|History:||Issued -- February 24, 2020|
|Revised -- February 24, 2020|
|Last Reviewed -- February 24, 2020|
|Related Policies:||Protection of Human Subjects in Research Policy|
|Additional References:||Disclosure of Intent to Use Biological Materials in Research Form; Dignitas Personae|
|Responsible Official:||Provost tel (202) 319-5244|
I. Policy Statement
The Catholic University of America recognizes the dignity and sanctity of life and that life begins at conception. The Catholic University of America does not conduct research nor does it allow students to be placed in off-campus academic situations (internships, etc.) involving human embryonic stem cells or other primary human fetal or embryo cells. Research at The Catholic University of America is guided by and complies with Dignitas Personae issued by the Congregation for the Doctrine of the Faith.
A. Human Embryonic Stem Cells mean pluripotent cells that are derived from human embryos.
B. Primary Human Embryo or Fetal Cells mean cells obtained directly from the embryo or fetus that have not undergone sub-culturing or passaging in the laboratory.
C. Approvable Cell Lines mean commercially-available Human embryonic or fetal cells that have been produced in their usable form by substantial laboratory processing, (Note: Not all Approvable Cell Lines will be approved for use in Catholic University research.)
D. Human-Derived Biologic Materials mean molecules, tissues, or cellular components that are derived from human cells. In the context of this policy, the human cells are considered to be of embryonic or fetal origin.
III. Process for Requesting Approval
Before any Human-Derived Biologic Materials can be used in the conduct of University research, regardless of funding source, the researcher must obtain the approval of the Vice Provost for Research. For externally-funded research projects, this approval must be obtained before proposing the project to the funding source. For internally- or un-funded research projects, the approval must be obtained before the materials are procured. Approval is requested by submission of the Disclosure of Intent to Use biological materials in research form to the Office of Sponsored Programs. The Disclosure form must be signed by both the Researcher and his or her Department Chair (or Dean if from a non-departmentalized School).
Approval will not be granted to pursue research involving the use of Human Embryonic Stem Cells or Primary Human Embryo or Fetal Cells.
Researchers requesting the use of Approvable Cell Lines must justify their use for technical reasons, and also show that there are no alternative materials available that can both produce the same scientific results, and whose origins do not violate the sanctity of human life as taught by the Catholic Church, and explicated in Dignitas Personae.
IV. Granting Approval
The Vice Provost for Research, consulting with an internal University ethical review board and others as needed for scientific and ethical background, may approve the use of Approvable Cell Lines or Human-Derived Biologic Materials if the researcher has made a compelling case that the project requires the use of that particular cell line, and that there are no reasonably-available alternatives.
V. Accommodations for Employees and Student Researchers
University faculty are responsible for informing any and all new hires, including, but not limited to laboratory staff (such as post docs) and student research assistants, of the potential use of Approvable Cell Lines or Human-Derived Biologic Materials in the laboratory and to this policy. Those potential hires that are uncomfortable with the policy or those who currently have or believe they might develop conscientious objections to working with these materials should be encouraged to pursue assignments in other laboratories or on other projects where no objectionable materials are employed. Should someone already working in a laboratory decide they have a conscientious objection, the faculty member will attempt to re-assign the objector to another suitable and acceptable position within the same laboratory. If another suitable and acceptable position cannot be found within the laboratory, every attempt will be made to accommodate the objector in another research laboratory. The objector will in no way be penalized for their objection, but he/she should realize that it is possible that a suitable and acceptable position may not be available, and if one is identified, there may be differences in salary, performance requirements, and supervision from the original position.