Update Apr 15 with new information on an extended comment period and a link to AAAS resources.
Currently there is a new rule under consideration for the EPA called “Strengthening Transparency in Regulatory Science.” It would require transparency in what studies are used in the formulation of EPA guidelines, rules, and regulation. In this case, “transparency” is not defined in the scientific sense and the rules would make it impossible to use any human health studies that have been conducted ethically.
In practice, this rule will eliminate all ethically conducted and scientifically-sound studies on the health impact of any substance that is regulated by the FDA. This includes the contents of the air we breathe and the water we drink.
For this rule, “transparency” is defined as raw data. Including confidential personal information. In science terms, “transparency” means that data is available for peer-review and sources are clearly stated. Personally identifiable information has been removed from the data to protect the privacy of the health subjects. Properly executed studies of human health are obligated to anonymized data before release. Removing personally identifiable information ensures that the privacy of the subjects is upheld. HIPAA laws and basic scientific ethics mandates this.
As a person, would you participate in any health study if you knew your health information could be traced back to you by thousands of strangers?
Would you like your air and water to be regulated only by evidence collected via unethical or unscientific methods?
Leave a public comment for the FDA. Recommend they revise the rule to enable the use of peer-reviewed, HIPAA-compliant, ethical, science. Deadline for comments has been extended to May 18.
Remember to be direct, clear, personal, and respectful.
- State your stand on the rule (oppose or support)
- State why you feel this way (i.e. “this is not based on science”)
- Provide personal touch (i.e. “As a mother, I am worried about my children.” “As a scientist, this is unethical.”)