Aggregated News
Untitled DocumentInstitutional review boards (IRBs), designed to serve as gatekeepers protecting patients from unethical human research practices, are under new scrutiny from federal regulators and ethicists.
Critics say studies with serious design flaws that could lead to unethical practices or participant harm continue to win approval because IRBs are too lax, have unqualified members, are riddled with institutional and personal conflicts of interest, and are overwhelmed by the volume of studies they must review.
Those involved with IRBs counter that while the system isn't perfect, the integrity of human research would be compromised without their involvement. They say IRBs have improved in terms of transparency and conflict disclosure.
Last month, the consumer advocacy group Public Citizen and the American Medical Student Association complained to HHS' Office for Human Research Protections (OHRP) about the ethical integrity of two ongoing studies analyzing the impact of longer-than-recommended work shifts for first-year medical residents on 30-day patient mortality rates. Public Citizen and the student association called the studies “highly unethical” for not seeking informed consent from the medical residents or the patients...
Critics say studies with serious design flaws that could lead to unethical practices or participant harm continue to win approval because IRBs are too lax, have unqualified members, are riddled with institutional and personal conflicts of interest, and are overwhelmed by the volume of studies they must review.
Those involved with IRBs counter that while the system isn't perfect, the integrity of human research would be compromised without their involvement. They say IRBs have improved in terms of transparency and conflict disclosure.
Last month, the consumer advocacy group Public Citizen and the American Medical Student Association complained to HHS' Office for Human Research Protections (OHRP) about the ethical integrity of two ongoing studies analyzing the impact of longer-than-recommended work shifts for first-year medical residents on 30-day patient mortality rates. Public Citizen and the student association called the studies “highly unethical” for not seeking informed consent from the medical residents or the patients...