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


Dr. 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.