; (B) in the case of an in vitro clinical test made available to investigators for clinical testing, obtain agreements from each investigator that any testing of the in vitro clinical test involving human subjects will be under such investigator’s supervision and in accordance with paragraph (C) and submit such agreements to the Secretary that ensure— (i) all investigators will comply with this section, regulations promulgated or revised under this section, and applicable human subjects regulations; and (ii) the investigator will ensure that— (I) informed consent is obtained as required under part 50 of title 21, Code of Federal Regulations (or any successor regulations), amended to apply to in vitro clinical tests; and (II) the requirements for institutional review board under part 56 of title 21 of the Code of Federal Regulations (or successor regulations), amended to apply to in vitro clinical tests, are met; and (C) ensure that informed consent will be obtained from each human subject (or the representative of such subject) of proposed clinical testing involving such in vitro clinical test, except where, subject to such other conditions as the Secretary may prescribe— (i) the proposed clinical testing poses no more than minimal risk to the human subject and includes appropriate safeguards to protect the rights, safety, and welfare of the human subject