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«Adolescent Assent Form Template ADOLESCENT ASSENT FORM TEMPLATE GENERAL REMARKS This assent form template is intended to assist investigators to ...»

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“It is not very well known how [drug name] will affect a pregnancy or the developing baby. If I am getting my menstrual periods I must agree to undergo pregnancy testing using a blood or urine sample ____ times or more, depending on how long I am in the

–  –  –

study. If I am sexually active, I must use a study-approved birth control method and agree to try not to get pregnant during the study.

“It is important that I contact my doctors right away if I think I may be pregnant, if I have missed a period or it is late, or I have a change in my usual menstrual cycle (for example, heavier or lighter bleeding than usual, or bleeding between periods).”

If applicable:

FOR BOYS: ARE THERE RISKS IF I GET SOMEONE ELSE PREGNANT?

If applicable, explain in simple and appropriate lay terms of any possible or unknown harm that may affect a pregnancy if the participant gets someone else pregnant.

“It is not very well known how [drug name] will affect a pregnancy or the developing baby. If I am currently sexually active, I must use a study-approved birth control method, and/or agree to not try to get someone else pregnant.” “It is important that my partner contact the study doctors right away if she think she may be pregnant, if she has missed a period or it is late, or she has a change in her usual menstrual cycle (for example, heavier or lighter bleeding than usual, or bleeding between periods).”

CAN I GET BETTER BY BEING IN THE STUDY?

Explain that no one knows whether the participant will feel any better during or after the study, and that they may even feel worse. Also explain any benefits the participant may feel as well.

Include any relevant information about the nature of the potential benefits (how important are these benefits?) and the likelihood of these benefits occurring, only to the extent this applies.

Sample wording:

“No one knows whether or not I will benefit from this study. I may feel worse from participating in this study. However, by participating in this study, the study doctors hope the frequency of my seizures may be reduced.

“The study doctors hope that the information learned from this study can be used in the future to benefit other people with epilepsy.”

ARE THERE ANY OTHER TREATMENTS FOR ME?

If applicable, explain that the participant does not have to be a part of this study to receive treatment for their illness and that other treatments are available. Emphasize that they can ask

–  –  –

their doctor or their parents about any other treatments and therapies. If there are no other alternatives, state in simple and appropriate lay terms that no other treatment alternatives exist.

This section should be omitted for a study with no prospect of direct therapeutic benefit.

Sample wording:

“Participating in this study is completely up to me. If I choose not to participate in this study or to withdraw at a later date, there are other treatment options that are known to reduce the frequency of seizures available for me: (List them) If I want to learn more about these other treatment options, I may contact the study team at any time or if I prefer, speak with my parents/legal guardian and family doctor.”

WHO WILL KNOW I AM IN THIS STUDY?

Explain, in simple terms, that the patient’s confidentiality will be respected and kept. Also explain how this will be done.

Sample Wording:

“My privacy will be respected. Unless I allow them to, the study team will not tell anybody else I am or have been a part of this study. They will not release any information to anybody else that could be used to identify me, unless they are required to do so by law. For example, researchers are required to report if a participant is believed to be at risk for harming him/herself or others.

In order to protect my privacy, the study team will remove any information that may be used to identify me from any study documents, and instead of my name appearing on them, I will be identified by a specific study code number that applies only to me. Only this code number will be used on any research-related information collected about me for this study, so that my identity as part of the study will be kept completely private.

Only Dr. _______ and his research assistants will have the ability to link this code number with my personal information, and the linking information will be kept in a locked cabinet in Room _____ of the BC Children’s Hospital under the supervision and control of Dr.________.“

WHAT WILL THE STUDY COST ME?

When applicable, begin this section with a general statement that research-related care and treatment will be provided at no cost to the participant.

–  –  –

Sample wording:

“All research-related medical care and treatment and any related tests that I will receive during my participation in this study will be provided at no cost to me.” Reimbursement Stipulate whether the participant will incur any personal expenses as a result of participation.

State whether their expenses will be reimbursed, which expenses, and how they should claim for reimbursement.

Otherwise, provide an explicit statement that there will be no reimbursement for study related expenses, if that is the case.

Researchers are encouraged to cover participants’ expenses such as parking, meals, travel, supportive care medications or other incidental costs over and above those needed for standard care they would not otherwise have been required to purchase.

Remuneration State whether the participant will be paid for their participation (e.g. “I will not be paid for participating”).

If participants will be paid for participation, include the details of any honoraria/incentives to be provided.

Such payments must not be weighted toward the end of the study, as an incentive to complete participation.

State that payments will be pro-rated if the participant withdraws from the study, if this is the plan.

WHO DO I CONTACT IF I HAVE QUESTIONS ABOUT THE STUDY DURING MY

PARTICIPATION?

Sample wording:

If I have any questions or desire further information about this study before or during participation, or if I experience any side effects that were not outlined in this assent form, I can contact [insert PI or his/her representative] at (xxx) xxx-xxxx, ext. xxxx.

WHO DO I CONTACT IF I HAVE ANY QUESTIONS OR CONCERNS ABOUT MY

RIGHTS AS A PARTICIPANT?

Sample wording:

If I have any concerns or complaints about my rights as a research participant and/or my experiences while participating in this study, I should contact the Research Participant

–  –  –

Complaint Line in the University of British Columbia Office of Research Ethics by e-mail at RSIL@ors.ubc.ca or by phone at 604-822-8598 (Toll Free: 1-877-822-8598).

FUTURE STUDIES

Include these statements or statements like these and checkboxes if you are interested in recruiting the participant for future research.

Sample Wording There is a chance that during or after this study the study team will find other questions needing answers that require future studies. If I am willing to hear about these future studies I will mark the “yes” box. This does not mean that I will have to take part in a new study, just that the study team will let me know about it. If I do not want to be contacted about new studies I will mark the “no” box.”

–  –  –

ASSENT TO PARTICIPATE

This section of the consent form should start on a new page. A copy of the signed and dated assent form must be given to the participant.

Sample:

SIGNATURE Participant Assent

My signature on this assent form means:

Sample Wording (Check List):

I have read and understood this adolescent information and assent form.

• I have had enough time to consider the information provided and to ask for advice if • necessary.

I have had the opportunity to ask questions and have had acceptable answers to my • questions.

I understand that all of the information collected will be kept confidential and that the • results will only be used for scientific objectives.

I understand that my participation in this study is voluntary and that I am completely • free to refuse to participate or to withdraw from this study at any time without changing the quality of care that I receive.

I understand that I can continue to ask questions, at any time, regarding my • participation in the study.

I understand that if I put my name at the end of this form, it means that I agree to be in • this study.

I will receive a signed copy of this assent form for my own records.

I agree to participate in this study.

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