Designing oversight for nanomedicine research in human subjects: systematic analysis of exceptional oversight for emerging technologies View Full Text


Ontology type: schema:ScholarlyArticle      Open Access: True


Article Info

DATE

2011-04

AUTHORS

Susan M. Wolf, Cortney M. Jones

ABSTRACT

The basic procedures and rules for oversight of U.S. human subjects research have been in place since 1981. Certain types of human subjects research, however, have provoked creation of additional mechanisms and rules beyond the Department of Health & Human Services (DHHS) Common Rule and Food and Drug Administration (FDA) equivalent. Now another emerging domain of human subjects research-nanomedicine-is prompting calls for extra oversight. However, in 30 years of overseeing research on human beings, we have yet to specify what makes a domain of scientific research warrant extra oversight. This failure to systematically evaluate the need for extra measures, the type of extra measures appropriate for different challenges, and the usefulness of those measures hampers efforts to respond appropriately to emerging science such as nanomedicine. This article evaluates the history of extra oversight, extracting lessons for oversight of nanomedicine research in human beings. We argue that a confluence of factors supports the need for extra oversight, including heightened uncertainty regarding risks, fast-evolving science yielding complex and increasingly active materials, likelihood of research on vulnerable participants including cancer patients, and potential risks to others beyond the research participant. We suggest the essential elements of the extra oversight needed. More... »

PAGES

1449-1465

References to SciGraph publications

  • 2011-04. Recommendations for oversight of nanobiotechnology: dynamic oversight for complex and convergent technology in JOURNAL OF NANOPARTICLE RESEARCH
  • 2009-08. Do Nanomedicines Require Novel Safety Assessments to Ensure their Safety for Long-Term Human Use? in DRUG SAFETY
  • 2006-10. The emerging nanomedicine landscape in NATURE BIOTECHNOLOGY
  • 2008. Law, Regulation and the Medical Use of Nanotechnology in EMERGING CONCEPTUAL, ETHICAL AND POLICY ISSUES IN BIONANOTECHNOLOGY
  • 2007-06. Nanomedicine–emerging or re-emerging ethical issues? A discussion of four ethical themes in MEDICINE, HEALTH CARE AND PHILOSOPHY
  • 2008. Data Safety and Monitoring Boards (DSMBs) in ESSENTIALS OF CLINICAL RESEARCH
  • 2002-12. Public Attitudes Toward Nanotechnology in JOURNAL OF NANOPARTICLE RESEARCH
  • 2010-08. Multicriteria mapping of stakeholder preferences in regulating nanotechnology in JOURNAL OF NANOPARTICLE RESEARCH
  • 2009. Emerging Issues in Nanomedicine and Ethics in NANOTECHNOLOGY & SOCIETY
  • Identifiers

    URI

    http://scigraph.springernature.com/pub.10.1007/s11051-011-0237-y

    DOI

    http://dx.doi.org/10.1007/s11051-011-0237-y

    DIMENSIONS

    https://app.dimensions.ai/details/publication/pub.1008963190

    PUBMED

    https://www.ncbi.nlm.nih.gov/pubmed/23226969


    Indexing Status Check whether this publication has been indexed by Scopus and Web Of Science using the SN Indexing Status Tool
    Incoming Citations Browse incoming citations for this publication using opencitations.net

    JSON-LD is the canonical representation for SciGraph data.

    TIP: You can open this SciGraph record using an external JSON-LD service: JSON-LD Playground Google SDTT

