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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.

Grant 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 subjects.

Re-engineer 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 (NBAC) report.

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.


Strengthen 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.

Enhance 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.

Steps should be taken to moderate the workload of institutional review boards and to ensure adequate resources for their activities

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 research.

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.

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 are signatories.

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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