Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators

 
Docket ID: HHS-OPHS-2011-0005
Agency: Department of Health and Human Services (HHS)

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    Oct 26, 2011 11:59 PM ET

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    HHS-OPHS-2011-0005-0736

    10/26/2011

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    HHS-OPHS-2011-0005-0078

    08/10/2011

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    HHS-OPHS-2011-0005-0701

    10/26/2011

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    HHS-OPHS-2011-0005-0726

    10/26/2011

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    HHS-OPHS-2011-0005-0785

    10/26/2011

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    HHS-OPHS-2011-0005-0382

    10/19/2011

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    HHS-OPHS-2011-0005-0355

    10/12/2011

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    HHS-OPHS-2011-0005-0849

    10/26/2011

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    HHS-OPHS-2011-0005-0130

    08/17/2011

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    HHS-OPHS-2011-0005-0228

    09/20/2011

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    HHS-OPHS-2011-0005-0741

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    HHS-OPHS-2011-0005-0666

    10/25/2011

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    HHS-OPHS-2011-0005-1106

    10/28/2011

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    Oct 26, 2011 11:59 PM ET

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    HHS-OPHS-2011-0005-0398

    10/19/2011

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    HHS-OPHS-2011-0005-0730

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    HHS-OPHS-2011-0005-0702

    10/26/2011

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    HHS-OPHS-2011-0005-0786

    10/26/2011

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    HHS-OPHS-2011-0005-0773

    10/26/2011

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    Oct 26, 2011 11:59 PM ET

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    HHS-OPHS-2011-0005-0833

    10/26/2011

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    HHS-OPHS-2011-0005-0941

    10/26/2011

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    HHS-OPHS-2011-0005-0588

    10/25/2011

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    Oct 26, 2011 11:59 PM ET

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    HHS-OPHS-2011-0005-0755

    10/26/2011

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    HHS-OPHS-2011-0005-1113

    11/03/2011

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    Oct 26, 2011 11:59 PM ET

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    HHS-OPHS-2011-0005-0850

    10/26/2011

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    HHS-OPHS-2011-0005-0118

    08/16/2011

      undefined
      • See attached file(s)

      • Public Submission
      • Posted:

        10/26/2011

      • ID:
        HHS-OPHS-2011-0005-0736
      • Organization:
        University of Michigan
      • Submitter Name:
        Judith Nowack
      • A single IRB for multicenter studies would be very helpful. Keeping a protocol unified across multiple centers is very difficult. IRB fees at each institution are becoming...

      • Public Submission
      • Posted:

        08/10/2011

      • ID:
        HHS-OPHS-2011-0005-0078
      • Organization:
        UC-Irvine
      • Submitter Name:
        Arnold Seto
      undefined
      • Please see attached document containing comments/questions from Seton Healthcare Family research community.

      • Public Submission
      • Posted:

        10/26/2011

      • ID:
        HHS-OPHS-2011-0005-0701
      • Organization:
        Seton Healthcare Family
      • Submitter Name:
        Loc-Uyen Vo
      undefined
      • See attached file(s)

      • Public Submission
      • Posted:

        10/26/2011

      • ID:
        HHS-OPHS-2011-0005-0726
      • Organization:
        Northwestern University
      • Submitter Name:
        Caroline Bledsoe
      undefined
      • See attached file(s)

      • Public Submission
      • Posted:

        10/26/2011

      • ID:
        HHS-OPHS-2011-0005-0785
      • Organization:
        Inova Health System
      • Submitter Name:
        Executive IRB
      undefined
      • See attached file(s)

      • Public Submission
      • Posted:

        10/19/2011

      • ID:
        HHS-OPHS-2011-0005-0382
      • Organization:
        Association of Clinical Research Professionals
      • Submitter Name:
        James Thomasell
      • I wish to add my concerns to the growing number of objections historians across the country are raising. These concerns relate to "Human Subject Research Protections," currently...

      • Public Submission
      • Posted:

        10/12/2011

      • ID:
        HHS-OPHS-2011-0005-0355
      • Organization:
        Graduate Student in History, University of Nevada, Las Vegas
      • Submitter Name:
        W. Phillip Strand
      undefined
      • Duke University appreciates the opportunity to provide the attached comments related to the ANPRM.

      • Public Submission
      • Posted:

        10/26/2011

      • ID:
        HHS-OPHS-2011-0005-0849
      • Organization:
        Duke University
      • Submitter Name:
        Wesley Byerly
      undefined
      • IRBs serve an important public good, which is the protection of human subjects from unnecessary risk. However, IRB boards fail to protect researchers and the public when they are...

      • Public Submission
      • Posted:

        08/17/2011

      • ID:
        HHS-OPHS-2011-0005-0130
      • Organization:
        Georgetown University
      • Submitter Name:
        Zach Warren
      • Judy E. Davidson DNP RN FCCM, Director Research Integration and Management, Scripps Health, Davidson.judy@scrippshealth.org Note: These comments are reflect the view of the author...

