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1
Does the document accurately describe how decisions are made within the activities/groups? How can this be enhanced? (Please note if any specific areas require enhancements.)Is the composition of the executive/steering committees of the various activities/groups effective? How can this be enhanced in certain activities?Is the Reporting Structure accurately described?Are any relationships (reporting and/or communication) between the activities/groups missing?Does Figure 1 accurately describe, in an uncomplicated way, the makeup of the [PROGRAM] Program? If not, what could be changed?Does the SC have suggestions for additional guidance and/or policies that [IC] can work collaboratively with the SC on and that the consortium would find useful?Open feedback appreciated:
2
It's too long - can we please simplify this document and reduce the redundancy.
Yes
Again, try to condense, simplify, and remove redundancy
No
No, are the hubs really in charge at the top of the org chart? Shouldn't the [PROGRAM] Program Steering Committee be at the top with the various DTFs, awards, initiatives, etc. below?
SC needs to be involved in major decisions such as changing funding from 5 to 4 years.
What motivated the drafting of this document?
3
The document sounds good, although as discussed on recent calls, some of the decisions seem to occur out of nowhere. For example, ACT seemed to disappear for several years, and has now returned, although where it is heading isn't clear. The TIN has been somewhat more transparent, but is very much a moving target. Unless one is engaged with the website and calls almost continuously, its very difficult to track. I am somewhat more hopeful about the RIC. The IOM report emphasized metrics, and I am sure all the PI's value common metrics across sites, but the process so far has been mostly reporting for its own sake and not closely tied to functioning.
The composition seems fine. However, some decisions seem to be made external to the steering committee.
See above, I think there has been something of a disconnect between structure and how things actually occur, leading to the recent affect-ridden calls. Everyone involved has a passion for this work, otherwise we wouldn't be doing it. The PI community is very experienced and, while some are set in their ways, they also all understand the need for flexibility and compromise. They've been doing this for a while.
While communication up to [IC] is appropriate, we don't always receive timely or comprehensive communication back to the hubs.
The horizontal lines aren't very helpful. Its not clear how the groups influence or communicate with each other.
Hubs are currently working under 3 somewhat different RFA's, which is making it difficult to coordinate across hubs. Harmonizing the activities would be very helpful.
4
Having the hubs at the top of the diagram (Figure 1) is misleading. Often the directives seem like they are coming 'top down'. The initiatives that [IC] aligns resources around seem to be those that emanate from [IC] rather than vice versa. For instance, there was a proposal put forth to explore creating a connection between VA and [PROGRAM] networks. This was a 'grass roots' proposal, but no resources put behind supporting that effort. To modify this to reflect accuracy, perhaps the hubs really should be placed at the bottom. Currently [IC] really does not come across as a service organization. There is certainly bi-directional communication, but the effectiveness of that communication on decision making is not clear. While there are the much appreciated efforts to enhance transparency about decision making, it is fairly apparent that currently the hubs have little input into how the program is run. For instance, decisions to allocate resources to the TIN at the expense of funding hubs (rather than seeking supplemental funding) seem to have happened 'behind closed doors.'
There is a description of the steering committee but no clear information on what influence the committee has on decision-making. Currently, the committee seems to be in place as a communication vehicle rather than to truly 'steer' [IC] priorities. This is misleading and should be modified to reflect the role of the committee. OR-- the committee function, value to running the organization, and influence in decision making should be refined.
This is NOT a reporting structure. The hubs all report to [IC] via the typical program officer/budget management structure. There is no 'reporting' to the PODs. So this should be re-labeled, probably brought together with another section describing the 'steering' (which should probably be relabeled 'communications' or 'liaison' committee. PODS are part of that communication/liaison structure but no reporting role.
Where are the DTFs in this communication/reporting structure? That should be explicitly worked in.
Figure needs work. First, it really does not reflect how the hubs currently feel about their 'reporting' to [IC]. In contrast to having hubs at top, it currently really does feel like [IC] at top. How exactly does the coordinating center relate to [IC]? What is its intended connection to all hubs? Currently it appears this hasn't been worked through. As a matter of considering how to restructure things, the coordinating center should probably be brought closer to the central 'communications/liaison/steering committee'. In one of the last meetings, it was clear that the coordinating committee will now also lead the common metrics initiative. So combining these boxes would be good.
I think the role of the SC needs a lot more thought. Currently our time is being under-leveraged. The extent to which SC recommendations are logged and adhered to is not clear. There is a collaborative atmosphere, but the role beyond a communications funnel is not clear. This is further muddied by the new coordinating center, which should be embedded somehow into the primary communications infrastructure.
I think all Hubs really should be able to comment on this document. If [IC] really wants to be inclusive with the hubs, there has to be a robust effort to reach out to individual hubs directly as much as possible. In addition, the Program Officers seem to be left out of this infrastructure. How does their monthly interaction with hubs feed into the central infrastructure? This is unclear. In our discussions, there is concern that there is too much reliance on the 2013 IOM recommendations which are now outdated given new configuration of the [PROGRAM] consortium as a network.
