The Ethics of Off-Label Prescribing for Pediatric Patients

Module 7 – IRB, Research with Human Subjects and EBM

Module Overview:

While you await feedback on your paper, we will revisit basic ethical principles and how they apply to human subject research. Hopefully, all of the studies you reviewed in the prior modules were conducted ethically and received proper IRB approval prior to their start. Unfortunately, this has not always been the case. In recent history ethical principles were violated for the sake of medical science. View this short video, The Tuskegee Syphilis Experiment and Medical Ethics, to learn more about the Tuskegee syphilis study. Research cannot be conducted without consequence and we need to learn from history so that we can conduct investigations ethically and humanely.

In this module you will be asked to view a tutorial on research ethics and human protections law and guidelines, and read a paper about controversial off-label prescribing practices. Following the tutorial, you will be presented with an ethical dilemma regarding off-label prescribing. At the conclusion of this module, you will have the opportunity to demonstrate your understanding of human protection concepts through a quiz and also demonstrate your ability to ethically apply these concepts given a clinical scenario.
Learning Objectives:

  • Discuss ethical considerations related to clinical  research and practice.
  • Discuss the role of the IRB, human subject research and vulnerable populations.
  • Apply lessons learned from unethical practice to inform ethical decision making.
  • Compare and contrast clinical experimentation research from evidence based practice and practice based improvement.

How to Proceed:

  1. Review the required and recommended resources
  2. Complete the IRB and Human Subjects
  3. Participate in Discussion 7.1
  4. Complete Assignment 7.1

Required Resources: 

  • Video: Watch videos about indications of the need for IRB approval and the IRB process at UMB from the UMB website Human Research Protections(2015). Retrieved from [Note: Requires free account registration] *Be sure to watch the IRB Process Videos & the Common Rule Revisions- Informed Consent Video*
  • Video: Wilding, A. (August 15, 2001). The Tuskegee Syphilis Experiment and Medical Ethics[Video file]. University of Maryland. Retrieved from View this short  video regarding the Tuskegee Experiment.

Recommended Resources:


  • Quiz: IRB and Human Subjects
  • Discussion 7.1:   Off-label Prescribing
  • Assignment 7.1: The Ethics of Off-Label Prescribing for Pediatric Patients

Differentiate a sample from a population
Determine inclusion versus exclusion criteria when developing a plan for sample selection
Explain how instruments are determined to be valid and reliable
Discuss types of internal validity and reliability

Quiz: IRB and Human Subjects

Complete the quiz on IRB and protection of human subjects.

Discussion 7.1: Off-label Prescribing

Given your knowledge of human subject protections, IRB and professional ethics, please answer the following question:

Should off-label prescribing be considered another form of human subjects research- why or why not?

Please post your opinion citing references to support your argument. Then, respond to a classmate preferably, who has an opinion that is different that yours.

Submit your first post no later than Wednesday. Then, respond to the comments of at least 1 colleague. The discussion will conclude Sunday at midnight.

Assignment 7.1: The Ethics of Off-Label Prescribing for Pediatric Patients

Use your skills of critical appraisal, knowledge of Protections for Human Research and IRB to make the best decision for the following scenario:

Parents of a 12-year juvenile arthritis sufferer have approached their pediatrician about receiving a stronger anti-inflammatory prescription for their child. The physician is considering prescribing a drug that has not been well tested in juveniles, but the drug is widely considered safe for adults. What are the potential ethical and medical considerations the physician should be aware of before deciding to prescribe the drug?

Write a 1-page double-spaced paper in 12-point Times New Roman font to express your decision and provide your rationale, citing the evidence.

Attach and submit your summary using the Assignment  7.1: The Ethics of Off-Label Prescribing for Pediatric Patients. Due Sunday.