OER Policy Announcement 2015-04 (12/22/2015)

New Administrative Code for Vertebrate Animals and Human Subjects in Institutional Training Applications and Awards

MEMO

DATE:December 22, 2015

TO:All Extramural Staff

FROM:Mike Lauer, NIH Deputy Director for Extramural Research

SUBJECT: Announcing a new administrative code for vertebrate animals and human subjects in NIH institutional training applications and awards

Purpose:This announcement serves to alert NIH extramural staff to the deployment of a new IMPAC II code 35for institutional training mechanisms that enable trainees to work on mentored projects that involve vertebrate animals or human subjects. This new code was deployed by eRA in October 2015. Starting with January 2016 receipt dates, institutional training applications that indicate “Yes” to vertebrate animals or human subjects will automatically be coded as 35 at receipt. This new code is specifically for institutional training mechanisms that typically do not fund the conduct of research but rather provide research training opportunities by enabling trainees to work on mentored research projects that are funded through other sources. Applicable mechanisms include: T15, T32, T34, T35, T36, T37, T90, R90, TL1, TL4, TU2.

Background: Current application instructions for institutional training mechanisms require applicants to check “Yes” to human subjects or vertebrate animals if training plans include or potentially will include trainees assigned to projects that involve human subjects or the use of vertebrate animals at any time during the proposed project period. In the past, such awards were coded as “30” in IMPAC II for human subjects or vertebrate animals. The projects that trainees will work on are generally supported by other research grants(with their own specific IRB and IACUC approvals) rather than being fundedthrough the institutional training awards themselves. However, assigning code 30 to these awards has created other administrative challenges for the funding ICs, such as the requirements to document IRB or IACUC approval of the training award and humansubjects training for key personnel. In the past, OEP and OLAW have advised the ICs to use other administrative codes (10 or 48) but this does not allow the ICs to clearly identify, for monitoring purposes, those awards in which trainees are involved in human subjects or vertebrate animal research projects. Working with the Training Advisory Committee (TAC), OER has created a unique administrative code (code 35) specifically for institutional training awards where trainees will be involved in projects with human subjects or vertebrate animals.

Policy: Starting with the January 2016 receipt date, applications for training mechanisms listed below that mark “Yes” to human subjects or vertebrate animals to indicate that trainees may work on such projects, will be automatically assigned a code 35 at receipt.

  • This policy applies only to institutional training mechanisms that are not directly supporting research but are supporting trainees to work on projects directed by a mentor and includes the following mechanisms: T15, T32, T34, T35, T36, T37, T90, R90, TL1, TL4, TU2.
  • Application instructions have also been changed to reflect this new policy. Specifically, applicants no longer need to submit lists of potential grants that trainees may work on and associated IRB or IACUC approvals but instead are directed to maintain IRB and IACUC approvals for applicable trainee research projects and provide this information to NIH when requested.

Application and Award Oversight Details:

  • Applications should undergo peer review per current policies and procedures. Peer reviewers should note any specific concerns about human subjects or vertebrate animals and raise these during discussion. Applications that have concerns should be coded as 44 after peer review. The identification of specific human subjects or vertebrate animal concerns in institutional training applications is likely to be very rare.
  • Awards that are coded as 35 will need to provide the relevant assurances [Federalwide Assurance,(FWA) for human subjects or Animal Welfare Assurance] to the funding IC during Just-in-Time.
  • No inclusion monitoring will be required for awards coded as 35 for human subjects.
  • IRB or IACUC approval dates will not be required for these awards. However, the human subjects or vertebrate animal research projects that involve trainees must have IRB or IACUC approval. Ensuring compliance with this requirement is the responsibility of the awardee institutions. ICs should continue current practices in terms of requesting that awardees provide the IC with IRB or IACUC approval documentation for specific projects with trainees, such as in progress reports.
  • ICs may wish to include a specific term in the Notice of Award about IRB and IACUC requirements, such as: “Trainees may only participate in human subjects or vertebrate animal research projects that have prior IRB and IACUC approvals.”
  • In some instances, trainees supported under these institutional training mechanisms can design and conduct their own human subjects or vertebrate animal research that is independent of the mentor’s project. Once that is determined to be the case, such awards should be coded as 30 for human subjects or vertebrate animals and all additional requirements associated with code 30 must be met (IRB or IACUC approval for the trainee projects, human subjects education, and inclusion of women, minorities and children). Program staff with such projects are responsible for working with grants management staff in the funding IC to ensure that these awards are coded appropriately for human subjects or vertebrate animal research.
  • Applications and awards that do not include any potential projects that involve human subjects or vertebrate animals will continue to be coded as 10.
  • Extramural staff at the ICs will have the same permissions in eRA to change human subjects and vertebrate animal codes for these institutional training applications and awards as for other mechanisms and should ensure that the codes accurately reflect the types of training and mentored projects. For example, if a training grant application is focusing on training in clinical research and does not anticipate any projects that involve vertebrate animals, it should be coded as 10 for vertebrate animals. However, after award, if a new mentor is added who has a vertebrate animal research projectthat a trainee opts to work on, the code can be changed to 35 to reflect this and the awardee would be required to provide their Animal Welfare Assurance number to the funding IC.

Questions about this new code 35 for institutional training should be directed to the following:

  • For questions related to Vertebrate Animals
  • Eileen Morgan

301-451-0384

  • For questions related to Human Subjects

301-435-2690 or 301-496-1369

  • For general questions about institutional training grant mechanisms and awards
  • Jennifer Sutton

301-435-2686

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