the first $2,000 received during a calendar year by such individual (or such spouse) as compensation for participation in a clinical trial involving research and testing of treatments for a rare disease or condition (as defined in section 360ee(b)(2) of title 21 ), but only if the clinical trial—

(A) has been reviewed and approved by an institutional review board that is established— (i) to protect the rights and welfare of human subjects participating in scientific research; and (ii) in accord with the requirements under part 46 of title 45, Code of Federal Regulations; and

(B) meets the standards for protection of human subjects as provided under part 46 of title 45, Code of Federal Regulations.