ORAL CONSENT SCRIPT TEMPLATE
INSTRUCTIONS
Oral Consent Template. This template should be used for oral consent for survey studies ONLY. It will guide you through writing the consent script. There is an additional document that will be helpful in writing the consent document:

Glossary Of Terms For Use In Preparing Informed Consent Documents
( http://www.einstein.yu.edu/docs/administration/institutional-reviewboard/forms/consent-glossary.pdf) .
The template contains language that meets OHRP and HIPAA requirements. There are some additional elements that may or may not apply to your study. We note in this template where they should be inserted if they apply.
Consent language.
We have provided suggested language for required and additional consent elements, but this language can be tailored to fit your specific study.
Instructions for use of the template.

DELETE THE INSTRUCTION PAGE BEFORE SUBMITTING THE CONSENT
DOCUMENT TO THE IRB.

DO NOT ADJUST THE MARGINS OF THE CONSENT TEMPLATE.

For new studies, use the most updated version of the consent template available on the IRB website.

Instructions within the template appear as comment bubbles. If the complete text of the instructions does not appear, click on the
…
to view the text. o Certain sections have DELETE IF NOT APPLICABLE in the comment bubble. Delete the not applicable sections. o Comment bubbles will not appear in the IRB-stamped document and may be left in the document.

The places you must insert your own study-specific language are in bolded in brackets [like this] .
Einstein IRB Oral Consent Script v. 4/11/2016

ORAL CONSENT SCRIPT
[Greeting] . My name is [name] , and I am from [Einstein/Montefiore/YU School] 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 participate, it is your choice.
Your decision will not affect your rights or benefits [or your access to care].
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/number of phone calls …] .
You may be uncomfortable answering some questions. You do not have to answer all the questions and you may stop at any time.
You may [describe direct personal benefit].
You will receive no direct benefit from this study.
We will/will not pay you to join this study.
We will do our best to keep your information safe by not writing down your name/using a special code We do/do not plan to share the information from this study with other researchers. Your study information will be kept as long as it is useful for this research.
There are several people and groups who may see your study information in order to make sure the study is being done correctly. This includes:

the research team and staff who work with them

the organization that funded the research [NAME]

organizations and institutions involved in this research: [LIST]

groups that review research such as the Einstein IRB, and the Office for Human
Research Protections
These people who receive your health information, may not be required by privacy laws to protect it and may share your information with others without your permission, if permitted by laws governing them. All of these groups have been asked to keep your information confidential.
If you change your mind a nd don’t want your information used for the study anymore, you can call the person in charge of this study. His/her name is [PI’s name] and she/he can be reached at [xxx-xxx-xxxx] . Or, you can call Einstein Institutional Review Board at 718-430-2253. They will let you know how to write to the Principal Investigator to let her/him you want to stop participating. Just remember, if we have already used your information for the study, the use of that information cannot be cancelled.
Do you have any questions? You may ask me now, or contact [ PI’s name] about your questions or problems with this study.
May I begin?
Page 1 of 2 Einstein IRB Oral Consent Script v. 4/11/2016

CONSENT TO PARTICIPATE
_________________________
Printed name of participant
_________________________ ________________________________________
Printed name of the person conducting the consent process
Signature
_________
Date
_________
Date
Einstein IRB Oral Consent Script v. 4/11/2016 Page 2 of 2