Research Management Group– (RMG)

Stanford PI Eligibility and Waiver Policy Guidelines

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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 Pilot PI waivers, etc.), and the procedures and checklists for preparing PI waiver memo requests.

For questions, please contact your Research Process Manager (RPM) in RMG. (RPM department assignment webpage >>).

For links to the PI waiver exception types and the Matrix of positions see the "On this Page" navigation box to the right.


What's new
Revised Clinician Educator (CE) faculty PI waiver criteria and checklist
more >>



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 exception* 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.

*Note: internal funding opportunities:
These PI eligibility and PI waiver policies only apply to externally sponsored projects. Exception: CE Faculty must request a CE Faculty PI waiver for each internal Stanford funding opportunity and each external sponsored project. See the CE Faculty PI waiver criteria section below >>.



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 Pilot 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 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 Pilot PI Career Development waiver program.		 Yes checkbox checkbox   checkbox   checkbox







































 

 

 

 

 

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




A.   PI Waiver Exception Types: Descriptions and Criteria

These PI waivers are subject to the approval of the Department Chair and School.

 


1.   EARLY PI-SHIP

UPDATE: Your faculty appointment must be pending, you accepted your offer letter, and your Long Form is in process. Your RPM will confirm with Rebecca Robinson in Academic Affairs, regarding the appointment status. An award cannot be accepted until the faculty appointment has been confirmed.
See the PI waiver Memo guideline checklists and templates below>>

 

2.  CONFERENCES/WORKSHOPS


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


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

 




B.    RARE EXCEPTIONS:



C.   CLINICIAN EDUCATOR (CE) FACULTY PI WAIVER



When do CE faculty need to request a CE Faculty PI waiver?
CE faculty (see eligibility below) must submit a CE Faculty PI Waiver request for each internal Stanford funding opportunity AND each external sponsored project/research grant you submit. CE PI waiver criteria apply equally to both externally and internally funded clinical research proposals.

Note: CE assistant professors may also submit Career Development PI Waivers requests for mentored career development awards (see above).


Description and Criteria (updated 09/23/2015)

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. 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.

Clinical Instructors in the Clinician Educator (CE) line are not eligible for CE Faculty PI waivers.

Exceptions for family care and other personal responsibilities will be evaluated on a case-by-case basis.

Exceptions for hospital nurses with CE appointments of less than 100% will be evaluated on a case-by-case basis assuming there is a relevant School of Medicine department that is supportive of the appointment

CEs who hold part-time jobs with for-profit or not-for-profit institutions, and CEs who have part-time positions because Stanford does not have a 100% position available are only eligible for waivers involving being PI's on clinical trials that take place at Stanford or Stanford affiliated institutions, and then only if they can adequately fulfill the human subject research responsibilities of the clinical trial within the context of a part-time appointment.

CE appointments with non-MD degrees must be engaged in full-time clinical care related activities in order to be eligible for a PI waiver consideration. Such situations will be evaluated on a case-by-case basis by the Senior Associate Dean for Academic Affairs and the Senior Associate Dean for Research for the School of Medicine with final approval from the University Vice Provost and Dean of Research.

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 Studies - 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 research studies that meet 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.

 

Waiver Request: 
A waiver request from the Department Chair and Division Chief (if applicable) must confirm the competency of the CE to serve as PI.  The request must also state that the CE will have sufficient protected time available to conduct the proposed research study and will have access to resources necessary to accomplish the research.

See the revised CE Faculty PI Waiver Checklist below >> for additional information that should be included in the waiver request.
 

