For this Case Assignment, you are part of a medical research team and are tasked with gaining informed consent from potential participants. The study will seek to test an experimental drug with patients suffering from late-stage leukemia. The sample will be divided into a control group and the experimental group. Participants in the control group will be given a placebo, which could increase the progression of their disease. The sample will be composed of children.

Case Assignment

Discuss how you would go about seeking the consent of participants.

• What questions would you expect from their parents/guardians?
• How much information should you share with the children?
• Should this type of study involve children given the risks of speeding the progression of the disease?

Assignment Expectations

1. Apply critical thinking skills within the write-up for this assignment, especially with regard to #2 and #3 above.
2. Limit your responses to a maximum of three pages, not including title and reference pages.
3. Provide scholarly support for your justifications. Be sure to properly cite all references.

Your paper will be evaluated based on the rubric criteria

Required Reading

Atac, A., et al. (2005). A Study of the Opinions and Behaviors of Physicians with Regard to Informed Consent and Refusing Treatment. Military Medicine, 170(7), 566-71.

Brudney, D. (2009, Mar./Apr.). Choosing for another: beyond autonomy and best interests. The Hastings Center Report. 39(2), 31-38.

Dickman, R. L. (2000, March). Bending the rules to get a medication. American Family Physician 61 (5), 1563. http://www.aafp.org/afp/2000/0301/p1563.html

Erlen, J. A. (2010). Informed consent: Revisiting the issues. Orthopaedic Nursing, 29(4), 276-80. Retrieved from

Lambert, V., & Glacken, M. (2011). Engaging with children in research: Theoretical and practical implications of negotiating informed consent/assent. Nursing Ethics, 18(6), 781-801. doi: http://dx.doi.org/10.1177/0969733011401122

Miller, F. G., & Wertheimer, A. (2011). The fair transaction model of informed consent: An alternative to autonomous authorization. Kennedy Institute of Ethics Journal, 21(3), 201-18. Retrieved from Waller, B. N., & Repko, R. A. (2008). Informed consent: Good medicine, dangerous side effects. Cambridge Quarterly of Healthcare Ethics, 17(1), 66-74.