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Consent Forms and Research

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Just need your opinion on these two articles.

See the following articles:

Albala, I., Doyle, M., & Appelbaum, P. S. (2010). The evolution of consent forms for research: a quarter century of changes. IRB: Ethics & Human Research, 7-11.

Brooks, R. (2010). The Development Of A Code Of Ethics: An Online Classroom Approach To Making Connections Between Ethical Foundations And The Challenges Presented By Information Technology. American Journal of Business Education, 3(10).

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Hello and welcome to Brain Mass today! You logged in and asked for my opinion of these two articles.

The first one that I read over was by Ilene Albala, Margaret Doyle, and Paul S. App and entitled

The Evolution of Consent Forms for Research:

A Quarter Century of Changes. This was an interesting article that focused on a case study concerning written consent forms. The authors began by discussing how federal regulations governing research with humans list different elements that they must reveal to the participants through consent forms. However, "Despite the critical role of consent forms in the research context, there is good reason to believe that, as currently formulated, they are often far from ideal. Among the problems that have been documented is excessive length, complexity of wording that exceeds average reading levels, and problems with the accuracy with which key aspects of the studies are described" (Albala, Doyle, & Apps). So, they conducted a study to see what type of consent forms are most appropriate to disclose the type of information that is needed as well as what kind of language the consent forms should be written in so that participants in the study ...

Solution Summary

The consent forms and researches are provided. An online classroom approach to making connections between ethical foundations and the challenges presented are given.

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Research and IRB

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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