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Research Ethics Board Elements of Informed Consent Guidance Note Subject informed consent is required prior to participation in any research study. The consent process may include a) a written consent

How to fill out elements of informed consent

How to fill out elements of informed consent:

1. Begin by clearly stating the purpose of the study or medical procedure. This should include information about what will be done and why it is being done.
2. Provide a detailed explanation of the risks and potential benefits associated with participating in or undergoing the procedure. It is important to include both common and rare risks to ensure the participant or patient is fully informed.
3. Clearly outline any alternatives to participating in the study or undergoing the procedure. This could include alternative treatment options, different research studies available, or even the option to not participate at all.
4. Include information about confidentiality and privacy. Participants or patients should be made aware of how their personal information will be collected, stored, and used during the study or procedure.
5. Make sure to cover the voluntary nature of participation. It is crucial that individuals understand they have the right to refuse or withdraw from the study or procedure at any time without consequence.
6. Consider including any additional information or requirements specific to the study or procedure. This could involve specific instructions or obligations for participants or patients to follow during the process.
7. Finally, provide contact information for any questions or concerns that may arise. Participants or patients should have a clear point of contact for any issues related to the study or procedure.

Who needs elements of informed consent?

Informed consent is necessary for any individual who will be participating in a research study or undergoing a medical procedure. This can include patients, research participants, or anyone who may be involved in the study in any capacity. It ensures that individuals have a clear understanding of what they are agreeing to and have an opportunity to make an informed decision about their participation. Informed consent is a fundamental ethical requirement in medical and research settings to protect the rights and well-being of individuals involved.

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