    [
      {
        "@context": "https://springernature.github.io/scigraph/jsonld/sgcontext.json", 
        "about": [
          {
            "id": "http://purl.org/au-research/vocabulary/anzsrc-for/2008/1117", 
            "inDefinedTermSet": "http://purl.org/au-research/vocabulary/anzsrc-for/2008/", 
            "name": "Public Health and Health Services", 
            "type": "DefinedTerm"
          }, 
          {
            "id": "http://purl.org/au-research/vocabulary/anzsrc-for/2008/11", 
            "inDefinedTermSet": "http://purl.org/au-research/vocabulary/anzsrc-for/2008/", 
            "name": "Medical and Health Sciences", 
            "type": "DefinedTerm"
          }
        ], 
        "author": [
          {
            "affiliation": {
              "alternateName": "University of Minnesota", 
              "id": "https://www.grid.ac/institutes/grid.17635.36", 
              "name": [
                "Consortium on Law and Values in Health, Environment & the Life Sciences, Law School, Medical School, Center for Bioethics, University of Minnesota, 55455, Minneapolis, MN, USA"
              ], 
              "type": "Organization"
            }, 
            "familyName": "Wolf", 
            "givenName": "Susan M.", 
            "id": "sg:person.01022552725.19", 
            "sameAs": [
              "https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.01022552725.19"
            ], 
            "type": "Person"
          }, 
          {
            "affiliation": {
              "alternateName": "University of Minnesota", 
              "id": "https://www.grid.ac/institutes/grid.17635.36", 
              "name": [
                "University of Minnesota Law School, 55455, Minneapolis, MN, USA"
              ], 
              "type": "Organization"
            }, 
            "familyName": "Jones", 
            "givenName": "Cortney M.", 
            "id": "sg:person.0575453207.58", 
            "sameAs": [
              "https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.0575453207.58"
            ], 
            "type": "Person"
          }
        ], 
        "citation": [
          {
            "id": "sg:pub.10.1023/a:1022805516652", 
            "sameAs": [
              "https://app.dimensions.ai/details/publication/pub.1003044264", 
              "https://doi.org/10.1023/a:1022805516652"
            ], 
            "type": "CreativeWork"
          }, 
          {
            "id": "sg:pub.10.1007/978-1-4020-6209-4_11", 
            "sameAs": [
              "https://app.dimensions.ai/details/publication/pub.1004586069", 
              "https://doi.org/10.1007/978-1-4020-6209-4_11"
            ], 
            "type": "CreativeWork"
          }, 
          {
            "id": "sg:pub.10.1007/978-1-4020-6209-4_11", 
            "sameAs": [
              "https://app.dimensions.ai/details/publication/pub.1004586069", 
              "https://doi.org/10.1007/978-1-4020-6209-4_11"
            ], 
            "type": "CreativeWork"
          }, 
          {
            "id": "https://doi.org/10.1001/jama.290.3.360", 
            "sameAs": [
              "https://app.dimensions.ai/details/publication/pub.1008513085"
            ], 
            "type": "CreativeWork"
          }, 
          {
            "id": "https://doi.org/10.1001/jama.2009.1917", 
            "sameAs": [
              "https://app.dimensions.ai/details/publication/pub.1008858005"
            ], 
            "type": "CreativeWork"
          }, 
          {
            "id": "sg:pub.10.1038/nbt1006-1211", 
            "sameAs": [
              "https://app.dimensions.ai/details/publication/pub.1009155276", 
              "https://doi.org/10.1038/nbt1006-1211"
            ], 
            "type": "CreativeWork"
          }, 
          {
            "id": "sg:pub.10.1038/nbt1006-1211", 
            "sameAs": [
              "https://app.dimensions.ai/details/publication/pub.1009155276", 
              "https://doi.org/10.1038/nbt1006-1211"
            ], 
            "type": "CreativeWork"
          }, 
          {
            "id": "https://doi.org/10.1111/j.1748-720x.2002.tb00407.x", 
            "sameAs": [
              "https://app.dimensions.ai/details/publication/pub.1010679734"
            ], 
            "type": "CreativeWork"
          }, 
          {
            "id": "https://doi.org/10.1111/j.1748-720x.2002.tb00407.x", 
            "sameAs": [
              "https://app.dimensions.ai/details/publication/pub.1010679734"
            ], 
            "type": "CreativeWork"
          }, 
          {
            "id": "https://doi.org/10.1056/nejme1007445", 
            "sameAs": [
              "https://app.dimensions.ai/details/publication/pub.1011196889"
            ], 
            "type": "CreativeWork"
          }, 
          {
            "id": "https://doi.org/10.1111/j.1748-720x.2009.00430.x", 
            "sameAs": [
