Secretary’s Advisory Committee on Human
Research Protections (SACHRP)
U.S. Department of Health and Human Services
April 18, 2005- April 19. 2005
1:30 pm
Committee finishing discussion on the report from the Children’s
Subcommittee. Long discussion about the definition of commensurate
criterion. Definition was changed to read:
Under Section 406 -- the commensurate criterion, some children
cannot experience even a minor increase over minimal risk because
of their or their parents or guardians unfamiliarity with the
procedure or because the research imposes an unfair burden on
the subjects.
2:00 pm
Subpart A Report. The report was given by Daniel Nelson, M.S.,
CIP, University of North Carolina Co-Chair of the Subpart A,
Subcommittee to SACHRP. The other co-chair is Felix Gyi, Pharm.D.,
M.B.A., CIP, Chesapeake Research Review, Inc.
The Subcommittee has met twice – once by teleconference
on January 18, 2005 and once in Alexandria, VA on February 14,
2005. The Subcommittee hopes to meet together sometime during
the summer, but is having difficulty setting the date due to
scheduling issues and commitments of its membership. Please
see the report (PowerPoint slides) marked “Subpart A Subcommittee
Update.” (will be sent by US Mail or fax, as you wish)
The oral report followed the written report exactly with only
a few additional comments to provide examples or background
information. The more substantive comments are recorded below.
Page 1, slide 3, goals: “the third goal (“Promote
scientifically and ethically valid research”) was added
after the Feb 1, 2005 SACHRP meeting at the request of the Committee”
Nelson - I believe that all of these goals are supportive of
one another and that efforts to promote any of them promote
all of them and that none are possible without the others.
Page 3, slide 3: investigator responsibilities are largely
lacking in the current Rule; such a section and focus needs
to be developed
Page 4, slide 1: exceptions and deviations are single setting,
single instance deviation
Page 4, slide 1: Adverse event reporting is not on the list
of issues that the Subcommittee plans to address because there
is “lots of activity on adverse event reporting at the
federal government level so we chose not to replicate the concentrated
national effort.”
The Subcommittee chose to move ahead with two issues:
• Continuing Review
• Expedited Review
See working groups and questions under consideration by each
group.
Continuing Review
Continuing review is a burden on IRBs that is important in research
and is an appropriate and valuable burden, but want to be certain
the burden is tied to research needs and is not bureaucratic
or administrative in nature
Page 5, slide 2, question 1: when can continuing review stop?
The example provided concerned a situation where the investigator
wanted to maintain a data set with identifying data long after
the active research on participants had ceased. Would the existence
of the data set mean that human research subjects still existed?
Page 5, slide 2, question 4: IRB re literature searches: seems
that the investigator might be the best person to be responsible
for literature searches; conversation ongoing because health
sciences librarians are discussing what their responsibility
is at their conferences; who should be held responsible?
Page 6, slide 1, question 10: date of continuing review: a 30
day rule is effectively in place now, does this time table fit
or is it too tight?
Page 6, slide 2, question 14: can existing guidance on continuing
review be consolidated and integrated?: Subcommittee certainly
wants to tie together the guidance more than is the case now
Expedited Review
No additional comments
Question from the Chair, Ernest Prentice to Subcommittee Co-Chair
Daniel Nelson:
Q. Prentice - Will your work require a change to the Common
Rule?
A. Nelson - The changes we foresee can primarily be taken care
of by additional interpretation and guidance and not changes
in regulations, although something might require such a change.
Comment from the audience by Gary Last Name? I believe that
he used to work at OHRP for many years. “The one year
rule would certainly require a change.” The investigator
responsibilities can be added to what is there.
