PI Eligibility and Waiver Process

Researchers who are not members of the Academic Council or the University Medical Line faculty may be approved to serve as PIs on a class of projects generically referred to as Career Development Awards, whose stated purpose is to advance the individual's scientific career. Such petitions may be approved if the project is to be carried out under the mentorship of an established faculty investigator, who is named in the proposal, and if the project can be conducted within the overall intellectual scope and laboratory space of the faculty mentor. Typically, in these cases the awards cover only the individual's salary and incidental expenses, but not incremental staff or students. Please refer to RPH 2.1 for Stanford policy regarding PI eligibility.

Exception requests are subject to the following:

1. Written approval of the faculty supervisor (who must be a member of University Tenure Line, University Medical Line, or Nontenure Line Research professoriate), the relevant department chair, center or institute director (if no departmental resources are to be used), and the School of Medicine Dean’s Office.
2. A guarantee of space and resources for the duration of the grant by the faculty mentor or department chair.
3. The understanding that the grant may not, under any circumstances, support a graduate student.
   
4. Approval of the GME Resident / Clinical Fellow form when applicable.

If the grant proposes funding to appoint a postdoctoral scholar, the PI would be responsible for the day-to-day research supervision of the work of the postdoctoral scholar. However, the overall career mentoring of the postdoctoral scholar would be the responsibility of an Academic Council or University Medical Line faculty member.

Career Development PI Waiver Template

• Career Development PI Waiver Template - Clinical Fellows & Residents

GME Resident / Clinical Fellow Form: Download Fillable Form

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. In addition, the research must conform to the NIH definition of Clinical Research and cannot involve/require "bench/lab-based" activities conducted by or resources required specifically for the CE requesting the waiver. Please refer to RPH 2.1 for Stanford policy regarding PI eligibility.

CEs who hold part time positions at Stanford of 75% or more will be evaluated on a case by case basis.

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
CE Faculty at the rank of clinical assistant professor and above may request a PI waiver to serve as 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. 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.

CEs may apply for PI waiver for a Data Use Agreement (DUA) using the template in the section below.

Clinician Educator PI Waiver Template

Clinician Educators at the level of Clinical Professor, Clinical Associate Professor, or Clinical Assistant Professor are eligible to apply for a PI waiver for a Data Use Agreement (DUA) or Material Transfer Agreement (MTA). 

Postdocs, Academic Research Staff, Instructors, and Clinical Instructors who have obtained a PI waiver for an externally sponsored project may act as PI on a DUA/MTA that is associated with that award.  No additional waiver required. Otherwise, a faculty member will need to act as PI of the DUA or MTA.

PI Waiver Process for DUAs/MTAs:

1. Download the PI Waiver Template below entitled Clinician Educator Data Use Agreement/Material Transfer Agreement PI Waiver Template
2. Complete the PI waiver request using the template
3. Combine the waiver letter, biosketch and a description of the project, scope of work, and/or protocol that will use the data into one PDF.
4. Obtain signature of the Division Chief and Department Chair
5. Send the completed PI waiver packet to: RMG_CT_Intake@stanford.edu
   • Please enter RMGwaiver DUA/MTA at the beginning of Subject Line followed by applicant’s last name

• Clinician Educator Data Use Agreement/Material Transfer Agreement PI Waiver Template

Researchers who are not members of the Academic Council or the University Medical Line faculty may be approved to serve as PIs 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. Please refer to RPH 2.1 for Stanford policy regarding PI eligibility.

Grants to fund travel to conferences also would meet the criteria.

Conferences, Exhibits, Workshops or Public Events PI Waiver Template

Faculty whose appointment start date is in the future may apply for a waiver to submit proposals through Stanford during the interim provided the project period start date is not prior to the appointment start date, and the appointment has been approved by the Provost. In addition, an award cannot be accepted until the member’s appointment has begun. Please refer to RPH 2.1 for Stanford policy regarding PI eligibility.

Early PI ship PI Waiver Template

Researchers who are not members of the Academic Council or the University Medical Line faculty may be approved to serve as PIs on projects within the scope of a large interdisciplinary program. For this purpose a "large interdisciplinary program" is defined as a research program which: a) is directed by a member of the Academic Council or University Medical Line faculty, b) has an expected duration beyond the involvement of any individual faculty participant, c) has more than one faculty member involved, and d) requires expertise in more than one discipline or technical area. Please refer to RPH 2.1 for Stanford policy regarding PI eligibility.

