Report on Responses from the RFI by NIHhealth

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									 Plan to Recognize Multiple Principal
 Investigators on NIH Grants
 Briefing Document




                                                              FINAL
                                                    Data through
                                             September 16, 2005 at 11:59 PM
                                              This document is confidential and is intended
                                                for NIH internal planning purposes only.
For Responses Received through 11:59 PM, Friday, September 16, 2005
                                                                                              0
Summary of Results
 745 comments, 25 day period                                     10c. How?
                                                                      It will affect prestige, recruitment,and allocation of
 Snapshot of who is answering                                          resources, and will serve as a method to compare
                                                                       performance.
      547 faculty members
                                                                 10d. Would lists satisfy your need?
      256 respondents from public universities                  Yes [48%], No [6%]
      268 respondents from medical schools
      96 respondents from private universities                  11a. Does a subcontract arrangement work to
                                                                 manage the project? Yes [66%] No [21%]
 9a. Apportionment of the budget? Yes [78%]
                                                                 11b. Does it create inequities?
 9b. Report on NoA and track? Yes [64%]                          Yes [55%] No [30%]

 9c. Facilitate [62%] or Interfere [19%]                         11c. Value in linked awards?
                                                                 Yes [78%] No [10%]
 Question 9 comments:
      Pro: Clear delineation will help those who get            11d. Do linked awards affect project mgmt.?
       rewarded by the amount of money,and with access           Yes [16%] No [64%]
       to research resources and make management
       responsibilities clear. It will also help with
       professional growth opportunities.                        Question 11 comments:
      Con: This will reduce flexibility and will require more        Cons: Someone must ultimately be in number
       administrative costs for scarce resources. The                  charge, “this will cost more in administration and loss
       current system is sufficient.
                                                                       of productivity.”
 10a. Use departmental ranking tables?                                Pros: The policy will support the nature of
                                                                       interdisciplinary research and the recruitment of
 Yes [38%], No [17%]                                                   talent to work on research.
                                                                      Generally the comments indicated that it depended
 10b. Institution be affected?                                         on the nature of the research and the PIs that
 Yes [16%] No [22%] Don’t Know [33%]                                   depending on the situation subcontracts are better
                                                                       sometimes and multiple PIs are better other times
            For Responses Received through 11:59 PM, Friday, September 16, 2005
                                                                                                                                 1
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.acce
    ss.gpo.gov/2005/pdf/05-14015.pdf.




       For Responses Received through 11:59 PM, Friday, September 16, 2005
                                                                             2
Timeline

       July 18, Release of OSTP RFI in Federal Register

           July 29, Notice and form released in the NIH Guide

                                   September 16, End of comment period




July         August       September                                      October

           Comment Period




             For Responses Received through 11:59 PM, Friday, September 16, 2005
                                                                                   3
Characteristics of Respondents
  I hold the following academic or other rank:
                           No Response                      26
                                  Other                                74
                      Graduate Student             0
               Postdoctoral Researcher                 11
                       Faculty Member                                                                            547
                     Department Chair                        37
  Research Administrator/Staff in Office
                                                            31
         of Sponsored Research
President/Provost/Dean/Chancellor/CEO                   19

                                               0                        100        200   300   400   500               600




  I am affiliated with the following type of organization:
                         No Response                        18
                                 Other                            28
 Advocacy Group/Professional Society               6
                          Government                   10
   Non-University Research Institution                                        63
                       Medical School                                                                            268
                     Private University                                            96
                      Public University                                                                    256

                                           0                            50         100   150   200   250                300



                For Responses Received through 11:59 PM, Friday, September 16, 2005
                                                                                                                              4
Allocation of Funds
 9a. Should NIH permit the PIs/grantee institution to ask for
 apportionment of the budget to each PI?
                    1%   3%
     23%                                                        Administrators

                                                                   Yes
                                                                   No
                                                                   Don't Know
                                                                   No Response
                                                  73%


                         2%1%
           16%
                                                                    Faculty
                                                                   Yes
                                                                   No
                                                                   Don't Know
                                                                   No Response

                                            81%
        For Responses Received through 11:59 PM, Friday, September 16, 2005
                                                                                 5
Allocation of Funds
 9b. Should NIH report budget apportionment on the Notice of Award (NoA)
 and track changes in apportionment throughout the project period?

                         7%
           10%
                                                                  Administrators

                                                                     Yes
                                                                     No
                                                                     Don't Know
                                                         52%
                                                                     No Response
    31%



                    9%        1%
                                                                      Faculty
   23%
                                                                     Yes
                                                                     No
                                                                     Don't Know
                                                                     No Response
                                                      67%

          For Responses Received through 11:59 PM, Friday, September 16, 2005
                                                                                   6
Allocation of Funds
 9c. Do you think that apportionment will interfere with or facilitate the
 efficient operation of the research team?
                         5%
            10%
                                                                 Administrators

                                                                    Facilitate
                                                                    Interfere
                                                                    Don't Know
   26%                                                 59%          No Response




                              1%
             16%
                                                                     Faculty

                                                                    Facilitate
                                                                    Interfere
                                                                    Don't Know
  18%
                                                                    No Response
                                                     65%

