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ASSENT FORM Minor

This document provides guidance for investigators on creating informed assent letters for research studies involving minors. It recommends using simple, straightforward language at an appropriate reading level. The template provided should be used unless an alternative format is approved. Assent forms should include the study title, investigator contact information, purpose, procedures, risks, benefits, confidentiality measures, compensation details if any, and contact information. Participation must be voluntary and participants can withdraw at any time.

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0% found this document useful (0 votes)
44 views5 pages

ASSENT FORM Minor

This document provides guidance for investigators on creating informed assent letters for research studies involving minors. It recommends using simple, straightforward language at an appropriate reading level. The template provided should be used unless an alternative format is approved. Assent forms should include the study title, investigator contact information, purpose, procedures, risks, benefits, confidentiality measures, compensation details if any, and contact information. Participation must be voluntary and participants can withdraw at any time.

Uploaded by

Jezzant Bastasa
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
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Note to Investigators:

When creating informed assent letters, investigators are encouraged to keep language and
vocabulary as basic and straightforward as possible. Investigators are also encouraged to use this
template when creating informed assent letters. Use of alternative wording or format is permitted,
but doing so may slow down the review process. All sections of the assent form, except the "assent"
section, should be written in second person ("You are invited...").

Headers should include “Informed assent” followed by the title of the study (e.g., the header in this
document). Footers should include page numbers. If your assent letter is more than one page, the
footer should also include a space for the participant’s initials (e.g., the footer in this document).

Be sure to include any basic components of informed assent that are appropriate to your study. If
components apply to your study, they must be included. Please refer to the document entitled
“components of informed assent” for more information. If you have any further questions, contact
the Director of Research at [email protected] .

**Information in italics is for your information and should be deleted from the actual
assent form. The material in brackets should be completed with relevant information.
Adjust the format of this template accordingly**
TITLE OF STUDY

[Insert title]

PRINCIPAL INVESTIGATOR

[Name]

[Department]

[Address]

[Phone]

[Email]

PURPOSE OF STUDY

You are being asked to take part in a research study. Before you decide to participate in this
study, it is important that you understand why the research is being done and what it will
involve. Please read the following information carefully. Please ask the researcher if there is
anything that is not clear or if you need more information.

The purpose of this study is to [Briefly describe the purpose of the study.]

STUDY PROCEDURES

List all procedures, preferably in chronological order, which will be employed in the study.
Point out any procedures that are considered experimental. Clearly explain technical and
medical terminology using non-technical language, if any. Explain all procedures using
language that is appropriate for the expected reading level of participants.

State the amount of time required of participants per session, if applicable, and for the
total duration of the study.
If audiotaping, videotaping or film procedures are going to be used, provide information
about the use of these products.

RISKS

List all reasonably foreseeable risks, if any, of each of the procedures to be used in the
study, and any measures that will be used to minimize the risks.

You may decline to answer any or all questions and you may terminate your involvement at
any time if you choose.

BENEFITS

List the benefits you anticipate will be achieved from this research. Include benefits to
participants, others, or the body of knowledge. If there is no direct benefit to the
participant, state so. For example, “There will be no direct benefit to you for your
participation in this study. However, we hope that the information obtained from this
study may….”

When applicable, disclose alternative procedures or courses of treatment, if any, which


might be advantageous to participants.

CONFIDENTIALITY

Your responses to this [survey/ interview] will be anonymous. Please do not write any
identifying information on your [survey/ interview]. OR For the purposes of this research
study, your comments will not be anonymous. Every effort will be made by the researcher to
preserve your confidentiality including the following:

[State measures taken to ensure confidentiality, such as those listed below:

· Assigning code names/numbers for participants that will be used on all research
notes and documents

· Keeping notes, interview transcriptions, and any other identifying participant


information in a locked file cabinet in the personal possession of the researcher.]
Participant data will be kept confidential except in cases where the researcher is legally
obligated to report specific incidents. These incidents include, but may not be limited to,
incidents of abuse and suicide risk.

COMPENSATION

If there is no compensation, delete this section.

Indicate what participants will receive for their participation in this study. Indicate other
ways participants can earn the same amount of credit or compensation. State whether
participants will be eligible for compensation if they withdraw from the study prior to its
completion. If compensation is pro-rated over the period of the participant's involvement,
indicate the points/stages at which compensation changes during the study.

CONTACT INFORMATION

If you have questions at any time about this study, or you experience adverse effects as a
result of participating in this study, you may contact the researcher whose contact
information is provided on the first page. If you have questions regarding your rights as a
research participant, or if problems arise that you do not feel you can discuss with the
Primary Investigator, please contact the Research Ethics Committee of Kolehiyo ng
Pantukan at [email protected].

VOLUNTARY PARTICIPATION

Your participation in this study is voluntary. It is up to you to decide whether or not to take
part in this study. If you decide to take part in this study, you will be asked to sign an assent
form. After you sign the assent form, you are still free to withdraw at any time and without
giving a reason. Withdrawing from this study will not affect the relationship you have, if any,
with the researcher. If you withdraw from the study before data collection is completed, your
data will be returned to you or destroyed.
Note: Please delineate the "assent" section of the Informed assent Form by drawing a line
across the page (like the one above this paragraph). This delineation is important because
the assent form grammar shifts from second person to first person, as shown in this
example.

ASSENT

I have read and I understand the provided information and have had the opportunity to ask
questions. I understand that my participation is voluntary and that I am free to withdraw at
any time, without giving a reason and without cost. I understand that I will be given a copy of
this assent form. I voluntarily agree to take part in this study.

Participant's signature ______________________________ Date __________

Investigator's signature _____________________________ Date _____

Control Number : (refer to your form 1)

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