Clinical Trial Between 2004 and 2007, the National Institutes of Health conducte

Question

Clinical Trial

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

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?

Explanation / Answer

**Risks and benefits of the study to participants includes,Prior to beginning of the study need to explain the risks like physical harm,psychological harm ,social and economic harm.
*physical harm includes the advrese effects of the drugs,discomforts related to drugs and the chances of continuing with HIV infection if vaccine is not effective etc.
*Psychological harm includes the undesired changes in thought process and emotions on sensitive topics such as drug use,sexual preferences when subject being interveiwed or filling out the questinnaire.
*social harm includes invasion of privacy and breaches of confidentiality may results in embarrassment within one's business or social group,loss ofemployment,or criminal prosecution etc.
Benefits of the study includes subject becomes a beneficiary of the treatment if the research study becomes sucessful.
**Ethical issues surrounding this study at the beginning are carefulness,respect for intellectual privacy,confidentiality and human subject protection.
*carefulness -researcher must be creful of not harming the subject at any cost.
*human subject protection includes protecting the subject life and health aspect is mandatory.
Ethical issues involved when Terminating the study are HUMAN SUBJECT PROTECTION IS MORE IMPORTANT.When researcher analyses the negative effects on case group when comparing with control group and showing the proof that the study is harming them ,the researcher must terminate the study to avoid furter harm to the subjects.

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