Informed Consent Overview - Module 1m Sec 1


Module 1 Objectives
The Process
Basic Principles
A Brief History
What Research Must Be Reviewed
IRB Review Criteria


r. Johnson is conducting a cancer research study that could potentially provide a vaccine against cancer. To complete her study, however, Dr. Johnson needs to perform experiments on healthy adults to determine the effectiveness of the vaccine. The research will involve an injection that in extremely rare cases may cause cancer to develop.

Would you agree to participate in this study? What would be your concerns? How would you decide?

Research involving human subjects in the Health and Biological Sciences poses complex ethical issues. It requires careful thought and consideration on the part of both researchers and research participants. Perspective participants must be given adequate information on both the possible risks and the potential benefits of their involvement to allow them to make informed decisions.

As a researcher, it is your responsibility to educate the participants about risks and benefits, obtain their consent before involving them in your research, and keep them informed. This is called the "informed consent process."

This and the rest of the materials are designed to teach you about the requirements and regulations involving human research and the informed consent process. They will also assist you in the creation of a consent document. This document must be submitted to the IRB for approval before any research with human subjects may take place. The last module (Module 4) will inform you of the requirements associated with continuing review of your research after approval.

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