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Research and IRB

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Can someone please help with this response. I need to answer ONE of the following questions and I am at a loss. I cannot find many informative references to arrive at a conclusion. It does not need to be a long answer, just a good starting point.

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You are conducting a randomized clinical trial to evaluate a new chemotherapy regimen for treatment of inoperable non-small-cell lung cancer. Patients with inoperable lung cancer will be randomized to the new regimen or no active care. It is hoped that the new regimen will improve disease-free survival and overall survival.

What evidence will the Committee on Human Subjects (IRB) require before approving your protocol?

or

What training would you provide to the people obtaining informed consent?

or

What material should be included in the informed consent form?

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Solution Summary

In reference to the scenario, this solution provides direction and information for the following question: What material should be included in the informed consent form?

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Hi,

Interesting question! Let's go with the informed consent, for which I located a wealth of information to assist you with the project. I attached an example of an informed consent form and a document explaining fully what to include in the informed consent, some of which this response is drawn.

Let's take a closer look.

RESPONSE:

1. What material should be included in the informed consent form?

Informed consent is an essential part of the research process, and is therefore more than obtaining a signature on a form. http://healthcare.partners.org/phsirb/infcons.htm Informed consent stems from the idea that both ethically and legally, every person has a right to make her or his own decision to voluntarily participate in the study after being fully informed about the clinical trial (see more detail at http://poynter.indiana.edu/sas/res/ic.pdf for ethical justifications for informed consent)
Informed consent is defined as "a process in which a person learns key facts about a clinical trial, including potential risks and benefits, before deciding whether or not to participate in a study. Informed consent continues throughout the trial" (http://www.medterms.com/script/main/art.asp?articlekey=22414).

Thus, researchers "must educate potential subjects to ensure that they can reach a truly informed decision about whether or not to participate in the research. Their informed consent must be given freely, without coercion, and must be based on a clear understanding of what participation involves" http://healthcare.partners.org/phsirb/infcons.htm

The research participants are informed through a process:

? First, potential subjects ...

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