5
While governance is described, decision making is not clearly specified (ie voting, majority rules, if any members have weighted votes, etc).
Yes, there is appropriate representation of hubs, community members, [IC].
Yes, accurately described.
No.
Accurately and clearly described, a little odd that 'oversight' is on the bottom.
No.
6
We think the document adequately reflects the decision processes within the [PROGRAM].
The current composition is effective.
Yes.Not to our knowledge.Yes.Yes.
7
The various groups and activities are generally accurately described. The process for making decisions is not very clearly presented, nor is the level and scope of authority of the groups delineated.
In the section on SC membership, it may be implied but not stated explicitly that approximately one-third of the PI members will be replaced in a given year, so as to achieve continuity. In the section on Common Metrics Executive Committee, it is not stated how members are selected or how long they serve (?'flexible'?).
See comments below regarding Figure 1.
The pod structure is mentioned in the text, but not portrayed in Figure 1. This would be a good addition to the figure.
In the pod discussion, most felt that the figure does not portray the program very effectively. For example, the TIN and CIAs don't really provide interfaces between hubs and SC, as shown. This type of relationship is, however, appropriate for DTFs and, to a lesser extent, the Common Metrics. The meaning of 'Coordinating Centers' is not clear - is it C4, +/- other centers?
A major need here is for more open and prospective discussions of program issues, so as to bring broad expertise to bear on decision making and allow for better planning for Consortium and hub operations. Financial issues, as recently discussed, are a key example.
Our pod discussion of the Common Metrics elicited from most participants that the processes used tend to be time-consuming and repetitive. Moreover, there seems to be a recurring pattern of revisions and adjustments that add to the workload. A greater degree of efficiency is needed in this area.
8
No. There is not a clear description of who is responsible for making final decisions. Does that power rest with a person? Or a group? Are decisions made by simple majority? consensus?
The composition of the SC is appropriate, however it is unclear how this comittee is actually contributing to steering the direction of the [PROGRAM]s.
The Reporting Structure sections describe the expectations of each group, but where the authority lies (which is what is meaningful and helpful when discussing Reporting Structures) is not discussed.
Reporting relationships aren't always clear.
It would be logical for the entity with the most 'power' to be at the top of the figure. So, this seems upside down. While the 'bi-directional communication' is interesting to note, describing the communication isn't the purpose here. Also, the double-headed arrows make this figure confusing. If the purpose of this figure is to show the governance, that is what should be shown. This figure should be re-drafted.
Ideally, the SC could form a partnership with [IC] leadership and be empowered to leverage the strengths of the individual [PROGRAM] hubs to achieve agreed upon goals. As is, the SC is simply a vehicle for [IC] leadership to transmit information, that is often confusing.
9
Within activities, I think the document is OK. What affects us the most, dwarfing the issues addressed herein, and what is least transparent, are the decisions at the top.
OKOKNoOKNo
10
Yes.
Common Metrics Executive Committee section: state here how the members are appointed. It's stated 2 pages later, in another section, but belongs here too.
Yes.No.
Move Collaborative Innovation and Trial Innovation boxes to same level as Individual [PROGRAM] Hubs box. The former two are not programs all [PROGRAM] hubs have or participate in and were clearly described by [IC DIRECTOR] in his July 24 call as on a par with the individual hubs.
No.
o [PROGRAM] Program Coordinating Center  Purpose and Scope • Add maintaining [PROGRAM]central.org • Add FOAs, like for the other grant-supported elements described?  Reporting Structure • Change 'PI' to 'corresponding PI.' Both PI and PI(s) are used, and the Coordinating Center might have multiple PIs, but only 1 PI from the Coordinating Center will be on the SC, so use 'corresponding PI' here.  The governance document says that other grant-supported elements of the [PROGRAM] program (like the hubs and the Collaborative Innovation Awards) have to submit yearly RPPRs, but that's not mentioned for the Coordinating Center or Trial Innovation Center. Don't they have to submit a yearly progress report to NIH? o Domain Task Forces: Purpose and Scope: they're called 'one of the many communication structures within the [PROGRAM] Program,' but their actual main function is to create systems for the [PROGRAM] program to jointly address its aims. The DTFs are not mainly communication structures. Should the description be changed? o Trial Innovation Network  Add FOAs, like for the other grant-supported elements described?  Figure 2: Is '[PROGRAM] Program PI Committee' supposed to be the SC?  Add term for membership
11
The organizational chart suggests that the Steering Committee has oversight of the DTF's etc; but in fact there is little bidirectional interplay between the groups. For example, the nature of the metrics group deliberations were reported to the SC but there was little change after discussion.
The composition is effective internally among the committees, but it needs to be made more clear how they interact with each other.
No, see my comments above.
See above.