All of the following conditions must be met in order for the department chair and school dean to approve PI exceptions in such cases:

1. The proposed project must be a demonstrably important component of the success of the overall interdisciplinary program, as defined above.
2. There is no member of the Academic Council or University Medical Line faculty associated with the large interdisciplinary project who is qualified to take responsibility for the scientific direction of the prospective research project.
3. No incremental space will be required for the project.
4. For each graduate student participating on the project, a qualified faculty member has been identified 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.
5. Exceptions approved under this provision will be reported to the Dean of Research on an annual basis.
   
   

• Specific Projects Which Are Part of a Large Interdiscplinary Program PI Waiver Template

In addition to the foregoing, rare exceptions to the PI eligibility policy may be made at the discretion of the Dean of Research in unusual and non-recurring situations that meet a particular need or opportunity for the University. Such requests will be considered only for a specific project with a specific project period. Examples of rare exceptions that have been granted are: proposals submitted by visiting faculty members and other senior visitors for a limited period of time; proposals submitted by a faculty candidate selected by a department but not yet approved by the Provost, Advisory Board, and President; permission for administrators to submit proposals in support of a project in their area (e.g., the museum or the Stanford University Press); special cases of sponsored instruction; and situations where an Academic Council or University Medical Line faculty investigator ceases to be available and it is necessary for the proposed PI to oversee an orderly phase out of a project.
 Please refer to RPH 2.1 for Stanford policy regarding PI eligibility.

Requests for such exceptions should be made by a member of the Academic Council or University Medical Line faculty on behalf of the proposed PI. Such requests are subject to the approval of the cognizant department chair, school dean, and the Dean of Research.

In all cases, the following six criteria must be met:

Criteria for Granting Rare Exceptions

1. The proposed research must meet a programmatic need of Stanford. Meeting a programmatic need means addressing an area of investigation that is not currently covered at Stanford and is endorsed by a sponsoring member of the Academic Council or University Medical Line faculty as directly relevant to and supportive of the research or teaching programs of the faculty. Research that may be important in its own right and for which outside funding is available will not be judged as meeting the programmatic need criterion unless it facilitates the ongoing objectives of the University in an identifiable and direct way.
2. The proposed research cannot be funded and/or conducted effectively at Stanford unless the proposed individual is the PI. Among other things, this generally will mean that there is no member of the Academic Council or University Medical Line faculty available to take the responsibility for the scientific direction of the project.
3. The proposed PI's qualifications to direct the project provide assurance that the work will be conducted in accord with the standards of excellence of the University.
4. No incremental space will be required for the project.
   For each graduate student participating in the project, a qualified faculty member has been identified 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.
5. The research must be designed and conducted in such a way that work can be discontinued when programmatic need ends or if the sponsoring faculty member ceases to be available.
6. Exceptions to the PI eligibility policy will be rare in situations other than those described in Section 2.A and 2.B [DL1]. A written copy of any such requests, along with the justification and approvals of the sponsoring faculty member, the chair, school dean, and Dean of Research should accompany the sponsored project proposal submitted to the Research Management Group.

Rare Exception PI Waiver Template

During a five year pilot period of April 22, 2021-April 21, 2026, MD or PhD-level researchers and staff who are not members of the Academic Council or the University Medical Line faculty may be approved to serve as PIs on projects within the scope of a shared facility or service center. For this purpose a "shared facility" or “service center” is defined as a center providing critical research infrastructure to the broader Stanford community, as follows: The shared facility or service center must:

1. have an expected duration beyond the involvement of any individual faculty participant,
2. have users spanning many (e.g., three or more) departments

For approval of PI exceptions in such cases the following criteria must be met:

1. Only shared facility/service center MD or Ph.D.-level staff are eligible.
2. The PI waiver would be dedicated specifically for funding opportunities in support of the shared facility/service center. 
3. There is a defined programmatic need of the shared facility/service center;
4. The proposed project is term limited;
5. There is no member of the Academic Council or University Medical Line faculty associated with the shared facility/service center who is qualified to take responsibility for the scientific direction and has the capacity to lead the prospective research project.
6. Waivers are reviewed on a case-by-case basis;
7. Approvals shall be obtained as follows:
   
