Informed Consent and the RAC

Appendix M-III Is Very Good Guidance

Proposed Additional Consent Form Guidance

The Context of Consent to GTR

Gene Transfer Research: Consent/Communication Issues

Consent and Subject Selection

The Three Types of Benefit

The Three Dimensions of Benefit

Trial Phases and Consent Information

Consent Forms May Inadvertently Convey Mixed Messages

Purpose: It has been explained to you that you have nonsmall cell lung cancer that requires radiation therapy to the chest to relieve symptoms. You have been invited to participate in this research study. This study involves treatment with an experimental agent called Adenovirus CMV-p53 which is a modified common virus designed to carry a normal copy of the tumor suppressor gene p53 into tumor cells. Tumor cells are often killed or their growth is suppressed when this gene is put into them, and the hope is that we can improve your symptoms and prolong your life with this treatment. Adenovirus CMV-p53 will be given to you by bronchoscopy or percutaneously (through the skin) to a portion of your lung affected by your tumor. The purpose of this study is to determine whether this procedure is safe and to evaluate the effect of this treatment on your lung cancer.

Benefits: It is not possible to predict whether or not any personal benefit will result. You have been told that, should your disease become worse, should side effects become very severe, should new scientific developments occur that indicate the treatment is not in your best interest, or should your physician feel that this treatment is no longer in your best interest, the treatment would be stopped.

Purpose and Benefit

A Good Benefits Section

A Range of Benefit-Related Language

Occasionally Seen

A Rare Inclusion

An Effort to Explain

The Social Construction of Benefit in Gene Transfer Research

What We’re Doing

Consent Form Analysis

IRB Interviews

GTR Study Participant Interviews

GTR Study Variables

Possible Variables

Consent Form Assessment Topics

Comparing Direct Benefit in PS and CF, Surrogate and Clinical Endpoints

Analysis Activities