Close family members are left with the decision, but there is no clear policy for this so-called “surrogate” consent. Because of that, research about the increasingly common disease is often stalled.
But a new study suggests that older Americans are very supportive of family surrogate-based research, and would support having their family members enrol them in research in case of future incapacity.
Because of uncertainties about federal policy, some institutions have gone so far as to not allow surrogate consent at all and research has been halted at other institutions, says lead author Scott Y. H. Kim.
The federal policy states that surrogate consent can be provided by legally authorised representatives of adult patients, but the federal government defers to states to define who these representatives are. The lack of a clear definition has caused widespread confusion and uncertainty for three decades, notes Kim.
If state policies are unclear, then it is the responsibility of hospitals and their Institutional Review Boards to determine the boundaries for surrogate-based research. Only three states - Virginia, New Jersey and California - have recently enacted research ethics laws that clearly address this issue.
Even though regulations remain unclear, however, the general public appears to accept the idea of family surrogate consent - both as a societal policy and for themselves, the new study found.
The participants answered questions regarding one of four randomly assigned surrogate-based research scenarios: lumbar puncture study, a drug randomised control study, a vaccine study and a gene transfer study. Each participant answered three questions: whether our society should allow family surrogate consent, whether the individual would want to participate in the research, and whether the individual would allow a surrogate some or complete leeway to override stated personal preferences.
MEDICA.de; Source: University of Michigan Health System