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 checklists for preparing PI waiver memo requests.
Questions? please contact your Research Process Manager (RPM) in RMG. (RPM department assignment webpage >>).
Matrix of positions
PI Waiver Exception Types: descriptions and criteria
- Career Development Award PI waiver
- Expanded Career Development PI Waiver-this waiver is only applicable for Postdoctoral Fellows/Scholars (M.D., M.D.PhD., Ph.D.) and Instructors in the School of Medicine
- Clinician Educator (CE) Faculty PI waiver
- Conferences and Workshops PI waiver
- Early PIship PI waiver
- Part of Large Interdisciplinary Project PI waiver
- Rare Exceptions PI waiver
How to prepare PI waiver request packets
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.
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 >>.
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.
| Type of Position | PI 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 |  |
|||||
| Academic Staff-Research: Research Associates Senior Research Scientists Senior Research Scholars |
Yes | |
|
|
|||
Clinician Educator (CE) Faculty |
Yes | |
|||||
| Clinician Educator (CE) Assistant Professors | Yes | |
|
||||
| Clinical Instructors (CE) |
Yes | ||||||
| Clinical / Medical Fellows | Yes | |
|||||
| 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 | |
|
||||
| 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 | |
|
|
|
||
*See the Rare Exception PI waiver category for those that do not flt within eligibility referenced above.
These PI waivers are subject to the approval of the Department Chair and School.
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.
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.
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.
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.
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.
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:
- CEs who hold part-time jobs outside of Stanford 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.
- CEs who hold part-time position at Stanford to accommodate family care or personal responsibilities will be considered.
- For hospital nurses with CE appointments of less than 100% will be considered assuming there is a relevant School of Medicine department that is supportive of the 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 Associate Dean for Research for the School of Medicine, with final approval from the University Vice Provost and Dean of Research.
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.
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.
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 or Co-PI for an R01- or R21- type federal or non-federal research grant (see types of grants and minimum dollar threshold below):
- Postdoctoral Fellows with M.D. or M.D./Ph.D. and Ph.D. degrees
- Instructors with M.D., M.D./Ph.D., and Ph.D. degrees
The number of waivers permitted per year is limited to 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.
Positions that are NOT eligible: individuals in Clinical Educator positions and Academic staff-research positions (i.e., basic research scientist, research associate positions) are not eligible to request this type of waiver.
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.
Additional Criteria:
- 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.
- University policy does not permit graduate students to be supported on any grant awarded under this PI career development waiver exception. However, the grant may 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.
WAIVER REQUEST SUBMISSION DEADLINES
Waiver requests must be reviewed and approved by the School of Medicine Research Committee. In order to facilitate this review process, we have established internal submission deadlines for waiver requests.
NOTE: the Expanded Career Development PI waiver requests are submitted directly to Jeanne Heschele in RMG (not to the RPMs). Jeanne will distribute the waiver request packets to a review committee.
- Remaining 2018 deadlines: June 5, July 9, Aug.7, Sept. 5, Oct. 3, Nov. 6, Dec . 4
- Applicants should select one of the above deadlines that will allow at least 6 weeks prior to the sponsor's deadline. It is strongly recommended that applicants consider submitting their waiver requests as follows to optimize the time available to prepare their final proposals/applications. Please do not wait until just before the application deadline to submit a waiver request.
- June, July or August for the October standard NIH application deadlines
- October, Nov. or December for the February standard NIH application deadlines
- February, March, or April for the June standard NIH application deadlines
- Applicants should select one of the above deadlines that will allow at least 6 weeks prior to the sponsor's deadline. It is strongly recommended that applicants consider submitting their waiver requests as follows to optimize the time available to prepare their final proposals/applications. Please do not wait until just before the application deadline to submit a waiver request.
The PI Waiver request guidelines are arranged according to the types of PI waivers:
NOTE: all waiver request memos must be addressed to Dr. Harry Greenberg, Associate Dean for Research, but submitted to your Research Process Manager (RPM in RMG >>). [However, the Expanded Career Development PI waiver request packets are submitted to Jeanne Heschele at jheschele@stanford.edu because those packets are distributed to a review committee.]
Clinician educator 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 one PDF file containing your PI waiver request packet [your waiver memo, abstract, your biosketch, and the copy of the funding opportunity announcement (internal or external)] via email attachment 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, Associate Dean for Research, for his review and approval.]
WAIVER REQUEST PACKET INSTRUCTIONS:
Download:
CE Faculty PI waiver request preparation checklist
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, Associate Dean for Research*. (Reminder: although the memo is addressed to Dr. Greenberg--do not deliver it directly to him. It must be included in the PDF file of the waiver packet via email to your RPM instead.)
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.
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
Copies of the approved waiver letters will be maintained in RMG.
career development, early piship, conferences/workshops, part of a large interdisciplinary project, rare exception
Send your PI Waiver Memo directly to your Research Process Manager (RPM Dept. assignments) in the Research Management Group (RMG).
Kathleen Thompson, the Director of RMG, will review and forward the memo to Dr. Harry Greenberg, Associate Dean for Research, for his approval. Use these guidelines only for the following PI Waiver types:
PI Waiver Request Preparation Checklists-Download
- Career Development
- Conference Workshop
- Early PI ship
- PI waiver for project that is part of a large interdisciplinary program
- Rare Exception*
(*For Rare Exception PI waiver requests for Core Directors for NIH Shared Instrumentation Grants and NIH High End Instrumentation grants-see above)
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, Associate Dean for Research*. (Reminder: although the memo is addressed to Dr. Greenberg--do not deliver it directly to him. It must be sent via email attachment to your RPM.)
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.
For these School of Medicine positions only:
- Postdoctoral Fellows with M.D. or M.D./Ph.D. and Ph.D. degrees
- Instructors with M.D., M.D./Ph.D., and Ph.D. degrees
PIs and Mentors- please follow Steps #1- #4 below >>
Please send your Expanded Career Development PI waiver request packet to Jeanne Heschele at jheschele@stanford.edu and not to your RPM. Jeanne 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 (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:
- Applicants should select one of the above deadlines that will allow at least 6 weeks prior to the sponsor's deadline. It is strongly recommended that applicants consider submitting their waiver requests as follows to optimize the time available to prepare their final proposals/applications:
- June, July or August for the October standard NIH application deadlines
- October, Nov. or December for the February standard NIH application deadlines
- February, March, or April for the June standard NIH application deadlines
- Please do not wait until just before the application deadline to submit a waiver request.
- PI: Instructor, Postdoctoral Fellow/Scholar with M.D. or M.D. plus advanced degree (i.e., M.D./ Ph.D. degree), and Ph.D.
- AND his/her mentor
- AND his/her division chief (if applicable)
- AND his/her department chair.
- Please include both the Sponsor Name, and funding opportunity title and number (ie., RFA-, PA-)*. Leave the SeRA Transaction # blank.
- This memo must addresses the above 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 postdoctoral fellow/scholar, the memo must also indicate that the department will appoint the individual in an Instructor position if awarded the grant.
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 2018 deadlines: June 5, July 9, Aug.7, Sept. 5, Oct. 3, Nov. 6, Dec . 4
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) memo 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:
Jeanne Heschele*
Research Management Group (RMG)
jheschele@stanford.edu
(*Please send your waiver request packet to Jeanne 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 PDF Form
**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.
4.3. One page description of your research project
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, Jeanne Heschele 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.
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