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PCC 46415UNIVERSITY OF PENNSYLVANIA RESEARCH SUBJECT INFORMED CONSENT AND HIPPO AUTHORIZATION FORM Protocol Title:Phase I/II study of pembrolizumab in patients failing to respond to or relapsing after
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How to fill out research subject informed consent

01
Begin by introducing yourself and explaining your purpose for conducting the research.
02
Provide a clear explanation of the study, including the objectives, procedures, and potential benefits or risks involved.
03
Clearly state that participation is voluntary and that subjects have the right to withdraw at any time without consequence.
04
Explain how the subjects' confidentiality and privacy will be protected, including any measures taken to ensure data security.
05
Provide a comprehensive and understandable overview of any compensation or incentives offered to participants.
06
Clearly outline the process of obtaining informed consent, including the signing of a consent form.
07
Allow subjects to ask questions and address any concerns they may have before proceeding.
08
Provide subjects with a copy of the informed consent form for their records.
09
Ensure that subjects have adequate time to review the informed consent form and make an informed decision.
10
Obtain the subjects' written consent by having them sign and date the consent form.
11
Make sure to maintain a record of all signed informed consent forms for future reference and documentation purposes.

Who needs research subject informed consent?

01
Researchers conducting any form of scientific or academic research involving human subjects need to obtain research subject informed consent. This includes studies conducted in medical, social sciences, psychology, biology, and other fields. Informed consent is essential to protect the rights and well-being of research participants and ensure ethical practices in research.
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Research subject informed consent is a process by which individuals voluntarily confirm their willingness to participate in a research study, after being informed of all aspects of the study that may affect their decision.
Researchers and institutions conducting the study are required to file research subject informed consent, ensuring compliance with ethical and legal standards.
To fill out research subject informed consent, the researcher should provide clear and comprehensive information about the study's purpose, procedures, risks, benefits, and the rights of participants. Participants must then sign the document to indicate their understanding and agreement.
The purpose of research subject informed consent is to protect the rights and welfare of participants by ensuring they are adequately informed about the study and its potential risks and benefits before agreeing to participate.
Information that must be reported includes the study's purpose, duration, procedures, risks, benefits, alternative options, confidentiality, and contact information for questions or concerns.
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