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NOTE: HARP IRB will not be accepting the submission of new protocols from January 18 - February 1, 2019, for a major update


The Dept. of Health and Human Services has revised the Common Rule which governs the protection of human research subjects for all federally funded (and much non-federally funded) research in the United States of America. Because of this change the HARP-IRB system will be updated to meet the new requirements. These alterations are currently underway and we anticipate having them in place and working well by February 1, 2019. The Revised Common Rule itself will be operational as of January 20, 2019. From January 18 to February 1, 209 the HARP IRB system will be closed to the submission of any new protocols involving human subjects research while we make the change over for the system and test it.

Here are some slides that will help explain the changes.

The HSC is LBNL's IRB and meets typically once a month. The committee is made up of staff scientists and community members and considers any research at LBNL involving humans or human tissues. Federal regulations concerning scientific research using human subjects may be found on the Office of Human Research Protection.

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You should also attach a copy of the California Medical Research Subject's Bill of Rights to your consent form.

  1. Consent form checklist
  2. General consent form outline
  3. Routine phlebotomy/blood draw consent form model
  4. Biomedical procedures consent form model
  5. California Medical Research Subject's Bill of Rights

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Note: to avoid delays, if you have any question about whether your study qualifies an an EVA please call HARC office staff at x6005. New researchers and first time those submitting LBNL human subject protocols submittees for the first time are well advised to consult with HARC office staff before submitting protocols to HARP.

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