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Abstract

Grant Number:	1S07RR018257-01
Project Title:	Human Subjects Research Enhancements Program

PI Information:	Name	Email	Title
	VISSCHER, WENDY A.	wav@rti.org

Abstract: RTI's mission is "to improve the human condition through objective, innovative, multidisciplinary research, development and technical services, setting the standard for scientific and professional excellence." To fulfill our mission, we must ensure that our research meets the highest ethical standards and that the rights and safety of all of our study participants are protected. RTI has an established human subjects protection program that enjoys the support of upper management and the respect of researchers. This grant will allow us to strengthen our program to keep pace with new issues in the changing human subjects environment. Our grant application consists of three complimentary components: (1) the development of an innovative technique for teaching the principles of informed consent to interviews through virtual reality, (2) the creation of focused, interactive, web-based tutorials on specific human subjects topics that will be available to both researchers and IRB members, and (3) the augmentation of our existing IRB management information system to add features such as generation of approval notices, tracking logs for amendments and adverse events, and templates for minutes and other communications. RTI hires and trains professional interviewers to collect data and obtain informed consent from participants in our research studies. We plan to develop a training application in which these individuals interact with a virtual human to convey the basics of informed consent. IRB members and researchers must stay abreast of new human subjects issues and regulations to be able to develop methods for protecting human subjects that are ethically sound and satisfy the federal regulations. We plan to develop 5 new web-based modules for these individuals to learn about such topics as the Belmont Report, school-based research, mandatory reporting, HIPAA, vulnerable populations, IRB procedures and requirements, DHHS vs. FDA regulations, collection of biospecimens and genetic analysis. Finally, our computerized IRB management information system (MIS) has been evolving over several years. We plan to augment this system by adding more features that will streamline the IRB administrative operations, while still assuring that we operate within all applicable regulations. This will allow the IRB staff to devote more time on review of research protocols and direct interactions with researchers about specific issues.

Public Health Relevance:
This Public Health Relevance is not available.

Thesaurus Terms:
computer system design /evaluation, education evaluation /planning, health science research support, information system, informed consent, training
Internet, data management, ethics, health administration, human rights

Institution:	RESEARCH TRIANGLE INSTITUTE
	BOX 12194, 3040 CORNWALLIS RD
	RESEARCH TRIANGLE PARK, NC 277092194
Fiscal Year:	2002
Department:
Project Start:	01-SEP-2002
Project End:	10-SEP-2003
ICD:	NATIONAL CENTER FOR RESEARCH RESOURCES
IRG:	ZRR1

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