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

    Public Submission

    HHS

    HHS-OPHS-2011-0005-0739

    10/26/2011

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    Oct 26, 2011 11:59 PM ET

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    HHS

    HHS-OPHS-2011-0005-0693

    10/26/2011

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    Oct 26, 2011 11:59 PM ET

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    HHS-OPHS-2011-0005-0179

    09/02/2011

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    Sep 26, 2011 11:59 PM ET

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    HHS

    HHS-OPHS-2011-0005-0069

    08/10/2011

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    Oct 26, 2011 11:59 PM ET

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    HHS

    HHS-OPHS-2011-0005-0701

    10/26/2011

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    Oct 26, 2011 11:59 PM ET

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    HHS-OPHS-2011-0005-0694

    10/26/2011

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    Oct 26, 2011 11:59 PM ET

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    HHS-OPHS-2011-0005-0845

    10/26/2011

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    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-2011-0005-0251

    09/23/2011

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    Oct 26, 2011 11:59 PM ET

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    HHS

    HHS-OPHS-2011-0005-0702

    10/26/2011

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    Sep 26, 2011 11:59 PM ET

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    HHS-OPHS-2011-0005-0041

    08/02/2011

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    Sep 26, 2011 11:59 PM ET

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    HHS-OPHS-2011-0005-0098

    08/15/2011

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    Oct 26, 2011 11:59 PM ET

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    HHS-OPHS-2011-0005-0250

    09/23/2011

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    Oct 26, 2011 11:59 PM ET

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    HHS-OPHS-2011-0005-0311

    10/06/2011

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    Sep 26, 2011 11:59 PM ET

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    HHS-OPHS-2011-0005-0084

    08/11/2011

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    Sep 26, 2011 11:59 PM ET

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    HHS-OPHS-2011-0005-0128

    08/17/2011

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    Oct 26, 2011 11:59 PM ET

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    HHS

    HHS-OPHS-2011-0005-0255

    09/23/2011

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    Oct 26, 2011 11:59 PM ET

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    HHS

    HHS-OPHS-2011-0005-0742

    10/26/2011

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    Oct 26, 2011 11:59 PM ET

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    HHS

    HHS-OPHS-2011-0005-0695

    10/26/2011

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    Oct 26, 2011 11:59 PM ET

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    HHS

    HHS-OPHS-2011-0005-0481

    10/21/2011

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    Oct 26, 2011 11:59 PM ET

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    HHS

    HHS-OPHS-2011-0005-1038

    10/26/2011

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    Sep 26, 2011 11:59 PM ET

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    HHS

    HHS-OPHS-2011-0005-0123

    08/16/2011

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    Oct 26, 2011 11:59 PM ET

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    HHS

    HHS-OPHS-2011-0005-0603

    10/25/2011

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    Oct 26, 2011 11:59 PM ET

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    HHS

    HHS-OPHS-2011-0005-0907

    10/26/2011

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    Sep 26, 2011 11:59 PM ET

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    HHS

    HHS-OPHS-2011-0005-0045

    08/04/2011

      • These comments reflect personal opinions and may not reflect the views of the SLU IRB. We are concerned that allowing the collection of prospective data under exempt/excused...

      • Public Submission
      • Posted:

        10/26/2011

      • ID:
        HHS-OPHS-2011-0005-0739
      • Organization:
        Saint Louis University
      • Submitter Name:
        Two IRB staff persons Two IRB staff persons
      undefined
      • See attached file(s)

      • Public Submission
      • Posted:

        10/26/2011

      • ID:
        HHS-OPHS-2011-0005-0693
      • Organization:
      • Submitter Name:
        Susan Delano
      undefined
      • See attached file(s)

      • Public Submission
      • Posted:

        09/02/2011

      • ID:
        HHS-OPHS-2011-0005-0179
      • Organization:
        Editor-in-Chief, American Anthropologist
      • Submitter Name:
        Tom Boellstorff
      • Having served over 25 years as an IRB Chair for two IRBs serving multiple facilities and organizations, I am reminded of certain events in history that suggest that centralization...

      • Public Submission
      • Posted:

        08/10/2011

      • ID:
        HHS-OPHS-2011-0005-0069
      • Organization:
        Catholic Healthcare West
      • Submitter Name:
        Craig Weiner, MD
      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
      • The attached comments are submitted on behalf of the Center for Genomics & Healthcare Equality at the University of Washington (Principal Investigator: Wylie Burke, MD, PhD)

      • Public Submission
      • Posted:

        10/26/2011

      • ID:
        HHS-OPHS-2011-0005-0694
      • Organization:
        Center for Genomics & Healthcare Equality, University of Washington
      • Submitter Name:
        Susan Trinidad
      undefined
      • See attached file(s)

      • Public Submission
      • Posted:

        10/26/2011

      • ID:
        HHS-OPHS-2011-0005-0845
      • Organization:
        Partners HealthCare
      • Submitter Name:
        Dennis Ausiello
      • 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
      undefined
      • To Whom it May Concern: Please see the attached comments of the American Psychiatric Association.

