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National Institute of Allergy and Infectious Diseases / Protocol Number ACTIV2/A5401Page 1 of 26INFORMED CONSENT FORM ADDENDUM
FOR STUDY DRUGS
Sponsor / Study Title:National Institute of Allergy and
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How to fill out informed consent form addendum
How to fill out informed consent form addendum
01
To fill out an informed consent form addendum, follow these steps:
02
Begin by reading the original informed consent form to understand the context and purpose of the addendum.
03
Write the date at the top of the addendum to indicate when it is being filled out.
04
Clearly state the purpose of the addendum in a concise and specific manner.
05
Include a brief explanation of why the addendum is needed and what it entails.
06
Provide any additional information or changes that need to be made to the original informed consent form.
07
Clearly explain any risks or benefits involved with signing the addendum, if applicable.
08
Include a section for the participant to indicate their agreement or refusal to sign the addendum.
09
Provide a space for the participant to provide their signature, date, and contact information.
10
Review the completed addendum for accuracy and clarity before obtaining signatures.
11
Make copies of the signed addendum for the participant, research team, and any other relevant parties.
12
Store the original addendum in a secure and confidential manner, following any applicable regulations or guidelines.
Who needs informed consent form addendum?
01
An informed consent form addendum may be needed in various situations, including:
02
- When there are changes to the study protocol or procedures that require additional participant consent
03
- When there is new information or updates regarding the potential risks or benefits of participation
04
- When there are changes to the confidentiality or data sharing practices
05
- When there are changes to the participant's rights or responsibilities
06
- When there are changes to the compensation or incentives offered to participants
07
- When there are changes to the contact information or personnel involved in the study
08
- When there are changes to the informed consent process itself
09
It is important to consult with the appropriate regulatory bodies, ethics committees, or legal professionals to determine if an addendum is necessary in a specific situation.
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What is informed consent form addendum?
An informed consent form addendum is a supplemental document that provides additional information about a research study or medical procedure to ensure that participants fully understand what they are consenting to.
Who is required to file informed consent form addendum?
Researchers or healthcare providers conducting a study or procedure that requires informed consent are required to file the informed consent form addendum.
How to fill out informed consent form addendum?
The informed consent form addendum is typically filled out by providing additional details or clarifications to the original informed consent form. It should be reviewed and signed by the participant before any further participation in the study or procedure.
What is the purpose of informed consent form addendum?
The purpose of the informed consent form addendum is to ensure that participants have all the necessary information to make an informed decision about their participation in a study or procedure.
What information must be reported on informed consent form addendum?
The informed consent form addendum should include any new information or updates that may affect the participant's decision to continue with the study or procedure. This could include new risks, benefits, or changes to the protocol.
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