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Minutes
Full Meeting of the Director's Council of Public
Representatives to Discuss Draft Human Research Protections Report
Conference Call
October 2, 2001
National Institutes of Health
Bethesda, Maryland
Summary Report
National Institutes of Health (NIH) Acting Director, Dr. Ruth Kirschstein,
welcomed members of the Director's Council of Public Representatives
(COPR) and thanked them for participating in this official, full meeting
by means of telephone conference to discuss a COPR working group's draft
report on human research protections. She then asked Ms. Debra Lappin,
who chaired the working group, to lead the discussion.
Ms. Lappin said the working group—other members include Dr. Melanie
Dreher, Ms. Barbara Lackritz, Ms. Joan Lancaster, Mr. Roland McFarland,
Dr. Isaac Montoya, Ms. Rosemary Quigley, Mr. Bob Roehr, and Mr. Tom
Vaalburg—is seeking comments, changes, and approval from COPR members
for its draft report. She thanked NIH officials for supporting the working
group in these efforts and also praised NIH more broadly for supporting
research-related patient protections; she additionally thanked the COPR
working group members in preparing the draft report.
Ms. Lappin said the draft report consists of a lengthy supporting document
and an executive summary, which contains recommendations. A commitment
to consider the subject of human research protections was made about
two years ago; plans evolved as the working group sought an appropriate
means to express COPR's views on these issues, recognizing that COPR
represents the interests of the general public.
One major thrust of the working group report is an emphasis on the
value of human life in the context of medical research, making it crucial
for researchers to observe high ethical standards when conducting that
research. Another major thrust entails ensuring that patients have a
greater voice in key decision-making that will affect the course of
medical research, according to Ms. Lappin. The working group believes
that NIH leadership in promoting this latter "patient empowerment"
effort is vital.
In framing its recommendations, the working group considered six key
areas: 1) informed consent, 2) transparency of information, 3) institutional
review boards (IRBs), 4) conflicts of interest, 5) confidentiality and
privacy, and 6) enhanced education and training of the public. Informed
consent, for example, should be considered a continuing process, not
a single event at the outset of a clinical research project, and should
allow potential participants broad freedom to learn fully about the
research being planned. In the same vein, information about such research—-including
data about adverse events, relevant information in the published literature,
and eventual outcomes of the research—should be available and made
"transparent" to active and potential participants.
The working group recognizes that many individual IRBs are under severe
strain. Therefore, the report urges NIH to critically reexamine the
entire system of IRBs and review the impact of conflicts of interest
on IRB performance. The working group also recommends that NIH encourage
appointments of independent members to the review boards. It also urges
that IRBs more fully disclose conflicts of interest to potential and
actual study participants and that NIH considers weighting its funding
awards in a way that will encourage institutions whose IRBs make such
disclosures fully and consistently.
Under its fifth recommendation, the working group suggests that measures
to protect patient confidentiality be fully woven into the informed
consent process. The group also urges NIH to develop model programs
for educating the public about participating in biomedical research
and improve the training and sensitivity of investigators who conduct
such research.
DISCUSSION OF WORKING GROUP DRAFT RECOMMENDATIONS
Dr. Luz Claudio asked how COPR might assess NIH's eventual implementation
of these recommendations. Ms. Lappin suggested that NIH could identify
milestones to mark progress in implementing the COPR recommendations.
Dr. Evelyn Bromet asked whether the draft report recommendations apply
broadly to research involving human subjects or more narrowly to clinical
research. She also asked whether there is a suitable title for the report.
In response, Dr. Isaac Montoya indicated that the working group members
focused on developing recommendations applicable primarily to clinical
research situations and deferred non-clinical matters to a future working
group. Dr. Bromet then recommended that the report delineate its scope
more clearly from the outset. Her comment prompted Ms. Lappin to suggest
the report be called, "Human Research Protections in Clinical Trials:
A Public Perspective."
In response to a question from Mr. Doug Yee, Ms. Lappin said informed
consent needs to be conducted on multiple levels and that documents
used for this purpose should be written simply and, if need be, in languages
other than English. Ms. Lackritz said the draft describes a wide variety
of situations that need to be dealt with to achieve informed consent.
Dr. Montoya added that the report encourages NIH to be innovative in
developing better means to inform participants about current clinical
research.
Dr. Bromet asked about making previously published reports (before
1966) and non-English language reports available to meet recommendations
calling for the informed consent process to be fully transparent. In
response, Dr. Kirschstein indicated that the National Library of Medicine
(NLM) staff can provide selected publications in translation but a comprehensive
selection may not always be available. Mr. Bob Roehr said the draft
report should recommend the use of the NLM Medline system "and
its successors" to incorporate any forthcoming improvements in
that system.
In response to comments from Rosemary Quigley, Ms. Lappin suggested
the report should say updated information will be made available to
research participants without recommending that specific FAQ (Frequently
Asked Questions) segments be updated.
Dr. Bromet asked whether or not NIH takes the lead in setting IRB policies.