     

     


D.   EXPANDED PILOT CAREER DEVELOPMENT PI WAIVER (formerly entitled, "Expanded Pilot PI Waiver")

Eligible positions:

  • Clinical Fellows with M.D. or M.D./Ph.D. degrees

  • Instructors with M.D., M.D./Ph.D., and Ph.D. degrees

  • Postdoctoral Scholars with M.D. or M.D./Ph.D. and Ph.D. degrees

Positions that are NOT eligible for this type of waiver:
Clinical Instructors, basic research scientist, and research associates

Eligibility/consideration criteria see below>>

Waiver request submission deadlines
Remaining 2015 deadlines**:  October 1, December 1
2016 deadlines**: Feb. 1, April 1, June 1, August 1, Oct. 3, December 1
**Note: exceptions to these deadlines can be made
Applicants should select the deadline that will allow at least 6 weeks prior to the sponsor's deadline.
Jeanne Heschele in RMG will distribute reminder announcements prior to each deadline.
For questions about this program, contact Jeanne at jheschele@stanford.edu

 Waivers request packet instructions: see below>>

Purpose

After an initial four-year evaluation period, the University Faculty Senate approved a continuation of the Expanded Pilot Career Development PI Waiver Program for the individuals in the following positions who meet the eligibility and consideration criteria. The Faculty Senate also approved an expansion of the criteria to include individuals with Ph.D. degrees: Clinical Fellows with M.D. or M.D./Ph.D. degrees; Instructors with M.D., M.D./Ph.D., and Ph.D. degrees; Postdoctoral Scholars with M.D. or M.D./Ph.D. and Ph.D. degrees

This program permits individuals in the above positions with two or more years of research training to request a PI waiver that allows him/her to serve as a PI on an extramural independent R01-type (or R21-type) federal and non-federal/ foundation/association grant (see clarification below)** on a one-time basis without the possibility of renewal (unless the trainee is appointed to the Stanford faculty).

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] provides at least $125,000 in direct costs per year for at least two years.
Note: it is expected that the funding should not cover mostly the PI's salary.

This one-time 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. 

The University Faculty Senate has also approved the number of waivers permitted per year:10 waivers per year for individuals with M.D. and M.D./Ph.D. degree and 10 waivers per year for individuals with Ph.D. degrees

Eligibility/ Consideration Criteria [revised April 2014]

A faculty mentor may request a PI waiver for an Instructor with M.D. or M.D./Ph.D. and Ph.D., a Postdoctoral Scholar with M.D. or an M.D, and Ph.D. or a Clinical Fellow with an M.D., or M.D./Ph.D., who meets the following criteria to serve as PI on an extramural independent RO1-type or R21-type grant [see clarification above >>] on a one-time basis without the possibility of renewal.

These positions are eligible:
Instructors with an M.D. or M.D./Ph.D. and Ph.D. degree; Postdoctoral Scholars who hold an M.D or an M.D. plus some other advanced degree (i.e., M.D./Ph.D) or a Ph.D. degree and Clinical Fellows with M.D. or M.D./Ph.D. degrees

Positions that are NOT eligible:
individuals in Clinical Instructors, basic research scientist, research associate positions are not eligible to request this type of waiver.

Candidates must have two or more years of research training

In addition, applicants should have a research record (publications and prior research training) that is consistent with their having a reasonable chance of success on the grant application in order to receive this specific PI career development waiver opportunity.

Written approval with signatures of the faculty advisor and department chair/ institute or center director are required to document that the individual will be assigned the appropriate space and other resources necessary to support the work described in the grant application for the duration of the grant period, should it be awarded.

Signature of the PI waiver candidate is required to document that s/he understands the terms of the waiver, including that there is no possibility of renewal if awarded, and no possibility of subsequent submissions (beyond those allowable for the specific grant application) should the application be unsuccessful.

If the Postdoctoral scholar is successful in receiving an award, the department must appoint him/her as an Instructor.

In addition, the School will not permit graduate students to be supported on any grant awarded under this PI career development waiver exception. It may be, however, that the grant will have funding to appoint a postdoctoral fellow. If so, the PI would be responsible for the day-to-day research supervision of the work of the postdoc. However, the overall career mentoring of the postdoc would be the responsibility of an Academic Council or Medical Center Line faculty member.




