【多选题】Which of the following statements on "NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (2016)" are correct?
A.
The guidelines detail safety practices and containment procedures for basic and clinical research involving recombinant or synthetic nucleic acid molecules, including the creation and use of organisms and viruses containing recombinant or synthetic nucleic acid molecules.
B.
The purpose of the NIH Guidelines is to specify the practices for constructing and handling: (i) recombinant nucleic acid molecules, (ii) synthetic nucleic acid molecules, including those that are chemically or otherwise modified but can base pair with naturally occurring nucleic acid molecules, and (iii) cells, organisms, and viruses containing such molecules.
C.
In the context of the NIH Guidelines, recombinant and synthetic nucleic acids are defined as: (i) molecules that a) are constructed by joining nucleic acid molecules and b) that can replicate in a living cell, i.e., recombinant nucleic acids; (ii) nucleic acid molecules that are chemically or by other means synthesized or amplified, including those that are chemically or otherwise modified but can base pair with naturally occurring nucleic acid molecules, i.e., synthetic nucleic acids, or (iii) molecules that result from the replication of those described in (i) or (ii) above.
D.
For a clinical trial site that is added after the completion of the NIH protocol registration process, no participants should be enrolled at the clinical trial site until IBC approval and IRB approval from that site have been obtained.