Stanford School of Medicine
Research Management Group (RMG)

Principal Investigator (PI) Waivers

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> Early PIship
 
> Conferences, Exhibits, Workshops or Public Events
 
> Career Development Award
 
> Specific Projects which are Part of Large Interdisciplinary Programs
   
> Clinician Educator waiver to serve as Principal Investigator
 
> Rare Exceptions
   
> PI Waiver Request Memo Guidelines-Clinician Educator
 
> PI Waiver Request Memo Guidelines -Career Development, Conferences/Workshops, Early PI Ship, Interdisciplinary Projects

Stanford PI Waiver Policy Guidelines

Research Policy Handbook
http://www.stanford.edu/dept/DoR/rph/2-4.html

Establishes the policy that principal investigatorship or co-principal investigatorship on externally-funded projects is limited to

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.

Associate Investigators

Members of the Academic Staff-Teaching (AS-T, Lecturers and Sr. Lecturers) and Academic Staff-Research (AS-R, Research Associates and Sr. Research Scientists, Sr. Research Engineers, and Sr. Research Scholars) are eligible to act as "Associate Investigators" on sponsored projects.

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.

Principal Investigator (PI) or Co-Principal Investigator
The designation of "PI" or "Co-PI" for a 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, as described below.

Those in "Instructor" positions are eligible to request a PI waiver under the Career Development Award only. Exception: Instructors with an active NIH K-Award can request a one time PI waiver for a research award.

Please note:
Clinician Educator Line instructors are not eligible for PI waivers.
Clinician Educator Line faculty are not eligible for PI waivers for sponsored projects except for specific situations outlined below.

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Exceptions Subject to the Approval of the Department Chair and School Dean

  1. EARLY PI-SHIP Faculty appointment must be pending. Long form must be submitted and accepted by the School of Medicine Dean's Office. 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.

  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. )

  4. PART OF LARGE INTERDISCIPLINARY PROJECT 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.

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Clinician Educator Waiver to serve as Principal Investigator 

Criteria

  1. Must hold rank of Clinical Assistant Professor, Clinical Associate Professor, or Clinical Professor. (Clinical Instructors are not eligible.)

  2. Eligible to be PI only for studies that are industry sponsored clinical trials.

  3. Studies must be multi-center/multi-site.  Stanford must be one of at least two sites, and the “Stanford” site is defined as and includes the VA/PAIRE, LPCH, SHC, and their affiliated institutions.

  4. The Clinician Educator may not be the overall multi-center trial director.

  5. No minimum time in rank is required.

  6. The waiver request from the Department Chair must state that the CE will have protected time available to conduct the prospective research study and that the Department Chair confirms the competency of the CE to serve as PI.

  7. This policy will be effective starting April 21, 2008 and forward.

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PI Waiver Request Memo Guidelines
for Clinician Educator

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

Kathleen Thompson, the Director of RMG, and Debbie Leong-Childs, the Associate Director for Clinical Research Administration, will review and forward the memo to Dr. Harry Greenberg and Dr. David Stevenson
for their approval.

Use these guidelines only for the Clinician Educator PI Waiver Request.
 
(
See the separate PI Waiver Memo Guidelines for Career Development Awards, Conferences/workshops, Early PI ship, Interdisciplinary projects.)

The Clinician Eductor PI Waiver memo* should include the following:

  1. Request for a PI Waiver on a specific industry-sponsored clinical trial 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 of Research and Dr. David Stevenson, Vice Dean and Senior Associate Dean for Academic Affairs.  Note: Although the memo is addressed to Drs. Greenberg and Stevenson, do not deliver it directly to them.  It must be delivered instead to your Clinical Trial RPM.
  3. Add signature lines to the document to allow Dr. David Stevenson and Dr. Harry Greenberg to provide their approval. 
  4. Include the name of the PI, degrees, appointment, term of appointment, and length in the appointment.
  5. Include the title of the study.
  6. Include the name of the sponsor.
  7. Attach a copy of your CV.
  8. Specify the type of waiver requested, i.e., CE waiver for industry-sponsored clinical trial.
  9. Discuss the exception criteria listed above with regard to the CE and the study.

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


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Exceptions Subject to the Approval of the Department Chair, School Dean, and University Dean of Research Office

Rare Exceptions
All other situations not listed above.  Please see the Research Policy Handbook.  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.

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PI Waiver Request Memo Guidelines for
Career Development, Conferences/Workshops,
Early PI Ship, Interdisciplinary Project


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: 

  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 of 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
  4. The type of the waiver (Early PIship, Conference/workshop, Career Development Award, Part of a Large Interdisciplinary Project)
  5. The specific request should address the exception criteria for each PI Waiver type
  6. The name and type of proposal
  7. The sponsor
  8. 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.





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