the participant
will be reimbursed by the study.
VOLUNTARY PARTICIPATION
You do not have to agree to be in this study, and you may change your mind at any time.
 Call the principal investigator, <<insert name>>, at <<telephone number>> if you
have questions or complaints about being in this study.
 If you have any questions about your rights as a research participant, or if you
think you have not been treated fairly, you may call the [local IRB or Johns
Hopkins School of Public Health Institutional Review Board (IRB) at 410-9553193, or 1-888-262-3242.]
For international studies, provide appropriate local contact information.
PERMISSION TO PROCEED
Is it okay to proceed with << the survey, questionnaire, other procedures listed
above>>?
Oral Consent Script 6_ General Template_Instructional_10Jun2015