Get the free Addendum to Informed Consent Template - Baruch College
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INSTRUCTIONS: Information provided throughout this form must be presented in sufficient
detail relating to the research, and must be organized and presented in a way that does not
merely provide lists
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How to fill out addendum to informed consent
How to fill out addendum to informed consent
01
To fill out an addendum to informed consent, follow these steps:
02
Start by reviewing the original informed consent document and identifying the specific changes or additions that need to be made.
03
Create a new section within the document titled 'Addendum' or 'Amendment' to clearly indicate that this is an additional document to the original consent form.
04
Clearly state the reason for the addendum, including any new risks, benefits, or changes in procedures that participants need to be aware of.
05
Include a statement explaining that the participant's rights and confidentiality will still be protected.
06
Provide a space for the participant or their legally authorized representative to indicate their consent to the addendum by signing and dating.
07
If necessary, consult with the study sponsor, Institutional Review Board (IRB), or legal counsel for any specific requirements or guidelines regarding addendums to informed consent forms.
08
Make sure to keep a copy of the addendum for your records and provide a copy to the participant or their representative.
Who needs addendum to informed consent?
01
Addendum to informed consent may be required in the following situations:
02
- When there are changes to the study procedures or protocol that may affect participant safety or rights.
03
- When new information or potential risks/benefits are discovered during the course of the study.
04
- When participants need to be informed of new options or alternatives that were not initially disclosed in the original consent form.
05
- When there are changes to the study funding or sponsor that may impact the participant's involvement.
06
It is important to consult with the Institutional Review Board (IRB) or regulatory authorities to determine if an addendum is necessary in specific cases.
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What is addendum to informed consent?
An addendum to informed consent is a document that includes additional information or changes to the original informed consent form.
Who is required to file addendum to informed consent?
Any party involved in a research study or clinical trial who needs to update or add information to the informed consent form.
How to fill out addendum to informed consent?
The addendum should be completed by including the new information or changes, and all parties involved should sign and date the document.
What is the purpose of addendum to informed consent?
The purpose of an addendum to informed consent is to ensure that participants are aware of any updates or changes to the original consent form.
What information must be reported on addendum to informed consent?
The addendum should include details of the changes or new information, as well as the reason for the update.
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