How do I submit a PI Waiver Memo Request? Memo Guidelines and Checklists


The PI Waiver memo guidelines are arranged according to the types of PI waivers:

 

 

PI Waiver Request Memo Guidelines for:

Clinician Educator (CE) Faculty (at the level of Assistant Professor and above)


Please read the Clinician Educator (CE) Faculty PI waiver description and eligibility criteria above >> before proceeding.

Send your PI waiver request packet [containing your waiver memo, abstract, your biosketch, and the copy of the funding opportunity announcement (internal or external)] directly to your Department/Division's Research Process Manager (RPM) or Clinical Trial Research Process Manager (CTRPM):

  • For clinical trials contact your Clinical Trial RPM

  • For all other clinical research proposals contact your RPM
    Note: RPM Department/Division assignments can be found on this webpage >>

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


CE Faculty PI Waiver Checklist (rev. 09/24/15)   checkbox



WAIVER REQUEST PACKET INSTRUCTIONS:


The PI Waiver request memo* should include the following:


1. Request for a PI Waiver on a specific proposal must be written on departmental letterhead and signed by your Division Chief and your Department Chair.

2. Address the memo to: Dr. Harry Greenberg, Senior Associate Dean for Research*. (Reminder: although the memo is addressed to Dr. Greenberg--do not deliver it directly to him. It must be delivered instead to your RPM first.)

3. Name of PI, degrees and appointment term and length

4. The type of the waiver (CE Faculty PI Waiver)

5. Sponsor

  • External sponsored projects: Provide the name of the sponsor for the external sponsored project.

  • Internal Stanford funding opportunity: Provide the name of the internal Stanford department program and name of the RFP.

6. Title of the proposed study

7. The memo should discuss the appropriateness of the waiver, focusing on the points specified in the PI Eligibility policy statement (context of the CE’s clinical practice and teaching responsibilities, consistency with the CE’s job description and FTE assignment for clinical duties and with department programmatic needs).

8. The memo must also confirm the competency of the CE to serve as PI. The request must also state that the CE will have sufficient protected time available to conduct the proposed research study and will have access to resources necessary to accomplish the research.

9. Provide information on patient population for the study (e.g., SHC, LPCH, PAVHC, etc.)

10. Add a signature line to the document to allow Dr. Harry Greenberg to provide his approval

* In addition to the waiver request memo, please attach:

        ––Abstract

        --your Biosketch

        --a copy of either the external sponsor's program announcement
          or a copy of the internal Stanford funding opportunity announcement


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

 

 

 

PI Waiver Request Guidelines and Checklists for:
       
       Career Development
       Early PI ship
       Conferences and Workshops
       Interdisciplinary Projects
       Rare Exception


Send your PI Waiver Memo directly to your Research Process Manager (RPM) in the  Research Management Group (RMG).

Kathleen Thompson, the Director of RMG, will review and forward the memo to Dr. Harry Greenberg for his approval. Use these guidelines only for the following PI Waiver types: 


PI Waiver Request Checklists-Download (rev. 06/21/13)

The PI Waiver request memo* should include the following:

1.  Request for a PI Waiver on a specific proposal must be written on departmental letterhead and signed by your Division Chief and your Department Chair. )

2.  Address the memo to Dr. Harry Greenberg, Senior Associate Dean for Research*. (Reminder: although the memo is addressed to Dr. Greenberg--do not deliver it directly to him. It must be delivered instead to your RPM first.)

3.  Add a signature line to the document to allow Dr. Harry Greenberg to provide his approval. 

4.  Name of PI, degrees and appointment

5.  The type of the waiver (Early PIship, Conference/workshop, Career Development Award, Part of a Large Interdisciplinary Project)

6.  For PI waivers under career development, the waiver should indicate that the project will be conducted in existing laboratory space assigned to the department; that incremental space will not be required; and approval of this PI waiver does not promise the candidate a faculty position.

