NDLI: The dilemma of bioengineering research on human subjects

Content Provider	IEEE Xplore Digital Library
Author	Schwartz, L.B.
Copyright Year	2002
Description	Author affiliation: Sect. of Vascular Surg., Chicago Univ., IL, USA (Schwartz, L.B.)
Abstract	The increased scrutiny of human subject research is underscored by the recent suspension of authority of several prestigious medical centers by the federal Office of Human Research Protection (OHRP). Fueled in part by the well-publicized death of a young patient enrolled in a gene therapy trial in 1999, the OHRP's "reign of terror" has had far-reaching implications for all scientists, patients, and administrators engaged in human subject research. In summary, there are fundamental differences in the way that standards are generated for clinical medicine, bioengineering research, and human subject research. The standards for both clinical medicine and research have generally been set by the practitioners and scientists through peer review. This is not the case with human subject research, and any practitioner or scientist that merely follows his or her internal ethical standards does so at the institution's peril. The standards for human subject research are rightfully set by agencies of the international community and federal government and strict adherence is mandated by law. Whether or not the rigid ethical standards can ever reasonably be relaxed depends on the commitment of the scientific community to the consistent performance of human subject research with vigilant respect for persons, beneficence, and justice.
Starting Page	2668
Ending Page	2669
File Size	124939
Page Count	2
File Format	PDF
ISBN	0780376129
ISSN	1094687X
DOI	10.1109/IEMBS.2002.1053483
Language	English
Publisher	Institute of Electrical and Electronics Engineers, Inc. (IEEE)
Publisher Date	2002-10-23
Publisher Place	USA
Access Restriction	Subscribed
Rights Holder	Institute of Electrical and Electronics Engineers, Inc. (IEEE)
Subject Keyword	Biomedical engineering Humans Medical diagnostic imaging Protection Testing Biomedical imaging Surgery Gene therapy Code standards Genetics
Content Type	Text
Resource Type	Article

Sl.	Authority	Responsibilities	Communication Details
1	Ministry of Education (GoI), Department of Higher Education	Sanctioning Authority	https://www.education.gov.in/ict-initiatives
2	Indian Institute of Technology Kharagpur	Host Institute of the Project: The host institute of the project is responsible for providing infrastructure support and hosting the project	https://www.iitkgp.ac.in
3	National Digital Library of India Office, Indian Institute of Technology Kharagpur	The administrative and infrastructural headquarters of the project	Dr. B. Sutradhar bsutra@ndl.gov.in
4	Project PI / Joint PI	Principal Investigator and Joint Principal Investigators of the project	Dr. B. Sutradhar bsutra@ndl.gov.in Prof. Saswat Chakrabarti will be added soon
5	Website/Portal (Helpdesk)	Queries regarding NDLI and its services	support@ndl.gov.in
6	Contents and Copyright Issues	Queries related to content curation and copyright issues	content@ndl.gov.in
7	National Digital Library of India Club (NDLI Club)	Queries related to NDLI Club formation, support, user awareness program, seminar/symposium, collaboration, social media, promotion, and outreach	clubsupport@ndl.gov.in
8	Digital Preservation Centre (DPC)	Assistance with digitizing and archiving copyright-free printed books	dpc@ndl.gov.in
9	IDR Setup or Support	Queries related to establishment and support of Institutional Digital Repository (IDR) and IDR workshops	idr@ndl.gov.in

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