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MORGAN STATE UNIVERSITY Application for Renewal of IRB ApprovalPlease submit 1 copy of this form if you wish to renew IRB approval of your research project. You must renew IRB approval of your project
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How to fill out human subjects protocol amendmentmodification

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How to fill out human subjects protocol amendmentmodification

01
Log in to the online human subjects protocol system.
02
Locate the protocol that needs to be amended or modified.
03
Click on the 'Amend' or 'Modify' button next to the protocol.
04
Fill out the required fields in the amendment/modification form.
05
Clearly explain the changes being made and the reasons for these changes.
06
Submit the amendment/modification form for review by the appropriate committee.

Who needs human subjects protocol amendmentmodification?

01
Researchers conducting studies involving human subjects, who need to make changes to the original protocol in order to ensure the safety and well-being of the participants.

What is Human Subjects Protocol Amendment/Modification Form?

The Human Subjects Protocol Amendment/Modification is a fillable form in MS Word extension required to be submitted to the required address to provide certain information. It must be completed and signed, which can be done manually, or via a certain solution such as PDFfiller. It lets you complete any PDF or Word document right in the web, customize it according to your needs and put a legally-binding electronic signature. Right after completion, user can send the Human Subjects Protocol Amendment/Modification to the relevant individual, or multiple individuals via email or fax. The template is printable as well because of PDFfiller feature and options proposed for printing out adjustment. Both in digital and physical appearance, your form will have a clean and professional appearance. Also you can save it as the template to use later, there's no need to create a new file over and over. You need just to edit the ready document.

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A human subjects protocol amendment/modification is a formal change or addition to an approved research protocol that involves human participants. It typically involves updates to methods, procedures, or consent forms.
Researchers or institutions involved in studies approved by an Institutional Review Board (IRB) are required to file a human subjects protocol amendment/modification when changes affecting the study are made.
To fill out a human subjects protocol amendment/modification, researchers should provide detailed information on the nature of the changes, including updated protocols, revised consent forms, and any new risks or benefits to participants.
The purpose of a human subjects protocol amendment/modification is to ensure that any changes to the study are reviewed and approved to maintain participant safety and uphold ethical standards.
Information that must be reported includes the specific changes made, reasons for the changes, impacts on participants, and any additional regulatory considerations.
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