Does the PHS Policy apply to the production of custom antibodies, or to the purchase of surgically modified animals?
The generation of custom antibodies is considered an activity involving vertebrate animals and covered by PHS Policy. Antibodies are considered customized if produced using antigen(s) provided by or at the request of the investigator (i.e., not purchased off-the-shelf). An organization producing custom antibodies for a grantee must have or obtain an assurance, or be included as a component of the grantee’s assurance. In addition, the applicant must provide the date (verification) of project-specific IACUC approval for the production of the antibodies.
The generation of custom antibodies is considered an activity involving vertebrate animals and covered by PHS Policy. Antibodies are considered customized if produced using antigen(s) provided by or at the request of the investigator (i.e., not purchased off-the-shelf). An organization producing custom antibodies for a grantee must have or obtain an Assurance, or be included as a component of the grantee’s Assurance. In addition, the applicant must provide the date (verification) of project-specific IACUC approval for the production of the antibodies. The same guidance applies if surgery is conducted in response to a specific, custom request (as opposed to animals previously modified and available prior to the request). An organization conducting custom surgery for a grantee must have or obtain an Assurance, or be included as a component of the grantee’s Assurance. In addition, the grantee must provide the date (verification) of project-specific IACUC approval for conducting the surger
The generation of custom antibodies is considered an activity involving vertebrate animals and covered by PHS Policy. Antibodies are considered customized if produced using antigen(s) provided by or at the request of the investigator (i.e., not purchased off-the-shelf). An organization producing custom antibodies for a grantee must have or obtain an Assurance, or be included as a component of the grantee’s Assurance. In addition, the applicant must provide the date (verification) of project-specific IACUC approval for the production of the antibodies.
Related Questions
- Is it possible to exclude from the delete policy some special custom tables not present in the original database schema?
- Does the PHS Policy apply to the production of custom antibodies, or to the purchase of surgically modified animals?
- Does the PHS Policy apply to use of animal tissue or materials obtained from dead animals?
