After having completed a study that involved the collection of tissue from the subjects, an investigator wishes to perform additional analysis of the archived tissue samples. This nature of this analysis was not explicitly stated in the original consent form.
Should the investigator be required to obtain explicit consent for the new research?
During the conduct of a large clinical trial of an investigational drug, preliminary analysis of results show that there were three times as many participants in the experimental group who experienced severe nausea and vomiting compared to the control group. Two of the cases were severe enough to require that the participants be hospitalized. This is despite the fact that the preliminary analysis shows that there may be a moderate benefit with the drug.
What should be done?
Mrs. Franklin, an 81-year-old Alzheimer's patient hospitalized under your care has been asked to participate in a clinical trial testing a new drug designed to help improve memory. You were present when the clinical investigator obtained a signed informed consent from Mrs. Franklin a few days ago. However, when you visit Mrs. Franklin today and ask her if she is ready to begin the study tomorrow, she looks at you blankly and seems to have no idea what you are talking about.
What should you do?
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Authors:
Mrs. Franklin, an 81-year-old Alzheimer's patient hospitalized under your care has been asked to participate in a clinical trial testing a new drug designed to help improve memory. You were present when the clinical investigator obtained a signed informed consent from Mrs. Franklin a few days ago. However, when you visit Mrs. Franklin today and ask her if she is ready to begin the study tomorrow, she looks at you blankly and seems to have no idea what you are talking about.
What should you do?
The competence of Mrs. Franklin to give an ethically valid informed consent is in doubt. You should contact the primary investigator to discuss Mrs. Franklin's participation in the trial. There may be a surrogate who can give consent for her participation if it is deemed to be in her best interests. Although she may be considered a vulnerable research subject because of her mental status, Mrs. Franklin does belong to the population the intervention is designed to assist, and the study may lead to beneficial interventions for Alzheimer's patients in the future. However, a careful balancing of risks and benefits should occur.
During the conduct of a large clinical trial of an investigational drug, preliminary analysis of results show that there were three times as many participants in the experimental group who experienced severe nausea and vomiting compared to the control group. Two of the cases were severe enough to require that the participants be hospitalized. This is despite the fact that the preliminary analysis shows that there may be a moderate benefit with the drug.
What should be done?
All adverse events are reported to the Data Safety Monitoring Board, and serious adverse events must be reported to the IRB. Investigators should consider reevaluating the balance of risks versus benefits. While these adverse events are probably not serious enough to suggest that the trial be terminated, these adverse events should be balanced by significant benefits. These findings may relate to each participant’s willingness to continue in the trial, and according to 45 CFR 46.116(b)(5) the findings should be provided to all current and future participants as part of the informed consent process.
After having completed a study that involved the collection of tissue from the subjects, an investigator wishes to perform additional analysis of the archived tissue samples. This nature of this analysis was not explicitly stated in the original consent form.
Should the investigator be required to obtain explicit consent for the new research?
While de-identified tissues and data are currently permitted for secondary research uses under the regulations the Common Rule and such practices are under sharp debate given the inherent identifiability of genetic information and the requirements of respect for persons. Institutional Review Boards have increasingly required that explicit consent be obtained, if practical, before archived tissue can used for research. Even if participants may be willing in general to have surplus tissue used for research purposes, they should still be asked for their consent when specific new uses for their samples are identified. (For further discussion of this topic, see Ludman et al., 2010.)