Hi Donna,I'm going to take a stab at answering this in the hopes that other will respond as well. Q: Can anyone simplify what is meant by a conditioned authorization and an unconditioned authorization for research example? I know that the authorizations can now be combined ... But I really do not know what is meant by conditioned and unconditioned. Any simplification would be appreciated!A: I would take this to mean that if the CE has an conditional authorization for the subject to sign that is in addition to the informed consent, the CE is seeking a conditional authorization for the use/disclosure of the subjects PHI. The subject would be excluded from the research study due to their refusal to sign the authorization. It is a condition to participate in the research study. The unconditioned is explained below in section 4. It states that in section one that a CE may add a condition, but not necessarily.
(3) Compound authorizations. An authorization for use or disclosure of protected health information may not be combined with any other document to create a compound authorization, except as follows:
(i) An authorization for the use or disclosure of protected health information for a research study may be combined with any other type of written permission for the same or another research study. This exception includes combining an authorization for the use or disclosure of protected health information for a research study with another authorization for the same research study, with an authorization for the creation or maintenance of a research database or repository, or with a consent to participate in research. Where a covered health care provider has conditioned the provision of research related treatment on the provision of one of the authorizations, as permitted under paragraph (b)(4)(i) of this section, any compound authorization created under this paragraph must clearly differentiate between the conditioned and unconditioned components and provide the individual with an opportunity to opt in to the research activities described in the unconditioned authorization.
This was also mentioned above and I thought I would in include due to its relevance. 164.508 (b)(4)(i)
(4) Prohibition on conditioning of authorizations. A covered entity may not condition the provision to an individual of treatment, payment, enrollment in the health plan, or eligibility for benefits on the provision of an authorization, except:
(i) A covered health care provider may condition the provision of research-related treatment on provision of an authorization for the use or disclosure of protected health information for such research under this section;