I addressed this in the first box. No, I do not think the Committees lie in between the SC and the HUBs; they seem to operate independently via contact with [IC] program direction.
There needs to be a way to integrate [IC] intramural programs with the [PROGRAM] network to enhance [IC] mission. This could be done via interactive U01 applications that fund Hub partnerships with [IC] intramural programs.
I firmly believe we are not utilizing the wealth of resources at the Hubs to the fullest extent. Perhaps an open discussion at the next face to face meeting following solicitation of new or unique programs/ideas/collaborations/etc. might facilitate this.
12
I am not sure that the document describes how decisions are made. I think decisions are made by [IC] staff and the structures are used as communication vehicles. The key issue are: 1) what are the [PROGRAM] GOALS? 2) how (and who) will review proposals 3) how are [IC] and each hub held accountable for achieving the goals. I do not believe that there is shared governance re: these issues.
i think the composition of the various groups are fine.
I think so
I think the role of the EAB's (and IAB's ?) should be noted. I believe these boards are critical to the success of each HUB.
I think the network portion should be de emphasized. I think linking [PROGRAM] with important functions (pilots, community, education, informatics, crc) would more effectively utilize federal funds. I do not believe establishing a network that may or may not be used by nih institutes may or may not be a wise use of federal funds.
I do not follow the question
k are generally funded for the quality of the question proposed, yet u components are driven by the 'science of science'. Shouldn't the different parts of the grant have better conceptual alignment?
13
see belowsee belowsee belowsee below
it's not consistent with the structure reflected in Figure 3.1 in the IOM report.
The PI's on the SC have lost their ability to help guide the [PROGRAM] consortium. The 2013 IOM is used as the rationale for the current state of affairs, but the report clearly did not suggest disempowerment of the PI's: It states, in part, '...more active [IC] leadership will require that it take on significant responsibilities in promoting collaborations, conducting evaluations of progress, and ensuring that the program leverages the innovations provided by each of the individual [PROGRAM]s ... Striking the right balance between top-down and grass-roots leadership will not be easy, and a number of challenges and possible unintended consequences need to be carefully considered as changes are made to the governance and leadership of the program. For example, imposing a top-down generated research agenda or priorities that do not meet the needs of local researchers, health care providers, and communities would conflict with the original intent and spirit of the program. In addition, an overly directive approach to leadership could dampen creativity, ingenuity, and collaboration among the on-the-ground researchers. More active, but appropriately balanced, leadership from [IC], combined with the creative talents and leadership from the PIs, will be critical in moving the [PROGRAM] Program to a more systems- and network-based approach to clinical and translational research and ensuring that the program remains focused on the outcomes most relevant to its overarching mission.'
The approach to consortium management has been a work-in-progress for over 5 years, and needs a re-examination.
14
although the reporting structures are described, they seem overly complex and burdensome with multiple layers. Just not presented very clearly -- although after several reads, it is digestible. So yes, this may be accurate
Perhaps include more individuals from non-PI level who are more actively engaged in work
yes
not clear where there is a central repository of information/meeting minutes
yes -- but unfortunately, shows that the hubs seem more isolated or removed from central decisions
greater input from hubs about planning
15
The way the document is written, it appears that the [PROGRAM] Program Steering Committee and the PODs only give 'feedback' to the [PROGRAM] program. In my experience this is true. If the network were a true collaboration, there would be more discussion and consulting rather than just 'feedback'. I believe this would have reduced the recent friction between the [IC] and the [PROGRAM] PIs.
See above. If the executive-steering committees are only there to provide feedback but not active collaboration and consulting on key issues, then they will not be effective.
As above. It is accurately described as it currently appears to exist.
No.
No. The figure implies that the [PROGRAM] program hubs lead the [PROGRAM] program, since they are on top of the org chart. This is inaccurate. [IC] is in charge of the [PROGRAM] program.
Not sure what this question is asking.
16
The organizational chart seems inaccurate. The steering committee, through the pods, is interacting directly with the individual [PROGRAM] program hubs. The org chart seems as if there is a 'layer' between them.
The question comes down to influence or perceived influence...PIs and even steering committee members feel as if they lack it.
YesYes
The org chart puts the hubs on top... but are they? The [PROGRAM] division at NIH and the PIs/steering committee should really be side-by-side partners.
None at this time
We should explore other collaborative models that appear to be more robust partnerships (e.g., NCI and cancer center consortium).
17
I believe the bi-directionality is perhaps somewhat overstated.
The structure is fine.
Uncertain, as the process has been somewhat opaque.
Not that one is able to tell.Yes.No.
18
For each of the components within the Program Governance document, the purpose, reporting structure, membership is defined but it is difficult to determine from the document how decisions are made. Is there a collective discussion of topics and a vote of the voting members or are recommendations made to another level where decisions are made. That is not clear from the provided document.
