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GREG KOSKI, PH.D., M.D.
DIRECTOR, OFFICE FOR HUMAN RESEARCH PROTECTIONS
OFFICE OF THE SECRETARY
DEPARTMENT OF HEALTH AND HUMAN SERVICES
FOR THE HEARING ON
HUMAN SUBJECTS PROTECTIONS IN VA MEDICAL RESEARCH
THE SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS
COMMITTEE ON VETERANS AFFAIRS
U.S. HOUSE OF REPRESENTATIVES
SEPTEMBER 28, 2000
Chairman Everett and distinguished members of the Subcommittee:
Thank you for this opportunity to discuss the new Office for
Human Research Protections (OHRP) and to outline some of the
initiatives the office is undertaking toward fulfillment of
the Secretary's committment to enhance protections for human
research subjects and to improve the biomedical research process.
Although the American people and Congress have long been
avid supporters of biomedical research, events of the past
several years threaten to further undermine the already shaken
public confidence in this important endeavor. Although some
real progress has been made as a result of steps taken by
NIH, FDA and other federal agencies, the need to continue
effective reform is great, and the pace of the reform effort
needs to be accelerated. Ensuring the public trust in the
biomedical research endeavor must be one of our highest priorities.
Although I officially assumed my position as director of
OHRP only two weeks ago, the Office has been working to develop
an ambitious action plan for reform that I am happy to describe
for you today. I would also like to emphasize that OHRP is
not alone in its concern over these issues, nor does it bear
sole responsibility. OHRP will join with and help to build
upon those actions already being taken by other offices and
agencies within the government and by private groups that
share these goals.
In my first weeks on the job, I have sensed an inspiring
level of commitment and a spirit of cooperation that bodes
very well for the future; indeed, creation of an effective
system for protection of human subjects depends upon cooperation
among all of the agencies that fund, conduct or regulate human
research, and our very first priority is to establish solid
collaborative relationships through which we can work toward
realization of our common goals.
First, I'd like to say a few words about the new office.
OHRP was created by Secretary Shalala earlier this year as
part of her program to enhance protections for human subjects.
Based upon recommendations of a review panel convened in 1999
by the Director of NIH, OHRP, which supersedes the former
Office for Protection from Research Risks (OPRR), was created
within the Office of the Secretary. This move was intended
to provide a more effective platform from which the new office
could lead reform, both within HHS and across all federal
agencies and departments subscribing to the federal regulations
for protection of human subjects in research known as the
Common Rule (Title 45 CFR Part 46, Part A).
OHRP differs from it predecessor in several important ways.
First, OHRP is responsible for oversight of research involving
human subjects only; animal research will be overseen by the
Office for Laboratory Animal Welfare (OLAW) which remains
within the administrative structure of the National Institutes
of Health (NIH). Second, OHRP's responsibilities include protection
of human subjects in all human research funded or regulated
by HHS, and the office is intended to provide leadership for
all agencies conducting or funding research under the Common
Rule. It is nevertheless important to understand that individual
agencies have specific regulatory and oversight responsibilities
that remain unchanged, such as FDA's enforcement authority
in FDA-authorized drug and medical device trials. OHRP also
has a new organizational structure and new leadership that
will afford greater effectiveness of its programs and greater
efficiency of its operations.
The office, and the country at large, will benefit from a
newly established National Human Research Protection Advisory
Committee (NHRPAC). Currently, the membership of this committee
is being selected by the Secretary from a group of nearly
130 nominees representing all viewpoints of the human research
community. An Executive Director is being sought to convene
the group which will soon begin its important work.
Among the challenges it faces will be consideration of important
matters related to informed and voluntary consent, vulnerable
populations of research participants, genetics research and
conflicts of interest. OHRP and the Department will look to
this advisory committee to provide guidance as policies and
procedures are developed. Its advice will ensure that we follow
a route that facilitates conduct of responsible research while
optimally protecting the interests and welfare of the participants.
The time has come for us to take a new approach, one based
upon recognition that the primary responsibility of every
party to the biomedical research process is to protect the
well-being of those brave and unselfish individuals who voluntarily
participate as subjects of our research. By their doing so,
all of us can reap enormous rewards from this endeavor, including
better understanding of human physiology and disease, safer
and more effective treatments and diagnostic procedures, and
new drugs, devices and biological agents that will improve
our health and the quality of our lives.
