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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    Sep 26, 2011 11:59 PM ET

    Public Submission

    HHS

    HHS-OPHS-2011-0005-0031

    08/02/2011

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    Sep 26, 2011 11:59 PM ET

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    HHS

    HHS-OPHS-2011-0005-0042

    08/02/2011

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    Oct 26, 2011 11:59 PM ET

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    HHS

    HHS-OPHS-2011-0005-0448

    10/20/2011

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    Oct 26, 2011 11:59 PM ET

    Public Submission

    HHS

    HHS-OPHS-2011-0005-0900

    10/26/2011

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    Oct 26, 2011 11:59 PM ET

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    HHS

    HHS-OPHS-2011-0005-0661

    10/25/2011

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    Oct 26, 2011 11:59 PM ET

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    HHS-OPHS-2011-0005-0544

    10/24/2011

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    Oct 26, 2011 11:59 PM ET

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    HHS

    HHS-OPHS-2011-0005-0633

    10/25/2011

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    Oct 26, 2011 11:59 PM ET

    Public Submission

    HHS

    HHS-OPHS-2011-0005-0390

    10/19/2011

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    Oct 26, 2011 11:59 PM ET

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    HHS

    HHS-OPHS-2011-0005-0902

    10/26/2011

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    Oct 26, 2011 11:59 PM ET

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    HHS-OPHS-2011-0005-0353

    10/12/2011

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    Oct 26, 2011 11:59 PM ET

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    HHS

    HHS-OPHS-2011-0005-0370

    10/13/2011

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    Oct 26, 2011 11:59 PM ET

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    HHS

    HHS-OPHS-2011-0005-0244

    09/21/2011

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    Oct 26, 2011 11:59 PM ET

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    HHS

    HHS-OPHS-2011-0005-0635

    10/25/2011

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    Sep 26, 2011 11:59 PM ET

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    HHS-OPHS-2011-0005-0117

    08/16/2011

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    Oct 26, 2011 11:59 PM ET

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    HHS

    HHS-OPHS-2011-0005-0324

    10/06/2011

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    Sep 26, 2011 11:59 PM ET

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    HHS

    HHS-OPHS-2011-0005-0066

    08/10/2011

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    Oct 26, 2011 11:59 PM ET

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    HHS

    HHS-OPHS-2011-0005-0652

    10/25/2011

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    Oct 26, 2011 11:59 PM ET

    Public Submission

    HHS

    HHS-OPHS-2011-0005-0577

    10/24/2011

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    Oct 26, 2011 11:59 PM ET

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    HHS

    HHS-OPHS-2011-0005-0436

    10/20/2011

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    Oct 26, 2011 11:59 PM ET

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    HHS

    HHS-OPHS-2011-0005-0716

    10/26/2011

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    Oct 26, 2011 11:59 PM ET

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    HHS

    HHS-OPHS-2011-0005-0444

    10/20/2011

    Public Submission

    HHS

    HHS-OPHS-2011-0005-0343

    10/06/2011

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    Oct 26, 2011 11:59 PM ET

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    HHS

    HHS-OPHS-2011-0005-0743

    10/26/2011

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    Oct 26, 2011 11:59 PM ET

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    HHS

    HHS-OPHS-2011-0005-0535

    10/24/2011

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    Oct 26, 2011 11:59 PM ET

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    HHS

    HHS-OPHS-2011-0005-0836

    10/26/2011

      • Requesting a 120 day extension.

      • Public Submission
      • Posted:

        08/02/2011

      • ID:
        HHS-OPHS-2011-0005-0031
      • Organization:
        The Psych Report
      • Submitter Name:
        James Pricer
      • As an investigator who conducts research at multiple institutions, I strongly support the proposed revisions regarding multiple use of IRB's, eliminating unneeded differences in...

      • Public Submission
      • Posted:

        08/02/2011

      • ID:
        HHS-OPHS-2011-0005-0042
      • Organization:
        Uniformed Services University
      • Submitter Name:
        David Krantz
      • I believe there should be full exclusion of oral history projects from the terms of the Common Rule. Oral history focuses on eliciting information about particular experiences of...

      • Public Submission
      • Posted:

        10/20/2011

      • ID:
        HHS-OPHS-2011-0005-0448
      • Organization:
        Virginia Tech
      • Submitter Name:
        Tamara Kennelly
      undefined
      • See attached file(s)

      • Public Submission
      • Posted:

        10/26/2011

      • ID:
        HHS-OPHS-2011-0005-0900
      • Organization:
        University of Michigan
      • Submitter Name:
        J Birk
      undefined
      • See attached file(s)

      • Public Submission
      • Posted:

        10/25/2011

      • ID:
        HHS-OPHS-2011-0005-0661
      • Organization:
        Stanford University
      • Submitter Name:
        Kathy McClelland
      • Dear Sirs and Madams~ I believe that we have gone far with the use of private medical information. This only puts a distrust between medicine/Drs. and our well-being/healthcare...

      • Public Submission
      • Posted:

        10/24/2011

      • ID:
        HHS-OPHS-2011-0005-0544
      • Organization:
      • Submitter Name:
        Sandra Amyotte
      undefined
      • See attached file(s)

      • Public Submission
      • Posted:

        10/25/2011

      • ID:
        HHS-OPHS-2011-0005-0633
      • Organization:
        Seattle Children's Research Institute
      • Submitter Name:
        Halle Salas
      undefined
      • Please see the attached document.

