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Ethical Issues in Environmental Health Research Related to Public Health Emergencies: Reflections on the GuLF STUDY
Conclusions Environmental health research related to disasters and other public health emergencies raises challenging ethical issues that need to be addressed beforehand, including Minimizing risks and promoting benefits to participants. Obtaining valid informed consent. Providing financial compensation to participants. Working with vulnerable participants. Protecting participant confidentiality. Addressing conflicts of interest. Dealing with legal implications of research. Obtaining review from the IRB, community groups, and other committees (e.g., scientific review committees). To ensure that these issues are handled p...
Source: EHP Research - September 1, 2015 Category: Environmental Health Authors: Sam Duvall Tags: Brief Communication September 2015 Source Type: research

21st Century Cures Update: Ebola Hearing October 16, FDA's LDT Draft Guidance
This past July we wrote about the 21st Century Cures initiative and its efforts to bridge the gap between medical advances and the regulatory policies that govern them. The initiative, a bipartisan collaboration between Rep. Fred Upton (R–MI), chair of the Energy and Commerce Committee, and Representative Diana DeGette (D–CO), one of the panel's senior Democrats, aims to examine the “full arc” of the innovation process to get new treatments and cures to patients more quickly and streamline the drug and device development process. Some of the initiative’s recent activity is summarized below. Antibiotic resistance ...
Source: Policy and Medicine - October 10, 2014 Category: American Health Authors: Thomas Sullivan Source Type: blogs