Goals and performance measures relate to: scientific integrity and human subjects protection, technology transfer, minority health, equal employment opportunity, program planning and evaluation, and health communication.

II-D.2a Scientific Integrity, Human Subjects Protection, and Technology Transfer

The Office of the Associate Director for Science (ADS) provides direction and training on matters of scientific integrity and human subjects protection. The ADS also manages CDC's intellectual property (e.g., patents, trademarks, copyrights) and promotes the transfer of new technology from CDC research to the private sector to facilitate and enhance the development of diagnostic products, new research methods, vaccines, and other products, and methods to improve occupational safety.

Performance Summary

In FY 2001, the Office of the ADS provided training and technical assistance for CDC staff on scientific integrity, protection of human subjects, and technology-transfer policies and procedures.

Technology Transfer

Federal technology transfer is generally defined as an active partnership between the Government and its scientists/engineers with members of the commercial enterprise to bring Federally developed technologies into practical application more rapidly than is likely to be achieved by passive sharing of information. Success in technology transfer requires effective activity at both ends of that partnership. From the Goverment side, it starts with the recognition by Federal employees of their many inventions and the benefits to the Goverment of reporting those inventions and working with commercial interests to promote their development into commercial products or services made available to the American public. For many new technologies, the best and most efficient, indeed for certain technologies the only way to achieve practical application and availability to the American public is through further development and marketing by private industry or through R&D collaboration with other public sector institutions. Partly because of the office's increased in-reach efforts aimed at CDC's scientists and engineers, the number of new employee invention reports has been increasing over the last several years.

The number of employee invention reports increased from 29 in FY 1998 to 34 in FY 1999 to 45 in FY 2000. The slight reduction seen in this measure in FY 2001 reflects the need in that fiscal to defer costs incurred to the next fiscal year as a result of a sudden significant increase in patent processing costs. The number of patent applications filed and issued tend to follow invention reports by one or more years, and reflect the patentability and marketability of the inventions. They are a reflection of the strength and breadth of the Agency's portfolio of technologies available for practical application by the private sector. The number of patents issued in FY 2001 is a result of the decision to postpone some patent prosecution actions to the succeeding fiscal year for the reason noted above for employee invention reports, and does not necessarily reflect a decrease in the quality or quantity of the Agency's patent portfolio.

The value of trying to achieve a predetermined ratio of licensed to unlicensed patents in our portfolio has been reconsidered and determined to be an inadequate measure of the effectiveness of technology transfer. As a world leader in disease control and prevention research, and with the mission of a Federal lab to anticipate public health needs and crises, a substantial number of our new technologies are "ahead of their time" or directed to niche markets. For example, notable in this category are inventions related to injury and workplace safety, which may not increase industry profit, yet are necessary to enhance the public health. In many instances, the private sector is not yet suitably positioned to exploit the advantages of these inventions. Nevertheless, it is important to maintain them in our portfolio for the time when the need becomes critical and companies are better positioned to make them available to solve needs as they develop. Therefore, this measure will be dropped.

Activities on the commercial side are important to successful technology transfer as well. Interest on the part of the commercial world in CDC's new technologies is partially reflected by the number of companies working with the agency either collaboratively in developing new technologies or refining and adapting them to commercial use through our technology licensing program. These collaborations have increased as a direct result of CDC's expanded outreach and marketing activities over the last few years. Largely as a result of the Agency's increasing marketing efforts, companies continue to recognize the value of CDC research and intellectual property rights. CDC executed 5 new patent license agreements and 5 other intellectual property (trademarks, copyright) license agreements, reflecting a continuing increase in licensing activities. License revenues for this fiscal year ($151,116) were down from last year's $346,530, which included a large one time license execution fee, but still a substantial increase over the previous year's revenue of $100,110. CDC uses these revenues to provide incentives to inventors and to support additional laboratory research. In addition, CDC has continued to make excellent use of biological materials license agreements to transfer specific CDC materials to universities and commercial entities for research and development purposes. Additional revenues from biological materials licensing agreements totaled more that $150,000 for FY 2001, continuing the increasing trend from the two previous fiscal years.

Much of this increased licensing activity reflects the success not only of our efforts to market specific new technologies, but also of our increased emphasis on more general outreach activities. These consist of ensuring visibility and understanding of CDC's technologies and research capabilities at various research, trade, and technology transfer meetings and conferences. The increasing use of the Cooperative Research and Development Agreement (CRADA) to foster collaborative research with private companies and universities also reflects this success. CRADAs provide an opportunity for CDC scientists to work with industry investigators to develop new or improved products or processes. The number of new CRADAS has increased steadily over the last few years, to an agency high of 11 new CRADAS initiated this year. CDC is a partner in 37 active CRADAs, generating approximately $1 million in non-appropriated funds for cooperative research. Several CRADAS have been renewed at least once, attesting to the benefits to both the agency and the participating companies.

