Writing an informed consent form is crucial for ethical research or medical practices. The form should provide participants with comprehensive information about the study, ensuring they understand the purpose, procedures, potential risks, benefits, and their rights. Here’s a general guide on how to write an informed consent form:

Title:

• Start with a clear and concise title such as “Informed Consent Form.”

Introduction:

• Begin with a brief introduction explaining the purpose of the study or procedure.
• Include information about the researcher, institution, and contact details.

Study/Procedure Overview:

• Provide an overview of the study or procedure in simple, non-technical language.
• Include the purpose, duration, and any relevant background information.

Voluntary Participation:

• Clearly state that participation is voluntary.
• Explain that participants are free to withdraw at any time without consequences.

Inclusion/Exclusion Criteria:

• Specify any criteria for participation (e.g., age, health conditions) to help potential participants determine their eligibility.

Study/Procedure Details:

• Provide detailed information about the study or procedure, including methods, tests, and interventions.
• Explain the expected timeline and frequency of participation.

Risks and Discomforts:

• Clearly outline potential risks or discomforts associated with participation.
• Distinguish between common, uncommon, and severe risks.

Benefits:

• Describe any potential benefits to the participant or society.
• Differentiate between direct and indirect benefits.

Confidentiality:

• Explain how participant information will be handled and emphasize the measures taken to maintain confidentiality.

Contact Information:

• Provide contact information for the researcher, including phone numbers and email addresses.
• Include emergency contact information if applicable.

Questions and Clarifications:

• Encourage participants to ask questions.
• Specify who participants can contact for clarifications.

Participant Rights:

• Clearly state the rights of participants, including the right to withdraw, refuse, or skip any part of the study.
• Emphasize that their decision will not affect their current or future medical care.

Consent Statement:

• Include a statement indicating that the participant understands the information provided and consents to participate voluntarily.

Witness and Date:

• Include spaces for the participant’s signature, the researcher’s signature, and a witness’s signature.
• Include the date of signing.

IRB/Ethics Committee Approval:

• Specify that the study has received approval from the Institutional Review Board (IRB) or ethics committee.

Remember to adapt the language to the specific context and target audience. If your study involves specific legal or ethical considerations, seek guidance from relevant authorities or experts. Additionally, it’s crucial to comply with local and international ethical standards and regulations.

*Refer to template below for guidance.

Informed Consent Form

[Title of the Project/Procedure/Study]

Introduction:

I, [Participant’s Full Name], have been fully informed and understand the nature, purpose, risks, and benefits of participating in [Title of the Project/Procedure/Study]. I have had the opportunity to ask questions and have received satisfactory answers.

Purpose:

The purpose of this [project/procedure/study] is to [briefly explain the main goals and objectives].

Procedures:

I understand that I will be involved in the following procedures: [List and describe each specific procedure in detail].

Risks:

I am aware that there may be risks and discomforts associated with my participation, including [enumerate potential risks]. The researchers/practitioners have explained these risks to me.

Benefits:

I understand that potential benefits of participating may include [enumerate potential benefits]. However, there may be no direct benefits to me.

Confidentiality:

I understand that my personal information will be kept confidential to the extent permitted by law. Only authorized personnel will have access to my information.

Voluntary Participation:

My participation in this [project/procedure/study] is entirely voluntary. I understand that I can withdraw at any time without penalty or loss of benefits to which I am otherwise entitled.

Compensation:

I have been informed of any compensation or reimbursement for my participation, including [details of compensation].

Contact Information:

If I have any questions or concerns about the [project/procedure/study], I can contact [researcher/practitioner’s name and contact information].

Statement of Consent:

I have read and understood the information provided in this form. I have had the opportunity to ask questions, and my questions have been answered to my satisfaction. I voluntarily agree to participate in [Title of the Project/Procedure/Study].

Participant’s Name: ___________________________

Signature: ___________________________ Date: _______________

Researcher/Practitioner Certification:

I confirm that I have provided adequate information to the participant and have answered their questions to the best of my ability.

Researcher/Practitioner’s Name: ___________________________

Signature: ___________________________ Date: _______________

Remember, this template is a general guide, and you should customize it to fit the specific requirements and regulations of your project or situation. Additionally, seek legal advice to ensure compliance with local laws and ethical standards.

Template can be downloaded at https://research.iium.edu.my/irec/?page_id=500