CONSENT FORM TO PARTICIPATE IN A RESEARCH STUDY



Parental Consent Form For A Child to Participate

in a Research Study

Name(s) Of Researcher(s):

Project IRB #:

Study Title:

This research study is about _________________________________/ We are doing this study to ___________________________________________________________________________.

We ask your permission for your child to take part in this research study, because they ______________________. This consent form tells you why we are doing the study, and what will happen if your child joins the study.

Please take as much time as you need to read this consent form. You can discuss it with your family, friends, or anyone you choose. If there is anything you do not understand, please ask us to explain. Then you can decide if you want your child to take part in the study or not.

Name of sponsor is providing the funding for this study.

Research studies help us to answer questions that may improve our understanding of human behavior, attitudes, beliefs, and interactions. Taking part in a research study is voluntary. You are free to say yes or no. We will only include your child in this study if you give us your permission first by signing this consent form.

Why is this study being done?

THE PURPOSE OF THIS RESEARCH IS TO [PROVIDE BRIEF, LAY EXPLANATION OF WHY STUDY IS BEING DONE].

How many children will be in this study?

About ______ children will take part in this study (Give a total number and a breakdown of numbers per location if applicable)

What will happen if my child takes part in this study?

If you agree, you child will come to ________ and do the following:

If you will be making audio or video recordings or taking photographs of participants, be sure to include that information here.

How long will my child be in the study?

Your child will be in the study for a total of ____ hours over ___ days/weeks.

OR: We will ask your child to ____ every ____ for _____ weeks/months/until a certain event.

Can my child stop being in the study?

Yes, your child can stop being in the study at any time without giving a reason. Just tell the researcher or study staff right away if your child wants to stop taking part.

Also, the researcher may decide to take your child off this study at any time, even if you and your child want to stay in the study. The researcher will tell you the reason why your child needs to stop being in the study. These reasons may be:

List circumstances as applicable:

Are there any benefits to taking part in this study?

There will/might be no direct benefit to your child from taking part in this study. However, the information we learn from your child during this study may help us better understand/learn more about _______.

Are there any risks to my child from being in this study?

Describe any reasonably foreseeable risks or discomforts to the subject. This includes any emotional/psychological risks/discomforts from questionnaires/surveys. Explain that participants may skip any questions they do not want to answer. Describe any actions that will be taken if participants experience distress during the study.

What other choices does my child have if they don’t take part?

Instead of being in this study, your child may:

List any alternatives to participation and/or the option to not take part.

Will information about my child be kept private?

[If applicable: The information we collect about your child will be stored in the researcher’s electronic/computer or paper files. Computer files are protected with a password and the computer is in a locked office that only study team members can open. Paper files are kept in a locked drawer in a locked office that only study team members can open.

We will give your child’s records a code number and they will not contain your child’s name or other information that could identify you. The code number that connects your child’s name to their information will be kept in a separate, secure location. Information that may identify your child may not be given to anyone who is not working on this study without your written consent, or if required by law.

We will do our best to make sure that your child’s personal information from this study is kept private, but we cannot guarantee total privacy. We may give out your child’s personal information if the law requires it. If we publish the results of this study or present them at scientific meetings, we will not use your child’s name or other personal information.

Include one of the two statements below, as applicable:

If participant data will be used for future research or shared with another investigator for future research studies without additional informed consent from the participant or LAR:

We will keep the information we collect from your child for this study to use in future research/to share with other investigators to use in future studies without asking for your consent again. Information that could identify your child will be removed from their research information so no one will know that it belongs to them.

OR

If participant data will not be used kept for future research or shared with other investigators for future studies: The information we collect from your child for this study will not be used or shared with other investigators for future research studies. This applies even if we remove all information that could identify your child from their information.

If you have or intend to obtain a Certificate of Confidentiality, include this language:

This research is covered by a Certificate of Confidentiality from the National Institutes of Health. The researchers with this Certificate may not disclose or use information or documents that may identify your child in any federal, state, or local civil, criminal, administrative, legislative, or other action, suit, or proceeding, or be used as evidence, for example, if there is a court subpoena, unless you have consented for this use.

