Informed Consent Form to Participate in a Research Study

(Flesch-Kincaid Grade Level = 6)

Study Title: (Insert study title)

Principal Investigator: (Insert name, credentials and affiliations)

Co-Investigator: (Insert name, credentials and affiliations)

Sponsor/Funder(s): (Insert the name of the sponsor or funder(s) of the research)

Dear Participant/Caregiver,

Introduction

  • Introduce the researcher and their role in the study.
  • Include a statement that the individual is being invited to participate in a research project.

For example:

My name is ______. I am part of a research team at the Bloorview Research Institute at Holland Bloorview that is developing a new walker for young children. We would like to invite you and your child to take part in a research study to test the new walker. Before agreeing to take part in this study, it is important that you understand how you and your child will be involved. This consent form provides you with information to help you make an informed choice.

What is the study about?

  • Include a statement to describe the purpose of the research project and include a clinical equipoise statement in plain language.
  • Include a statement to describe the rationale for doing the research project.
  • Indicate the total number of participants involved at Holland Bloorview and at all sites.

For example:

Caregivers and therapists have told us that walkers do not always meet the needs of children and could be improved. They believe that it is sometimes hard for children to reach tables or play with their friends when using their walkers. Other children have trouble walking outdoors with their walkers. We also learned that some caregivers do not like the look of walkers and find them difficult to manage. We met with caregivers and therapists and made changes to the walker based on their comments.

We’re not sure how well this new walker works. In this study, 10 children and their caregivers will try the walker so we can learn more about this. We want to invite you and your child to be one of the families who tries it.

How will my child and I be involved in this study?

  • Include the expected duration and nature of participation.
  • Include a description of the research procedures, including an explanation of the participant’s responsibilities.

For example:

We want to invite you and your child to Holland Bloorview to meet with a physiotherapist. Your child will learn how to use the new walker. We will ask your child to get into the walker, move through a simple track in the therapy gym, get blocks from table and place them in the walker bin, and then leave the walker. Your child will also be asked to do the same things with his/her own walker.

We will also ask you if your child performed like he/she would at home or school, and ask your child to tell us if the walker helped them during the tasks.

This research session at Holland Bloorview will last one hour.

Will anyone know what I say?

  • Indicate what information [including data, audio, and video recordings] will be collected about participants and for what purpose;
  • Indicate who will have access to information collected about the identity of participants;
  • Indicate who will have access to the research records for auditing, monitoring and compliance purposes;
  • Describe how confidentiality will be protected;
  • Describe the anticipated uses of the data;
  • Indicate who may have a duty to disclose information collected and to whom such a disclosure could be made;
  • Indicate any proposed data linkages and the likelihood that identifiable data could be created through linkages;
  • Describe the measures to be undertaken for dissemination of research results and indicate whether participants will be identified directly or indirectly.

For example:

We will use a video camera to record what your child does during the meeting. We need to use the camera to review what your child did in more detail. Only researchers on the project will watch what your child did during this session. We will destroy the recording at the end of the project.

All the information we collect about you and your family will be kept confidential. We will not make public anything that might identify you or your family, unless legally required to do so. For example, the law requires us to give information about you/your child:

  • If a child has been abused;
  • If you /your child has an illness that could spread to others;
  • If you or someone else talks about suicide (killing themselves);
  • If the court orders us to give them the study papers.

Authorized representatives of the following organizations may look at your original (identifiable) medical/clinical and/or research records at the site where these records are held.

  • The Holland Bloorview Research Ethics Board who oversees the ethical conduct of this study
  • Holland Bloorview representatives to check that the information collected for the study is correct and follows proper laws and guidelines.

Additionally include organizations requiring permission for direct access to participant medical and/or research records containing identifying information e.g., permission to conduct on-site monitoring/auditing. Include a brief description of their role in the research. See suggestions below, or modify as applicable to the research.

  • (Insert sponsor name), the Sponsor of this study
  • Health Canada because they oversee the use of natural health products/drugs/devices in Canada[include for studies under Health Canada oversight]
  • U.S. Food and Drug Administration because they oversee the use of natural health products/drugs/devices in the United States[include for studies subject to US FDA oversight]

If the results of the study are published, your name will not be used and no information that discloses your identity will be released or published without your prior agreement. We must keep the research data we collect for 7 years after study completion as required by Holland Bloorview.

Do I have to do this?

  • Provide assurance that prospective participants:
  • Are under no obligation to participate;
  • Are free to withdraw at any time without prejudice to pre-existing entitlements;
  • Will be given, in a timely manner, information that is relevant to their decision to continue or withdraw from participation, and include a description of the process for this to occur;
  • Will be given information on their rights and the process to request the withdrawal of data or biological materials, including any limitations on the feasibility of withdrawals;
  • Include a statement that outlines the process for termination of participation.

