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2. Plan to Recognize Multiple Principal Investigators on NIH Grants Briefing Document FINAL Data throughSeptember 16, 2005 at 11:59 PM This document is confidential and is intended for NIH internal planning purposes only.

3. 745 comments, 25 day period Snapshot of who is answering 547 faculty members 256 respondents from public universities 268 respondents from medical schools 96 respondents from private universities 9a. Apportionment of the budget? Yes [78%] 9b. Report on NoA and track? Yes [64%] 9c. Facilitate [62%] or Interfere [19%] Question 9 comments: Pro: Clear delineation will help those who get rewarded by the amount of money,and with access to research resources and make management responsibilities clear. It will also help with professional growth opportunities. Con: This will reduce flexibility and will require more administrative costs for scarce resources. The current system is sufficient. 10a. Use departmental ranking tables? Yes [38%], No [17%] 10b. Institution be affected? Yes [16%] No [22%] Don’t Know [33%] 10c. How? It will affect prestige, recruitment,and allocation of resources, and will serve as a method to compare performance. 10d. Would lists satisfy your need? Yes [48%], No [6%] 11a. Does a subcontract arrangement work to manage the project? Yes [66%] No [21%] 11b. Does it create inequities? Yes [55%] No [30%] 11c. Value in linked awards? Yes [78%] No [10%] 11d. Do linked awards affect project mgmt.? Yes [16%] No [64%] Question 11 comments: Cons: Someone must ultimately be in number charge, “this will cost more in administration and loss of productivity.” Pros: The policy will support the nature of interdisciplinary research and the recruitment of talent to work on research. Generally the comments indicated that it depended on the nature of the research and the PIs that depending on the situation subcontracts are better sometimes and multiple PIs are better other times Summary of Results

4. Relevant Web Links • NIH Guide Notice • http://grants.nih.gov/grants/guide/notice-files/NOT-OD-05-055.html • Comment Page • http://grants.nih.gov/cfdocs/mult_pi/add_mult_pi.htm • OSTP RFI • http://a257.g.akamaitech.net/7/257/2422/01jan20051800/edocket.access.gpo.gov/2005/pdf/05-14015.pdf.

5. Timeline July 18,Release of OSTP RFI inFederal Register July 29,Notice and form released in the NIH Guide September 16, End of comment period July August September October Comment Period

6. Characteristics of Respondents • I hold the following academic or other rank: • I am affiliated with the following type of organization:

7. Allocation of Funds • 9a. Should NIH permit the PIs/grantee institution to ask for apportionment of the budget to each PI? Administrators Faculty

8. Allocation of Funds • 9b. Should NIH report budget apportionment on the Notice of Award (NoA) and track changes in apportionment throughout the project period? Administrators Faculty

9. Allocation of Funds • 9c. Do you think that apportionment will interfere with or facilitate the efficient operation of the research team? Administrators Faculty

10. Don’t Apportion Funds Give the individual institutions the flexibility to allocate funds. Having multiple PIs getting credit is sufficient; we don’t need funds allocated. Find alternatives for giving credit instead without apportionment of funds. It will create an administrative burden to allocate funds. One person needs to be in charge of the budget. There is a greater chance of misusing funds. There would be a lot of time and resources spent in negotiation, which would be a waste of resources. The current mechanisms (subcontracting, or linked awards) of apportionment are sufficient and does not need changing. Do Apportion Funds Fund allocation determines the “credit” given and access to resources at my institution. It will make the relationship more clear at the beginning and therefore easier to manage. If you allocate funds, to allow the institutions the flexibility to make changes. Without this there will be struggles for power and money between PIs This is important for the growth of younger faculty Apportionment of funds is more cost effective than the double overhead associated with subcontracts. This will facilitate the formation of teams. Apportionment of Funds Comments

11. Departmental Ranking Tables • 10a. Comments on departmental ranking tables: Does your institution use the departmental ranking tables? Administrators Faculty

12. Departmental Ranking Tables • 10b. Would your institution be affected if NIH eliminated the departmental ranking tables? Administrators Faculty

