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EthicsCaseStudyForm edit

Title Vulnerable populations - clinical trials
Long Title Ethical concerns affecting vulnerable populations in clinical trials.
Contributor Tolulope Falaiye
Kelli King-Morris
CTSA Vanderbilt
Case Study Provided Maria is a 36 year old single mother of 3 with end stage renal disease who performs peritoneal dialysis daily. Maria takes her medicine as prescribed and is meticulous with her catheter care as she wants to stay as healthy as possible for her children.

Maria has always been suspicious about the health care system. She grew up hearing stories about her grandfather in the Tuskegee medical trials, in which syphilis patients were purposefully not treated so doctors could watch the effects of the disease. However, Maria has grown to trust her primary nurse, Carol, at the dialysis center. Due to her health problems and the restraints of her dialysis routine, Maria is unable to continue working as a college administrator. She has fallen on hard financial times. She is behind on her mortgage but unable to sell her house due to a difficult housing market. Maria has described her predicament to Carol as they make joint decisions about her medical care in light of her limited budget.

Maria has routine monthly visits to the dialysis center at a nearby academic medical center. During one of these visits, Carol tells one of the research nurses that Maria might be interested in their research study as she qualifies to participate, and “she could sure use the money.” Carol alerts Maria that one of her colleagues is going to come in and speak with her about a potential study “if that’s okay.” The research nurse proceeds to speak with Maria, emphasizing the substantial compensation she may receive if she were to complete each portion of the study. The study involves invasive medical procedures such as a muscle biopsy which involve risks such as nerve damage, bleeding, infection and a significant side effect of pain. The research study will pay Maria $100.00 for each muscle biopsy, and she could have up to 6 procedures over the course of the study. Total compensation may add up to over $1000.00 if she participates in the entire research study. This decision ways heavily on her mind as this additional income would be very helpful to her family. Despite her reservations, she decides to enroll.

After Maria’s first biopsy, she stays in the hospital as required by the research study protocol. Unfortunately, she suffers a complication from the procedure and requires more medical intervention and a longer stay in the hospital than initially planned. She also suffers some long term side effects that limit her physical abilities. On follow up with the research nurse, Maria is told that she is no longer in the study because she has an infection. Although the costs of the hospital stay are covered, she now has significant burden with childcare costs given her prolonged hospitalization. She is significantly limited in her ability to care for her home and children now physically as well as financially.
Discussion_Questions Does Maria’s vulnerable financial status qualify her a part of a vulnerable population?
Was it appropriate for the research nurse to approach Maria after being made aware of Maria’s financial hardship?
Should Carol, the dialysis nurse, have discussed Maria’s financial situation with the research nurse? Maria would have been approached for the study with routine screening. Does that change your answers to the previous questions?
Considering these issues, should the research nurse enroll Maria in the trial?
Should the research nurse tell the primary investigator about the situation?
How can the research nurse ensure that Maria understands that her participation is voluntary and she has the right to withdraw from the trial at anytime? Consider the Nuremburg code in your answer.
Does this outcome change your answers to those questions above?
Is there misconduct by the research nurse or clinical nurse under the University’s Policy for Responding to Allegations of Research Misconduct?
Would your answers to these questions be different if Maria’s child was the patient and enrolled in the trial?
RCR Keyword Research Misconduct
Other RCR Keywords

Case Difficulty Middle
Type of Case Realistic dilemma
Core_Instructional_Areas Policies regarding human subjects_Live vertebrate animal subjects in research_ Safe laboratory practices, Research misconduct and policies for handling misconduct

URL https://www.ctspedia.org/do/edit/CTSpedia/RCRCaseStudyAUTOINC000?t=110734&templatetopic=EthicsCaseStudyFormTemplate&topicparent=EducationalMaterialsRCR
References Nuremberg code: http://ohsr.od.nih.gov/guidelines/nuremberg.html

Topic revision: r2 - 25 May 2012 - 12:29:59 - TolulopeFalaiye

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