The model envisioned, a model that resonates with the recommendations
of major professional, industrial, academic and advocacy groups,
as well as those of the OIG, is based upon achieving greater
responsibility and accountability at every level of participation.
We envision a system in which every party to research is
properly trained and educated to fulfill their responsibilities
and in which every individual personally acknowledges and
accepts responsibility for protecting research subjects as
a condition of participation.
Further, we envision a system in which objective, uniform,
nationally recognized performance standards provide the basis
for certification of individual competencies and accreditation
of groups conducting review, approval and continuing oversight
of research. And while we will be working to strengthen these
processes, we will also work with our colleagues throughout
government to clarify, simplify and streamline the regulatory
environment, to reduce administrative burdens and eliminate
or modify rules and regulations that impair the effectiveness
and efficiency of our system without adding commensurate value.
While compliance with regulations is essential, compliance
alone will not achieve our goals. We must focus on responsible
conduct rather than compliance per se. We must establish a
research environment in which every individual does the right
thing because it is the right thing to do. And those who will
not accept their responsibilities must not be allowed to participate,
as the cost to society is simply too great. Biomedical research,
like the practice of medicine itself, involves relationships
that must be founded upon and sustained by an enduring sense
of trust and mutual respect between subject and investigator.
Anything less is not enough.
In April of this year, the OIG issued a follow-up report
on the status of its earlier recommendations. That status
report acknowledges that the creation and positioning of OHRP
affords a significant new opportunity for HHS to exert broad
federal leadership in protection of human subjects. The status
report goes on to "urge the new office to give significant
attention to our previous recommendations and to those that
will be forthcoming from NBAC".
That, Mr. Chairman, is precisely what OHRP intends to do.
These recommendations, and the need for a balanced approach,
one that combines efforts to simplify regulatory requirements
and facilitate compliance with enhanced education and heightened
oversight are the heart of OHRP's vision of the future, a
vision that I believe is broadly shared. And I will reiterate,
OHRP cannot realize this vision alone. We must take a collaborative
approach toward integration of activities with all who share
this vision if we are to succeed. Needless to say, we understand
the need to carefully coordinate the activities of this office
with those already being undertaken by NIH, FDA, CDC, AHRQ,
and other HHS entities. OHRP recognizes and appreciates the
efforts being made as an encourging sign. A number of working
groups have been working in several areas, and we hope to
join these efforts.
I would like to discuss in more concrete terms specific steps
that are being taken or are planned to give substance to this
vision so that everyone can better appreciate where we hope
to go. To a large extent, the road to success has been thoughtfully
mapped by the Office of the Inspector General's (OIG) report
originally issued in 1998, entitled Institutional Review
Boards: A Time for Reform (US Government Printing Office).
Although the recommendations are general in nature, they provide
a useful framework for discussing specific initiatives that
are in various stages of planning and implementation.
institutional review boards greater flexibility but hold them
more accountable for results.
1. We will implement a simplified assurance process that
will avoid the time-consuming negotiation process that has
distracted attention and resources from more effective and
desirable approaches to achieving true protection of human
research subjects, such as more effective education and
oversight programs. We hope to be able to implement the
new system as soon as possible.
2. OHRP will devote additional resources, including those
freed by implementation of a simplified assurance process,
to enhance oversight and educational activities. These will
include a dramatic expansion of not for cause technical
support visits to assist institutions, investigators and
IRBs in fulfilling their responsibilities.
3. In cooperation with FDA and other federal agencies,
including the Department of Veterans Affairs (VA), we will
work to develop and implement a unified registration system
for all human research review boards.