         For Responses Received through 11:59 PM, Friday, September 16, 2005
                                                                                  7
Apportionment of Funds Comments
 Don’t Apportion Funds                        Do Apportion Funds
   Give the individual institutions the        Fund allocation determines the “credit”
    flexibility to allocate funds.               given and access to resources at my
   Having multiple PIs getting credit is        institution.
    sufficient; we don’t need funds             It will make the relationship more clear
    allocated.                                   at the beginning and therefore easier to
   Find alternatives for giving credit          manage.
    instead without apportionment of funds.     If you allocate funds, to allow the
   It will create an administrative burden      institutions the flexibility to make
    to allocate funds.                           changes.
   One person needs to be in charge of         Without this there will be struggles for
    the budget.                                  power and money between PIs
   There is a greater chance of misusing       This is important for the growth of
    funds.                                       younger faculty
   There would be a lot of time and            Apportionment of funds is more cost
    resources spent in negotiation, which        effective than the double overhead
    would be a waste of resources.               associated with subcontracts.
   The current mechanisms                      This will facilitate the formation of
    (subcontracting, or linked awards) of        teams.
    apportionment are sufficient and does
    not need changing.




        For Responses Received through 11:59 PM, Friday, September 16, 2005
                                                                                            8
Departmental Ranking Tables
 10a. Comments on departmental ranking tables:
 Does your institution use the departmental ranking tables?
                             1%
                14%
                                                                  Administrators

                                                                     Yes
                                                                     No
                                                         51%         Don't Know
                                                                     No Response
    34%



                            2%
                                                                      Faculty
                                                       37%
                                                                     Yes
                                                                     No
                                                                     Don't Know
  49%
                                                                     No Response


                                          12%
          For Responses Received through 11:59 PM, Friday, September 16, 2005
                                                                                   9
Departmental Ranking Tables
 10b. Would your institution be affected if NIH eliminated the
 departmental ranking tables?
                           2%
       23%                                         32%          Administrators

                                                                   Yes
                                                                   No
                                                                   Don't Know
                                                                   No Response


                     43%

                           2%            14%
                                                                    Faculty
                                                       18%         Yes
                                                                   No
                                                                   Don't Know
                                                                   No Response
      66%
        For Responses Received through 11:59 PM, Friday, September 16, 2005
                                                                                 10
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.



        For Responses Received through 11:59 PM, Friday, September 16, 2005
                                                                                       11
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?

                 15%
                                                                     Administrators
    10%
                                                                        Yes
                                                                        No
                                                                        Don't Know
                                                           57%          No Response
       18%



                   11%
                                                                         Faculty
                                                           48%          Yes
                                                                        No
                                                                        Don't Know
    37%                                                                 No Response


                               4%
          For Responses Received through 11:59 PM, Friday, September 16, 2005
                                                                                       12
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?

                         8%    1%
          13%                                                       Administrators

                                                                       Yes
                                                                       No
                                                                       Don't Know
                                                                       No Response

                                                  78%


                   10%        2%
                                                                        Faculty

    24%                                                                Yes
                                                                       No
                                                                       Don't Know
                                                                       No Response
                                                        64%

            For Responses Received through 11:59 PM, Friday, September 16, 2005
                                                                                           13
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?

                    11%        0%
                                                                   Administrators

                                                                      Yes
                                                                      No
                                                          51%         Don't Know
                                                                      No Response
     38%




                 11%         2%
                                                                       Faculty

                                                                      Yes
                                                                      No
                                                                      Don't Know
    30%                                                  57%          No Response


           For Responses Received through 11:59 PM, Friday, September 16, 2005
                                                                                           14
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?

                      7%      1%
      16%                                                          Administrators

                                                                      Yes
                                                                      No
                                                                      Don't Know
                                                                      No Response

                                                  76%


                    8%       2%
         9%                                                            Faculty

                                                                      Yes
                                                                      No
                                                                      Don't Know
                                                                      No Response

                                               81%
          For Responses Received through 11:59 PM, Friday, September 16, 2005
                                                                                       15
Awards to More than One Institution
 11d. Do you think a Linked Award arrangement is likely to interfere with effective
 project management?

                               0%
                  16%                         17%
                                                                    Administrators

                                                                       Yes
                                                                       No
                                                                       Don't Know
                                                                       No Response


                             67%

                            3%               15%
            16%
                                                                        Faculty

                                                                       Yes
                                                                       No
                                                                       Don't Know
                                                                       No Response


                                 66%
          For Responses Received through 11:59 PM, Friday, September 16, 2005
                                                                                      16
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.




            For Responses Received through 11:59 PM, Friday, September 16, 2005
                                                                                                                                    17
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.)



         For Responses Received through 11:59 PM, Friday, September 16, 2005
                                                                               18
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




       For Responses Received through 11:59 PM, Friday, September 16, 2005
                                                                                 19
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



             For Responses Received through 11:59 PM, Friday, September 16, 2005
                                                                                   20
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




           For Responses Received through 11:59 PM, Friday, September 16, 2005
                                                                                         21
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




          For Responses Received through 11:59 PM, Friday, September 16, 2005
                                                                                  22
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




           For Responses Received through 11:59 PM, Friday, September 16, 2005
                                                                                        23
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)




          For Responses Received through 11:59 PM, Friday, September 16, 2005
                                                                                24
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




          For Responses Received through 11:59 PM, Friday, September 16, 2005
                                                                                 25
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




          For Responses Received through 11:59 PM, Friday, September 16, 2005
                                                                                26
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




          For Responses Received through 11:59 PM, Friday, September 16, 2005
                                                                                     27
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)




          For Responses Received through 11:59 PM, Friday, September 16, 2005
                                                                                   28

								
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