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Since 1992 the Department of Defense (DOD), through the U.S. Army
Medical Research and Material Command, has received congressionally
earmarked appropriations for programs of biomedical research on
prostate, breast, and ovarian cancer; neurofibromatosis; tuberous
sclerosis; and other health problems. Appropriations for these
Congressionally Directed Medical Research Programs are used to
support peer reviewed extramural research project, training, and
infrastructure grants. Congress has become concerned about funding
increases for these programs given current demands on the military
budget. At the request of Congress, the Institute of Medicine (IOM)
examined possibilities of augmenting program funding from
alternative sources. The resulting IOM book, Strategies to Leverage
Research Funding: Guiding DODa (TM)s Peer Reviewed Medical Research
Programs, focuses on nonfederal and private sector contributions
that could extend the appropriated funds without biasing the peer
review project selection process.
When 18-year-old Jesse Gelsinger died in a gene transfer study at
the University of Pennsylvania, the national spotlight focused on
the procedures used to ensure research participants' safety and
their capacity to safeguard the well-being of those who volunteer
for research studies. Responsible Research outlines a three-pronged
approach to ensure the protection of every participant through the
establishment of effective Human Research Participant Protection
Programs (HRPPPs). The approach includes: Improved research review
processes, Recognition and integration of research participants'
contributions to the system, and Vigilant maintenance of HRPPP
performance. Issues addressed in the book include the need for
in-depth, complimentary reviews of science, ethics, and conflict of
interest reviews; desired qualifications for investigators and
reviewers; the process of informed consent; federal and
institutional oversight; and the role of accreditation.
Recommendations for areas of key interest include suggestions for
legislative approaches, compensation for research-related injury,
and the refocusing of the mission of institutional review boards.
Responsible Research will be important to anyone interested in the
issues that are relevant to the practice of using human subjects as
research participants, but especially so to policy makers, research
administrators, investigators, and research sponsors?but also
including volunteers who may agree to serve as research
participants. Table of Contents Front Matter Executive Summary 1
Introduction 2 A Systematic Approach to Human Research Participant
Protection Programs 3 Back to Basics: A Scientific, Conflict of
Interest, and Ethical Review of Research Protocols 4 The
Participant-Investigator Interface 5 Improving Protection Through
Oversight and Data and Safety Monitoring 6 Improving Human Research
Participant Protection Program Performance and Clarifying Roles 7
Improving an Evolving National Human Research Participant
Protection System References Appendix A: Data Sources and Methods
Appendix B: Protecting Particpants in Social, Behavioral, and
Economic Science Research: Issues, Current Problems, and ...
Appendix C: Clarifying Protocol Accountability Appendix D:
Committee Biographies Index
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