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  1. Article: How to do human-subjects research if you do not have an institutional review board.

    Rice, Todd W

    Respiratory care

    2008  Volume 53, Issue 10, Page(s) 1362–1367

    Abstract: ... that all human-subjects research must be overseen by an institutional review board (IRB) or ethics committee ... many of these nontraditional research facilities do not have easy access to an IRB. This does not render such research exempt ... Biomedical research with human subjects has expanded outside of traditional medical centers and ...

    Abstract Biomedical research with human subjects has expanded outside of traditional medical centers and hospitals into other health care entities, such as rehabilitation facilities, free-standing out-patient treatment centers, and even home-health agencies. Regardless of the location, federal regulations mandate that all human-subjects research must be overseen by an institutional review board (IRB) or ethics committee to ensure the research abide by the Code of Federal Regulations. Consequently, all human-subjects research must be reviewed and approved by an IRB prior to initiation of any research procedures. Unfortunately, many of these nontraditional research facilities do not have easy access to an IRB. This does not render such research exempt from federal oversight. Clinicians at these facilities have viable options for obtaining IRB approval and legally conducting such research. This paper outlines the available options and their pros and cons.
    MeSH term(s) Biomedical Research/organization & administration ; Ethics Committees, Research ; Federal Government ; Government Regulation ; Human Experimentation ; Humans ; United States
    Language English
    Publishing date 2008-10
    Publishing country United States
    Document type Journal Article ; Review
    ZDB-ID 603252-7
    ISSN 0020-1324 ; 0098-9142
    ISSN 0020-1324 ; 0098-9142
    Database MEDical Literature Analysis and Retrieval System OnLINE

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    In stock of ZB MED Cologne/Königswinter

    Zs.B 2285: Show issues Location:
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    bis Jg. 2021: Bestellungen von Artikeln über das Online-Bestellformular
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  2. Article ; Online: How US institutional review boards decide when researchers need to translate studies.

    Klitzman, Robert

    Journal of medical ethics

    2013  Volume 40, Issue 3, Page(s) 193–197

    Abstract: ... language, posing questions that have not been examined concerning decisions by institutional review boards ... for how many or what proportion of potential subjects), why to do so and how to decide. Difficulties ... Informed consent is crucial in research, but potential participants may not all speak the same ...

    Abstract Informed consent is crucial in research, but potential participants may not all speak the same language, posing questions that have not been examined concerning decisions by institutional review boards (IRBs) and research ethics committees' (RECs) about the need for researchers to translate consent forms and other study materials. Sixty US IRBs (every fourth one in the list of the top 240 institutions by The National Institutes of Health funding) were contacted, and leaders (eg, chairs) from 34 (response rate=57%) and an additional 12 members and administrators were interviewed. IRBs face a range of problems about translation of informed consent documents, questionnaires and manuals-what, when and how to translate (eg, for how many or what proportion of potential subjects), why to do so and how to decide. Difficulties can arise about translation of specific words and of broader cultural concepts regarding processes of informed consent and research, especially in the developing world. In these decisions, IRBs weigh the need for autonomy (through informed consent) and justice (to ensure fair distribution of benefits and burdens of research) against practical concerns about costs to researchers. At times IRBs may have to compromise between these competing goals. These data, the first to examine when and how IRBs/RECs require researchers to translate materials, thus highlight a range of problems with which these committees struggle, suggesting a need for further normative and empirical investigation of these domains, and consideration of guidelines to help IRBs deal with these tensions.
    MeSH term(s) Adult ; Choice Behavior/ethics ; Consent Forms ; Cultural Characteristics ; Decision Making/ethics ; Ethics Committees, Research ; Ethics, Research ; Female ; Humans ; Interviews as Topic ; Male ; Middle Aged ; Research Personnel/ethics ; Research Personnel/standards ; Surveys and Questionnaires ; Translations ; United States
    Language English
    Publishing date 2013-03-08
    Publishing country England
    Document type Journal Article ; Research Support, N.I.H., Extramural
    ZDB-ID 194927-5
    ISSN 1473-4257 ; 0306-6800
    ISSN (online) 1473-4257
    ISSN 0306-6800
    DOI 10.1136/medethics-2012-101174
    Database MEDical Literature Analysis and Retrieval System OnLINE

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    In stock of ZB MED Cologne/Königswinter

    Zs.A 1163: Show issues Location:
    Je nach Verfügbarkeit (siehe Angabe bei Bestand)
    bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular
    Jg. 1995 - 2021: Lesesall (1.OG)
    ab Jg. 2022: Lesesaal (EG)

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