These standards recognize that there are situations where the individual's right
to control his/her PHI is overridden by society's need for the that individual's
PHI for research that will benefit others. In theory, these exceptions should be
as narrow as possible, and the information should be carefully protected from
further disclosure. The identifiers should be destroyed as soon as they are no
longer needed, absent specific reasons to retain them. There are two problems
with these standards which raise troubling questions. First, there is no review
of the underlying importance of the research being done. There is no balancing
between the value of the research and the individual's privacy: any research
can qualify for a waiver or modification of the authorization requirements,
without regard to its merits. Second, the IRB or Privacy Board does not review
the actual authorization that will be used. It is only required to decide whether
a waiver or modification is allowable, but it is the researchers who get to
decide what the form will look like. Since this provision does not prohibit IRBs
or Privacy Boards from reviewing these modified forms, it is anticipated that
they will get some review to assure that they really meet the representations
made to the IRB or Privacy Board.