Reference no: EM133663894

Assignment:

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 Breakthrough University Institutional Review Board member. Breakthrough University is in the United States, and FDA and Department of Health and Human Services regulations apply. One of the physician researchers, 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 the lead on reviewing the informed consent form. At the next meeting, you need to inform the entire IRB Board 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-if they are not in the consent form, you would recommend including these items.

This writing assignment should not exceed two standard pages (single-spaced) or four standard pages (double-spaced) in no less than 12-point font. Title and reference pages are not included in the page limit. Concisely discuss your three most important items for the consent and your reasons for choosing them, including any basis in the regulations, ethical considerations and support for your position from the Belmont Report.