[an error occurred while processing this directive]
Research Management Group (RMG)

Stanford PI Eligibility and Waiver Policy Guidelines


This webpage contains information on Principal Investigator (PI) eligibility, the criteria for obtaining PI waivers for those without PI eligibility, the various types of PI waiver exceptions (i.e., Career development, CE faculty waivers, Expanded Career Development PI waivers, etc.), and the procedures and the *new* PI Waiver templates for preparing PI waiver memo requests.

All PI waiver requests must be submitted to your Research Process Manager (RPM) in RMG. (RPM department assignment webpage >>).

Matrix of positions


PI Waiver Exception Types
: descriptions, criteria, and *new* PI waiver templates:

 







Who has principal investigatorship (PI) eligibility?

 

Principal Investigatorship (PI) Eligibility and Criteria for Exceptions (Research Policy Handbook RPH 2.1 >>)

Per this policy, eligibility to act as a principal investigator (PI) or co-principal investigator (Co-PI) on externally sponsored projects (see the exceptions* below >>) is a privilege limited to members of the Academic Council and to the MCL faculty (and includes faculty with UTL and NTL-Research appointments). This policy limitation is in place because principal investigators are responsible for determining the intellectual direction of the research and scholarship, and for the training of graduate students.




obtaining pi waivers for those who do not have pi eligibility




The designation of "PI" or "Co-PI" for any member of the Academic Staff, or other individual who is not a member of the University's Academic Council or MCL faculty, requires specific approval by the relevant department chair, school dean and, in some cases, the Dean of Research, by obtaining PI Waivers as described under PI Waiver Exception Types.

Who can submit PI waiver requests? See matrix of positions below >>.




Other Designations

Who can be Associate Investigators? The following individiuals can be "Associate Investigators" on sponsored projects: Members of the Academic Staff-Teaching (AS-T, Lecturers and Sr. Lecturers) ; Academic Staff-Research (AS-R, Research Associate); Senior Research Scientists

Who can be Co-Investigators?
Senior members of the Academic Staff-Research also may be designated by their Academic Council or MCL faculty supervisors as "Co-Investigators" on those externally-funded projects in which the senior AS-R members carry substantial roles.




Matrix: Who can submit requests for PI waivers?


 

  Type of PositionPI Waiver Exception Types*
  Eligible for a PI waiver? Expanded Career Development PI Waiver Program Career Development Clinician Educator Conferences and
Workshops
Early PI ship Inter-disciplinary Project
Faculty with acting appointments
Yes         checkbox  
Academic Staff-Research:
Research Associates
Senior Research Scientists
Senior Research Scholars
Yes   checkbox   checkbox   checkbox

Clinician Educator (CE) Faculty

Yes  

 

checkbox      
Clinician Educator (CE) Assistant Professors Yes         checkbox checkbox      
Clinical Instructors (CE)

Yes  

checkbox

       
Clinical / Medical Fellows Yes   checkbox        
Instructors
Instructors with M.D. , M.D./Ph.D., and Ph.D. degrees are eligible for the Expanded Pilot Career Development PI waiver program

Yes checkbox checkbox        
Postdoctoral Fellows
PI waivers not needed for Fellowships; but for Fellowships which are mentored career development grants.

Postdocs with M.D., M.D./Ph.D. and Ph.D. degrees are eligible for the Expanded PI Career Development waiver program.
Yes checkbox checkbox   checkbox   checkbox







































 

 

 

 

 

*See the Rare Exception PI waiver category for those that do not flt within eligibility referenced above.




A.  PI waiver exception types: Descriptions, criteria and *new * PI waiver templates




These PI waivers are subject to the approval of the Department Chair and School
of Medicine Associate Dean for Research.

 





1. EARLY PI-SHIP pi waiver


 

Criteria: Your faculty appointment must be pending, you've accepted an offer letter, and the Long Form is in process. Your RPM will confirm with the Office of Academic Affairs the faculty appointment status. Based on this criteria the waiver qualifies for approval with the understanding that an award cannot be accepted until the faculty appointment is final.




 

2. Conferences/workshops pi waiver

 


Criteria: May serve as PI on externally-sponsored projects whose sole purpose is to fund short conferences, exhibits, workshops, or other public events of a character appropriate to the University.


 


3. Career development award pi waiver

 

 


Criteria:

Why is this Career Development PI waiver necessary?

University policy for conducting research is established by the Research Policy Handbook. PI eligibility is limited faculty (see RPH 2.1 webpage >>.   Academic Staff positions (Postdocs, Instructors, and other research positions) can request a PI waiver under specific exceptions also outlined in the policy. One of those exceptions includes a PI waiver for “career development” type of grants.


Who needs a Career Development PI waiver?