13. Departmental Ranking Tables Comments • 10c. How would you be affected? • It would adversely affect recruitment (faculty and graduate students) and the prestige of an institution. • Ranking tables determine access and the allocation of institutional resources and space. • The tables are used to compare performance with research done on a national level. • The tables are used to evaluate institutional productivity . • The tables are used to determine the future trajectory of research programs. (goal setting, planning and decision making) • Institutions would be less motivated to take on research projects solely for the purpose of improving an institutions rating. • This would affect the Annual World New and Reports Ranking of medical institutions • These tables are used for “bragging rights” and are not substantive, therefore will have no effect.

14. Departmental Ranking Tables • 10d. Would lists of awards with their associated PIs and their institutional and departmental affiliations satisfy your institution’s need for information about NIH awards attributable to specific departments? Administrators Faculty

15. Awards to More than One Institution 11a. Comments on awards to more than one institution: Do you think a consortial or a sub contract arrangement between the primary and secondary institutions permits the leadership team to effectively manage a project spanning the involved institutions? Administrators Faculty

16. Awards to More than One Institution 11b. Does the sub contract arrangement create inequities between a PI(s) at the awardees institution and a PI(s) at the sub contract institution? Administrators Faculty

17. Awards to More than One Institution • 11c. Do you see value in offering Linked Awards in the case of multiple PIs located across multiple institutions? Administrators Faculty

18. Awards to More than One Institution 11d. Do you think a Linked Award arrangement is likely to interfere with effective project management? Administrators Faculty

19. Linked Awards Comments • Against • Without one “lead” PI a policy of decision by committee would be ineffective. (someone must be ultimately in charge.) • This process would create greater inefficiencies and a loss of productivity. • More time would be spent on grant administration and less on the research. • Sub contractor relationships give the PI control and accountability over the performance of the research. • I am concerned about confusion concerning who to contact about certain aspects of the research, thereby creating a possible communications barrier. • Undetermined • It depends highly on the interdisciplinary nature of the research and the nature (and personality) of the investigators on the grant. • Either subcontracts or linked awards could work if proper credit was given under both situations. • It can be challenging to determine when and how to use this mechanism. • Support • Linked awards would address concerns about recognition and credit-making it easier to attract individuals and to acknowledge when multiple scientists make equivalent intellectual contributions. • The credit is important for individual investigators to achieve tenure and to gain access to institutional resources. • The credit is important for individual institutions which need to compete for and to attract researchers and graduate students. • If institutions are concerned about management issues then they opt to continue in a lead a research project with a sub contractor role. • This would reduce the “double overhead” associated with subcontractor arrangements. • There may be greater incentive for other institutions to complete their part of the research where in subcontracting arrangements there are not the same incentive.

20. Implementation Questions Comments • Can this be retroactive to grants currently in submission? • Multiple PIs would be most appropriate for larger grants. Is there a dollar value associated with when this would be applicable? • Under this multiple PI system, it would be helpful to allow for mutual IRBs monitored via the eRA link. • Furthermore, at least the IRB training certifications could be standardized. Currently, the institutions implement and recognize their own training mechanisms, in addition to the one required by NIH. • I would suggest using the NSF model for Linked Awards. • Consider whether or not the naming of multiple PIs is appropriate for various types of grants (eg. R01, SBIRs, P01s, P30s, etc.)

21. OSTP RFI • Types of Respondents: Total 63 • Biomedical Scientists: 29 • University Office of Sponsored Projects or VP for Research : 23 • Professional Association: 9 • Small Business: 1 • Unknown: 1 • Overall Opinion on Multiple PI Policy • Favor: 45 • Oppose: 8