      • Public Submission
      • Posted:

        09/20/2011

      • ID:
        HHS-OPHS-2011-0005-0228
      • Organization:
        Scripps Health
      • Submitter Name:
        Judy Davidson
      • Applying the HIPAA Privacy Rule standards for de-identification to research broadly in an attempt to protect against the informational risks described in the ANPRM is poorly...

      • Public Submission
      • Posted:

        10/26/2011

      • ID:
        HHS-OPHS-2011-0005-0741
      • Organization:
      • Submitter Name:
      • 1) Regarding whether “certain fields of study [such as history] whose methods of inquiry were not intended to or should not be covered,” we argue for full exclusion of oral history...

      • Public Submission
      • Posted:

        10/25/2011

      • ID:
        HHS-OPHS-2011-0005-0666
      • Organization:
        UC Irvine
      • Submitter Name:
        Thuy Vo Dang
      undefined
      • Public Submission
      • Posted:

        10/28/2011

      • ID:
        HHS-OPHS-2011-0005-1106
      • Organization:
        The Ohio State University
      • Submitter Name:
        Janet Weisenberger
      undefined
      • Please see the attached document for the Children's Oncology Group's comments on this Notice.

      • Public Submission
      • Posted:

        10/19/2011

      • ID:
        HHS-OPHS-2011-0005-0398
      • Organization:
        Children's Oncology Group
      • Submitter Name:
        Peter Adamson
      undefined
      • I agree completely with this recently published comment in Nature, which I have also attached here: Research ethics: Treat donors as partners in biobank research Krishanu Saha & J...

      • Public Submission
      • Posted:

        10/26/2011

      • ID:
        HHS-OPHS-2011-0005-0730
      • Organization:
        Utah Foundation for Biomedical Research
      • Submitter Name:
        Gholson Lyon
      undefined
      • comments attached

      • Public Submission
      • Posted:

        10/26/2011

      • ID:
        HHS-OPHS-2011-0005-0702
      • Organization:
        Massachusetts Department of Public Health IRBs
      • Submitter Name:
        James Ballin
      undefined
      • Please see attached PDF file strongly criticizing ANPR as insufficiently deregulatory.

      • Public Submission
      • Posted:

        10/26/2011

      • ID:
        HHS-OPHS-2011-0005-0786
      • Organization:
        Self-employed Rearcher
      • Submitter Name:
        Thomas Becket
      undefined
      • See attached file(s)

      • Public Submission
      • Posted:

        10/26/2011

      • ID:
        HHS-OPHS-2011-0005-0773
      • Organization:
        Cystic Fibrosis Foundation
      • Submitter Name:
        Robert Beall
      undefined
      • See attached file(s)

      • Public Submission
      • Posted:

        10/26/2011

      • ID:
        HHS-OPHS-2011-0005-0833
      • Organization:
        American Lung Association
      • Submitter Name:
        Elizabeth Lancet
      undefined
      • See attached file(s)

      • Public Submission
      • Posted:

        10/26/2011

      • ID:
        HHS-OPHS-2011-0005-0941
      • Organization:
        Electronic Frontier Foundation
      • Submitter Name:
        Lee Tien
      undefined
      • The Society for Clinical and Translational Science (SCTS, an organization of over 50 leading translational science institutions, is responding to the Department of Health and Human...

      • Public Submission
      • Posted:

        10/25/2011

      • ID:
        HHS-OPHS-2011-0005-0588
      • Organization:
        Society for Clinical and Translational Science
      • Submitter Name:
        Monica Liebert
      • As the former Chairman of Oral and Maxillofacial Pathology at the Armed Forces Institute of Pathology, I have specific concerns regarding the proposed changes regarding the use of...

      • Public Submission
      • Posted:

        10/26/2011

      • ID:
        HHS-OPHS-2011-0005-0755
      • Organization:
        Naval Postgraduate Dental School
      • Submitter Name:
        Robert Foss
      undefined
      • Public Submission
      • Posted:

        11/03/2011

      • ID:
        HHS-OPHS-2011-0005-1113
      • Organization:
        CHDI
      • Submitter Name:
        Robi Blumenstein
      • The IRB changes do not appear to be based on sound scientific data but rather on bureaucratic and administrative expediency. The fact that independent IRB review slows down the...

      • Public Submission
      • Posted:

        10/26/2011

      • ID:
        HHS-OPHS-2011-0005-0850
      • Organization:
      • Submitter Name:
      • Most social science research (e.g., business, communication, etc.) is low risk. The current regulatory burdens for social science research in low-risk fields are overly cumbersome...

      • Public Submission
      • Posted:

        08/16/2011

      • ID:
        HHS-OPHS-2011-0005-0118
      • Organization:
        George Mason University
      • Submitter Name:
        R W
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