              "https://app.dimensions.ai/details/publication/pub.1018835584"
            ], 
            "type": "CreativeWork"
          }, 
          {
            "id": "https://doi.org/10.1111/j.1748-720x.2009.00430.x", 
            "sameAs": [
              "https://app.dimensions.ai/details/publication/pub.1018835584"
            ], 
            "type": "CreativeWork"
          }, 
          {
            "id": "https://doi.org/10.1056/nejm199310143291607", 
            "sameAs": [
              "https://app.dimensions.ai/details/publication/pub.1020254835"
            ], 
            "type": "CreativeWork"
          }, 
          {
            "id": "https://doi.org/10.1056/nejm200205023461814", 
            "sameAs": [
              "https://app.dimensions.ai/details/publication/pub.1020625689"
            ], 
            "type": "CreativeWork"
          }, 
          {
            "id": "https://doi.org/10.1001/jama.285.9.1201", 
            "sameAs": [
              "https://app.dimensions.ai/details/publication/pub.1027910199"
            ], 
            "type": "CreativeWork"
          }, 
          {
            "id": "https://doi.org/10.4065/79.5.645", 
            "sameAs": [
              "https://app.dimensions.ai/details/publication/pub.1029079741"
            ], 
            "type": "CreativeWork"
          }, 
          {
            "id": "https://doi.org/10.1001/jama.282.20.1947", 
            "sameAs": [
              "https://app.dimensions.ai/details/publication/pub.1029170439"
            ], 
            "type": "CreativeWork"
          }, 
          {
            "id": "https://doi.org/10.1016/j.jvir.2009.04.027", 
            "sameAs": [
              "https://app.dimensions.ai/details/publication/pub.1031571309"
            ], 
            "type": "CreativeWork"
          }, 
          {
            "id": "sg:pub.10.1007/s11019-006-9014-6", 
            "sameAs": [
              "https://app.dimensions.ai/details/publication/pub.1032271144", 
              "https://doi.org/10.1007/s11019-006-9014-6"
            ], 
            "type": "CreativeWork"
          }, 
          {
            "id": "https://doi.org/10.1191/1740774504cn004rr", 
            "sameAs": [
              "https://app.dimensions.ai/details/publication/pub.1032412977"
            ], 
            "type": "CreativeWork"
          }, 
          {
            "id": "https://doi.org/10.1191/1740774504cn004rr", 
            "sameAs": [
              "https://app.dimensions.ai/details/publication/pub.1032412977"
            ], 
            "type": "CreativeWork"
          }, 
          {
            "id": "sg:pub.10.1007/978-1-4020-8486-7_9", 
            "sameAs": [
              "https://app.dimensions.ai/details/publication/pub.1034483054", 
              "https://doi.org/10.1007/978-1-4020-8486-7_9"
            ], 
            "type": "CreativeWork"
          }, 
          {
            "id": "sg:pub.10.1007/s11051-011-0233-2", 
            "sameAs": [
              "https://app.dimensions.ai/details/publication/pub.1035628628", 
              "https://doi.org/10.1007/s11051-011-0233-2"
            ], 
            "type": "CreativeWork"
          }, 
          {
            "id": "https://doi.org/10.1525/ae.2006.33.4.507", 
            "sameAs": [
              "https://app.dimensions.ai/details/publication/pub.1037356090"
            ], 
            "type": "CreativeWork"
          }, 
          {
            "id": "https://doi.org/10.1016/j.addr.2009.11.008", 
            "sameAs": [
              "https://app.dimensions.ai/details/publication/pub.1041473897"
            ], 
            "type": "CreativeWork"
          }, 
          {
            "id": "https://doi.org/10.1016/b978-0-12-374537-8.00039-0", 
            "sameAs": [
              "https://app.dimensions.ai/details/publication/pub.1042040910"
            ], 
            "type": "CreativeWork"
          }, 
          {
            "id": "sg:pub.10.1007/978-1-4020-8649-6_11", 
            "sameAs": [
              "https://app.dimensions.ai/details/publication/pub.1043302313", 
              "https://doi.org/10.1007/978-1-4020-8649-6_11"
            ], 
            "type": "CreativeWork"
          }, 
          {
            "id": "sg:pub.10.1007/978-1-4020-8649-6_11", 
            "sameAs": [
              "https://app.dimensions.ai/details/publication/pub.1043302313", 
              "https://doi.org/10.1007/978-1-4020-8649-6_11"
            ], 
            "type": "CreativeWork"
          }, 
          {
            "id": "sg:pub.10.1007/s11051-010-0006-3", 
            "sameAs": [
              "https://app.dimensions.ai/details/publication/pub.1044987209", 
              "https://doi.org/10.1007/s11051-010-0006-3"
            ], 
            "type": "CreativeWork"
          }, 
          {
            "id": "sg:pub.10.1007/s11051-010-0006-3", 
            "sameAs": [
              "https://app.dimensions.ai/details/publication/pub.1044987209", 
