A 32-year-old unemployed woman with type I diabetes mellitus comes to the physician at a free clinic serving patients of low socioeconomic status. Despite compliance with her insulin regimen, she continues to have difficulty controlling her diabetes. Her recent HgbA1C was 9% and her home glucose log shows several readings 200 mg/dL and many as low as 50 mg/dL. The patient is very concerned about the possible complications of uncontrolled diabetes. She has been told several times that an insulin pump would help stabilize her glucose levels, but she cannot afford it. Her physician has recently begun enrolling patients in a clinical trial for type I diabetes in which an insulin pump is paid for by the drug company sponsoring the study. The company also provides a small stipend for participating in the trial. Considering the patient's low socioeconomic status and the fact that she cannot afford an insulin pump, what would be appropriate to tell her about the clinical trial?

Question

A 32-year-old unemployed woman with type I diabetes mellitus comes to the physician at a free clinic serving patients of low socioeconomic status.  Despite compliance with her insulin regimen, she continues to have difficulty controlling her diabetes.  Her recent HgbA1C was 9% and her home glucose log shows several readings >200 mg/dL and many as low as 50 mg/dL.  The patient is very concerned about the possible complications of uncontrolled diabetes.  She has been told several times that an insulin pump would help stabilize her glucose levels, but she cannot afford it.  Her physician has recently begun enrolling patients in a clinical trial for type I diabetes in which an insulin pump is paid for by the drug company sponsoring the study.  The company also provides a small stipend for participating in the trial.  Considering the patient's low socioeconomic status and the fact that she cannot afford an insulin pump, what would be appropriate to tell her about the clinical trial?

Quizplus · Accepted Answer

Explanation: Recruiting economically disadvantaged patients into clinical trials presents a number of ethical concerns. One of these is that patients may feel coerced to participate in order to receive needed treatment or compensation that they could not obtain otherwise. The Food and Drug Administration requires that all clinical trials be reviewed by institutional review boards (IRBs) to ensure protection of the rights and welfare of research participants. This includes assessing the risks of study participation, adequacy of informed consent documentation, disclosure of all known risks of the study medication or device, and a review of recruitment procedures. Most IRBs follow guidelines regarding ethical treatment of clinical subjects from economically disadvantaged backgrounds. These guidelines typically emphasize the importance of avoiding coercion while still including these individuals in research. Methods for achieving this include avoiding excessive financial compensation and ensuring that patients receive compensation in a stepwise manner rather than only upon completion of the trial. Any discussion of clinical trial participation should involve an upfront discussion of risks and benefits. (Choices A and B) Individuals of low socioeconomic status have the right to receive information about a clinical trial for which they may be eligible. Provision of a free medical device and a small stipend are inducements to participate but are not considered coercive or unethical. Researchers must inform the patient of risks, benefits, and alternatives to trial participation. (Choice D) Participation in clinical trial research is entirely voluntary, and subjects have the right to discontinue study participation at any point and for any reason. Researchers should provide compensation in a stepwise manner (rather than a lump sum at study completion) to minimize coercion in economically disadvantaged patients. (Choice E) Making participation in the trial a prerequisite to obtaining information about it is unethical and coercive. This patient must be informed of all available options, including treatment as usual and involvement in medical device patient assistance programs. She should be told about the study first and then provided with the option of participating. Educational objective: Patients of low socioeconomic status should not be targeted or avoided when recruiting subjects for clinical trials. Steps should be taken to minimize coercion in an economically disadvantaged population. References: Clinical research: protection of the "vulnerable"? (http://www.ncbi.nlm.nih.gov/pubmed/18313131) Clinical research with economically disadvantaged populations. (http://www.ncbi.nlm.nih.gov/pubmed/17601862)

A 32-Year-Old Unemployed Woman with Type I Diabetes Mellitus Comes