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Informed Consent Procedures
and Writing Participant
Informed Consent Forms
Standard Operating Procedure
Office of Health and Medical Research
Queensland Health
SOP reference:006Version number:1Effective
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How to fill out informed consent procedures

How to fill out informed consent procedures
01
Begin by explaining the purpose of the informed consent procedures to the participant.
02
Provide the participant with a clear and concise description of the study or procedure, including any potential risks or benefits.
03
Ensure that the participant understands the information presented by using plain language and avoiding jargon or technical terms.
04
Give the participant ample time to ask questions and clarify any doubts or concerns they may have.
05
Make sure the participant is aware that their participation is voluntary and that they have the right to withdraw at any time without facing any negative consequences.
06
Provide the participant with a written informed consent document that includes all relevant information discussed during the process.
07
Clearly explain any confidentiality or privacy measures that will be implemented to protect the participant's data.
08
Obtain the participant's signature or verbal consent, depending on the requirements of the study and the local regulations.
09
Keep a copy of the informed consent document for future reference and ensure that it is stored securely and confidentially.
10
Continuously assess the participant's understanding and willingness to participate throughout the study or procedure.
Who needs informed consent procedures?
01
Informed consent procedures are necessary for any research study or medical procedure involving human subjects.
02
This includes but is not limited to clinical trials, experimental treatments, psychological studies, surveys, and interviews.
03
Informed consent procedures ensure that participants are aware of the purpose, procedures, and potential risks or benefits of their involvement.
04
This helps to protect participants' rights and autonomy, allowing them to make an informed decision about their participation.
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What is informed consent procedures?
Informed consent procedures involve providing individuals with all relevant information about a research study or medical procedure so they can make an informed decision about participating.
Who is required to file informed consent procedures?
Researchers, medical professionals, and institutions conducting research or providing medical treatment are required to file informed consent procedures.
How to fill out informed consent procedures?
Informed consent procedures are typically filled out by providing information about the study or procedure, risks and benefits, participant rights, and obtaining signatures from participants.
What is the purpose of informed consent procedures?
The purpose of informed consent procedures is to ensure that individuals understand the risks and benefits of participating in a research study or medical procedure, and to protect their rights.
What information must be reported on informed consent procedures?
Informed consent procedures must include details about the study or procedure, risks and benefits, participant rights, and contact information for questions or concerns.
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