Summary Comment by Chair Prentice - a great deal accomplished
in a short time, thank you for your hard work
Subpart C Subcommittee
See “Report of the Subpart C Subcommittee to SACHRP, April
18, 2005" (to be sent by US Mail or fax, as you wish):
Prisoners
The Report was accepted with the following changes proposed
by Chair Prentice – all accepted by the Subcommittee Chair,
Mark Barnes
1) At all places in the text where the text reads “The
Subcommittee suggests...”, the text be changed to read,
“The Subcommittee recommends....” (e.g., page 3
bold type)
2) Page 5, main bullet point no. 3 (from the top of the page)
“A prisoner member or consultation with a prison expert....”
be changed to “A prisoner advocate or consultation with
a prison expert....”
3) Page 5, last bullet point (at bottom of the page), last sentence:
“In such circumstances, the incarceration of a subject
would be treated appropriately as an unexpected adverse event
in the study, perhaps requiring a protocol change, approved
either through expedited or full IRB review.
want to change the terminology from unexpected adverse event
as that terminology means something quite specific
Ada Sue Selwitz commented that what they want to happen is that
the incarceration of a subject would be something that would
be reported; should be treated as a reportable event, then determine
how to deal with it based on the specific circumstances
decision was made to have the wording read “In such circumstances,
the incarceration of a subject would be treated appropriately
in the study, perhaps requiring a protocol change, approved
either through expedited or full IRB review.”
4) Page 6 - Committee Chair wondered about pronoun “her”.....do
want recommendations to apply to male prisoners too, don’t
you?
Subcommittee Chair - yes, we varied the pronoun use, sometimes
using her and sometimes using his
agreed that his/her would be used throughout the report
5) Page 7, bullet point 2: terminology “all federal government
IRBs....” meant to cover all FWA, Subpart A IRBs reviewing
protocols involving prisoners — clarify
6) Page 9, number 2, last sentence: “....Subpart D for
chronically ill children - additional risks on top of those
already present (insert: because of a chronic illness) are not
justified.”
7) Page 9, number 6, first sentence: drop the word “ratio”
and modify, so that the sentence reads “When IRBs contemplate
the risks and benefits of research they should begin......”
Motion: to accept the Subpart C Subcommittee report as final
was moved and seconded, passed without objection.
Summary Comment: Chair Prentice - Thank you to members of the
Subcommittee. We look forward to the report of the IOM Committee
working on research on prisoners.
End of Meeting
Before adjourning, Chair Prentice asked Bernard Schwetz, D.V.M.,
Ph.D., Director OHRP, whether he had any comments.
1) Schwetz - Subpart A Committee asked about priorities for
next focus. “Seems a unique opportunity to learn from
the community that you are trying to help.” Could ask
IRBs their highest priorities, certainly are not bound by their
responses, but you could learn what they consider to be issues
and areas where they could use help.
Daniel Nelson - we have made some efforts to reach out without
receiving much input back
Ernest Prentice - could offer a workshop on Subpart A at the
annual PRIM&R meeting and ask about their concerns. Would
be well attended session. He has discussed this idea in the
past with Dr. Schwetz.
Nelson - will try to carry out
2) Schwetz - asked about the specifics of the brokenness of
the IRB system – why is it broken?, what is it that is
broken?, how approach to get an idea of how to fix the system?
Not certain of speaker – “the biggest problem is
the inconsistency of resources and inconsistency of education
for IRBs across the country”
Prentice - remarkable changes since 1998, it is probably more
tragedies could happy because we are only human beings...the
system needs more fixing, but it is not broken
Not certain of speaker – Mary Polan? - what about approaching
this question using empirical analysis and assessment –
see what works and does not work
Prentice? – Academy of Engineering recent report - need
something like the system that airlines or railroads have where
they do not fire employees who report near misses, healthcare
fires people who report near misses so the reports do not come
in; the VA HealthCare system has a system that permits reporting
of near misses – we need a better way to gather information
about “near misses”
Susan Kornetsky - attention to near misses is occurring within
a hospital or within a committee, but not outside of the institution
Mark Barnes - focus on the obligations of the investigators
and their responsibilities
Meeting Adjourned
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