Information or documents protected by this Certificate cannot be disclosed to anyone else who is not connected with the research except, if there is a federal, state, or local law that requires disclosure (such as to report child abuse or communicable diseases but not for federal, state, or local civil, criminal, administrative, legislative, or other proceedings, see below); if you have consented to the disclosure, including for your child’s medical treatment; or if it is used for other scientific research, as allowed by federal regulations protecting research subjects. 

[You may use the following language as applicable] You should understand that a Certificate of Confidentiality does not prevent you or your child from voluntarily releasing information about your child or their involvement in this research. If you want your child’s research information released to an insurer, medical care provider, or any other person not connected with the research, you must provide consent to allow the researchers to release it.

[Include this statement if researcher intends to disclose information covered by a Certificate, such as potential child abuse, or intent to hurt self or others in response to specific federal, state, or local laws.] The Certificate of Confidentiality will not be used to prevent disclosure as required by federal, state, or local law of [list what will be reported, such as child abuse and neglect, or harm to self or others]. 

[Include this statement if researcher intends to disclose information covered by a Certificate, with the consent of research participants.] The Certificate of Confidentiality will not be used to prevent disclosure for any purpose you have consented to in this informed consent document [restate what will be disclosed, such as including research data in the medical record].

_______________________End of CoC language_________________________________

If you anticipate obtaining information during the research study which might fall under mandated reporting guidelines, add this language:

We will/might collect information from you or your child that indicates the possibility of child abuse or neglect/elder abuse or neglect/intent to harm their self or others/sexual harassment/sexual violence. One or more of the study staff are mandated reporters. This means that they are required by law to report any of these findings to the appropriate state agencies. These agencies include (the select the applicable agency) the Missouri Department of Social Services/Missouri Department of Health and Senior Services/Title XI officials/other.

Add the following if photographs, audio or video recordings will be taken of subjects: You must give us permission to use the photographs/audio recordings/video recordings we take of your child during the study. You will be able to look at/listen to/watch them before you give your permission for us to use them.

Will i or my child be paid for taking part in this study?

You and your child will not be paid for taking part in this study.

OR

In return for your time and effort, and to cover your travel expenses, we will give you $___ for taking part in the study. Describe how the payment will be prorated according to the study.

OR

In return for your time and effort, you will be given any other compensation (e.g. membership to gym, gift certificate, etc.).

[If your subjects are students and they will be offered extra credit, please include the number of extra credit points. In the case where extra credit is offered, the researcher MUST offer a comparable alternate method to obtain the credit points for those who decline to participate in the research study. Describe the alternative here].

What are my child’s rights as a study participant?

TAKING PART IN THIS STUDY IS VOLUNTARY. IF YOU AND CHILD DO DECIDE TO TAKE PART, YOU BOTH HAVE THE RIGHT TO CHANGE YOUR MIND AND DROP OUT OF THE STUDY AT ANY TIME. WHATEVER YOUR AND YOUR CHILD’S DECISION, THERE WILL BE NO PENALTY TO EITHER OF YOU IN ANY WAY.

We will tell you about any new information discovered during this study that might affect your child’s health, welfare, or change your mind about them taking part.

Who can i call if i have questions, concerns, or complaints?

If you have more questions about this study at any time, you can call ____________ at _____.

You may contact the University of Missouri Institutional Review Board (IRB if you:

• Have any questions about your child’s rights as a study participant;

• Want to report any problems or complaints; or

• Feel under any pressure to have your take part or stay in this study.

• The IRB is a group of people who review research studies to make sure the rights of participants are protected. Their phone number is 573- 882-3181.

If you want to talk privately about your child’s rights or any issues related to their participation in this study, you can contact University of Missouri Research Participant Advocacy by calling 888-280-5002 (a free call), or emailing MUResearchRPA@missouri.edu.

We will give you a copy of this consent form. Please keep it where you can find it easily. It will help you to remember what we discussed today.

Signature of Parent/Guardian

CONSENT TO PARTICIPATE IN RESEARCH

By signing my name below, I confirm the following:

• I have read/had read to me this entire consent form.

• All of my questions were answered to my satisfaction.

• The study’s purpose, procedures/activities, potential risks and possible benefits were explained to me.

• I voluntarily agree to allow my child take part in this research study. I have been told that my child can stop taking part at any time.

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|Subject’s Signature |Date |

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|Signature of Witness (if applicable)* |Date |

*A witness is required when a participant is competent to provide consent but is blind, or cannot read or write.

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IRB USE ONLY

Approval Date:

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