Assignment : Discussion Assignment

The discussion assignment provides a forum for discussing relevant topics for this week based on the course competencies covered.

To support your work, use your course and text readings and also use outside sources. As in all assignments, cite your sources in your work and provide references for the citations in APA format.

Start reviewing and responding to the postings of your classmates as early in the week as possible. Respond to at least two of your classmates.

Participate in the discussion by asking a question, providing a statement of clarification, providing a point of view with a rationale, challenging an aspect of the discussion, or indicating a relationship between two or more lines of reasoning in the discussion.

Clinical Trial

Between 2004 and 2007, the National Institutes of Health conducted a STEP vaccine clinical trial-Phase IIB "test-of-concept" study.

The STEP study is the name of a clinical trial to test an experimental human immunodeficiency virus (HIV) vaccine. The STEP study enrolled 3,000 participants at sites in Australia, Brazil, Canada, the Dominican Republic, Haiti, Jamaica, Peru, Puerto Rico, and the United States. The study was designed to test an HIV vaccine, which aimed to stimulate production of immune system T-cells that can kill HIV-infected cells.

Based on its first evaluation of vaccine efficacy, the findings showed there were 24 cases of HIV infection among the 741 volunteers who received at least one dose of the investigational vaccine compared with 21 cases of HIV infection among the 762 volunteers who were vaccinated with the placebo.

In volunteers who received at least two vaccinations, there were 19 cases of HIV infection among the 672 volunteers who received the investigational vaccine and 11 instances of HIV infection among the 691 volunteers who received placebo. The study investigators of the vaccine trials have decided to cease immunizations and are contacting study volunteers to inform them of the developments.

Reference:

National Institutes of Health (2007). National Institute of Allergy and Infectious

Diseases: Immunizations are discontinued in two HIV vaccine trials.

Retrieved from http://www.niaid.nih.gov/news/newsreleases/2007/

Pages/step_statement.aspx

Using the South University Online Library or the Internet, research further on the STEP study, the STEP vaccine clinical trials, and their parameters.

Based on your research, understanding, and above information, answer the following questions:

Prior to beginning this study, how would you have described the risks and benefits of the study to participants?

What are the ethical issues surrounding this study at the beginning and when the decision was made to terminate the study?