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 Pilot PI waivers, etc.), and the procedures and checklists for preparing PI waiver memo requests. For questions, please contact your Research Process Manager (RPM) more >>

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



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 with the exception that 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

Clinical Educator (CE) Faculty

Yes  

 

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

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


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 submit and receive approval for your Career Development PI waiver through your RPM prior to submitting your letter of intent, pre-proposal, or preliminary proposal.

Reminder:
the Career Development PI waiver is the routine waiver you request for each mentored career development award you wish to apply for. This is separate from the one-time only Expanded Pilot Career Development PI waiver request (see below >>).




4.   PART OF LARGE INTERDISCIPLINARY PROJECT

 




B.    RARE EXCEPTIONS:




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 new 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

May 6, 2013: Memo from Dr. Lloyd Minor, Dean of the School of Medicine, regarding Clinician Educator (CE) Faculty PI waiver changes. Download PDF file PDF file

When do CE faculty need to request a CE Faculty PI waiver?
Updated 10/04/13: CE faculty*: you must submit a request memo for a CE Faculty PI Waiver for each internal Stanford funding opportunity AND each external sponsored project/research grant you submit.
See memo guidelines below >>


Description and Criteria

*Eligibility: all Clinician Educator (CE) Faculty at the rank of clinical assistant professor and above.
Clinical Instructors are not eligible.

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.

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 most forms of clinical research studies that include a significant component of patients and/or communities served by Stanford Hospital and Clinics, the Lucile Packard Children’s Hospital, the Palo Alto Veterans Administration Health Care System, the Santa Clara Valley Medical Center as well as the Stanford affiliated medical centers. 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.

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 trials
        • development of new technologies
    2. Epidemiological and behavioral studies
    3. Outcomes research and health services research

Included in this waiver category, as mentioned above, are clinical trials. Clinician Educator (CE) Faculty may request a waiver to serve as a Principal Investigator (PI) for any clinical trials that include participants at the Stanford Hospital & Clinics, the Lucile Packard Children’s Hospital, the Palo Alto Veterans Administration Healthcare System, the Santa Clara Valley Medical Center and/or Stanford affiliated medical centers, whether as an individual PI or as an  overall PI for a multi-site study (industry-funded, NIH or other funded) or as the PI for a single-site study. A clinical trial is defined by the NIH as: “A prospective biomedical or behavioral research study of human subjects that is designed to answer specific questions about biomedical or behavioral interventions (drugs, treatments, devices, or new ways of using known drugs, treatments, or devices). Clinical trials are used to determine whether new biomedical or behavioral interventions are safe, efficacious, and effective”.   

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 use of 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.  

     

     


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

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

Waiver request submission deadlines and instructions
Waivers requests must be submitted per these waiver request instructions >>
by these remaining 2015 deadlines: June 1, August 3, October 1, December 1

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.


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). 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. degrees and 10 waivers per year for individuals with Ph.D. degrees


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.

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 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: Department/Division assignments can be found on this webpage >>

Submit the waiver request to your RPM or CTRPM. 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. 10/04/13)   checkbox


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

* Attachment to the CE PI Waiver Memo:
--Abstract
--Biosketch
--a copy of the external sponsor's program announcement and a copy of the internal Stanford funding opportunity announcement (if applicable)


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.)

    1. The Primary Mentor should discuss the candidate and the waiver with his/her department chair. If the department chair approves proceeding with the waiver request, then the primary mentor should contact Dr. Harry Greenberg, the Senior Associate Dean for Research, at harry.greenberg@stanford.edu to discuss the potential candidate after s/he has obtained support from the Department Chair.

    2. Determine the internal deadline
    Waivers requests must be submitted per these instructions >> by the following deadlines. Applicants should select the deadline that will allow at least 6 weeks prior to the sponsor's deadline.

    • Remaining deadlines 2015:   June 1, August 3, October 1, December 1
      Note: Exceptions to these deadlines can be made.

    Jeanne Heschele in RMG will distribute reminder announcements prior to each deadline. For questions about this program, contact Jeanne at jheschele@stanford.edu.



    3. REQUIRED WAIVER COVER SHEET
    Download this fillable PDF form. This is the required cover sheet for your waiver request packet**

    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*

    *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.

    4. ADDITIONAL DOCUMENTATION
    In addition to the cover sheet, please attach the appropriate documentation to the cover sheet which includes:


    • Memo prepared by your mentor and co-signed your division chief or 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.confirm that if awarded the R01-type grant.

    • 1-page description of research project

    • Applicant's biosketch


    5. WAIVER SUBMISSION
    By the above internal deadline, please submit the completed pilot PI waiver request form and documentation (memo, research project description, applicant biosketch) in one PDF file via email attached to:

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


    6. 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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