Informed Consent Overview - Module 1s 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 research study involving girls' skills
in math, science, and computer science. The research separates seventh-grade
boys and girls into gender-specific classes in order to provide girls with
more participation in these subjects.

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

Research involving human
subjects in the Social and Behavioral 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 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.