HIPAA, Researchers and the IRB: Part Two. Alan Homans, IRB Chair and Nancy Stalnaker, IRB Administrator. Introduction. AGAIN… Don’t kill the messenger – we didn’t write this rule!
Alan Homans, IRB Chair and
Nancy Stalnaker, IRB Administrator
Privacy rule applies to research that uses Protected Health Information (PHI).PHI is individually identifiable health information received from a covered entity.
Three categories of identifiability:
The Draft FAHC Authorization language template is now finished and will be piloted beginning this week. It is a SEPARATE document to be executed in addition to the Informed Consent Document.
Protocols Approved Prior to 4/14/03:
Review of authorization forms for existing protocols will be done on a first-come, first-serve basis – if you know you will be entering new subjects soon after 4/14/03, get your authorizations as soon as possible.
The process for determining which new protocols will require authorization is currently being developed, including a revision to our protocol cover sheet. We will let you know as soon as this is available.
In research, authorization is not required if it meets the criteria for waiver outlined in the privacy rule.
Not adversely affect rights and welfare of subjects
Research cannot be done without waiver
When appropriate, information will be provided to subjects of research
No more than minimal risk to privacy, based on, at least:
Plan to protect identifiers
Plan to destroy identifiers ASAP
Written assurance that PHI will not be used/disclosed with few exceptions
Research cannot be done without waiver, and
Research cannot be done without this PHICRITERIA FOR WAIVER OF AUTHORIZATION
The process and forms are currently being developed to address the required criteria necessary for the IRB to approve a waiver. We will let you know when these are available.