      • Public Submission
      • Posted:

        10/19/2011

      • ID:
        HHS-OPHS-2011-0005-0390
      • Organization:
      • Submitter Name:
        James Freshman
      • I certainly hope that this strengthens the rights and protection of individuals that are exposed to such research and does not weaken them. It should be illegal to conduct...

      • Public Submission
      • Posted:

        10/26/2011

      • ID:
        HHS-OPHS-2011-0005-0902
      • Organization:
      • Submitter Name:
        Randy Jones
      • I absolutely support changes to consent as it relates to minors. I just received a survey in the mail from my son's school. It only gives me an "opt out" option. If I agree to...

      • Public Submission
      • Posted:

        10/12/2011

      • ID:
        HHS-OPHS-2011-0005-0353
      • Organization:
      • Submitter Name:
        Melissa Freeman
      undefined
      • See attached file(s)

      • Public Submission
      • Posted:

        10/13/2011

      • ID:
        HHS-OPHS-2011-0005-0370
      • Organization:
        Adventist Healthcare, Inc.
      • Submitter Name:
        Debarati Dasgupta
      undefined
      • See attached file(s)

      • Public Submission
      • Posted:

        09/21/2011

      • ID:
        HHS-OPHS-2011-0005-0244
      • Organization:
        Mayo Clinic
      • Submitter Name:
        Mary Hopper
      undefined
      • See attached file(s)

      • Public Submission
      • Posted:

        10/25/2011

      • ID:
        HHS-OPHS-2011-0005-0635
      • Organization:
        Virginia Commonwealth University
      • Submitter Name:
        Heather Traino
      • I agree that local IRB review is often duplicative and cumbersome to investigators. However, multiple sites across many states involves nuances in state/local law to which a...

      • Public Submission
      • Posted:

        08/16/2011

      • ID:
        HHS-OPHS-2011-0005-0117
      • Organization:
      • Submitter Name:
      undefined
      • See attached file(s)

      • Public Submission
      • Posted:

        10/06/2011

      • ID:
        HHS-OPHS-2011-0005-0324
      • Organization:
        Boston University School of Medicine
      • Submitter Name:
        James Feldman
      • With regard to doing away with "exempt", the terminology "excuses" seems more accurate and less confusing. Are you suggesting that if any retrospective data is used that has...

      • Public Submission
      • Posted:

        08/10/2011

      • ID:
        HHS-OPHS-2011-0005-0066
      • Organization:
        VA Eastern Kansas Health Care System
      • Submitter Name:
        Mary Oehlert
      undefined
      • This posting is in response to the notice in the Federal Register published on Tuesday, July 26 2011: "comments are sought not only on ways to improve the efficiency of the current...

      • Public Submission
      • Posted:

        10/25/2011

      • ID:
        HHS-OPHS-2011-0005-0652
      • Organization:
        The Viet/American Cervical Cancer Prevention Project
      • Submitter Name:
        Eric Suba
      undefined
      • See attached file(s)

      • Public Submission
      • Posted:

        10/24/2011

      • ID:
        HHS-OPHS-2011-0005-0577
      • Organization:
        American Nurses Association
      • Submitter Name:
        Louise Kaplan
      undefined
      • Amgen is a global biotechnology company based in Thousand Oaks, CA. We are pleased to have the opportunity to provide comments regarding the Department of Health and Human...

      • Public Submission
      • Posted:

        10/20/2011

      • ID:
        HHS-OPHS-2011-0005-0436
      • Organization:
        Amgen, Inc.
      • Submitter Name:
        Ellenie Parthenis
      undefined
      • See attached file(s)

      • Public Submission
      • Posted:

        10/26/2011

      • ID:
        HHS-OPHS-2011-0005-0716
      • Organization:
        American Association of Neuropathologists
      • Submitter Name:
        Raymond Sobel
      undefined
      • See attached file for full text On behalf of the 19 Consortia, 103 Study Chairs, and 114 domestic and 26 international active/enrolling sites that form the Rare Diseases Clinical...

      • Public Submission
      • Posted:

        10/20/2011

      • ID:
        HHS-OPHS-2011-0005-0444
      • Organization:
        Rare Diseases Clinical Research Network
      • Submitter Name:
        Alan Percy
      undefined
      • Public Submission
      • Posted:

        10/06/2011

      • ID:
        HHS-OPHS-2011-0005-0343
      • Organization:
        21. Association of Pathology Chairs and the American Society for Investigative Pathology
      • Submitter Name:
        Priscilla Markwood
      undefined
      • October 26, 2011 Jerry Menikoff, MD, JD Office of Human Research Protections 1101 Wootton Parkway Suite 200 Rockville, MD 20852 RE: Docket ID Number HHS-OPHS-2011-0005 Dear Dr...

      • Public Submission
      • Posted:

        10/26/2011

      • ID:
        HHS-OPHS-2011-0005-0743
      • Organization:
        Association of Pathology Chairs
      • Submitter Name:
        Peter Jensen
      undefined
      • see below

      • Public Submission
      • Posted:

        10/24/2011

      • ID:
        HHS-OPHS-2011-0005-0535
      • Organization:
        astrazeneca
      • Submitter Name:
        mark tuersley
      undefined
      • See attached file(s) from UCSF.

      • Public Submission
      • Posted:

        10/26/2011

      • ID:
        HHS-OPHS-2011-0005-0836
      • Organization:
        University of California, San Francisco
      • Submitter Name:
        Eric Mah
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