   1. The Faculty Lead of the shared facility/service center confirms that the proposed PI has the requisite qualifications to serve as PI on the specific project;
   2. The Faculty Lead of the shared facility/service center provides assurance that the work will be conducted in accord with the standards of excellence of the University; and,
   3. The Faculty Lead of the shared facility/service center confirms all appropriate PI trainings have been completed;
8. The shared facility/service center Faculty Lead, the Center Advisory Board (if one exists), and the School Dean or designee (if applicable) all agree on the selection of the PI;
9. The research or development to be conducted must be conducted within the shared facility/service center and affiliated locations only; 
10. For each graduate student participating on the project, a qualified faculty member is identified 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.
11. Exceptions approved under this provision will be reported to the Vice Provost and Dean of Research or their designee on an annual basis, who will provide annual updates to C-Res.

Specific Projects Which are Part of a Shared Facility or Service Center PI Waiver Template

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 for an R01- or R21- type federal or non-federal research grant. Individuals in other schools are not eligible for this waiver program. Please refer to RPH 2.1 for Stanford policy regarding PI eligibility.

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.

Individuals in these School of Medicine positions who meet the eligibility criteria below may request this type of waiver:

• 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

School of Medicine positions that are NOT eligible to request this type of waiver:

• Individuals in Clinical Educator positions (i.e., Clinical Instructors)
• Individuals in Academic or Research Staff positions (i.e., basic research scientist, research associate positions)

Number of approved waivers permitted per year:

The Faculty Senate limits the number of approved waivers permitted per year for each of these School of Medicine groups to:

• 10 approved waiver requests for Postdocs & Instructors with M.D. and M.D./Ph.D. degrees
• 10 approved waiver requests for Postdocs & Instructors 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] 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.

Eligibility Criteria:

• School of Medicine Postdoctoral Fellows with M.D. or M.D./Ph.D. and Ph.D. degrees
• School of Medicine Instructors with M.D., M.D./Ph.D., and Ph.D. degrees
• 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 University Medical Line faculty member.
  

Expanded Career Development PI waiver request deadlines, instructions and memo/template:

Please send your Expanded Career Development PI waiver request packet to Chelsey Perry (not to your RPM).  Chelsey will distribute your packet to the faculty review committee.

Please note: this is separate from the routine Career Development PI waiver request that is needed for each mentored career development award and is submitted through your RPM.

Required Steps:

Step 1: The Primary Mentor should discuss the candidate and the waiver with his/her department chair to determine eligibility and department support.

Step 2:  Determine the waiver request deadline:

Annual Deadlines: January 15, March 15, May 15, July 15, September 15, November 15

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:

• Summer dates for the October standard NIH application deadlines
• Fall dates for the February standard NIH application deadlines
• Spring dates  for the June standard NIH application deadlines
• Please do not wait until just before the application deadline to submit a waiver request.

Step 3: Prepare and submit the waiver request packet:

Please send ONE PDF file containing the following, in the order listed below, via email attachment to:

Chelsey Perry
Senior Program Manager
Research Management Group 

3.1. Expanded Career Development PI Waiver Cover Memo. Download, complete, and obtain all of the necessary signatures on the required PI Waiver Cover Memo. The Expanded Career Development PI Waiver Cover Memo must be completed and signed by:

• PI: Instructor, Postdoctoral Fellow
• His/her mentor
• Hhis/her division chief (if applicable)
• His/her department chair.
  

3.2. PI Waiver prepared by your mentor and co-signed by your mentor, your division chief and your department chair. Download and complete the Expanded Career Development PI waiver template.

3.3.  2 page description of your research project - include project title, bold headings (i.e., goal, aims, etc.), and references

3. 4. Applicant's biosketch

Selection process:

The proposals will be distributed to an internal School of Medicine review committee. That committee will decide whether the applicant will receive approval for their PI waiver. After the internal review committee and Dr. Ruth O'Hara, Senior Associate Dean for Research, have completed their review, Chelsey 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. 

PI Waiver Cover Memo

Expanded Career Development PI waiver template