Alteration of Elements of Informed Consent (Option #3) Checklist

Alteration of Elements of Informed Consent (Option #3): All conditions must be met:
(1) The study involves an in vitro diagnostic device investigation.
(2) The testing is noninvasive
(3) The testing does not require an invasive sampling procedure that presents significant risk.
(4) The testing does not by design or intention introduce energy into a subject.
(5) The device is not used as a diagnostice procedure without confirmation of the diagnosis by another, medically established diagnostic product or procedure.
(6) Either of the following is true (indicate which one in the box below):
(a) For a product in the laboratory research phase of development, and not represented as an effective in vitro diagnostic product, all labeling bears the statement, prominently placed: "For Research Use Only. Not for use in diagnostic procedures."
(b) For a product being shipped or delivered for product testing prior to full commercial marketing (for example, for use on specimens derived from humans to compare the usefullness of the product with other products or procedures which are in current use or recognized as useful), all labeling bears the statement, prominently placed: "For Investigational Use Only. The performance characteristics of this product have not been established."
(7) The study uses one or more of the following (indicate in the box below):
(a) Specimens collected for routine clinical care or analysis that would have been discarded.
(b) Speciamens obtained from specimen repositories.
(c) Leftover specimens that were previously collected for other research purposes.
(8) The identity of the subject is not known to the investigator or any other individuals associated with the investigation, including the sponsor.
(9) Neither the investigator not any other individuals associated with the investigation, including the sponsor can readily ascertain the identity of the subject.
(10) One of the following is true:
(a) Specimens are not coded ("Coded" means that 1) a number, letter, symbol, or combination thereof (i.e., the code) has replaced identifying information (such as name or social security number) that would enable the investigator or any other individuals associated with the investigation, including the sponsor to readily ascertain the identity of the individual to whom the specimen pertains; and 2) a key to decipher the code exists, enabling linkage of the identifying information to the specimen.)
(b) Neither the investigator(s) nor any other individuals associated with the investigation or the sponsor can link the specimen to the participant from whom the specimen was collected, either directly or indirectly through coding systems.
(11) One of the following are true. (indicate in the box below):
(a) The specimens are not accompanied by clinical information.
(b) Clinical information that accompanies the specimens does not make the specimen source identifiable to the investigator or any other individual associated with the investigation, including the sponsor.
(12) The individuals caring for the patients are different from those conducting the investigation and do not share information about the patient with those conducting the investigation.
(13) The individuals caring for the patients do not share information about the patient with those conducting the investigation.
(14) The specimens are provided to the investigators without identifiers.
(15) The supplier of the specimens has established policies and procedures to prevent the release of personal information.
(16) The study has been reviewed by an IRB in accordance with 21 CFR Part 56, except for determining compliance with 21 CFR Part 50