Awards whose stated purpose is to advance the individual's scientific career. The project must be carried out under the mentorship of an established faculty investigator who is named in the proposal, and must be conducted within the overall intellectual scope and laboratory space of the faculty advisor [School of Medicine]. (Note: a photocopy of the eligiblity requirements of the non-governmental sponsor's RFP must be attached to the PI Waiver Memo to confirm that the funding opportunity is indeed a career development award.) If an external mentored career development grant requires a letter of intent, pre-proposal or preliminary proposal, you must obtain approval for your Career Development PI waiver through your RPM prior to submitting your letter of intent, pre-proposal, or preliminary proposal.




4. part of large interdisciplinary project pi waiver



Criteria:

Projects within the scope of a large interdisciplinary program defined as:

  • is directed by a member of the Academic Council
  • has an expected duration beyond the involvement of any individual faculty  participant
  • has more than one faculty member involved, and
  • requires expertise in more than one discipline or technical area.


All of the following conditions must be met in order for the department chair and school dean to approve PI exceptions in cases:

  • The proposed project must be a demonstrably important component of the success of the overall interdisciplinary program, as defined above
  • There is no member of the Academic Council associated with the large interdisciplinary project who is qualified to take responsibility for the scientific direction of the prospective research project
  • No incremental space will be required for the project
  • For each graduate student participating on the project, an Academic Council member has been identified to serve as research advisor to assure that the student's research program and the education derived from it are consistent with the degree for which the student is a candidate
  • Exceptions approved under this provision will be reported to the Dean of Research on an annual basis.

 



B. Rare exception pi waiver



Criteria:  
 All other situations not listed above.  These are subject to the Approval of the Department Chair, School Dean, and University Dean of Research Office. Please see the Research Policy Handbook PI Eligibility and Criteria for Exceptions in the DoResearch RPH 2.1 webpage >>.  Waivers requiring University approval may be approved at the discretion of the Dean of Research in unusual and non-recurring situations that meet a particular need or opportunity for the University.  Waivers under these situations, however, will rarely be granted.




 



C. clinician educator (ce) faculty pi waiver




When do CE faculty need to request a CE Faculty PI waiver?

CE faculty must submit a CE Faculty PI Waiver request to obtain approval to be a PI or Co-PI for each external sponsored project/research grant they submit. CE faculty PI waivers are not needed for internal funding opportunities.
Note: CE assistant professors may also submit Career Development PI Waivers requests for mentored career development awards (see above).


Description and Criteria

Eligibility:

Primary Criteria:
All Clinician Educator (CE) Faculty at the rank of clinical assistant professor and above who are full-time Stanford employees with 100% CE faculty appointments are eligible to request CE Faculty PI waivers (Clinical Instructors are not eligible for CE Faculty PI waivers). Research must conform to the NIH definition of Clinical Research (see below) and cannot involve/require "bench/lab-based" activities conducted by or resources required specifically for the CE requesting the waiver. 

Exceptions evaluated on a case-by-case basis:

Note: CEs with PI waivers do not have the authority to be the primary mentor of graduate students. They can be a primary mentor of MD postdoctoral trainees engaged in clinical trials, clinical database reviews or other forms of clinical research that directly and primarily focuses on patients in the Standard Medicine healthcare system.

 

Eligible Studies:

Clinical Research and Teaching Studies  
(clarification* added 02/26/2016)
Clinician Educator (CE) Faculty at the rank of clinical assistant professor and above may request a PI waiver to serve as a Principal Investigator (PI) for clinical studies. These clinical studies may involve diagnosis, treatment, or rehabilitation of patients as well as population studies, innovative systems of care, novel methods of clinical teaching*, and other forms of clinical research. The primary criteria for evaluating clinical research will be the NIH clinical research definition (see below). Studies cannot involve/require "bench/lab-based" activities conducted by the CE PI nor require lab-based resources specifically for the CE requesting the waiver.



Clinical Research
is defined by the NIH as research with human subjects that is:


1. Patient-oriented research. Research conducted with human subjects (or on material of human origin such as tissues, specimens, and cognitive phenomena) for which an investigator (or colleague) directly interacts with human subjects. Excluded from this definition are in vitro studies that utilize human tissues that cannot be linked to a living individual. It includes: mechanisms of human disease, therapeutic interventions, clinical trial, or development of new technologies
2. Epidemiological and behavioral studies
3. Outcomes research and health services research
Note: The NIH exclusion of studies falling under 45 CFR 46.101(b) (4) (Exemption 4) is not applicable for the CE waiver criteria.