              "https://doi.org/10.1007/s11051-010-0006-3"
            ], 
            "type": "CreativeWork"
          }, 
          {
            "id": "https://doi.org/10.1016/j.outlook.2008.06.004", 
            "sameAs": [
              "https://app.dimensions.ai/details/publication/pub.1045231027"
            ], 
            "type": "CreativeWork"
          }, 
          {
            "id": "sg:pub.10.2165/00002018-200932080-00002", 
            "sameAs": [
              "https://app.dimensions.ai/details/publication/pub.1046103968", 
              "https://doi.org/10.2165/00002018-200932080-00002"
            ], 
            "type": "CreativeWork"
          }, 
          {
            "id": "sg:pub.10.2165/00002018-200932080-00002", 
            "sameAs": [
              "https://app.dimensions.ai/details/publication/pub.1046103968", 
              "https://doi.org/10.2165/00002018-200932080-00002"
            ], 
            "type": "CreativeWork"
          }, 
          {
            "id": "https://doi.org/10.1016/j.yrtph.2006.04.009", 
            "sameAs": [
              "https://app.dimensions.ai/details/publication/pub.1048566753"
            ], 
            "type": "CreativeWork"
          }, 
          {
            "id": "https://doi.org/10.2217/17435889.2.3.345", 
            "sameAs": [
              "https://app.dimensions.ai/details/publication/pub.1049437362"
            ], 
            "type": "CreativeWork"
          }, 
          {
            "id": "https://doi.org/10.1111/j.1748-720x.2008.00267.x", 
            "sameAs": [
              "https://app.dimensions.ai/details/publication/pub.1050359949"
            ], 
            "type": "CreativeWork"
          }, 
          {
            "id": "https://doi.org/10.1111/j.1748-720x.2008.00267.x", 
            "sameAs": [
              "https://app.dimensions.ai/details/publication/pub.1050359949"
            ], 
            "type": "CreativeWork"
          }, 
          {
            "id": "https://doi.org/10.1089/bsp.2007.0048", 
            "sameAs": [
              "https://app.dimensions.ai/details/publication/pub.1059240081"
            ], 
            "type": "CreativeWork"
          }, 
          {
            "id": "https://doi.org/10.1188/06.cjon.153-154", 
            "sameAs": [
              "https://app.dimensions.ai/details/publication/pub.1064135961"
            ], 
            "type": "CreativeWork"
          }, 
          {
            "id": "https://doi.org/10.2105/ajph.69.12.1252", 
            "sameAs": [
              "https://app.dimensions.ai/details/publication/pub.1068869209"
            ], 
            "type": "CreativeWork"
          }, 
          {
            "id": "https://doi.org/10.2174/156720111795256156", 
            "sameAs": [
              "https://app.dimensions.ai/details/publication/pub.1069186713"
            ], 
            "type": "CreativeWork"
          }, 
          {
            "id": "https://doi.org/10.2307/3350283", 
            "sameAs": [
              "https://app.dimensions.ai/details/publication/pub.1070280222"
            ], 
            "type": "CreativeWork"
          }, 
          {
            "id": "https://doi.org/10.4245/sponge.v2i1.3517", 
            "sameAs": [
              "https://app.dimensions.ai/details/publication/pub.1072400606"
            ], 
            "type": "CreativeWork"
          }, 
          {
            "id": "https://doi.org/10.7326/0003-4819-140-3-200402030-00013", 
            "sameAs": [
              "https://app.dimensions.ai/details/publication/pub.1073707141"
            ], 
            "type": "CreativeWork"
          }, 
          {
            "id": "https://doi.org/10.7326/0003-4819-146-12-200706190-00010", 
            "sameAs": [
              "https://app.dimensions.ai/details/publication/pub.1073709098"
            ], 
            "type": "CreativeWork"
          }, 
          {
            "id": "https://doi.org/10.1177/016224398400900403", 
            "sameAs": [
              "https://app.dimensions.ai/details/publication/pub.1074930545"
            ], 
            "type": "CreativeWork"
          }, 
          {
            "id": "https://doi.org/10.1177/016224398400900403", 
            "sameAs": [
              "https://app.dimensions.ai/details/publication/pub.1074930545"
            ], 
            "type": "CreativeWork"
          }, 
          {
            "id": "https://doi.org/10.2307/3564159", 
            "sameAs": [
              "https://app.dimensions.ai/details/publication/pub.1074930656"
            ], 
            "type": "CreativeWork"
          }, 
          {
            "id": "https://doi.org/10.2307/3564020", 
            "sameAs": [
              "https://app.dimensions.ai/details/publication/pub.1074934510"
            ], 
            "type": "CreativeWork"
          }, 
          {
            "id": "https://app.dimensions.ai/details/publication/pub.1074965664", 
