On This Page
- Who has PI eligibility?
- Obtaining PI waivers for those who do not have PI eligibility
- Other designations:
Associate and Co-Investigators - Who can submit PI waivers? (Matrix)
- PI Waiver Exception Types: Descriptions and Criteria
- Early PIship
- Conferences and Workshops
- Career Development Award
- Part of Large Interdisciplinary Project
- Rare Exceptions
- Clinician Educator (faculty)
- Expanded Pilot PI Waiver
- PI Waiver Request Memo Guidelines and Templates
Special Announcement
Clinician Educator (Faculty)
Multi-site Clinical Trial CE PI waiver >>
Practice of Medicine CE PI waiver >>
Who has Principal Investigatorship (PI) Eligibility?
Principal Investigatorship (PI) Eligibility and Criteria for Exceptions (Research Policy Handbook RPH 2.4>>)
Per this policy, eligibility to act as a principal investigator (PI) or co-principal investigator (Co-PI) on externally-funded projects is a privilege limited to members of the Academic Council and to the MCL faculty. 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. See the table below for position types and whether or not they can submit PI waiver requests.
Who can submit PI waiver requests?
-See matrix 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 Position | PI Waiver Exception Types* | ||||||
|---|---|---|---|---|---|---|---|
| Eligible for a PI waiver? | Pilot PI Waiver Program | Career Development | Clinician Educator | Conferences and Workshops |
Early PI ship | Inter-disciplinary Project | |
| Faculty with acting appointments |
Yes |  |
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| Clinical Educator Line Faculty There are two CE PI waiver categories: -Multi-site Clinical Trial CE PI waiver -Practice of Medicine CE PI waiver |
Yes | |
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| Clinical Instructors (Per Stanford PIship policy, Clinical Instructors cannot be PIs for external sponsored projects) |
No | ||||||
| Clinical / medical fellows | Yes | |
|
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| Instructors (Only Instructors with M.D. or M.D. / Ph.D. degrees are eligible for the Pilot PI waiver program) |
Yes | |
|
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| Postdoctoral Fellows (PI waivers not needed for Fellowships; but for Fellowships which are career development grants. Only Postdocs with M.D. and M.D. / Ph.D. degrees are eligible for the Pilot PI waiver program) |
Yes | |
|
|
|
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| Academic Staff-Research: Research Associate; Senior Research Scientists; Senior Research Scholars |
Yes | |
|
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*See the Rare Exception PI waiver category for those that do not fll within eligibility referenced above.
A. Exceptions Subject to the Approval of the Department Chair and School
Early pi-ship pi waiver
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.
See the PI waiver Memo guideline checklists and templates below>>
conference/workshop pi waiver
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.
PI waiver Memo guideline checklists and templates below>>
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.
)
4. PART OF LARGE INTERDISCIPLINARY PROJECT
large interdisciplinary project pi waiver
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 Exceptions Subject to the Approval of the Department Chair, School
Dean, and University Dean of Research Office
rare exception PI waiver
All other situations not listed above. Please
see the Research Policy Handbook PI Wiaver Guidelines (RPH 2.4). 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 (Faculty) Waivers to serve as Principal Investigator
MULTI-SITE CLINICAL TRIAL CE PI waiver
C.1 Multi-Site Clinical Trial Clinician Educator
( Faculty) Waiver to serve as Principal Investigator:
Criteria:
- Must hold rank of Clinical Assistant Professor, Clinical Associate Professor, or Clinical Professor.
- Clinical Instructors are not eligible.
- Eligible to be PI only for studies that are multi-site clinical trials.
- 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.
- The Clinician Educator may not be the overall multi-center trial director.
- No minimum time in rank is required.
- 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.
PRACTICE OF MEDICINE CE PI waiver
C.2 Practice of Medicine Clinician Educator (Faculty) Waiver to serve as Principal Investigator:
- Must hold rank of Clinical Assistant Professor, Clinical Associate Professor, or Clinical Professor.
- Clinical Instructors are not eligible.
- The study must directly benefit the CE's patients and improve CE's ability to practice optimal medicine. For details on the types of research studies permitted, see CE PI Waiver Rationale, Criteria and Process Document above.
- The study must be exclusively or very highly focused on the patient populations served by CEs practicing at SHC, LPCH, PAVA, SCVMC, and affiliated medical centers.