For example:

You and your child do not need to do this study. It’s okay if you decide not to take part. If you decide to take part, you can change your mind at any time. Whatever you decide will not affect the services you and your child get from Holland Bloorview.

New information that we get while we are doing this study may affect your decision to take part in this study. If this happens, we will tell you about this new information and we will ask you if you still want to be in the study.

What are the risks and benefits?

  • Include a plain language description of all reasonably foreseeable risks and potential benefits that may arise, both to the participant and in general (i.e. society) from research participation;
  • Include information concerning the possibility of commercialization of research findings;
  • Include a statement to the effect that, by consenting, participants have not waived any rights to legal recourse in the event of research-related harm.

For example:

We think that using this new walker has the same risks as using your child’s current walker in the therapy gym. You and your child may not directly benefit from this research. However, we think that you and your child will help improve the walker we are designing.

If the walker works well, a company may decide to make and sell it to make money. We might even get some money by letting the company sell it. However, you and your family will not be entitled to any product rights or money from the sale of this product.

You will not waive your legal rights in the event of research-related harm if you decide to take part in this study.

  • For studies that include health assessments or testing:
  • Include a statement regarding the possibility of unexpected or ‘incidental’ findings, and describe the plan for disclosing any material incidental findings to the participant of the participant’s SDM.
  • Include a statement regarding the availability of the results of the research to participants.

For example:

If this study gives information that might be helpful to your child’s current or future health, the investigator would offer to discuss these findings with you. The investigator would first advise you of any risks and benefits of sharing this information with you. The investigator may recommend consultation with a health professional and repeat testing in a clinical setting.

You can receive a copy of the study results at the end of the study.

Do the investigators have any conflicts of interest?

  • Include a statement to identify any real, potential and perceived conflict of interest (COI) on the part of the researchers, their institutions or the research sponsor. A declaration of conflict of interest must included:
  • Identity of the person with the COI;
  • Type of incentive or inducement;
  • Its source.
  • Include a statement concerning any personal benefits that may accrue to the qualified investigator.

For example:

Some of the people doing this study may have a conflict of interest. That means that they may benefit personally, financially, or in some other way from this study.

The (insert name) is receiving personal financial payment from (identify source of funds) for (include reason) for payment. You may request any details about this payment.

Or

I (insert PI name) and the other research team members have no conflicts of interest to declare related to this study.

Reimbursement:

  • Include information about payments, including incentives for participants, reimbursement for participation-related expenses and compensation for injury.

For example:

We will pay your expenses such as baby-sitting for other children if needed. We will also pay for your gas and parking so you can attend. You will receive a $10 gift card and your child will receive a small gift as tokens of appreciation for participating in this study.

What if I have questions?

  • Provide the identity and contact information of a qualified designated representative who can explain the scientific aspects of the research to participants;
  • Provide the contact information of the appropriate individual outside of the research team whom participants may contact regarding possible ethical issues in the research.

For example:

Please call (insertname of researcher) to explain anything you don’t understand before signing the consent form. My phone number is 416-425-6220 extension 35xx. If you leave a message, I will return your call within 48 hours.

You will get a letter at the end of the study to learn about the study findings.

If you have any questions about your rights as a research participant, please contact the Holland Bloorview Research Ethics Board at 416-425-6220 ext. 3507.

INFORMED CONSENT FORM

HOLLAND BLOORVIEW KIDS REHABILITATION HOSPITAL

Re: (Insert Study Title)

Please complete this form below and return it to the researcher. You will receive a signed copy of this form.

By signing this form, I confirm that:

  • (Insert name of person obtaining consent) explained this study to me and answered all of my questions.
  • I read the attached Informed Consent Formdated (insert version date)and understand what this study is about.
  • I understand the known risks and benefitsof participating in this research study.
  • I understand that my child or I may drop out of the study at any time. My decision about taking part in the study will not affect the services my child and I get at Holland Bloorview
  • I am free now, or in the future to ask questions about the study.
  • I know that study records related to my child will be kept confidential except as described in this form.
  • I understand that information that identifies my child or family will not beshared with anyone without first asking my permission
  • I agree to participate in this study and allow/support my child’s decision to participate.

______

Participant/Caregiver’s Name SignatureDate

(please print)

I have explained this study to the above participant/caregiver and have answered all their questions.

______

Name of Person Obtaining ConsentSignatureDate

Version date: ______

Revised May 2017Page 1 of 6