            "type": "CreativeWork"
          }, 
          {
            "id": "https://app.dimensions.ai/details/publication/pub.1077119055", 
            "type": "CreativeWork"
          }, 
          {
            "id": "https://doi.org/10.2307/3563953", 
            "sameAs": [
              "https://app.dimensions.ai/details/publication/pub.1077126242"
            ], 
            "type": "CreativeWork"
          }, 
          {
            "id": "https://app.dimensions.ai/details/publication/pub.1077492132", 
            "type": "CreativeWork"
          }
        ], 
        "datePublished": "2011-04", 
        "datePublishedReg": "2011-04-01", 
        "description": "The basic procedures and rules for oversight of U.S. human subjects research have been in place since 1981. Certain types of human subjects research, however, have provoked creation of additional mechanisms and rules beyond the Department of Health & Human Services (DHHS) Common Rule and Food and Drug Administration (FDA) equivalent. Now another emerging domain of human subjects research-nanomedicine-is prompting calls for extra oversight. However, in 30 years of overseeing research on human beings, we have yet to specify what makes a domain of scientific research warrant extra oversight. This failure to systematically evaluate the need for extra measures, the type of extra measures appropriate for different challenges, and the usefulness of those measures hampers efforts to respond appropriately to emerging science such as nanomedicine. This article evaluates the history of extra oversight, extracting lessons for oversight of nanomedicine research in human beings. We argue that a confluence of factors supports the need for extra oversight, including heightened uncertainty regarding risks, fast-evolving science yielding complex and increasingly active materials, likelihood of research on vulnerable participants including cancer patients, and potential risks to others beyond the research participant. We suggest the essential elements of the extra oversight needed.", 
        "genre": "research_article", 
        "id": "sg:pub.10.1007/s11051-011-0237-y", 
        "inLanguage": [
          "en"
        ], 
        "isAccessibleForFree": true, 
        "isFundedItemOf": [
          {
            "id": "sg:grant.2668773", 
            "type": "MonetaryGrant"
          }, 
          {
            "id": "sg:grant.3067449", 
            "type": "MonetaryGrant"
          }
        ], 
        "isPartOf": [
          {
            "id": "sg:journal.1028317", 
            "issn": [
              "1388-0764", 
              "1572-896X"
            ], 
            "name": "Journal of Nanoparticle Research", 
            "type": "Periodical"
          }, 
          {
            "issueNumber": "4", 
            "type": "PublicationIssue"
          }, 
          {
            "type": "PublicationVolume", 
            "volumeNumber": "13"
          }
        ], 
        "name": "Designing oversight for nanomedicine research in human subjects: systematic analysis of exceptional oversight for emerging technologies", 
        "pagination": "1449-1465", 
        "productId": [
          {
            "name": "readcube_id", 
            "type": "PropertyValue", 
            "value": [
              "2ab36c2307ae66a1cb758b6da2a001036bbad7e0e7e73330efe0072eeb91c987"
            ]
          }, 
          {
            "name": "pubmed_id", 
            "type": "PropertyValue", 
            "value": [
              "23226969"
            ]
          }, 
          {
            "name": "nlm_unique_id", 
            "type": "PropertyValue", 
            "value": [
              "101088075"
            ]
          }, 
          {
            "name": "doi", 
            "type": "PropertyValue", 
            "value": [
              "10.1007/s11051-011-0237-y"
            ]
          }, 
          {
            "name": "dimensions_id", 
            "type": "PropertyValue", 
            "value": [
              "pub.1008963190"
            ]
          }
        ], 
        "sameAs": [
          "https://doi.org/10.1007/s11051-011-0237-y", 
          "https://app.dimensions.ai/details/publication/pub.1008963190"
        ], 
        "sdDataset": "articles", 
        "sdDatePublished": "2019-04-10T23:23", 
        "sdLicense": "https://scigraph.springernature.com/explorer/license/", 
        "sdPublisher": {
          "name": "Springer Nature - SN SciGraph project", 
          "type": "Organization"
        }, 
        "sdSource": "s3://com-uberresearch-data-dimensions-target-20181106-alternative/cleanup/v134/2549eaecd7973599484d7c17b260dba0a4ecb94b/merge/v9/a6c9fde33151104705d4d7ff012ea9563521a3ce/jats-lookup/v90/0000000001_0000000264/records_8693_00000510.jsonl", 
        "type": "ScholarlyArticle", 
        "url": "http://link.springer.com/10.1007%2Fs11051-011-0237-y"
      }
    ]
     