Generally, the composition appears appropriate. For the PIs on the Steering Committee, it should be clear that they solicit input from their POD members and bring it back to SC which in our case has not happened to date. This request for input is the only time in which we have interacted with our POD and that was largely at my insistence. If the goal is a bidirectional communication between SC/[IC] leadership and the individual hubs through the PODS, the director of the PODs need to understand this and be directed to ensure that the hub leadership knows of what SC is doing and also being an effective conduit for bringing 'grass roots' input back to the SC.
Overall, the reporting structure seems poorly delineated and is limited to what is described on Figure 1. As an example as a PI, i do not know how the Common Metrics intiative is being vetted either to the hubs or SC or the program oversight at [IC].
I am not entirely sure specifically how reporting is accomplished so I am at a disadvantage to answer this question.
I think Figure 1 is overly simplistic because the DTFs do not have direct relationships with the hubs other than members from the hubs who participate on the DTFs. I have not totally 'broken the code' on how the Coordinating Center(s) support activities within my hub or how we interact with it/them on an ongoing basis.
It would be helpful if the results of the Face-to-Face PI meetings would be vetted with SC and determine how some of the important suggestions might be implemented to help the overall consortium to develop application of best practices across sites that might find them useful.
1. Membership on the SC. It seems that to identify leadership from PIs to be on SC, a newly identified member of a POD should be rotated to the SC every 3 years on a staggered basis for the pods so there is not a totally fresh group of POD representatives appointed at any one time. 2. Common Metrics Executive Committee: Membership and Terms: It is not clear how members (the 5 PIs ) are chosen. This should be stipulated and again terms should be stated and staggering of terms defined. 3. Evaluators Group: it is not stated how members are chosen and how one might participate in this group. Again if PIs are participating, there should be some staggering of terms and some defined process for identifying members.
19
The document is somewhat accurate, however it seems that decisions are made generally in a top down fashion. Figure 1 should be inverted.
The composition is good. I do not know how to evaluate its effectiveness.
Yes
As a [PROGRAM] PI, I would like to know more about the effectiveness of the DTFs.
As noted, [IC] should be on top, since the flow of information is 'top-down'
I have given suggestions to members of the SC; I do not know if they have been discussed with [IC].
20
More communication from PODs to leadership with feedback from leadership on ideas discussed in meetings would be helpful. This does not yet seem to be fully bi-directional.
committee composition is adequate
yesno
It seems as if we are missing an opportunity if the DTFs are not involved in providing expert advice to the TIN. It is suggested that a mechanism for bidirectional arrows connecting them be implemented.
yes, the SC can work with [IC] to define metrics for the TIN.
21
Overall, the document is reasonable, although we have some thoughts and suggestions to detailed questions below.
It says that SC provides feedback on activities relevant to the [PROGRAM]...but it does not say who it provides feedback to.
No, see comments below regarding figure 1.
no
No. We are concerned about several aspects. 1. not all boxes on the second line refer to programs or groups of equal weight. For example, the DTFs are advisory groups without decision-making authority. The coordinating centers are very different. 2. We are not sure what the innovation suite is. Is it just a bunch of awards? How does the suite communicate up and down? 3. Similar with the common metrics initiative. We are told what to do by these folks, so it seems like a different animal. 4. We would like to see more detail. What are the coordinating centers? 5. We would like to see more detail. Who does the program report to at [DIVISION]? Is it to the Director, to the group as a whole? The box says '[PROGRAM] Program Oversight'. The other boxes say what the entity is, not what it does. This seems like a strange way to put it.
I don't understand this question.
22
Our ICTS leadership group and Pod discussed these issues in detail. We agreed with what was reported to us from the steering committee that the questions in this survey seemed rather arbitrary. It was not clear to us whether there was input from the Steering Committee in these questions. I report this because it does sort of answer the question: there seems to be a disconnect between the [IC] leadership and the local hubs. A number of our leadership group noted that the definition of 'U' awards includes the idea that there is shared governance between the NIH and the grantees. The current governance structure seems not to embody the spirit of this mandate.
In the first years of the Steering Committee, there was an elected body. This approach was abruptly ended and replaced by the current governance document. This document was never discussed or voted upon by the hub leadership. We should revisit the governance structure and start from scratch with true and legitimate involvement of the hubs.
We felt that the reporting structure was arcane and burdensome. Can we simplify it?
If anything, there are too many, too frequently, too much.
It is a very complicated diagram. It does not accurately reflect how decisions are made. There is no mention of budget, and we know that decisions have been made (e.g., the allocation of 4 years of funding to some centers with absolutely no input from the hubs). [IC] colleagues, it is difficult to have it both ways: you cannot welcome the input of the hubs but not grant them ANY real decision making authority.
Real authority and decision-making should be granted to the SC.
23
It is a generally good document, but is not as clear as it should be on actual 'governance (line authority) reporting' as opposed to 'communication reporting.' It suggests but doesn't clearly call out a centralized governance approach.
The role of the Steering Committee isn't really clear in its description and in its operation as it is now.
See above first question response.
See above first question response.
See above first question response.
