Clinical Trials: Special Considerations for Career Development, Fellowship, Training, and Research Education Programs

Notice Number: NOT-OD-18-001

Key Dates
Release Date: November 6, 2017

Related Announcements
None

Issued by
National Institutes of Health (NIH)

Purpose

The purpose of this notice is to provide prospective applicants for career development, NRSA fellowships or training grants, and research education grants advanced information about the upcoming funding opportunity announcements (FOA), expected dates of FOA issuance, and application due dates.

As indicated in NOT-OD-17-043, effective January 25, 2018, all grant applications with plans to conduct independent clinical trials must be submitted in response to an FOA which specifically states that independent clinical trials are allowed.

Individual Career Development (K) Awards
Career Development Award applications may request support for either an independent clinical trial or propose to gain research experience in a clinical trial lead by another investigator (e.g., mentor/sponsor), depending on the FOA.

  • Some K FOAs will be designated as 'Independent Clinical Trial Required' and will require applicants to propose to lead an independent clinical trial or an independent ancillary trial to an ongoing clinical trial with proper mentorship. K award applicants to these FOAs will be required to complete the clinical trial specific fields on the PHS Human Subjects and Clinical Trials Information form.
  • Some K FOAs will be designated as 'Independent Clinical Trial Not Allowed' and will not allow applicants to propose to lead an independent clinical trial, but will allow them to propose research experience in a clinical trial led by a mentor or co-mentor.
  • For career development applicants proposing research experience in a clinical trial, NIH expects the mentor or individual receiving support for the larger trial to have the overall responsibility for the trial.
  • Career development applicants proposing to gain mentored research experience in a clinical trial will be instructed to provide details of their contribution to the study in the 'Research Strategy' section rather than in the clinical trial specific fields on the PHS Human Subjects and Clinical Trials Information form.
  • New Parent career development award (K) FOAs are anticipated to be issued by December 12, 2017, for applications due on February 12, 2018 or subsequent K award application dates.

Ruth L. Kirschstein National Research Service Award (NRSA) Individual Fellowships
The NIH strongly supports training towards a career in clinically relevant research and so gaining experience in clinical trials under the guidance of a sponsor or co-sponsor is permitted and encouraged for those fellowship applicants interested in clinical research. 

  • NRSA individual fellowship FOAs will be designated as 'Independent Clinical Trial Not Allowed' and will not allow fellowship applicantsto propose to lead an independent clinical trial, but will allow them to propose research experience in a clinical trial led by a sponsor or co-sponsor.
  • NIH expects the sponsor or individual receiving support for the clinical trial to assume overall responsibility for the trial. Fellowship applicants proposing to gain research experience in a clinical trial will be instructed to provide details of their contribution to the study in the 'Research Strategy' section rather than in the clinical trial specific fields on the PHS Human Subjects and Clinical Trials Information form.
  • New Parent fellowship FOAs are anticipated to be issued by February 8, 2018, for applications due on April 8, 2018 or subsequent fellowship application dates.  

Ruth L. Kirschstein National Research Service Award (NRSA) Institutional Training Grants
The NIH strongly supports training towards a career in clinically relevant research and so gaining experience in clinical trials under the guidance of a mentor or co-mentor is permitted and encouraged for those trainees interested in clinical trials research.

  • Trainees appointed to NRSA institutional training grants will not be permitted to lead independent clinical trials, but may gain research experience in a clinical trial led by a mentor or co-mentor.
  • NIH expects the mentor or individual receiving support for the clinical trial to assume overall responsibility for the trial.
  • Applications proposing to offer appointed trainees the opportunity to obtain clinical trial research experience will be instructed to provide details of such training in the 'Training Program Plan' section rather than in the clinical trial specific fields on the PHS Human Subjects and Clinical Trials Information form.
  • New Parent training FOAs are anticipated to be issued by November 25, 2017, for applications due on January 25, 2018 or subsequent training grant application dates.

Institutional Career Development (K12) and International Research Training Grants (D43)

  • Some K12 and D43 FOAs may be designated as 'Clinical Trials Optional' and will allow the appointment of scholars (K12) or trainees (D43) proposing to serve as the lead investigator of an independent clinical trial (or a feasibility or ancillary trial), or proposing to gain research experience in a clinical trial led by another investigator, as part of their research and career development.
  • In addition, these FOAs will allow appointment of Scholars (K12) or Trainees (D43) proposing to gain research experience in a clinical trial led by another investigator, as part of their research and career development.
  • New Institute/Center-specific K12 FOAs are anticipated to be issued by December 12, 2017, for applications due on February 12, 2018 or subsequent K12 application dates.
  • New Institute/Center-specific D43 FOAs are anticipated to be issued by November 25, 2017, for applications due on January 25, 2018 or subsequent D43 application dates.

Institutional Research Education Grants (R25)

  • Participants appointed to Research education (R25) grants will not be permitted to lead independent clinical trials, but these awards will allow participants to gain research experience in a clinical trial led by a mentor or co-mentor.
  • New Institute/Center-specific FOAs are anticipated to be issued by November 25, 2017, for applications due on January 25, 2018 or subsequent R25 application dates.

Inquiries

Please direct all inquiries to:

Division of Biomedical Research Workforce
Office of Extramural Programs
Office of Extramural Research
Website: https://researchtraining.nih.gov 
Email: NIHTrain@mail.nih.gov