- The waiver request must include a statement confirming the Department Chair approves that the CE will take appropriate time away from primary clinical care and educational responsibilities to conduct the prospective research study and that the PI will have access to resources necessary to accomplish the research
IMPORTANT:
#1: Please download and read this document for detailed eligiblity criteria:
CE PI Waiver Rationale, Criteria and Process Document download PDF file >>) (Revised 04/27/12)
#2. Please see the Comparison of CE PI Waiver Chart below >>#3: Please see the revised CE PI Waiver Practice of Medicine Checklist and the new CE PI Practice of Medicine PI Waiver Summary Form below >>
Criteria:
C3. Comparison of Clinical Educator PI waivers
Comparison of Clinical Educator PI Waivers
Assistant, Associate or Professor (Instructors are not eligible)Multi-Site Waiver Practice of Medicine Waiver Protocol Provided by industry sponsor Written by PI or other Other sites Stanford at least 1 of 2 sites; Stanford=VA, LPCH, SHC, affiliated medical centers Highly focused on Stanford, VA, LPCH and affiliated medical centers Topic Industry sponsored clinical trial of drug, device, diagnostic Focused on the local practice of medicine and its improvement Patients/ subjects No guidelines or restrictions on subjects Exclusively highly focused on patients within Stanford, VA, LPCH, affiliated medical centers including PI's practice Funding Industry Any source F&A Rate 28% generally Varies by location and funding source Other Information CE cannot be over-all multi-site study PI Call your Research Process Manager (RPM) in RMG for further information more >>
D. Expanded Pilot PI waiver option for:
Clinical Fellows,
Instructors with M.D. or M.D./Ph.D. Degrees,
Postdoctoral Scholars with M.D. or M.D./Ph.D. Degrees
PILOT pi waiver
Background
On Dec. 2, 2010, the Faculty Senate approved a proposal that allows Clinical Fellows and M.D. Postdoctoral Scholars with two or more years of research training to request a PI waiver that allows him/her to serve as PI on an extramural independent RO1-type grant** on a one-time basis without the possibility of renewal (unless the trainee is appointed to the Stanford faculty). (Instructors with M.D. or M.D./Ph.D degrees have subsequently been added to the eligibility.) Stanford report article>>
**What is an R01-type grant?
It is 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.
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. Only 10 waivers per year will be allowed during this 4-year evaluation period. The Faculty Senate approval includes a 4-year evaluation process that will be monitored by the Committee on Research (C-Res) and the Dean of Research. The Faculty Senate will then consider the possibility of an extension, termination, or permanent incorporation into Stanford policy (Research Policy Handbook, RPH 2.4) at the end of the evaluation period. For more information, see >>
Consideration (eligibility) Criteria
Faculty mentors may request a PI waiver for Instructors with M.D. or M.D./Ph.D.s, Clinical Fellows and Postdoctoral Scholars with M.D. or an M.D. plus an advanced degree (i.e., M.D./Ph.D.) who meet the following criteria to serve as PI on an extramural independent RO1-type grant on a one-time basis without the possibility of renewal.
- Only Instructors with an M.D. or M.D./Ph.D., Clinical Fellows and Postdoctoral Scholars who hold an M.D or an M.D. plus some other advanced degree (i.e., M.D./Ph.D.) are eligible. Clinical Instructors and Research Associates are not eligible.
- 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 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 postdoctoral trainee 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 Postdoc 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 prepare the Pilot PI waiver memo guidelines? see below>>)
Why are only postdoctoral fellows, clinical fellows and Instructors with M.D. or M.D./Ph.D degrees eligible? Why are individuals with Ph.D.s not eligible for this Pilot PI waiver program?
"To help the career development of physician-scientists-in-training – MDs who plan careers conducting research and treating patients – the Faculty Senate last week approved a trial plan to allow them to serve as the lead scientists on federal grants.""He [Dr. Harry Greenberg] said physician-scientists who join the faculty of clinical departments in medical schools have two primary ways to earn money – clinical care and grants. Early in their careers, if they do not have independent grant support, they face tremendous economic pressure to shift more and more of their attention to patient care and away from research, due to financial constraints. 'This plan would permit people to have protected time from the beginning to get their research going and to protect them from having to do that clinical work right at the get-go,' Greenberg said." See Stanford report article>> *.
(*note: Instructors with M.D. and M.D./Ph.D. degrees, not mentioned in this original article, were subsequently made eligible for this Pilot PI waiver program.)
| PI Waiver Request Memo Guidelines for Clinical Educator (Faculty) |
|---|
| IMPORTANT: Please read the CE PI waiver categories' eligibility criteria and descriptions above >> before proceeding. Send your PI Waiver Memo directly to your Research Process Manager (RPM) or your Clinical Trial Research Process Manager (CT 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. Please allow sufficient time for both of the Senior Associate Deans to review your waiver request (3-5 days).
|
| PI Waiver Guidelines and Checklists for Career Development, Early PI ship, Conferences and Workshops, Interdisciplinary Projects and Rare Exception | |||||
|---|---|---|---|---|---|
Send your PI Waiver Memo directly to your Research Process Manager (RPM) in
the Research Management Group (RMG).
The PI Waiver memo* should include the following: Attachments to the PI Waiver Memo for Career Development Awards: Senior Research Associates/Scientists; Post-Docs
|
| Pilot PI Waiver Request Memo Guidelines for Clinical Fellows Postdoctoral Fellows (with M.D., M.D./Ph.D. degrees) Instructors (with M.D. or M.D./ Ph.D degrees) |
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