The role of the Steering Committee isn't really clear in its description and in its operation as it is now. Previously under [Previous IC] it had actual steering role for the overall program, including Strategic Goal Committees, and took substantial responsibility for the [PROGRAM] Program's direction. That is no longer the case, but rather that is done by [IC] leadership.
24
This document describes governing committees' activities and memberships but does not necessarily describe how decisions are made.
Committees are generally quite large, which raises concerns regarding effectiveness. Large size of DTF's in particular is not conducive to effective function.
Yes
Not clear how each of these entities interacts and what their roles are in decision-making. Presumably, all final decisions rest with Steering Committee? Also, not clear as to which decisions are made by [IC] alone and which are made in conjunction with the Steering Committee.
Figure 1 lists the major components but does not effectively convey the functional relationships between the entities, some of which are programs, and some of which are advisory groups to the Steering Committee and [IC]. Most importantly, this figure does not convey who are the major, equal partners in the relationship: the Steering Committee and [IC] Administration.
[IC]-Steering Committee communications are helpful, but activities seem to be ad hoc. Would be helpful for [IC]-Steering Committee partnership to apprise investigators on an annual basis of high priority goals and strategic initiatives and provide metrics on achievement. Also, have listened to many TIN presentations and still not clear as to what TIN goals and functions are -- would be good to clarify.
25
More organizational structure than actual governance or ho decisions are made
YesYesno
Comments submitted via our Pod conversation
?? not on SC
26
Yes. Wider engagements with the PIs after initial plans or decisions are made.
yesyesYesYes
There is need for much greater focus on and expansion of career development programs (T and K), which are currently not adequate given dwindling numbers of physician scientists in US.
There is great need for the [PROGRAM] consortium to expand its efforts to influence congress so as to increase funding of NIH programs, particularly those directly engaged in improving human health.
27
The scope of the SC is described as 'provides feedback on activities relevant to the [PROGRAM] Program.' This does not seem to capture the spirit of a cooperative agreement, which should be about shared decision making. The PI co-chair and committee members are chosen by [IC] without input by the [PROGRAM]s.
Is this question meant just for SC members?
These are complicated issues - in my opinion better served by discussion and dialogue between [PROGRAM] hub leaders and [IC] than by a questionnaire
28
there is lack of granularity about how common metrics are established. the linkage with the evaluator group is not very strong; one evaluator with 5 [PROGRAM] PIs results in the selection of common metrics that are poorly defined, difficult to address and change over too long a time. the document doesnt reflect how priorities are established for the DTFs. the description of the DTFs as a 'communication' structure is not how their activities are viewed in the extramural committee.
yes, generally. see comment above about the common metrics
yes
there needs to be better working between the evaluation and the common metrics group
figure 1 implies that all the DTFs, CC etc report to the steering committee. in many instances, there is direct report with [IC], which is not represented on the figure
there hav been major issues with the metrics, the changing of the reporting of the metrics, and communicaiton that the SC has raised. to my knowledge, most of these have not been addressed.
29
Notification about topics that will be under consideration for decision should be made; communication of decisions should be detailed and made rapidly and accurately; The language speaks of active [PROGRAM]s, but those with NCE, have representation on the Steering Committee. How is that possible?
While the composition of the executive/steering committees of the various activities/groups seems effective for the most part, due consideration to recruitment of ad hoc members with expertise or experience relative to activities under consideration would be most beneficial
The steering committee seemingly has no rule over TIN, TIC or RIC, despite the positioning of these entitites between the hubs and the steering committee.
NoAdequately describedNo
30
yes
composition is ok; not clear that there is true input into decisions
yes
Relationship between PIs and input to oversight and steering committee is missing.
Should have some direct contact with steering committee from PIs
Not sure; not on SC
31
The document describes the [PROGRAM] steering committee as a group that provides feedback, rather than a decision-making body or one that advances [PROGRAM]-wide initiatives. The Pods are primarily used for information dissemination and feedback. While central coordination is necessary in such a large organization, the current model does not have decision making or innovation advancement within the [PROGRAM] consortium guided by the steering committee. This reduces the engagement of the steering committee and PIs overall and risks the quality and sustainability of the work coming out of the [PROGRAM] program. A greater balance between central control and central guidance with substantive hub involvement is desirable.
The composition of the groups is appropriate. The ability of the groups to function beyond a feedback capacity is hampered by the current structure. The steering committee should serve a role beyond feedback and communication and should reflect the hubs in advancing the [PROGRAM] mission. The intellectual capital and talent of this team is not being as effectively leveraged as possible to ensure the success of the [PROGRAM]s in carrying out their missions.
The reporting structure is acurately described.
None noted.
Figure 1 is interesting. It seems to be a foundation of [IC]; Steering Committee; DTF and TIN, innovation awards, etc; on top of which rest the [PROGRAM] hubs. The [PROGRAM] hubs form the basis for the work being done and contribute to the membership of all of these groups (besides [IC]). The foundation of the [PROGRAM] program seems to be both [IC] support and the [PROGRAM] hubs. Alternatively, one could envision the hubs as central to the mission of the [PROGRAM]s.
