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IRB Policy 13: Informed Consent
Revision date: October 6, 2008, revised July 10, 2009, revised
July 27, 2010, revised January 27, 2011, revised 2×9/15,
revised 10×15/15, revised November 18, 2015,
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How to fill out irb policy 13 informed
01
Start by carefully reading IRB Policy 13 to familiarize yourself with its requirements. Pay attention to any specific instructions or guidelines mentioned in the policy.
02
Identify if your research involves human subjects and if it falls under the jurisdiction of IRB Policy 13. This policy typically covers research that involves informed consent from human subjects.
03
Determine if you are the principal investigator or a member of the research team responsible for filling out the IRB Policy 13 informed consent form. Usually, the principal investigator takes on this responsibility.
04
Gather all necessary information and materials required to complete the informed consent form. This may include details about the study objectives, procedures, potential risks and benefits, confidentiality measures, and any compensation offered to participants.
05
Follow the specific format and layout provided by your institution's IRB office for the informed consent form. Pay attention to the sections that need to be filled out, such as participant information, study information, risks and benefits, and signatures.
06
Clearly and thoroughly explain the study to potential participants in a language that they can understand. Include all relevant information that they need to make an informed decision about participating in the research.
07
Ensure that the informed consent form includes provisions for participant consent, voluntary participation, and the freedom to withdraw from the study at any time.
08
Seek assistance or guidance from the IRB office or experienced researchers if you need clarification or help in completing the form accurately.
09
Once the form is completed, review it carefully for accuracy and completeness before submitting it to the IRB for review and approval.
10
Remember to maintain a copy of the informed consent form and any accompanying documents for your records as well as for future reference.
Who needs IRB Policy 13 informed?
01
Researchers, including principal investigators and their research teams, who are conducting studies that involve human subjects and require informed consent fall under the scope of IRB Policy 13. This policy ensures that ethical considerations, participant rights, and regulatory requirements are met during the research process.
02
Institutions or organizations that have research programs or departments, particularly those involved in human subjects research, are responsible for adhering to IRB policies, including Policy 13. These institutions typically have designated IRB offices or committees that oversee the process of obtaining informed consent and ensuring compliance with ethical standards.
03
Participants or potential subjects involved in studies that require informed consent from human subjects may also benefit from being aware of IRB Policy 13 informed. Understanding this policy helps participants make informed decisions about whether to participate in a research study and ensures their rights and well-being are protected throughout the research process.
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What is irb policy 13 informed?
IRB Policy 13 informed refers to the policy regarding reporting of any information related to research studies or projects that involve human subjects.
Who is required to file irb policy 13 informed?
Researchers and investigators conducting research studies or projects involving human subjects are required to file IRB Policy 13 informed.
How to fill out irb policy 13 informed?
To fill out IRB Policy 13 informed, researchers need to provide all relevant and required information about their research study or project involving human subjects.
What is the purpose of irb policy 13 informed?
The purpose of IRB Policy 13 informed is to ensure transparency and compliance in research studies or projects involving human subjects.
What information must be reported on irb policy 13 informed?
Researchers must report details about their research study, including the purpose, methodology, risks involved, and measures taken to protect human subjects.
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