Exceptions:

Some forms of “clinical research” studies are not permitted under this waiver. Examples of research that do not meet the PI waiver criteria include laboratory-based research requiring the PI to conduct or use research laboratory space (even if it is available to the department or on loan from a faculty member with PI status). However, CEs may wish to pursue lab based components of their studies through a collaboration with a faculty member who has a research laboratory and may request a waiver to be a Co-PI under such circumstances.

 

CE Faculty PI Waiver Instructions and Memo/Template

 
Download template:
CE Faculty PI Waiver Request Template*   Word doc


*Unless otherwise instructed, send your PI waiver request packet directly to your Department/Division's Research Process Manager (RPM) or Clinical Trial Research Process Manager (CTRPM):

[The Director of RMG, Kathleen Thompson, will review and forward to Dr. Harry Greenberg, Associate Dean for Research, for his review and approval.]

A copy of the waiver request will be kept in RMG.


     

D. expanded career development pi waiver


 


Purpose

On April 26, 2018, the University Faculty Senate approved the continuation of the Expanded Career Development PI Waiver Program for the individuals in the following School of Medicine positions who meet the eligibility and consideration criteria to request approval to be the PI for an R01- or R21- type federal or non-federal research grant (see types of grants and minimum dollar threshold below). Individuals in other schools are not eligible for this waiver program.

This ONE-TIME ONLY opportunity is restricted to only one grant application and its allowable resubmissions,
with no possibility of additional applications or resubmissions beyond those allowable for the specific grant application.

 


Types of Grants and Minimum Dollar Threshold

A R01-type or a R21-type grant: is an extramural independent research grant that is either a federal or non-federal [i.e., foundation or association] that provides at least $125,000 in direct costs per year for at least two years.  Note: it is expected that the funding provided is not intended to primarily support the PI's salary but includes support for research expenses related to the research scope of work.

Eligibility Criteria

 


Expanded Career Development PI waiver request deadlines, instructions and memo/template



Please send your Expanded Career Development PI waiver request packet
to Chelsey Perry, Funding Opportunities Manager in the Research Management Group (RMG), chelseyp@stanford.edu, and not to your RPM.  Chelsey will distribute your packet to a special review committee.

Reminder: this particular waiver request is for individuals in one of the above two positions in the School of Medicine-Postdoctoral Fellows with M.D. or M.D./Ph.D. and Ph.D. degrees and Instructors with M.D., M.D./Ph.D., and Ph.D. degree (who meet the consideration criteria) to obtain approval on a one-time basis to be the PI for an R01- or R21-type research grant application (that otherwise only faculty with PI eligibility could apply for).

(Please note: this is separate from the routine
Career Development PI waiver request that is needed for each mentored caree development award and is submitted through your RPM.)



Required Steps

Step #1.  The Primary Mentor should discuss the candidate and the waiver with his/her department chair.


Step #2 If the department chair approves proceeding with the waiver request, then the primary mentor should call Dr. Harry Greenberg, the Associate Dean for Research, (and not Dr. Mark Cullen) to discuss the potential candidate after s/he has obtained support from the Department Chair.


Step #3.  Determine the waiver request deadline:

Remaining 2019 deadlines*:   June 25,  July 23,  Aug. 20,  Sept. 17,  Oct. 22,  Nov. 19,  Dec. 10



Step #4: Prepare and submit the waiver request packet:


Please send ONE PDF file containing the following
[(4.1) completed/signed cover sheet, (4.2) PI waiver template from mentor/division chief/dept. chair, (4.3) description of the research project, (4.4) applicant's biosketch] in the order listed below via email attachment to:

Chelsey Perry
Funding Opportunities Manager
Research Management Group (RMG)
chelseyp@stanford.edu

(*Please send your waiver request packet to Chelsey and not to your RPM.)


4.1. Download, complete and sign the required Waiver Cover Form

Download, complete, and obtain all of the necessary signatures** on the required waiver packet cover form.
Download Fillable waiver cover form PDF File  PDF file



**The Expanded Career Development PI Waiver Request Cover Sheet form must be completed and signed by:


4.2. Memo prepared by your mentor and co-signed by your mentor, your division chief and your department chair.

Download the Expanded Career Development PI waiver memo/template
   Word doc


4.3.  2 page description of your research project-include project title, and bold headings (i.e., goal, aims, etc.) and references


4. 4. Applicant's biosketch


Selection process:

The proposals will be distributed to an internal School of Medicine review committee. That committee will decided whether an applicant may receive approval for their PI waiver and the OK to proceed with their one-time R01-type application for their proposed research.

After the internal review committee and Dr. Harry Greenberg, the Associate Dean for Research, have completed their reviews, Chelsey Perry will subsequently distribute copies of the Expanded Career Development PI Waiver request forms to each faculty mentor indicating whether or not the request was approved.

Copies of the approved waiver letters will be maintained in RMG.


 

 




   top  Top

Footer Links: