Reference no: EM133394886

We have discussed the Role of the IRB in reviewing and approving protocols and consent forms in class. We have also discussed ethical considerations and issues with genetic research.

Your writing assignment is to consider yourself as a member of the Breakthrough University Institutional Review Board. Breakthrough University is located in the United States and FDA and Department of Health and Human Services regulations are applicable. One of the physician researches, Professor Dr. Alvin Funk, has submitted a protocol for a Phase II Gene Transfer study to evaluate his new gene therapy in patients with refractory, late-stage ovarian cancer. The Chairman of the IRB has asked you to take a lead on reviewing the informed consent form. You need to inform the entire IRB Board at the next meeting what are the three most important aspects to consider in reviewing the consent form language. In other words, what are the three most important things you need to look for in the draft consent form-and if they are not in the consent form, you would recommend the inclusion of these items.