Here is the informed consent template I have (I tweaked it to make it more applicable; obviously it can be shortened or expanded as appropriate to us) – the “fill in the blanks” parts are in italics @alberto @nadia @ivan
INFORMED CONSENT FOR:
Principal Investigator’s Name, Phone, and E-mail address:
You are being asked to be a participant in a research study.
What is the purpose of this study?
The purpose of this study is [describe in lay terms the reason why the research is being conducted; what is the purpose of the study].
What will you have to do, if you agree to be in the study?
If you agree to be in this study, your part will involve [provide full detail regarding all research procedures the participant will undergo if consent is provided]
Are there any possible risks to being in this study?
If you agree to be in this study, there are no foreseeable risks to you, above those that you experience in your daily life.
Are there any possible benefits to being in this study?
There is no direct benefit to you by participating in this study OR You may benefit by being in this study by [explain how the participant may benefit if applicable]. AND/OR The results of this study will indirectly benefit the scientific field by adding new information about the topic being studied.
(include only if applicable) Will you be paid as a research participant? [NICA NOTE: NOT RELEVANT FOR US HERE IF THERE ARE NO INCENTIVES – BEER DOES NOT COUNT J ]
Yes, you will be paid [identify the amount of payment, and how it will be prorated over the course of the subject’s participation, if longer than a single session]
How will your anonymity be protected?
Use this statement if the subject’s information is not connected to their identity at all, including via use of a code, other label, or IP address: Your name will not be linked in any way to the information you provide. Your consent form will be kept separate from your study information.
OR , If data will be connected in any way to the subject’s identity:
We will make every effort to protect the confidentiality of study information that identifies you [add specific details and any security measures for electronic data-password protection, encryption etc].
Your information will be viewed by the study team and other people within [name of institution/commissioning client/publicly posted online – @matthias ] who help administer and oversee research. If information from this study is published or presented at scientific meetings, your name and other identifiable information will not be used. [Modify as applicable to the study]:
Important Contact Information
Please contact the [Principal Investigator Name] via e-mail at [E-mail address] if you have any questions about the study, or if you believe you have experienced harm or injury as a result of being in this study.
Your participation is voluntary!
Your participation in this study is voluntary. You may decide not to participate at all or, if you start the study, you may withdraw at any time without any penalty.
Signing your name below indicates that you (a) have read this consent form, (b) you agree to be a participant in this study, and (c) you are over [X] years old.
Participant’s Signature Person Obtaining Consent
Printed Name Printed Name