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Parental Consent Document Sample with Tips

The Parental Informed Consent Template here is meant to provide guidance; it is not a required format.  Please review Basic Elements of Informed Consent for additional information.

Parental Informed Consent Document Tips

Parental consent documents explain to the parents of potential participants:

  • the nature of the research project,
  • what risks, benefits, and alternatives are associated with the research, and
  • what rights their child has as a research subject.

The consent form is one part of the dialogue that investigators have with parents.

It is recommended that forms for adult subjects be written at a 6th grade reading level or lower, which means:

  • sentences and paragraphs are short,
  • terms and concepts are simple, and
  • technical information is explained in non-technical ways.

Information should be accurate and precise. The consent form should be easy to look at, with:

  • a clear layout,
  • white-space borders, and
  • easy to read fonts.

Since this document is for the parent(s) of potential subjects, they should be directly addressed and the phrase “your child” used when appropriate; investigators are referred to as “we.”

Parental Informed Consent Document Template

PROJECT TITLE

INTRODUCTION
Your child has been invited to join a research study to look at ________________. Please take whatever time you need to discuss the study with your family and friends, or anyone else you wish to. The decision to let you child join, or not to join, is up to you.
In this research study, we are investigating/testing/comparing/evaluating __________________.

The information here should be a clear and short description of the “bottom line” of the study. Hold details of the study until later in the document.  Briefly give the subjects some background information about why this study is being done, this can inclue information about what is already known and what you hope to learn

WHAT IS INVOLVED IN THE STUDY?
Your child will be asked to  ___________________.   We think this will take him/her ___________minutes. 

Describe exactly what subjects can  expect.  Explain what will happen during the study and how the study will work.  Include everything that subjects will be asked to do.  Describe all surveys and data collection instruments that subjects will experience.  Indicate how long each survey or procedure will take and state how long (e.g. minutes, hours, days, months, until a certain event or endpoint) the subjects will be part of the study.

The investigators may stop the study or take your child out of the study at any time they judge it is in your child’s best interest. They may also remove your child from the study for various other reasons. They can do this without your consent.

If appropriate, list any additional reasons why subjects might be taken off the study.

Your child can stop participating at any time.  If your child stops he/she will not lose any benefits.

RISKS
This study involves the following risks.
Very likely: __________________
Less likely but serious: ___________________
Rare: ____________________
Other risks of this study include ____________________________.
There may also be other risks that we cannot predict. 
List the physical and non-physical risks of participating in the study above.
Non-physical risks may include  social, psychological, or economic harm; risk of criminal or civil liability; or reputation.

BENEFITS TO TAKING PART IN THE STUDY?
It is reasonable to expect the following benefits from this research: _______________________. However, we can’t guarantee that your child will personally experience benefits from participating in this study. Others may benefit in the future from the information we find in this study.

List all the benefits that might reasonably be expected from participating in the study.  First describe benefits to subjects, then describe benefits to others. If there are no benefits from participating in the research, state that fact.

CONFIDENTIALITY
Your child’s name will not be used when data from this study are published.  Every effort will be made to keep clinical records, research records, and other personal information confidential. 

We will take the following steps to keep information confidential, and to protect it from unauthorized disclosure, tampering, or damage: ___________

List all individuals and agencies who will have access to the data and records, and how data will be described if published or shared with others.  

Describe confidentiality protections here.  Explain how you are protecting the subject’s information. Give details as appropriate: for example, are data files kept in locked cabinets, are the data kept on a computer, is a password required for getting onto the system; who has access to the data, etc.

INCENTIVES
Indicate if subjects will receive anything for participating.

YOUR RIGHTS AS A RESEARCH PARTICIPANT?
Participation in this study is voluntary. Your child has the right not to participate at all or to leave the study at any time. Deciding not to participate or choosing to leave the study will not result in any penalty or loss of benefits to which your child is entitled, and it will not harm his/her relationship with _______________.
If your child decides to leave the study, the procedure is: _____________________. 
Describe procedures for withdrawing and any follow-up that you will request for subjects who withdraw early. Follow-up such as questionnaires that are part of the research cannot be forced upon subjects who wish to withdraw.

CONTACTS FOR QUESTIONS OR PROBLEMS?
Call  ____________________ at ___________________  or email___________ at ___________if you have questions about the study, any problems, if your child experiences any unexpected physical or psychological discomforts, any injuries, or think that something unusual or unexpected is happening.
Provide the name of one or more researchers who can be reached for assistance.

Permission for a Child to Participate in Research
As parent or legal guardian, I authorize _________________________________ (child’s name) to become a participant in the research study described in this form. 

Child’s Date of Birth

Parent or Legal Guardian’s Signature                         Date
___________________________________________________

Upon signing, the parent or legal guardian will receive a copy of this form, and the original will be held in the subject’s research record.