The SC as currently configures provides feedback. Empowering that group through governance to champion initiatives, provide input, and engage in bi-directional conversation to advance the [IC]-[PROGRAM] mission would more effectively take advantage of the resources disseminated throughout the [PROGRAM]s in order to more efficiently advance the mission.
The governance document refers to 2 TICs, instead of 3, and [DIVISION], instead of the coordinating center. These should be corrected in the final document
32
Still seems very top heavy. Rather than [IC] appointing the Program leadership could there be vote by the [PROGRAM] Program PIs and [IC] leadership?
Continues to appear top heavy.finenot particularlyfine
Pods seem like a feasible method for this.
33
The document describes the system as established. Nonetheless, the network would benefit from greater bi-directional discussion and decision-making among the hub PIs, Steering committee and [IC] staff. It is too early to understand how the new coordinating center will function, and interactions with the RICs and TICs is evolving and at the moment remains opaque. Some submitted projects have been declined services but the rationale for rejection is unclear in light of the stated mission. Further, while the statement regarding the role of the TIC serving the needs of the ICs is reasonable it is not clear that the ICs have bought into this and value needs to be demonstrated.
The leadership is appropriate, representing both the stakeholders (PIs of individual [PROGRAM] recipients) and [IC].
Yes
Many of the more productive relationships with respect to clinical trials are less formal (e.g. among interested investigators, etc) and based on common interest. Not clear how the TICs will recruit appropriate investigators among the network and even less certain how the RICs will contribute more than the local recruiting groups (which more likely have greater expertise with the local communities) mandated as part of each [PROGRAM]. As noted, the network would benefit from more birdirectional communication and decision making between the Steering Committee and [IC].
It is upside down- hubs should be on the bottom.
Not a member of the SC.
34
The [PROGRAM] Steering Committee needs to be renamed to reflect what it actually does. It does not really 'steer' - mainly provide feedback.
Please see above regarding Steering Committee. Other Committees seem fine.
yesnot that I can seeyes
One major issue is the relative instability of the [PROGRAM] sites compared, for example, to the Cancer Center sites, due to ups and downs in funding, gap years, etc. Perhaps [IC] could look at the NCI model and see if some of those concepts could be incorporated.
I think [IC DIRECTOR] needs to be much more directly involved and visible in the consortium.
35
Yes. Document is too long.YesYesNot that we can determine.YesNo
36
The document accurately describes how decisions are made. Well-written, thorough and conclusive.
The composition is appropriate. Effectiveness of POD leaders appears quite variable. A protocol for how Pod leaders should lead a Pod might enhance their effectiveness.
YesNone apparent
The figure depicts leadership and authority at the SC level; however, in reality, not sure that is the case. Most direction and decision-making is handed down from [IC]
Unknown, SC to respond
Decisions are made and changed quite rapidly, does not lend itself well to stability in the program (making it difficult to prioritive HUB activity)
37
no specific comment/feedbackno specific comment/feedback
no specific comment/feedback
It would be useful to add a description of the expected communication to the Hubs for each group as an example of the bidirectional nature of the relationship.
no specific comment/feedbackno specific comment/feedback
38
This document clearly defines the structure and membership of various committees but does not describe in detail decision making mechanisms, mechanisms for conflict resolution, and mechanisms for replacement of SC members and other committee members.
Although well-intentioned, the representation of individual hub challenges/concerns are often not relayed to the SC by POD leaders. Consideration should be given to a more effective informational dissemination approach.
Yes, the reporting structure of the SC is accurately and clearly described.
It is important for [PROGRAM] Hub Administrators to be informed of [IC] activities and priorities discussed during Steering Committee and other Consortia meetings to facilitate adherence to [PROGRAM] program efforts. Consideration should be given to include an identified hub administrative contact to be included on written correspondence.
Coordinating Centers should be underneath 'Individual [PROGRAM] Program Hubs' so that it transcends all committees and working groups. There is no representation of the Executive Committees (TIN; CMI, etc.). A suggested reorganization of figure 1 is suggested below: I. [IC] Division of Clinical Innovation ([PROGRAM] Program Oversite) II. [PROGRAM] Program Steering Committee III. Coordinating Centers (CD2H-CC / CC) IV. [Consortia / Hub Activities]: a. Trial Innovation Network (TICs / RIC / [PROGRAM] Hubs) b. Domain Task Forces (Collaboration Engagement; Informatics; Lifespan; Methods & Processes; Workforce Development) c. Common Metrics Executive Committee d. Collaborative Innovation Award Projects e. Communication Officers Group f. Evaluators Group V. [PROGRAM] Program Hubs
No suggestions at this time.