4. An inter-agency working group will be established to
review current regulations and guidance as part of an ongoing
effort to identify and eliminate inconsistencies and inefficiencies
that do not contribute effectively to protection of human
the Federal oversight process
1. Recognizing the need for and value of greater uniformity
and public accountability in the review and approval process,
OHRP, with the support of the National Institutes of Health
(NIH), the Food and Drug Administration (FDA), the Centers
for Disease Control and Prevention(CDC) and the Agency for
Healthcare Research and Quality (AHRQ), will engage the
Institute of Medicine (IOM) to recommend uniform, performance
and resource-based standards for private, voluntary accreditation
of human research review boards. This effort will draw upon
work already undertaken by major national organizations
to develop and test these standards by the spring of 2001,
followed by initiation of a formal accreditation process
before the end of next year.
2. As part of this effort, IOM will also be asked to conduct
a study of the human research system to determine the extent
to which they address issues raised by the OIG and the recommendations
of the forthcoming National Bioethics Advisory Commission's
3. IOM will also be asked to develop objective criteria
for measuring the effectiveness of the system for protection
of human subjects in research. These criteria will then
be used on an ongoing basis for continuing assessment of
the system and regular reports to Congress and the public.
continuing protections for research subjects
1. Working with FDA and NIH and other agencies, we will
carefully examine the continuing review process and develop
guidance for institutions and review boards regarding appropriate
mechanisms for ongoing monitoring of approved research.
These must include more effective monitoring of adverse
event reports, development and implementation of quality
improvement processes, and programs for on-site inspections
and evaluations of research programs and IRB processes.
2. OHRP will establish a publicly accessible 'hotline'
to provide information and to address complaints or concerns
raised by subjects, investigators, IRB members or the general
public in real time on an on-going basis. This will serve
as a national resource for human subjects protection.
3. We will work vigorously to improve inter-agency communications
and integrate each agency's existing oversight processes
to develop an enhanced 'safety net' for research subjects
that will optimize ongoing oversight without redundancy.
education for research investigators and IRB members
1. Recognizing the need for enhanced education, essentially
all of the federal agencies and OHRP have already enhanced
and will continue to expand their educational programs.
OHRP's programs will include national and regional workshops
and conferences, 'town meetings', technical assistance support
visits, and 'ambassadorial visits' by the director and senior
staff . The latter are intended to help institutions and
review boards develop a culture that embraces human subject
protection as an integral part of the research process and
as a responsibility shared by all.
2. While the OIG has called for enhanced education of investigators
and IRB members, OHRP does not believe this to be sufficient.
To achieve the goals outlined above, there must be more
effective education and training for all members of the
research team, institutional officials, research subjects
and the general public. Indeed, education of the public
at large is one of the most important steps that can be
taken toward improving the informed consent process and
toward enhancing public awareness and accountability of
the research process.
3. In collaboration with NIH, FDA and other agencies, OHRP
will develop guidance for uniform, minimal educational requirements
applicable to all clinical investigators regardless
of the source of funding or sponsorship of their research.
4. OHRP, NIH, FDA and other federal agencies, and the Office
for Research Integrity (ORI), will work to integrate and
coordinate their educational programs with those of institutions
and sponsors to achieve maximal effectiveness of these programs
and optimal utilization of resources. Toward this end, OHRP
will convene an 'educational summit meeting' to clarify
educational goals for each party to the research process
and will issue appropriate guidance on this topic.
5. OHRP will encourage and support efforts to develop independent
certification programs for investigators, and to expand
existing programs for certification of clinical research
coordinators (CRCs), clinical research associates (CRAs)
and IRB professionals. Establishment of nationally recognized
standards for certification, in combination with enhanced
public education and awareness, will strongly encourage
all participants to achieve a high level of competence in
their respective areas of endeavor. This will improve both
the quality of their research and protection for human subjects.
6. OHRP will establish an on-line library of educational
resources that will be publicly available to promote and
augment private educational programs for investigators,
institutions, review boards, research subjects and the general
public. We hope to develop this as a shared resource.
should be taken to moderate the workload of institutional
review boards and to ensure adequate resources for their activities
Greater cooperation among the federal departments subscribing
to the Common Rule is a desirable and achievable goal, and the
creation of OHRP affords an opportunity to provide leadership
in this area. The full potential of the Common Rule for unifying
our national system for protection of human research subjects
has never been realized. In fact, the Common Rule has been cited
by the OIG and others as an impediment to creating
a more uniform and effective system, because of the time and
effort required to effect changes among the 17 agencies that
1. Many institutions and IRBs are attempting to meet their
responsibilities, but may lack necessary resources. NIH
has already taken steps to avoid unnecessary review of proposals
that are unlikely to be funded, thereby reducing workload.
