1.800.785.7808
  • Contact Us
  • MENU

    Start the Conversation

    Final Rule Published Without Biospecimen Provisions

    Over the last year and a half, academic and government researchers have joined to voice their opposition to proposed updates to the Common Rule regarding biomedical and behavioral research involving human subjects in the United States. Specifically, they opposed consent changes that would stifle the progress of science. It seems the U.S. Department of Health and Human Services listened.

    Whether it was a rush to announce prior to the administration transition or serendipity, on the eve of Inauguration Day, the Feds published the Final Rule, minus the biospecimen provisions.

    The spark that ignited 17 months of debate, angst, and uncertainty was a proposal that would have required researchers to obtain written consent before using biospecimens such as DNA, cells, blood, and tumor samples obtained during clinical care or a specific research study. This proposal would have required consent even if the biospecimens were de-identified (stripped of personally identifiable information). As of today, and for the indefinite future, those biospecimens can now be used for government-funded research without the donor’s consent, provided they are de-identified.

    While academic and government researchers may collectively exhale in response to the recently published Final Rule, privately funded programs cannot.  Lobbyists and patient advocates were unsuccessful in their efforts to convince HHS to expand the regulations on human subjects to include Industry (Biotech and Pharmaceutical). The procedures and regulation of industry-sponsored human subject research are more stringent and remain unchanged.

    The key takeaway for any researcher: It is your responsibility to ensure that all biospecimens intended or used in the course of your research were obtained in compliance with the appropriate Federal Regulation.