      • Public Submission
      • Posted:

        09/23/2011

      • ID:
        HHS-OPHS-2011-0005-0251
      • Organization:
        American Psychiatric Association
      • Submitter Name:
        Julie Clements
      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
      • Re: Issue 5- to revise regulations regarding consent form language. I recommend being specific about the grade level or age appropriate language to be used in consent forms...

      • Public Submission
      • Posted:

        08/02/2011

      • ID:
        HHS-OPHS-2011-0005-0041
      • Organization:
        Duke Biobank, Duke University
      • Submitter Name:
        Helena Ellis
      • This rule does NOT include the necessary competencies, training, familiarity with the behavioral and theoretical literature, and specialty diagnostic skills to do "intensive...

      • Public Submission
      • Posted:

        08/15/2011

      • ID:
        HHS-OPHS-2011-0005-0098
      • Organization:
      • Submitter Name:
        Kimberly Obitz
      • I have conducted research with human subjects for over 30 years and have served on the IRB for two different research universities. I am keenly aware of the need to protect people...

      • Public Submission
      • Posted:

        09/23/2011

      • ID:
        HHS-OPHS-2011-0005-0250
      • Organization:
        School of Psychology, Georgia Institute of Technology
      • Submitter Name:
        Randall Engle
      • I believe that most Parkinson's patients are Senior Citizens in their later years and some what confused by lengthy forms. It has been my experience that most Government forms...

      • Public Submission
      • Posted:

        10/06/2011

      • ID:
        HHS-OPHS-2011-0005-0311
      • Organization:
        My wife has Parkinson's
      • Submitter Name:
        Spencer Wessling
      • The IRB's duties are two-fold. First, to protect participants from harm and second to facilitate research. Unfortunately, many IRBs tend to lean too far to either direction, and...

      • Public Submission
      • Posted:

        08/11/2011

      • ID:
        HHS-OPHS-2011-0005-0084
      • Organization:
        Public University
      • Submitter Name:
      undefined
      • Please see attached Letter

      • Public Submission
      • Posted:

        08/17/2011

      • ID:
        HHS-OPHS-2011-0005-0128
      • Organization:
        Translational Genomics Research Institute (TGen)
      • Submitter Name:
        Stephanie Buchholtz
      undefined
      • See attached file(s)

      • Public Submission
      • Posted:

        09/23/2011

      • ID:
        HHS-OPHS-2011-0005-0255
      • Organization:
        Albert Einstein Healthcare Network
      • Submitter Name:
        John Whyte
      undefined
      • See attached file(s)

      • Public Submission
      • Posted:

        10/26/2011

      • ID:
        HHS-OPHS-2011-0005-0742
      • Organization:
        Wellspan Health
      • Submitter Name:
        Tara Moore
      • 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:

        10/26/2011

      • ID:
        HHS-OPHS-2011-0005-0695
      • Organization:
        Utah Valley University
      • Submitter Name:
        Michele Welch
      • I am the medical director of a medical school / cancer center human biospecimen bank. My group also provides services regarding archived surgical pathology specimens. In my view...

      • Public Submission
      • Posted:

        10/21/2011

      • ID:
        HHS-OPHS-2011-0005-0481
      • Organization:
        University of New Mexico School of Medicine
      • Submitter Name:
        Therese Bocklage
      undefined
      • See attached file(s)

      • Public Submission
      • Posted:

        10/26/2011

      • ID:
        HHS-OPHS-2011-0005-1038
      • Organization:
        Hurlbut PhD, J. Benjamin, Arizona State University & Saha PhD, Krishanu, Whitehead Institute for Biomedical Research
      • Submitter Name:
      • As both a research assistant for UNC's Southern Oral History Program and a historian with many colleagues who use oral history in their research, I'd like to submit my opinion that...

      • Public Submission
      • Posted:

        08/16/2011

      • ID:
        HHS-OPHS-2011-0005-0123
      • Organization:
        PhD Candidate, History, University of North Carolina at Chapel Hill
      • Submitter Name:
        Anna Krome-Lukens
      • These proposed regulations just take your breath away. The American public knows that a doctor cannot speak with their family without their permission but has no idea that...

      • Public Submission
      • Posted:

        10/25/2011

      • ID:
        HHS-OPHS-2011-0005-0603
      • Organization:
      • Submitter Name:
        Susan Israel, MD
      undefined
      • See attached file(s)

      • Public Submission
      • Posted:

        10/26/2011

      • ID:
        HHS-OPHS-2011-0005-0907
      • Organization:
        Dartmouth College
      • Submitter Name:
        Elizabeth Bankert
      • Most consent forms for cancer clinical trials are too lengthy and complex for patients to comprehend. I doubt many potential research subjects ever read an entire consent. I...

      • Public Submission
      • Posted:

        08/04/2011

      • ID:
        HHS-OPHS-2011-0005-0045
      • Organization:
        South Georgia Medical Center
      • Submitter Name:
        Mary Ann Heddon
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