Submit Consent Documents in Microsoft WordONLY
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Approval date:
Approved consent version No.:

JOHNSHOPKINSBLOOMBERGSCHOOL 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.
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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”, 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 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. For questionnaires, be sure to state that subjects may refuse to answer any question(s) that they do not wish to answer.

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.

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.

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 Johns Hopkins School of Public Health Institutional Review Board (IRB) at 410-955-3193, 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>?

Insert an identifier such as version number and/or date