    Download the RDF metadata as:  json-ld nt turtle xml License info

    HOW TO GET THIS DATA PROGRAMMATICALLY:

    JSON-LD is a popular format for linked data which is fully compatible with JSON.

    curl -H 'Accept: application/ld+json' 'https://scigraph.springernature.com/pub.10.1007/s11051-011-0237-y'

    N-Triples is a line-based linked data format ideal for batch operations.

    curl -H 'Accept: application/n-triples' 'https://scigraph.springernature.com/pub.10.1007/s11051-011-0237-y'

    Turtle is a human-readable linked data format.

    curl -H 'Accept: text/turtle' 'https://scigraph.springernature.com/pub.10.1007/s11051-011-0237-y'

    RDF/XML is a standard XML format for linked data.

    curl -H 'Accept: application/rdf+xml' 'https://scigraph.springernature.com/pub.10.1007/s11051-011-0237-y'


     

    This table displays all metadata directly associated to this object as RDF triples.

    216 TRIPLES      21 PREDICATES      72 URIs      21 LITERALS      9 BLANK NODES

    Subject Predicate Object
    1 sg:pub.10.1007/s11051-011-0237-y schema:about anzsrc-for:11
    2 anzsrc-for:1117
    3 schema:author N4746c3af68394c918287b2b616125214
    4 schema:citation sg:pub.10.1007/978-1-4020-6209-4_11
    5 sg:pub.10.1007/978-1-4020-8486-7_9
    6 sg:pub.10.1007/978-1-4020-8649-6_11
    7 sg:pub.10.1007/s11019-006-9014-6
    8 sg:pub.10.1007/s11051-010-0006-3
    9 sg:pub.10.1007/s11051-011-0233-2
    10 sg:pub.10.1023/a:1022805516652
    11 sg:pub.10.1038/nbt1006-1211
    12 sg:pub.10.2165/00002018-200932080-00002
    13 https://app.dimensions.ai/details/publication/pub.1074965664
    14 https://app.dimensions.ai/details/publication/pub.1077119055
    15 https://app.dimensions.ai/details/publication/pub.1077492132
    16 https://doi.org/10.1001/jama.2009.1917
    17 https://doi.org/10.1001/jama.282.20.1947
    18 https://doi.org/10.1001/jama.285.9.1201
    19 https://doi.org/10.1001/jama.290.3.360
    20 https://doi.org/10.1016/b978-0-12-374537-8.00039-0
    21 https://doi.org/10.1016/j.addr.2009.11.008
    22 https://doi.org/10.1016/j.jvir.2009.04.027
    23 https://doi.org/10.1016/j.outlook.2008.06.004
    24 https://doi.org/10.1016/j.yrtph.2006.04.009
    25 https://doi.org/10.1056/nejm199310143291607
    26 https://doi.org/10.1056/nejm200205023461814
    27 https://doi.org/10.1056/nejme1007445
    28 https://doi.org/10.1089/bsp.2007.0048
    29 https://doi.org/10.1111/j.1748-720x.2002.tb00407.x
    30 https://doi.org/10.1111/j.1748-720x.2008.00267.x
    31 https://doi.org/10.1111/j.1748-720x.2009.00430.x
    32 https://doi.org/10.1177/016224398400900403
    33 https://doi.org/10.1188/06.cjon.153-154
    34 https://doi.org/10.1191/1740774504cn004rr
    35 https://doi.org/10.1525/ae.2006.33.4.507
    36 https://doi.org/10.2105/ajph.69.12.1252
    37 https://doi.org/10.2174/156720111795256156
    38 https://doi.org/10.2217/17435889.2.3.345
    39 https://doi.org/10.2307/3350283
    40 https://doi.org/10.2307/3563953
    41 https://doi.org/10.2307/3564020
    42 https://doi.org/10.2307/3564159
    43 https://doi.org/10.4065/79.5.645
    44 https://doi.org/10.4245/sponge.v2i1.3517
    45 https://doi.org/10.7326/0003-4819-140-3-200402030-00013
    46 https://doi.org/10.7326/0003-4819-146-12-200706190-00010
    47 schema:datePublished 2011-04
    48 schema:datePublishedReg 2011-04-01
    49 schema:description The basic procedures and rules for oversight of U.S. human subjects research have been in place since 1981. Certain types of human subjects research, however, have provoked creation of additional mechanisms and rules beyond the Department of Health & Human Services (DHHS) Common Rule and Food and Drug Administration (FDA) equivalent. Now another emerging domain of human subjects research-nanomedicine-is prompting calls for extra oversight. However, in 30 years of overseeing research on human beings, we have yet to specify what makes a domain of scientific research warrant extra oversight. This failure to systematically evaluate the need for extra measures, the type of extra measures appropriate for different challenges, and the usefulness of those measures hampers efforts to respond appropriately to emerging science such as nanomedicine. This article evaluates the history of extra oversight, extracting lessons for oversight of nanomedicine research in human beings. We argue that a confluence of factors supports the need for extra oversight, including heightened uncertainty regarding risks, fast-evolving science yielding complex and increasingly active materials, likelihood of research on vulnerable participants including cancer patients, and potential risks to others beyond the research participant. We suggest the essential elements of the extra oversight needed.
    50 schema:genre research_article
    51 schema:inLanguage en
    52 schema:isAccessibleForFree true
    53 schema:isPartOf N6b93b0de684b4cadb614975c8db50574
    54 Nbf91d272cf8e42968ac4e357cadf47ef
    55 sg:journal.1028317
    56 schema:name Designing oversight for nanomedicine research in human subjects: systematic analysis of exceptional oversight for emerging technologies
    57 schema:pagination 1449-1465
    58 schema:productId N0473f28f432e43eabfcba910edfd62f6
    59 N203632d93f69403a9a228eb0c468bb1e
    60 N88afe81935294a478eb8d5f0baed0b0e
    61 N8ab9892deef14d3bb8409a9056d06015
