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