However, another performance measure that has been used in the past has been reevaluated and determined to be an inaccurate reflection of the purpose of CRADAs. The measure of the number of employee invention reports arising from cooperative research with the private sector is a misleading measure of the success of the collaboration. It is, of course, a desired result since it tends to lead to more rapid practical application of new inventions and quicker delivery to the public. But it is not the primary benefit of such a collaboration. More often, the benefit to both the company and to CDC is a better understanding of the science or engineering underlying a companies products or processes or an area of interest to CDC, and which leads to more efficient operation, more effective pursuit of new opportunities, reduction in costs (and price), or cost avoidance. All of these ultimately benefit the mission of the Agency and the technology transfer program.

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Overall, we continue to have increasing success in making our researchers aware of the opportunities available through the technology transfer program, and in recruiting private sector involvement in developing, manufacturing, and marketing new CDC technologies to the benefit of the American economy and the public welfare.

Human Subjects Protection

Increase IRB approvals after no more than one report from the CDC IRB: In September 2001, the Human Subjects Activity (HSA) hired one IRB administrator, and in January, 2002 the National Center for Infectious Diseases hired an additional administrator, increasing our total IRB support staff from one to three employees. When these new employees are fully trained, individual administrative workloads for HSA staff will decrease. This will allow our staff to devote considerably more time to human subjects educational and training activities targeted to both IRB reviewers and CDC researchers. As the authors and recipients of IRB reports develop a better working knowledge of the ethical principles and regulatory requirements embodied in 45 CFR 46, the number of reports required to bring reviewed protocols into compliance will decrease.

Increase the number of states with assurances of compliance and IRBs: CDC's Assurance Coordinator
provides advice and assistance to State and local health departments seeking to obtain Federal-Wide
Assurances (FWA), and our Intranet and Internet home pages both contain links to the Office for Human
Research Protections (OHRP) Assurance Guidance Website. However, CDC has limited influence over
State health departments to persuade them to obtain FWAS - the decision to apply for and obtain an
FWA is affected by many factors. CDC's advice and support on this topic are usually minor
considerations in the States' ultimate decision on whether to go through the application and certification
process. CDC indirectly influences State health departments to obtain FWAS by requiring them as a
condition of funded research or when we enter into a research collaboration. For a variety of reasons,
neither of these indirect modes of influence apply to many state health departments, especially those
that lack the resources to engage in research. Therefore, this performance measure should be
eliminated.

Increase the number of CDC scientists who receive computer-based training in scientific ethics: Since
1998, CDC has required mandatory scientific ethics training of all CDC scientists engaged in research
involving human subjects. Those scientists not engaged in human subjects research are encouraged to
complete the training; however, at this time it is not mandatory that they do so. The training is offered
via the CDC intranet or CD-ROM (for field personnel). The FY 01 goal of 80% all CDC scientists passing
the training was not achieved, probably because the training is not mandatory. Also, a culture of
performing science ethically has been assumed. Greater media exposure to unethical science at various
research institutions in the United States and abroad, more scrutiny by the Office of Human Research
Protections in violations of research subjects' rights, and increased efforts on the part of the Office of
Research Integrity to train scientists in the Responsible Conduct of Science have shown that previously
held assumptions may not be accurate. Efforts will be made in FY 02 to achieve projected goals through
more education.

CDC trains CDC investigators on regulations, policies, and procedures to protect human subjects in research. A total of 706 investigators were trained in human subjects issues during FY2001 and four workshops were held that trained 59 members of Institutional Review Boards on regulations, policies, and procedures. An additional 10 IRB members were tutored to serve as expeditors. Presentations on the protection of human subjects in research were provided to the EHDI Grantees (NCEH), CDC's Procurement and Grants Staff, the Roosevelt Warm Springs Institute for Rehabilitation, Epidemic Intelligence Service incoming class, Morehouse School of Medicine, and the Association of Black Cardiologists. In addition, a Public Health Ethics Seminar Series was established and 3 seminars were held in the Atlanta area during FY 2001.

Goal-by-Goal Presentation of Performance

Performance Goal: Identify, evaluate, and protect novel technologies.