On May 23, 2000, President Clinton announced that the Department of Health and Human Services is taking new steps to strengthen Federal oversight and increase the accountability of researchers conducting clinical trials with human subjects in order to protect the safety of individuals participating in all clinical trials. New actions include:
1) issuing new guidelines stating that investigators must obtain new informed consent from participants after any unexpected death or serious adverse health event related to their clinical trial that may affect their willingness to participate;
2) issuing new guidelines stating that Institutional Review Boards are expected to conduct an annual audit of safety protocols to ensure that informed consent has been obtained and is being maintained appropriately;
3) beginning a systematic evaluation of the informed consent process to ensure that it safeguards the rights of trial participants;
4) proposing new civil monetary penalties of up to $250,000 per individual and $1 million per institution to promote compliance with current regulations;
5) expanding human safety training requirements for researchers;
6) taking initial steps to address potential financial conflict of interest issues.
These new actions, which respond to a Presidential request made in December, are necessary to strengthen requirements designed to protect the safety of participants, increase public confidence in clinical trials, and in so doing, enhance likely participation in these clinical trials.
The above was excerpted from a White House press release dated May 23, 2000. Based on the remainder of the information contained in the press release, there are some guidance documents to be issued and legislation to be passed. Much of it will be happening soon. Stay tuned!