    62 N8e665f089e3d4e32b5f65802c54afd1b
    63 schema:sameAs https://app.dimensions.ai/details/publication/pub.1008963190
    64 https://doi.org/10.1007/s11051-011-0237-y
    65 schema:sdDatePublished 2019-04-10T23:23
    66 schema:sdLicense https://scigraph.springernature.com/explorer/license/
    67 schema:sdPublisher N300efa60f2fb42f687f4795e90de7929
    68 schema:url http://link.springer.com/10.1007%2Fs11051-011-0237-y
    69 sgo:license sg:explorer/license/
    70 sgo:sdDataset articles
    71 rdf:type schema:ScholarlyArticle
    72 N0473f28f432e43eabfcba910edfd62f6 schema:name dimensions_id
    73 schema:value pub.1008963190
    74 rdf:type schema:PropertyValue
    75 N203632d93f69403a9a228eb0c468bb1e schema:name pubmed_id
    76 schema:value 23226969
    77 rdf:type schema:PropertyValue
    78 N300efa60f2fb42f687f4795e90de7929 schema:name Springer Nature - SN SciGraph project
    79 rdf:type schema:Organization
    80 N4746c3af68394c918287b2b616125214 rdf:first sg:person.01022552725.19
    81 rdf:rest Nca092452f325489aac7af17e6fe846c9
    82 N6b93b0de684b4cadb614975c8db50574 schema:volumeNumber 13
    83 rdf:type schema:PublicationVolume
    84 N88afe81935294a478eb8d5f0baed0b0e schema:name nlm_unique_id
    85 schema:value 101088075
    86 rdf:type schema:PropertyValue
    87 N8ab9892deef14d3bb8409a9056d06015 schema:name doi
    88 schema:value 10.1007/s11051-011-0237-y
    89 rdf:type schema:PropertyValue
    90 N8e665f089e3d4e32b5f65802c54afd1b schema:name readcube_id
    91 schema:value 2ab36c2307ae66a1cb758b6da2a001036bbad7e0e7e73330efe0072eeb91c987
    92 rdf:type schema:PropertyValue
    93 Nbf91d272cf8e42968ac4e357cadf47ef schema:issueNumber 4
    94 rdf:type schema:PublicationIssue
    95 Nca092452f325489aac7af17e6fe846c9 rdf:first sg:person.0575453207.58
    96 rdf:rest rdf:nil
    97 anzsrc-for:11 schema:inDefinedTermSet anzsrc-for:
    98 schema:name Medical and Health Sciences
    99 rdf:type schema:DefinedTerm
    100 anzsrc-for:1117 schema:inDefinedTermSet anzsrc-for:
    101 schema:name Public Health and Health Services
    102 rdf:type schema:DefinedTerm
    103 sg:grant.2668773 http://pending.schema.org/fundedItem sg:pub.10.1007/s11051-011-0237-y
    104 rdf:type schema:MonetaryGrant
    105 sg:grant.3067449 http://pending.schema.org/fundedItem sg:pub.10.1007/s11051-011-0237-y
    106 rdf:type schema:MonetaryGrant
    107 sg:journal.1028317 schema:issn 1388-0764
    108 1572-896X
    109 schema:name Journal of Nanoparticle Research
    110 rdf:type schema:Periodical
    111 sg:person.01022552725.19 schema:affiliation https://www.grid.ac/institutes/grid.17635.36
    112 schema:familyName Wolf
    113 schema:givenName Susan M.
    114 schema:sameAs https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.01022552725.19
    115 rdf:type schema:Person
    116 sg:person.0575453207.58 schema:affiliation https://www.grid.ac/institutes/grid.17635.36
    117 schema:familyName Jones
    118 schema:givenName Cortney M.
    119 schema:sameAs https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.0575453207.58
    120 rdf:type schema:Person
    121 sg:pub.10.1007/978-1-4020-6209-4_11 schema:sameAs https://app.dimensions.ai/details/publication/pub.1004586069
    122 https://doi.org/10.1007/978-1-4020-6209-4_11
    123 rdf:type schema:CreativeWork
    124 sg:pub.10.1007/978-1-4020-8486-7_9 schema:sameAs https://app.dimensions.ai/details/publication/pub.1034483054
    125 https://doi.org/10.1007/978-1-4020-8486-7_9
    126 rdf:type schema:CreativeWork
    127 sg:pub.10.1007/978-1-4020-8649-6_11 schema:sameAs https://app.dimensions.ai/details/publication/pub.1043302313
    128 https://doi.org/10.1007/978-1-4020-8649-6_11
    129 rdf:type schema:CreativeWork
    130 sg:pub.10.1007/s11019-006-9014-6 schema:sameAs https://app.dimensions.ai/details/publication/pub.1032271144
    131 https://doi.org/10.1007/s11019-006-9014-6
    132 rdf:type schema:CreativeWork
    133 sg:pub.10.1007/s11051-010-0006-3 schema:sameAs https://app.dimensions.ai/details/publication/pub.1044987209
    134 https://doi.org/10.1007/s11051-010-0006-3
    135 rdf:type schema:CreativeWork
    136 sg:pub.10.1007/s11051-011-0233-2 schema:sameAs https://app.dimensions.ai/details/publication/pub.1035628628
    137 https://doi.org/10.1007/s11051-011-0233-2
    138 rdf:type schema:CreativeWork
    139 sg:pub.10.1023/a:1022805516652 schema:sameAs https://app.dimensions.ai/details/publication/pub.1003044264
    140 https://doi.org/10.1023/a:1022805516652
    141 rdf:type schema:CreativeWork
    142 sg:pub.10.1038/nbt1006-1211 schema:sameAs https://app.dimensions.ai/details/publication/pub.1009155276
    143 https://doi.org/10.1038/nbt1006-1211
    144 rdf:type schema:CreativeWork
    145 sg:pub.10.2165/00002018-200932080-00002 schema:sameAs https://app.dimensions.ai/details/publication/pub.1046103968
    146 https://doi.org/10.2165/00002018-200932080-00002
    147 rdf:type schema:CreativeWork
    148 https://app.dimensions.ai/details/publication/pub.1074965664 schema:CreativeWork
    149 https://app.dimensions.ai/details/publication/pub.1077119055 schema:CreativeWork
    150 https://app.dimensions.ai/details/publication/pub.1077492132 schema:CreativeWork
    151 https://doi.org/10.1001/jama.2009.1917 schema:sameAs https://app.dimensions.ai/details/publication/pub.1008858005