22. OSTP Q 1: Will listing more than one individual as a PI present any difficulties for you or your institution? • Need explicit criteria; give examples of what is and is not a PI (7) • PI means and needs to be just one individual (12) • Keep Co-PI or Co-I titles (9) • Possible abuse – too many PIs (6) • Maintain maximum institutional flexibility and autonomy in designating PIs (7) • Institutions will have to revise processes and databases (7) • Concerns about accountability (3) • New investigators named as PI might lose status as new investigator (4) • May be administratively cumbersome (2) • Increased administrative burden (2) • Concern about decision-making; if no one is in charge, nothing gets done (2) • Harder to evaluate departments for grant ranking • Should be reserved for large, complex projects, not R01-type • Should allow use for just two close collaborators on R01-type • Require minimum percent effort (e.g.., 20%) (2) • Do not require minimum effort

23. OSTP Q 2: Do you see any difficulties that would be created by designation of one PI as the Contact PI? Are there institutional issues that the agencies should consider? • Contact PI may become the de facto chief PI (6) • Favor since it is important that institution/project speak with one voice (3) • Most junior PI may be assigned this role and/or may feel put upon (4) • Must be able to enforce communication responsibilities (2) • Create Chief Operating/Admin Officer (2) • Create Lead PI or Project Director for management and regulatory compliance issues • Agency or institution could set up email group for all PIs (2) • Diffusion of accountability (2) • Not practical if awards to more than one institution • Should be able to switch over course of grant

24. OSTP Q 3: What issues should the agencies consider in developing their instructions for applications naming more than one PI? • Management plan a good idea, but only when needed by the type of project (15) • Need detailed description of each PI’s role and why that justifies PI status; give examples of contributions that do or do not justify PI status (15) • When is agency approval needed for budget reallocation? (3) • Grants.gov form allows only one PI (3) • Uniform criteria should be adopted across agencies; definition in RFI is adequate (2) • Limit # of PIs • Need guidelines for compliance, coordination, decision-making, publication

25. OSTP Q 4: Recognizing that agencies differ in the structure of their business arrangements with institutions, are there ways for the agencies to recognize PIs for a team effort involving multiple departments or institutions that would work well for your institution? • Each type of award structure (subawards, separate awards) has its advantages in different situations; maintain range of award structures as appropriate to each situation (12) • Linked awards are a good idea, when appropriate (5) • Linked awards may affect institution’s FAR simplified acquisition threshold • Need to address distribution of indirect costs among institutions/departments (3) • Accountability issues between institutions (3) • Institutions can handle these issues themselves

26. OSTP Q 5: Do you favor granting access to award and review information to all named PIs, not just the Contact PI? • Favor granting access to all (27); oppose (0)

27. OSTP Q 6a: Do you anticipate significant benefits from listing more than one PI in agency databases? • Will guarantee appropriate credit for team PIs (everyone cited this) • Should include Co-Investigators as well as PIs (7) • Enable better tracking of funding by agencies and institutions • Will benefit junior investigators (2) • NIH ranking tables would be more accurate (2) • Harder to monitor duplicate funding (2) • Allows identification of potential future collaborators • Provides for multiple contacts per project; but not all contacts appropriate

28. OSTP Q 6b: Do you anticipate using agency data systems with PI information, such that investment in alterations to such systems would be worthwhile? • Warrants investment (9); maybe (2); no (0) • Numerous comments that this would be the most important single aspect of implementing the multiple PI policy

29. OSTP Q 7: Overall, do you think that the changes proposed for official recognition of multiple PIs will benefit multi-disciplinary and inter-disciplinary research? • This was taken for granted and RFI rationale restated by most of the respondents; no new information provided by responses

30. OSTP Q 8: What other suggestions do you have for facilitating the recognition of multiple PIs? • Apportion budgets among PIs (favor: 18, distributed evenly across PI, university, association respondents; oppose : 2, one university one association) • Minimize additional administrative burden of financial and programmatic management (3) • Need designation of responsibility for ethical conduct, human subjects, animal welfare (2) • Other agencies do not provide tracking data as NIH and NSF do (2) • Need procedures for resolving disputes • Should have definition of Co-Investigator • Urge rapid and uniform implementation across agencies • Provide institutions with ability to apportion responsibility along with recognition • Allow collaborating PIs to participate in other grant mechanisms (e.g., cap on number of grants/PI)