While there may be additional steps that can be taken to
reduce administrative burdens and improve efficiency, these
steps can do little for those IRBs that either are not given
sufficient resources by their institutions, or for institutions
that lack a sufficient base of research funding to build
the necessary infrastructure to support an effective and
efficient IRB process. OHRP, through its technical assistance
programs, will work with institutions and IRBs to identify
efficient ways to optimize utilization of resources.
The system for protection of research subjects should
not be viewed as a costly but necessary inconvenience associated
with doing human research. Rather, it should be recognized
as an important cornerstone upon which public trust in biomedical
research is founded, and it should be supported appropriately.
Unfortunately, the true costs of the human subjects protection
process are not known, and what constitutes appropriate
funding is not well-defined. OHRP will encourage funding
agencies and institutions to continue to work together to
identify appropriate mechanisms for funding that ensure
an effective system of protection of human research subjects,
and if necessary, include specific provisions in new research
awards to support this critical infrastructure.
2. We will work to develop guidelines for appropriate staffing
and workload levels for IRBs. These benchmarks will give
institutions and research review boards a clear sense of
the level of resources required for an effective process
for review, approval and continuing oversight of clinical
3. As part of the re-engineering process recommended by
the OIG report and are under consideration by NBAC, structural
changes in the human research review and oversight process
should be carefully considered. Concerns about conflicts
of interest and autonomy of institutionally-based
review boards deserve careful attention. Further, the current
system necessitates redundant and often conflicting reviews
of an individual study by multiple IRBs, resulting in considerable
inefficiency and dilution of effectiveness. This situation
gives rise as well to the practice of "IRB shopping". In
our present system, research that is approved by any
IRB can be done, regardless of disapproval by several
other IRBs. The resultant "sinking to the lowest standard",
as some have described the process, is not in the interest
of effective human subjects protection or good research
practice and should be corrected.
A system of human research review boards that is not based
at the level of single institutions, one that would encourage
more effective utilization of resources and that would concurrently
enable a more robust, autonomous and effective process,
while preserving sensitivity to important local considerations,
is worthy of consideration as a long-term goal. A nationally
(or even internationally) recognized system for accreditation
of human research review boards will be a strong step toward
resolution of this dilemma. Toward this end, OHRP will frame
this question for consideration by the NHRPAC following
release of NBAC's final report and a period of public comment.
We have before us an opportunity to improve this situation.
Now is the time to strengthen the bonds among the federal
departments who collectively share the important responsibility
for protection of human subjects in research, to work together
more closely to integrate our activities with an eye toward
greater uniformity, simplicity and effectiveness. Already
, we have extended our hand to the VA and other Executive
Branch agencies, and our overtures have been welcomed.
We are working closely with ORCA to build a strong relationship
with the VA, and I believe that this relationship may become
an example of how the Common Rule agencies can work together
more effectively. In truth, the need for a unified system
for protection of human subjects in research is sufficiently
great that if we are unable to foster such an approach voluntarily,
calls for new legislation to require it will likely intensify.
And so to conclude my remarks, I will say once again that
the time has come to translate vision to action. The program
before us is admittedly ambitious; it will require both collaboration
and compromise, but these objectives can be realized in a
surprisingly short time-frame if we can simply work together.
Indeed, many of the initiatives described here today are already
underway or are in various stages of planning, although many
details remain to be worked out. We hope to initiate as many
of these actions as we can during the next several weeks,
recognizing that sufficient time must be allowed to follow
appropriate procedures for issuing guidance, etc., and to
ensure proper discussion and coordination among the participating
agencies and offices.
Protection of human subjects in research is everyone's responsibility.
I continue to be impressed that the spirit of determination
and cooperation is very much alive and is stronger right now
for this cause than it is ever likely to be again. As we move
forward, we will work continually to strengthen our interactions
with other agencies and departments that share our common
goals. Our challenge is to take full advantage of the very
significant opportunity before us, and to do so now.
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