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The informed consent process

You may already have experience with signing consent forms for other things, such as having a certain medical procedure. However, informed consent for a research study involves much more than just reading and signing a piece of paper. Rather, it involves two very important parts: a document and a process.

The informed consent document provides a summary of the research study including its purpose, any procedures, schedules, potential risks and benefits, and alternatives to participation. The document explains your rights as a research participant. It is designed to begin the informed consent process, which is about conversations between you and the research team. If you then decide to participate in the research study, you give your consent by signing the document. You will be given a copy of the informed consent document. You can use it as an information resource throughout your participation in the study.

Even though the informed consent process varies from study to study and among different medical and non-medical settings, you generally should expect the following three things:

An initial meeting when members of the study team provide you with the informed consent document and explain it to you. You can bring a family member or friend for support, and to help you keep track of the information presented to you. This information should be given logically and at a comfortable pace, with plenty of time for you to consider it and ask questions. It is okay for you to tell the research team anything you don't understand.

Time to digest the information. It can be very difficult to absorb all of this information in one sitting, especially if it is a stressful time. You should be given a copy of the document so that you can take it home, review it as many times as you need, and discuss it with family, friends, social workers, clergy, a patient representative, or other trusted advisors as appropriate.

Assessment of your understanding. The research team should take some steps to ensure that you understand the information about the study, either by having you fill out a questionnaire, asking you questions, or having you explain certain aspects of the study in your own words. You should tell the study team members about anything you do not understand. If you find that the document is written in words that are too difficult for you, don't hesitate to let them know.




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