    152 rdf:type schema:CreativeWork
    153 https://doi.org/10.1001/jama.282.20.1947 schema:sameAs https://app.dimensions.ai/details/publication/pub.1029170439
    154 rdf:type schema:CreativeWork
    155 https://doi.org/10.1001/jama.285.9.1201 schema:sameAs https://app.dimensions.ai/details/publication/pub.1027910199
    156 rdf:type schema:CreativeWork
    157 https://doi.org/10.1001/jama.290.3.360 schema:sameAs https://app.dimensions.ai/details/publication/pub.1008513085
    158 rdf:type schema:CreativeWork
    159 https://doi.org/10.1016/b978-0-12-374537-8.00039-0 schema:sameAs https://app.dimensions.ai/details/publication/pub.1042040910
    160 rdf:type schema:CreativeWork
    161 https://doi.org/10.1016/j.addr.2009.11.008 schema:sameAs https://app.dimensions.ai/details/publication/pub.1041473897
    162 rdf:type schema:CreativeWork
    163 https://doi.org/10.1016/j.jvir.2009.04.027 schema:sameAs https://app.dimensions.ai/details/publication/pub.1031571309
    164 rdf:type schema:CreativeWork
    165 https://doi.org/10.1016/j.outlook.2008.06.004 schema:sameAs https://app.dimensions.ai/details/publication/pub.1045231027
    166 rdf:type schema:CreativeWork
    167 https://doi.org/10.1016/j.yrtph.2006.04.009 schema:sameAs https://app.dimensions.ai/details/publication/pub.1048566753
    168 rdf:type schema:CreativeWork
    169 https://doi.org/10.1056/nejm199310143291607 schema:sameAs https://app.dimensions.ai/details/publication/pub.1020254835
    170 rdf:type schema:CreativeWork
    171 https://doi.org/10.1056/nejm200205023461814 schema:sameAs https://app.dimensions.ai/details/publication/pub.1020625689
    172 rdf:type schema:CreativeWork
    173 https://doi.org/10.1056/nejme1007445 schema:sameAs https://app.dimensions.ai/details/publication/pub.1011196889
    174 rdf:type schema:CreativeWork
    175 https://doi.org/10.1089/bsp.2007.0048 schema:sameAs https://app.dimensions.ai/details/publication/pub.1059240081
    176 rdf:type schema:CreativeWork
    177 https://doi.org/10.1111/j.1748-720x.2002.tb00407.x schema:sameAs https://app.dimensions.ai/details/publication/pub.1010679734
    178 rdf:type schema:CreativeWork
    179 https://doi.org/10.1111/j.1748-720x.2008.00267.x schema:sameAs https://app.dimensions.ai/details/publication/pub.1050359949
    180 rdf:type schema:CreativeWork
    181 https://doi.org/10.1111/j.1748-720x.2009.00430.x schema:sameAs https://app.dimensions.ai/details/publication/pub.1018835584
    182 rdf:type schema:CreativeWork
    183 https://doi.org/10.1177/016224398400900403 schema:sameAs https://app.dimensions.ai/details/publication/pub.1074930545
    184 rdf:type schema:CreativeWork
    185 https://doi.org/10.1188/06.cjon.153-154 schema:sameAs https://app.dimensions.ai/details/publication/pub.1064135961
    186 rdf:type schema:CreativeWork
    187 https://doi.org/10.1191/1740774504cn004rr schema:sameAs https://app.dimensions.ai/details/publication/pub.1032412977
    188 rdf:type schema:CreativeWork
    189 https://doi.org/10.1525/ae.2006.33.4.507 schema:sameAs https://app.dimensions.ai/details/publication/pub.1037356090
    190 rdf:type schema:CreativeWork
    191 https://doi.org/10.2105/ajph.69.12.1252 schema:sameAs https://app.dimensions.ai/details/publication/pub.1068869209
    192 rdf:type schema:CreativeWork
    193 https://doi.org/10.2174/156720111795256156 schema:sameAs https://app.dimensions.ai/details/publication/pub.1069186713
    194 rdf:type schema:CreativeWork
    195 https://doi.org/10.2217/17435889.2.3.345 schema:sameAs https://app.dimensions.ai/details/publication/pub.1049437362
    196 rdf:type schema:CreativeWork
    197 https://doi.org/10.2307/3350283 schema:sameAs https://app.dimensions.ai/details/publication/pub.1070280222
    198 rdf:type schema:CreativeWork
    199 https://doi.org/10.2307/3563953 schema:sameAs https://app.dimensions.ai/details/publication/pub.1077126242
    200 rdf:type schema:CreativeWork
    201 https://doi.org/10.2307/3564020 schema:sameAs https://app.dimensions.ai/details/publication/pub.1074934510
    202 rdf:type schema:CreativeWork
    203 https://doi.org/10.2307/3564159 schema:sameAs https://app.dimensions.ai/details/publication/pub.1074930656
    204 rdf:type schema:CreativeWork
    205 https://doi.org/10.4065/79.5.645 schema:sameAs https://app.dimensions.ai/details/publication/pub.1029079741
    206 rdf:type schema:CreativeWork
    207 https://doi.org/10.4245/sponge.v2i1.3517 schema:sameAs https://app.dimensions.ai/details/publication/pub.1072400606
    208 rdf:type schema:CreativeWork
    209 https://doi.org/10.7326/0003-4819-140-3-200402030-00013 schema:sameAs https://app.dimensions.ai/details/publication/pub.1073707141
    210 rdf:type schema:CreativeWork
    211 https://doi.org/10.7326/0003-4819-146-12-200706190-00010 schema:sameAs https://app.dimensions.ai/details/publication/pub.1073709098
    212 rdf:type schema:CreativeWork
    213 https://www.grid.ac/institutes/grid.17635.36 schema:alternateName University of Minnesota
    214 schema:name Consortium on Law and Values in Health, Environment & the Life Sciences, Law School, Medical School, Center for Bioethics, University of Minnesota, 55455, Minneapolis, MN, USA
    215 University of Minnesota Law School, 55455, Minneapolis, MN, USA
    216 rdf:type schema:Organization
     




    Preview window. Press ESC to close (or click here)


    ...