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What should be included in an informed consent form?

B. Basic Elements of Informed Consent Description of Clinical Investigation. ... Risks and Discomforts. ... Benefits. ... Alternative Procedures or Treatments. ... Confidentiality. ... Compensation and Medical Treatment in Event of Injury. ... Contacts. ... Voluntary Participation.

What is the purpose of an information sheet?

The information sheet should give a brief summary of the research project and its aims, clearly outlining the entire research process in a language accessible for a non-expert audience. It should also outline what participation means in practice; how long participation takes, where it takes place and what it involves.

What is the purpose of a participant information sheet?

The participant Information Sheet gives potential participants the necessary understanding for the motivation and procedures of the study and sources of information to answer any further questions to allow them to give informed consent.

How do you write a research participant?

Specific terms are used in certain contexts. When writing about people who participate in research, descriptive terms such as \u201ccollege students,\u201d \u201cchildren,\u201d or \u201crespondents\u201d as well as the more general terms \u201cparticipants\u201d and \u201csubjects\u201d are acceptable.

What does an information sheet do?

The information sheet should give a brief summary of the research project and its aims, clearly outlining the entire research process in a language accessible for a non-expert audience. It should also outline what participation means in practice; how long participation takes, where it takes place and what it involves.

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How do you write an information sheet?

Guide to writing an Information sheet for research participants What is it? Give the name of the project and a brief, easily understandable overview. Who are you? ... Why are you doing it? ... Why me? ... Do I have to? ... What will I be asked to do? ... Will I be reimbursed? ... Are there any risks?

Why would you use an information sheet and consent form?

This Participant Information Sheet/Consent Form tells you about the research project. It explains the processes involved with taking part. Knowing what is involved will help you decide if you want to take part in the research.

What should an information sheet include?

The information sheet should give a brief summary of the research project and its aims, clearly outlining the entire research process in a language accessible for a non-expert audience. It should also outline what participation means in practice; how long participation takes, where it takes place and what it involves.

What goes in a participant information sheet?

The participant information sheet is used to explain the purpose of the research and what participants will be required to do /how participants will be involved. It should be in plain English, using language appropriate to the target audience.

What is an information consent form?

An informed consent document is typically used to provide subjects with the information they need to make a decision to volunteer for a research study. Federal regulations (45 CFR 46.116 ) provide the framework for the type of information (i.e., the "elements") that must be included as part of the consent process.

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