Dr. Kirschstein said many IRB practices are determined at the local
institutional level but NIH will soon be providing additional financial
support to IRBs, which would serve to improve practices. She also noted
that the Office for Human Research Protections within the U.S. Department
of Health and Human Services reviews IRB performance—a task that
was formerly conducted by the NIH Office of Protection from Research
Risks.
Dr. Kirschstein said NIH relies on local institutions to appoint and
train its members who represent the public but is considering ways to
strengthen its role in advising local IRBs about involving the public.
Ms. Quigley said that ways are needed to strengthen public members role's
at individual IRBs. She further noted the working group did not make
specific recommendations about improving the training of IRB members
because it recognizes that such efforts are underway elsewhere. Ms.
Lappin said, in effect, the working group's first recommendation calls
for wholesale reevaluation of the system as a basis for improving IRBs,
including better training of IRB members.
Mr. Yee, Mr. Roehr, and Ms. Lappin considered whether the draft report
recommendations are aimed to extend beyond NIH-supported research. They
concluded that COPR's mandate restricts the council to making recommendations
to NIH.
Dr. Len Tamura asked whether the draft report specifically makes a
recommendation about incentives for better handling of conflicts of
interest by institutions. Dr. Bromet said that improved performance
in handling conflicts of interest might be added as a criterion for
evaluating and reviewing grants. Ms. Lappin said that perhaps incentives
should be based on institutions improving their overall performance
against a checklist of patient protection measures rather than restricting
incentives to improvements in handling conflicts of interest. Mr. Roehr
suggested that such incentives be viewed as tools for measuring implementation
of the recommendations embodied in the forthcoming COPR report.
Dr. Bromet said it may be important to make handling of conflicts of
interest a criterion since it is not currently a specific criterion
during grant reviews. After some additional discussion, Dr. Kirschstein
urged COPR members to review this suggestion very carefully before finalizing
it. Dr. Montoya also urged special care in this area, saying that COPR
would do better to frame general, rather than detailed, recommendations
in this context. He pointed out that reviewers are told to focus on
the scientific merit of proposals. Dr. Bromet differed on this point,
stating that evaluating how human subjects will be treated during clinical
trials is an integral part of the scientific review.
Dr. Kirschstein interjected that NIH routinely conducts reviews on
two levels—the first focuses on scientific merit and the second,
by advisory councils, on broader issues, including potential conflicts
of interest. Dr. Kirschstein also indicated that councils delay funding
of proposals until any concerns over such issues are satisfactorily
addressed. She further pointed out that NIH is studying a report indicating
that some 25 percent of all IRBs have mechanisms for disclosing and
examining conflicts of interest. In light of this discussion, Dr. Montoya
recommended changing the working groups draft to say that conflict of
interest review practices should be considered but not invoked, so approval
of otherwise acceptable clinical research proposals would not be delayed.
Ms. Lappin and Mr. Roehr agreed to modify the draft report to include
milder language recommending that NIH review panels may include a criterion
about conflicts of interest. Namely, that review panels could include
a criterion that institutions submitting a proposal have systems in
place for disclosing conflicts of interest and that such review panels
indicate that this criterion could become a factor in the allocation
of resources.
Dr. Tamura suggested that, as with informed consent, ensuring confidentiality
and privacy of clinical research participants should be explicitly described
in the working group report as an ongoing process, not a static event.
In response, Mr. Roehr and several other COPR members said that the
draft could be reworded to reflect his suggestion.
CONCLUSION
Ms. Lappin requested NIH to circulate the amended working group document
among COPR members for final changes and approval, and that the completed
report be submitted to Dr. Kirschstein at the COPR meeting scheduled
for October 23, 2001.
Mr. Yee expressed concern about how additional comments from the public
might be handled. Dr. Kirschstein said that the agenda for the next
meeting will be made public and that members of the public will have
the opportunity to send comments on the document, once it's available.
She said that after COPR officially submits the working group report,
NIH will review it to determine how to implement the recommendations.
The final report also may be posted on the NIH Web site—and certainly
on the COPR Web site—as one way for COPR to share its recommendations.
Dr. Kirschstein noted that once the report is presented to NIH by COPR,
the typical process is for NIH senior staff to review the report and
determine how to integrate the recommendations, including taking into
consideration actions being taken by sister agencies, such as the Office
for Human Research Protections and the Food and Drug Administration.
She indicated that asking NIH for measurable results, as mentioned earlier
in the discussion, could prove difficult. NIH could more readily update
COPR periodically on progress in implementing the forthcoming recommendations.
COPR members and Dr. Kirschstein briefly discussed the need for heightened
sensitivity to language in matters concerning human research protection
in the aftermath of the September 11, 2001, attacks.
I hereby certify that, to the best of my knowledge, the foregoing
minutes are accurate and complete.
Ms. Jennifer Gorman Vetter, Executive Secretary
Director's Council of Public Representatives
Ruth L. Kirschstein, M.D., Acting Director, NIH
Table of Acronyms
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