    Click to Tweet

    Leave a Comment

    *

    1. ewpori

      November 15, 2019

      Your comment is awaiting moderation.
    2. icolasud

      November 14, 2019

      Your comment is awaiting moderation.
    3. imazeka

      November 5, 2019

      Your comment is awaiting moderation.
    4. anaoubu

      October 31, 2019

      Your comment is awaiting moderation.
    5. vinfoxe

      October 20, 2019

      Your comment is awaiting moderation.
    6. inciawod

      October 17, 2019

      Your comment is awaiting moderation.
    7. GreggGauch

      October 11, 2019

      Your comment is awaiting moderation.
    8. GreggGauch

      October 11, 2019

      Your comment is awaiting moderation.
    9. GreggGauch

      October 11, 2019

      Your comment is awaiting moderation.
    10. GreggGauch

      October 10, 2019

      Your comment is awaiting moderation.
    11. GreggGauch

      October 10, 2019

      Your comment is awaiting moderation.
    12. tivoamqecoj

      October 6, 2019

      Your comment is awaiting moderation.
    13. aehuveru

      October 6, 2019

      Your comment is awaiting moderation.
    14. fuomisisiqiho

      October 5, 2019

      Your comment is awaiting moderation.
    15. odocitujiyme

      October 5, 2019

      Your comment is awaiting moderation.
    16. ipupuumicami

      October 5, 2019

      Your comment is awaiting moderation.
    17. avihezoyid

      October 5, 2019

      Your comment is awaiting moderation.
    18. ifuulozoqa

      October 5, 2019

      Your comment is awaiting moderation.
    19. ifesixru

      October 5, 2019

      Your comment is awaiting moderation.
    20. elokeqesezoj

      October 5, 2019

      Your comment is awaiting moderation.
    21. aqjexrilijeyi

      October 5, 2019

      Your comment is awaiting moderation.
    22. ivvicew

      October 5, 2019

      Your comment is awaiting moderation.
    23. ucoreliso

      October 5, 2019

      Your comment is awaiting moderation.
    24. avalosunu

      October 5, 2019

      Your comment is awaiting moderation.
    25. uxaftog

      October 5, 2019

      Your comment is awaiting moderation.
    26. uxfupgiidoahi

      October 5, 2019

      Your comment is awaiting moderation.
    27. ofuaakuyibe

      October 5, 2019

      Your comment is awaiting moderation.
    28. iexoyomireci

      October 5, 2019

      Your comment is awaiting moderation.
    29. xdusijubibebe

      October 4, 2019

      Your comment is awaiting moderation.
    30. ewafopvsudafa

      October 4, 2019

      Your comment is awaiting moderation.
    31. anivuvweraj

      October 4, 2019

      Your comment is awaiting moderation.
    32. exokodoku

      October 4, 2019

      Your comment is awaiting moderation.
    33. efikifepoywi

      October 4, 2019

      Your comment is awaiting moderation.
    34. okezkikaotoh

      October 4, 2019

      Your comment is awaiting moderation.
    35. luxuyuitu

      October 4, 2019

      Your comment is awaiting moderation.
    36. ikodulexa

      October 4, 2019

      Your comment is awaiting moderation.
    37. icutuweh

      October 4, 2019

      Your comment is awaiting moderation.
    38. ajanoyou

      October 4, 2019

      Your comment is awaiting moderation.
    39. uquajuhpaye

      October 4, 2019

      Your comment is awaiting moderation.
    40. opeutediqomi

      October 4, 2019

      Your comment is awaiting moderation.
    41. evisewibefoj

      October 4, 2019

      Your comment is awaiting moderation.
    42. udirasazta

      October 4, 2019

      Your comment is awaiting moderation.
    43. utisoedrb

      October 4, 2019

      Your comment is awaiting moderation.
    44. erkujacyo

      October 3, 2019

      Your comment is awaiting moderation.
    45. eizovakovuzoz

      October 3, 2019

      Your comment is awaiting moderation.
    46. ivfjosgila

      October 3, 2019

      Your comment is awaiting moderation.
    47. eufurasenatad

      October 3, 2019

      Your comment is awaiting moderation.
    48. ogozaxusiziz

      October 3, 2019

      Your comment is awaiting moderation.
    49. uvzejmosuq

      October 3, 2019

      Your comment is awaiting moderation.
    50. uvupiguf

      October 3, 2019

      Your comment is awaiting moderation.
    51. otisojhi

      October 3, 2019

      Your comment is awaiting moderation.
    52. ovabogassunu

      October 3, 2019

      Your comment is awaiting moderation.
    53. edifimajenad

      October 3, 2019

      Your comment is awaiting moderation.
    54. axoyuoy

      October 3, 2019

      Your comment is awaiting moderation.
    55. imikaliwof

      October 3, 2019

      Your comment is awaiting moderation.
    56. obaajuyec

      October 3, 2019

      Your comment is awaiting moderation.
    57. cevatuhay

      October 3, 2019

      Your comment is awaiting moderation.
    58. ocaxositdoku

      October 3, 2019

      Your comment is awaiting moderation.
    59. azagukodupe

      October 2, 2019

      Your comment is awaiting moderation.
    60. ivobuevanuxq

      October 2, 2019

      Your comment is awaiting moderation.
    61. jutagxeyuxoko

      October 2, 2019

      Your comment is awaiting moderation.
    62. uttazjofkuva

      October 2, 2019

      Your comment is awaiting moderation.
    63. ibacamabolan

      October 2, 2019

      Your comment is awaiting moderation.
    64. uriqiwor

      October 2, 2019

      Your comment is awaiting moderation.
    65. ozuqumasiroma

      October 2, 2019

      Your comment is awaiting moderation.
    66. ikikadoziwih

      October 2, 2019

      Your comment is awaiting moderation.
    67. ezeqatits

      October 2, 2019

      Your comment is awaiting moderation.
    68. efunbvugo

      October 1, 2019

      Your comment is awaiting moderation.
    69. ufozeneap

      October 1, 2019

      Your comment is awaiting moderation.
    70. umiwusate

      October 1, 2019

      Your comment is awaiting moderation.
    71. ihuuvaluxobom

      October 1, 2019

      Your comment is awaiting moderation.
    72. ewacumusid

      October 1, 2019

      Your comment is awaiting moderation.
    73. ututubac

      September 24, 2019

      Your comment is awaiting moderation.
    74. Alwine

      September 5, 2019

      Your comment is awaiting moderation.
    75. olaviwaje

      August 20, 2019

      Your comment is awaiting moderation.
    76. acusodeiwu

      July 27, 2019

      Your comment is awaiting moderation.
    77. ecuwuromu

      July 27, 2019

      Your comment is awaiting moderation.
    78. ifikabe

      July 11, 2019

      Your comment is awaiting moderation.
    79. qxojexojilai

      July 10, 2019

      Your comment is awaiting moderation.
    80. hodaxaxak

      July 10, 2019

      Your comment is awaiting moderation.
    81. ekckebiv

      July 1, 2019

      Your comment is awaiting moderation.
    82. afozanoec

      July 1, 2019

      Your comment is awaiting moderation.
    83. http://canadianorderpharmacy.com/

      June 5, 2019

      Your comment is awaiting moderation.
    84. Vidmbomma

      April 26, 2019

      Your comment is awaiting moderation.
    85. Gordonlax

      April 21, 2019

      Your comment is awaiting moderation.
    86. Gordonlax

      April 15, 2019

      Your comment is awaiting moderation.
    87. Gordonlax

      April 11, 2019

      Your comment is awaiting moderation.
    88. Gordonlax

      April 10, 2019

      Your comment is awaiting moderation.
    89. Tutubomma

      April 2, 2019

      Your comment is awaiting moderation.
    90. lädt iphone

      March 8, 2019

      Your comment is awaiting moderation.
    91. anstössige inhalte iphone

      March 8, 2019

      Your comment is awaiting moderation.
    92. iphone

      March 8, 2019

      Your comment is awaiting moderation.
    93. a screenshot

      March 8, 2019

      Your comment is awaiting moderation.
    94. ringtones for

      March 6, 2019

      Your comment is awaiting moderation.
    95. Cash Advance

      March 1, 2019

      Your comment is awaiting moderation.