UPDATE ON MARYLAND ATTORNEY GENERAL'S WORKING GROUP
                      By Jack Schwartz, Esq.
     MR. SCHWARTZ:  Thank you.  I'll summarize the current status
and identify some current issues pending before our group.  My
summary of those issues will make it plain, I think, the areas in
which we need your help.
     The Maryland Working Group has been about its task for more
than two years.  Our objective was to come up with a draft
statute on research involving decisionally impaired people that
could actually be enacted by the Maryland legislature.
     That last qualification is an important one.  I daresay that
many members of the Maryland legislature have never even heard
the word "bioethics" but they know a bioethics controversy when
they see one and they know how to avoid it.
     So for legislation of this kind to have a realistic chance
of enactment, it must arrive at the legislature with a fair
degree of consensus.  If the hearing on the bill turns into an
ethical debate, the bill will simply disappear without a trace.
     A consensus is not achievable without something that
resembles a public conversation.  So we have been at pains to try
to have public reaction to our thinking as we go along through
the medium of now three reports that we issued soliciting public
comments.  The last two of these three included draft statutory
language that people could react to.  The more you ask people to
give you comments, the more they do.
     So a satisfying aspect of this process is that, at least in
the last go-round, some people participated, reacted, who didn't
have an a priori interest in the subject, people who had no
particular organizational identification, leaders of religious
groups in Maryland, advocates for the homeless.
     Their overall reaction was twofold.  To think that the
essentially unregulated status quo about research involving
decisionally impaired subjects was unsatisfactory, but that the
proposal then on the table, the August '97 version of our
document, fell short in a number of respects.  I'll summarize
those in a moment.
     But the upshot, from my perspective, is that, given the
current reaction to our draft that's on the table, given the
prospect that you all will serve as the cavalry coming over the
hill to save us in some respects, that it was not ready for
introduction in the session of the Maryland legislature that
begins next week.
     Hence, we will not offer a proposal in the '98 session of
the legislature, which is a three-month session.  Essentially, if
we were going to do it we would have had to have done it by now. 
That is to say, have a draft that was essentially ready, talk to
key member of the legislature.  None of that has happened because
we're not ready yet.
     So we will have the opportunity to be guided by the
Commission's report as we continue this process.  I anticipate
that we'll have another draft out by middle of spring, again,
soliciting public comment.  Our goal method was to try and share
our thinking as we went along.  That's been fruitful, and I
commend that strategy to you.
     Let me try and summarize in general terms the reaction that
commentors had to the proposal that's now on the table, our
proposal.
     The first, was to be nervous about something that we did not
include in the document that we left out, and that is the issue
of capacity assessment.  The current Maryland draft simply takes
as a premise that the individuals who are the potential research
subjects are decisionally incapacitated and regulates from there.
     Well, there was much focus on the lack of discussion or lack
of provision in the bill for a process of capacity assessment, so
we are wrangling with that.  Our sense, of course, is that
despite the excellent scholarship in this field, Dr. Applebaum's
and others', that there is no broad agreement within the field on
the methodology for capacity assessment.
     Hence, I think it is likely that our next proposal will
simply impose an obligation on researchers where the research
subjects have a condition that raises a red flag, if you will,
about capacity to describe what method they are planning to use
to assess capacity and charge the IRB with reviewing that
recommendation or that proposal by the investigator.
     Hence, there will be no command and control state
regulation, but instead the obligation on the part of the
investigator and IRB to address the issue.
     The commentors were wary of things that we had included in
the measure, not only things that we had left out.  There was
considerable concern over a topic that you all have addressed
this morning, and that is Research Advance Directives and the
circumstances under which those ought to be given the legal
security of a statute.
     An interesting aspect of concern was, what is to prevent
investigators from potentially turning these into blank checks,
to essentially solicit the signing of a research advance
directive upon admission to a facility, worry that if the
provisions on advance directives were too open-ended, that it
might invite abuse of that kind.
     A second aspect of concern was over capacity, assessing
capacity to executive an advance directive.  There seemed to be
general recognition of the truism that people may have differing
capacities for differing decisions and, therefore, the fact that
an individual might not be capable of giving informed consent to
research participation did not necessarily imply that the
individual lacked the capacity to execute an advance directive.
     Those are different decisions, depending on what the advance
directive is, of course.  I'm speaking now of proxy-type advance
directives designating a substitute or surrogate decision maker.
     Yet, there were worries that at least the -- in situations
where an investigator had determined that a potential research
subject lacked the capacity to give informed consent and yet then
solicited an advance directive, was a worrisome phenomenon and,
hence, ought to be addressed through some provision calling for,
at least in those circumstances, an assessment of capacity to
execute the advance directive, a separate issue than capacity to
give informed consent.
     There was worry over elements of our proposal that
essentially borrowed Federal concepts.  We had understood our own
role from the outset as being unable to fix problems that arose
from the common rule itself.
     So, insofar as there are difficulties, as there plainly are,
with the definition or concept of risk, as reflected in the
Federal or in the common rule, we imported those difficulties
into our proposal because we simply borrowed the definition of
minimal risk and erected categories of risk based on that sandy
foundation.
     But we didn't think that we could, in Maryland, do anything
useful by way of addressing a problem that is a fundamental one,
as you've identified, and that has national import, and we have
been criticized for that.
     How can you, people say, invest substitute decision makers
with authority in particular categories of risk when, to borrow
Professor Capron's phrase, the categories are bounded by pieces
of spaghetti.
     There isn't any satisfactory answer that we can give to
that, except this was sort of the given for us.  So to the extent
that the Commission is able to help inform our understanding of
risk and, hence, of the categories of decision making authority
that can be built on risk, we would be most grateful.
     Another issue that will engage us at our next meeting in, I
think, early February has to do with what limitations, if any,
state law ought to place on participation by decisionally
impaired subjects in placebo-controlled studies.
     The concern is over circumstances in which there is standard
therapy and yet individuals with decisional incapacity are
enrolled in placebo-controlled studies so that they are removed--one arm of the study--from their standard therapy and given
placebo.
     As usual, we lack data in knowing how often this occurs, but
the commentors were worried that the proposal, as currently
framed, would allow that because it really doesn't address very
much about placebo, or the control aspects of a randomized
clinical trial.  So that's another matter on our particular
table.
     So those are what we are grappling with.  Any aid from you
all would be deeply appreciated.  We will be having a set of
discussions within the working group over February and March.
     I would imagine by late March, early April we ought to be in
a position to again share our thinking with you and the public
through the publication of another report.
     The idea would be to be in a position by summer to have
completed our work and identify consensus, if there is one, and
then go about the business of trying to develop legislative
support for the proposal.
     CHAIR CHILDRESS:  Thank you.  Thank you very much, Jack.
     Are there any questions or comments?
     (No response)
     CHAIR CHILDRESS:  Well, thank you very much.
     MR. SCHWARTZ:  Thank you.
     CHAIR CHILDRESS:  We appreciate your sharing with us.
     Bill Freeman.  I saw him a moment ago.  Oh, he's on the
telephone now.  The latest word, is that right, Bill?
     DR. FREEMAN:  Not quite.
     CHAIR CHILDRESS:  Bill, we're grateful to you for updating
us on the report.
     Let me just mention, for those who may not have been here
when we talked before, the plan is to complete the report from
the Genetics Subcommittee and the Commission as a whole on tissue
samples and the one on decisionally impaired research subjects,
and then to complete the one on the Federal Agency Report,
perhaps in conjunction with recommendations about Federal
oversight.  So this will be the third report released.  The data
collection is still in process, but almost done.  So Bill is
going to update us about that.