7.  The specific request should address the exception criteria for each PI Waiver type

8. The name and type of proposal

9. The sponsor

Discussion of the appropriateness of the waiver, focusing on the points specified in the PI Eligibility policy statement

Attachments to the PI Waiver Memo for Career Development Awards: Senior Research Associates/Scientists; Post-Docs 

1.  A  biosketch

2.  A  photocopy of the eligibility requirements of the sponsor's RFP must be attached to the PI Waiver Memo to confirm that the funding opportunity is a career development award (note: this is not needed for government awards)
 
Copies of the approved waiver letters will be maintained in RMG.







Expanded Pilot Career Development PI Waiver Request Memo Guidelines for:
        
     Instructors with M.D., M.D./ Ph.D or Ph.D.
     Postdoctoral Fellows with M.D., M.D./Ph.D. and Ph.D.
     Clinical Fellows with M.D. and/or M.D./Ph.D.

Reminder: this pilot waiver request is for individuals in one of the above three positions in the School of Medicine (who meet the consideration criteria) to obtain approval on a one-time basis to be the PI for an R01 or R21-type grant application.

(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.)

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 Senior Associate Dean for Research, to discuss the potential candidate after s/he has obtained support from the Department Chair.

STEP #3. Determine the waiver request deadline:
Waivers requests must be submitted per the instructions below by the following deadlines. Applicants should select the deadline that will allow at least 6 weeks prior to the sponsor's deadline.

Deadlines for submitting waiver requests:
Remaining 2015 deadlines**:  October 1, December 1
2016 deadlines**: Feb. 1, April 1, June 1, August 1, Oct. 3, December 1
**Note: exceptions to these deadlines can be made

Applicants should select the deadline that will allow at least 6 weeks prior to the sponsor's deadline. Jeanne Heschele in RMG will distribute reminder announcements prior to each deadline. For questions about this program, contact Jeanne at jheschele@stanford.edu



HOW TO PREPARE AND SUBMIT THE WAIVER REQUEST PACKET

Please send ONE PDF file containing the following (completed/signed cover sheet, memo from mentor/division chief/dept. chair, research project, applicant's biosketch) in the order listed below via email attachment to:

Jeanne Heschele
Research Management Group (RMG)
Phone: 650-245-2351
Email: jheschele@stanford.edu

1. REQUIRED WAIVER COVER SHEET
Download, complete, and obtain all of the necessary signatures** on the required waiver packet cover form (this fillable PDF form).
Download Fillable Form (rev. 06/03/2014) PDF file

**The Expanded Pilot Career Development PI Waiver Request Cover Sheet form must be completed and signed by the Instructor, Clinical Fellow or Postdoctoral Fellow with M.D. or M.D. plus advanced degree (i.e., M.D./ Ph.D. degree) AND his/her mentor
AND his/her department chair.
Please include both the Sponsor Name, RFA # and RFA Title*
Leave the SPO # blank.

*Reminder: it must be for an extramural independent research grant (federal or non-federal) that provides at least $125,000 in direct costs per year for at least two years.  The funding should not cover mostly the PI's salary.


2. MEMO PREPARED BY YOUR MENTOR AND CO-SIGNED BY YOUR MENTOR, YOUR DIVISION CHIEF AND YOUR DEPARTMENT CHAIR.

  • This memo must addresses the consideration criteria >> and should include:
  • the department’s commitment to his/her career,
  • describes the applicant’s unique qualifications and why s/he is likely to receive the grant and provides additional support for the quality of the proposed science
  • include information on the location of the proposed research space, locations of other resources required for the period of this grant including equipment, research staff, etc.
  • and, if the PI is a clinical fellow or postdoctoral fellow, the memo must also indicate that the department will appoint the individual in an Instructor position if awarded the grant.

3. ONE PAGE DESCRIPTION OF YOUR RESEARCH PROJECT

4. APPLICANT'S BIOSKETCH

Selection process:
The proposals will be distributed to an internal School of Medicine review committee. Up to three candidates for each internal deadline* 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 Senior Associate Dean for Research, have completed their reviews, Jeanne Heschele will subsequently distribute copies of the Expanded Pilot 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.




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