University of Southern Maine SAMPLE CONSENT FORM Format

Revised January 2018

Boston College[SAMPLE] Child Assent Form

The format may be modified or expanded, but the consent form is to contain all the elements included below. Please revise the language so that it is appropriate for the age of the participants. Starred (*) items may be omitted if they do not apply), however, the IRB may require that they be included. The heading should include the following:

Heading (e.g. Boston College School of Nursing)

Assent toParticipate in [Title of Study]

[Name of Investigator]

Child assent ages 12-17

Introduction

You are being asked to be in a research study of [insert general statement about study]. Taking part in this study is voluntary.
You were selected as a possible participant because [explain how subject was identified, include any exclusionary criteria].
Please read this form and ask any questions that you may have before agreeing to be in the study.

Important Information about the Research Study

The purpose of the study is to [briefly describe the study purpose]. If you decide to participate, you will be asked to [do what, when, where, and how]. This will take approximately [period of time].
Risks or discomforts from this research include [briefly describe].
The study will [description of potential direct benefits to subjects – or no benefits].
Taking part in this research project is voluntary. You don’t have to participate and you can stop at any time.
Please take time to read this form and ask questions before deciding whether to take part in this research project. [ES1]

Purpose of Study[ES2]:

The purpose of this study is [explain research question and purpose in lay language].
Other people being asked to be in the study are from [state what area(s) they are from] OR The total number of people in the study will be about [insert number].

Description of Study Procedures:

If you agree to be in this study, we would ask you to do the following things: [explain procedures and tasks; identify any procedures that are experimental; describe length of time for participation, frequency and duration of procedures; etc.]
[If applicable, explain any alternative procedures or courses of treatment available to the subject.]
[For studies involving the collection of sensitive information or questions that may be upsetting, include examples of the types of questions that will be asked, or describe the sensitive topic areas that are involved.]
[If applicable, include a statement about whether research results will be shared with the subject and under what conditions.]

Risks to Being in Study:

The study has the following risks. First, [explain first risk, including the likelihood of the risk]. Second, [explain second risk, including the likelihood of the risk]. Third, …

[If there are no foreseeable risks, state as such] There are no reasonable foreseeable(or expected) risks. There may be unknown risks.

Benefits of Being in Study:

The benefits of being in the study are [explain benefits of participation that will be gained by the participants and/or others].

[If there are no expected benefits, state as such.]

Payments:

You will receive the *****for being in the study: [*****explain amount of payment or other reimbursement information (e.g., class points, tokens, donations, etc.), as well as when payment and/or reimbursement will occur].If there will be no payment, state this.

Costs:

There is no cost to you to participate in this research study.

Confidentiality:

The records of this study will be kept private. We will not let anyone else see personal information about you. Research records will be kept in a locked file. Only the researchers will be able to access the research records – but you should know some officials at Boston College or people who are paying for this study may also ask to see the records as well.

[If audio or video tape recordings are made, explain specifically who will have access to them, if they will be used for educational purposes, and when they will be erased/destroyed.]

What will happen to the information we collect about you after the study is over?

I/we will/will not keep your research data to use for [future research or other purpose].
Your name and other information that can identify you will be kept secure and stored separately from the research data collected as part of the project. [OR] Your name and other information that can directly identify you will be deleted from the research data collected as part of the project.
I/we may share your research data with other researchers without asking for your consent again, but it will not contain information that could directly identify you. [If data must or will be deposited in a public or other repository, briefly describe]. [OR] We will not share your research data with other investigators.

Voluntary Participation/Withdrawal:

Your participation is voluntary.
You are free to stop being in the study at any time for any reason.
There isno penalty if you do not take part or if you decide not to continuebeing in the study. [For studies with students, state that the subject does not jeopardize grades nor risk loss of present or future faculty/school/University relationships [Explain any consequences (e.g., adjusted monetary benefits) due to early withdrawal.]

Dismissal From Study:

If you do not follow the instructions you are given you will be dismissed from the study. OR If the study sponsor decides to stop or cancel the study you will be dismissed from the study. OR etc.

Contacts and Questions:

The researchers conducting this study are [insert name(s) of investigators, including the PI]. For questions or more information concerning this research you may contact her/him/them at [telephone number or other way to contact person].
*If you believe you may have suffered a research related injury, contact [specify name, usually researcher] at [telephone number] who will give you further instructions.
If you have any questions about your rights as a research subject, you may contact: Director, Office for Research Protections, Boston Collegeat (617)552-4778,

Copy of Consent Form:

You will be given a copy of this form to keep for your records and future reference.

Statement of Consent:

For Oral Child Assent: This form was read to the subject and/or the subject has read this form. An explanation of the research was given and questions from the subject were solicited and answered to the subject's satisfaction. In my judgment, the subject has demonstrated comprehension of the information.

Signatures/Dates(Delete this section if the IRB approves oral assent).

Study Participant (Print Name):

Study Participant (Signature):

Witness/Auditor (Signature): Date:

[ES1]Please note: this “concise statement” is a recommendation that is part of the Revised Common Rule, effective as of 1/19/2018. If your consent form is already concise (3 pages or less), you do not have to include this additional section.

[ES2]If you insert the “concise statement” section above, you can use this section to provide additional details.