ASE STUDY Cancer-killing bacteria Ralph, a 57-year-old man, was diagnosed with colon cancer. His oncologist discussed the use of radiation and chemotherapy as treatments, both of which can cause debilitating side effects. Ralph decided to explore other options and went to a cancer clinic. He learned that researchers in a synthetic biology program were testing the use of genetically modified bacterial cells designed to selectively invade specific tumors and kill cancer cells, with no effects on normal cells. Ralph decided to participate and was informed that he would be part of a phase III trial, comparing the effects of the modified bacterial cell treatment against conventional chemotherapy. However, as part of the trial, he would be randomly assigned to receive one or the other treatment. He was disappointed to learn this, because he assumed that he would receive the bacterial therapy. Question: Informed consent is legally and ethically required before someone participates in a clinical trial. After potential participants receive information about the trial and what constitutes informed consent, research indicates that 25 percent of prospective participants do not understand that these trials are designed primarily to establish the efficacy of the treatment rather than directly benefit participants. What should investigators do to make sure that clinical trial participants understand that the trial is not primarily intended to help them?
CASE STUDY Cancer-killing bacteria
Ralph, a 57-year-old man, was diagnosed with colon cancer.
His oncologist discussed the use of radiation and
chemotherapy as treatments, both of which can cause
debilitating side effects. Ralph decided to explore other options
and went to a cancer clinic. He learned that researchers in a
synthetic biology program were testing the use of genetically
modified bacterial cells designed to selectively invade specific
tumors and kill cancer cells, with no effects on normal cells.
Ralph decided to participate and was informed that he would
be part of a phase III trial, comparing the effects of the modified
bacterial cell treatment against conventional chemotherapy.
However, as part of the trial, he would be randomly assigned to
receive one or the other treatment. He was disappointed to learn
this, because he assumed that he would receive the bacterial
therapy.
Question: Informed consent is legally and ethically required before
someone participates in a clinical trial. After potential participants
receive information about the trial and what constitutes informed consent, research indicates that 25 percent of prospective
participants do not understand that these trials are
designed primarily to establish the efficacy of the treatment
rather than directly benefit participants. What should investigators
do to make sure that clinical trial participants understand
that the trial is not primarily intended to help them?
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