39
The Steering Committee serves primarily as a conduit for information between [IC] and the individual PI's and hubs. While there is some opportunity for input, there is little decision-making at the SC or PI level. The SC could give more effective input if there was more discussion about some of the transformative decisions made within the [PROGRAM], such as the creation of the RICs, TICs and TIN, role of the Coordinating Center. Decision making appears to be 'top-down'. It would also be useful to have regular metrics and progress reports to the SC on the RICs, TICs and TINs, Coordinating Center and some of the [IC] functions such as Pilot Project review. This type of report would allow the SC to give more meaningful input. The diagram on Page 2 does not accurately display the functional organization. The SC should have a direct line in one direction to [IC] and in the other direction to Pods (missing from the diagram), and Pods to individual [PROGRAM] Hubs.
Composition of committees is appropriate although it would be useful to have a more formal role/committee for the [PROGRAM] Administrator group. This group is often the primary communicators across [PROGRAM]'s about important day-to-day functions, sharing efficiencies, etc.
The description is fair, but as above, the diagram does not fairly represent the reporting structure.
Informal communications between Administrators group should be formalized.
As above, not accurate
It would be useful to have more open and transparent discussions with the SC group about issues like the rationale for variable funding cycles across [PROGRAM]'s, rationale for multiple RFA's per year as this seems to increase the review burden, some input or 'heads-up' about other financial and administrative decisions, role of the Coordinating Center
We appreciate the opportunity to give input re: the Governance document, but this is such a critical topic that we think it would be best to dedicate more time to this issue in a face-to-face discussion
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Not really sure, as I am not closely involved in the decision making
The SC member that leads our pod does a good job of communicating, Not sure what the hubs might miss. Feels like we are somewhat remote from decision making process.
To the best of my knowledge yes
Not that I know ofTo the best of my knowledge, yes.Need to ask the SC members.
This governance is very complex, too much so to be solved by survey. Needs further discussion. In general I think the pendulum has swung to far to top down management. There is much focus on the national activities and TIN, not enough on local opportunities and needs in the hubs. Needs more balance.
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Somewhat, although there is a need to build greater trust between the PIs and [IC] leadership, likely developed through more open discussion of options.
SC is not as effective as it could be, largely due to the ambiguity of its role (see below). The TIN NEC seems quite large, and not clear how it functions.
The exact role of the SC is still somewhat vague. The IOM suggested it would participate in program leadership, and that needs to be strengthened, in collaboration with [IC] leadership. Moreover,
The potentially important role of the pods is not adequately described. Moreover, the pods do not appear in Figure 1 -- and they should to emphasize their important role in communication between PIs and [IC] through the PI members of the SC.
Not sure it does. At present, it's not clear how the TIN, the Innovation Suite of Awards, or the Coordinating Centers report to the SC. Moreover, the graphic suggests that the SC relates to the hub PIs through a series of intermediate groups. That is really not the case. Lastly, the pods are not reflected.
The main value of the SC is to ensure that [IC] leadership is viewed with a sense of trust by hub PIs. The SC should be able to reflect the importance of local issues faced by each hub PI, such that an optimal network/local balance can be maintained.
The importance of each [PROGRAM] hub to its local site is of utmost importance. [IC] needs to consider ways to ensure the stability of each hub if its important role locally is to be protected. The lack of assured stability can undermine the effectiveness of each local hub, and thus, of the consortium itself.
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Historically it appears to me that this process is not necessarily followed.
No - there has been inadequate representation from non-coastal [PROGRAM]'s.
Too complicated
The org chart is very vague. The role of DTF's TIN etc. and how they relate to SC and hubs is not clear. Seems to be a lot of overlap.
It is more complicated under current DTF structure with working group than previous structure or few years ago.
[IC] does not seem to have flushed out plan related to TIN.
We have too many working groups with overlap activities and no guidance.
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Yes
Yes although it might be helpful to have further details on balancing and how this integrates bi-directional conversation with PIs and [IC]
Yes-might also include any other advisory or other groups for [PROGRAM] program
How do we constitute special group to address new need?
yesNo
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Activities are described but decision process is not very clear and can be improved. This can be enhanced by clearly describing how decisions are made and by whom.
It could be more effective in addressing the problems raised by pod leaders.
The reporting structure is described but in reality, does not function as it should.
There should be more inclusion of administrators in many aspects of governance structure including steering committee.
Reporting structure is not clear, and decisions are usually made using top-down approach.
SC can be much more active when it comes to guidance, policies and decision making and reporting these decisions to the hub.
n/a
45
Decisions tend to be driven by [IC] without sufficient input from hubs. Information necessary for decisions is not always shared.
SC members are selected by [IC] rather than through a more collaborative process. Would be beneficial to engage PI's in this process more directly. Also SC members are assigned to co-lead DTF's apparently without regard to expertise nor DTF desires.
Current structure described but some lack of clarity regarding actual implementation. Hubs/PIs have insufficient information and input.
no.
it is a bit disingenuous to put [IC] at bottom given current decision making processes.
