April 26, 2023
The Honorable Cathy McMorris Rodgers
Chair
Committee on Energy and Commerce
U.S. House of Representatives
Washington, DC 20515
Dear Chair Rodgers:
Thank you for your March 30, 2023, letter regarding research on mpox, formerly known as monkeypox, and the National Institute of Allergy and Infectious Diseases (NIAID), a component of the National Institutes of Health (NIH). NIAID and NIH take the safe and secure conduct of research very seriously and have robust guidance, procedures, and protocols in place to ensure that intramural and extramural scientists, including those proposing research on mpox, maintain the highest possible standards for biosafety and biosecurity, as well as follow all applicable laws and regulations. I am pleased to respond on behalf of NIH.
At the outset, I want to respond specifically to the portion of your letter that described a September 2022 Science article that referenced a potential sub-project, which you called the “clade 1 study.” This study has not been formally proposed, and NIAID has no plans to move forward with this research. This type of research would require a formal proposal to be submitted for review, and the proposal would need to undergo the rigorous review process described in this letter before it could be initiated.
By way of background, NIH intramural projects are required to follow all applicable NIH policies and procedures, including adherence to biosafety and biosecurity guidance as outlined in the current edition of the Biosafety in Microbiological and Biomedical Laboratories, the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines),[1] the Federal Select Agent Regulations,[2] and other applicable regulations as appropriate. All NIH intramural research is subject to a standard review process whenever new experimental procedures are scientifically necessary. This standard NIH intramural review process includes specific requirements based upon the proposed experiments and initiates upon submission of a research proposal to the relevant committees. Notably, the proposed research cannot begin until approved by all relevant entities.
- ↑ NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules. https://osp.od.nih.gov/wp-content/uploads/2019_NIH_Guidelines.htm
- ↑ Federal Select Agent Program. Select Agents Regulations. https://www.selectagents.gov/regulations/index.htm
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