Program could be more truly a cooperative agreement if SC were chosen by PI's rather than appointed by [IC] and if it were a true decision making body. Decisions should be made through consensus of PI's and [IC].
This is a complex endeavor and governance could best be addressed through an open and candid discussion among the PI's and [IC]. A survey does not do this topic justice.
46
Reasonably well coordinated given the number of [PROGRAM]s. PODs are a good mechanism to facilitate broader input to decision making that is more centralized.
YesYesNoYes
Federated biobanking across [PROGRAM]s.
47
yes - decisions are made in a transparent fashion by the Trial innovation Network Executive Committee
48
The document describes well the current structure. The additional information about how new members will be selected is helpful.
The description of the Steering Committee's role in providing 'feedback on activities relevant to the [PROGRAM] Program' seems an accurate description of the current activities.
YesNo feedbackYes. No recommended changesNo feedback
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Yes.
State how Common Metrics Executive Committee members are appointed in the section on that committee. It's stated 2 pages later, in another section, but belongs here too.
Yes.No.
Move Collaborative Innovation and Trial Innovation boxes to same level as Individual [PROGRAM] Hubs box. The former two are not programs all [PROGRAM] hubs have or participate in and were clearly described by [IC DIRECTOR] in his July 24 call as on a par with the individual hubs.
No.
o [PROGRAM] Program Coordinating Center  Purpose and Scope • Add maintaining [PROGRAM]central.org • Add FOAs, like for the other grant-supported elements described?  Reporting Structure • Change 'PI' to 'corresponding PI.' Both PI and PI(s) are used, and the Coordinating Center might have multiple PIs, but only 1 PI from the Coordinating Center will be on the SC, so use 'corresponding PI' here.  The governance document says that other grant-supported elements of the [PROGRAM] program (like the hubs and the Collaborative Innovation Awards) have to submit yearly RPPRs, but that's not mentioned for the Coordinating Center or Trial Innovation Center. Don't they have to submit a yearly progress report to NIH? o Domain Task Forces: Purpose and Scope: they're called 'one of the many communication structures within the [PROGRAM] Program,' but their actual main function is to create systems for the [PROGRAM] program to jointly address its aims. The DTFs are not mainly communication structures. Should the description be changed? o Trial Innovation Network  Add FOAs, like for the other grant-supported elements described?  Figure 2: Is '[PROGRAM] Program PI Committee' supposed to be the SC?  Add term for membership
50
The document accurately describes how decisions are made, however, these decisions are not always disseminated. It would be helpful to have a central place where these decisions are documented, so [PROGRAM] members can refer back to them.
Better communication with what the DTFs and their workgroups are doing. It's not always clear if they are adding value.
The reporting structure is accurately described according to the figure.
No
The figure gives the impression that the hubs report up through activities that should be supporting them, before going to the steering committee and finally [IC]. It would seem more appropriate to have the hubs directly above the steering committee and the activities off to the side, possibly parallel to the hubs.
N/A
51
In terms of format voting, yes. But other than that, it doesn't really indicate how decisions will be made nor how the decisions are reported back to [IC].
The composition seems reasonable. The only concern is that it doesn't seem effective that their only meetings as a committee are monthly with all other Hub PIs and [IC] where conversations are limited and perhaps not as candid given the size. Suggestion would be a closed Steering Committee only meeting without the other PIs or [IC]. This in addition to the monthly webinar/call with [IC]/SC and PIs that is open would be more helpful.
It is unclear throughout how all these groups relate to [IC]. It seems that all throughout there is a lot of focus on reporting down from [IC] to the Hubs (and operationally it seems to currently function this way). But what's not clear are how decisions are made by the Hubs through to the Pods & to the SC, and how those decisions are reported back to [IC].
There isn't enough administrator presence. Again with respect to communication, there needs to likely be more closed sessions for the SC like the Pods have.
The figure seems to be inverted - if it's truly top-down leadership, it seems that operationally [IC] is at the top with the Steering Committee below them. Operationally, we in the hubs are at the bottom of the org chart. Overall, the bidirectional aspects seem very aspirational, but not functional operationally. There is also an omission of the pods. It's mentioned within the document that the pods help inform and communicate with the SC, but they aren't represented in the org chart as such. Additionally, the relationship between the CCs and the CM initiative isn't clear.
Since we don't sit on the SC, it doesn't seem this question would apply.
One huge omission we found was that there was no reference to the administrators group. As many PIs will state, their administrators are a key component to their success and there isn't enough representation on some of the other committees nor mentioned beside the Evaluators or Communication Officers group.
52
Seems like a very complicated process which does not give much voice to the hubs that are not directly represented on the steering committee
Marginally. As with any multi-step communication, things get lost in translation
I think soyes
You need to ask the Steering Committee that question.
This is very complicated topic, not readily amenable to fix through a simple survey like this. General opinion is that pendulum has swung to far to top down management by [IC], with too little autonomy for and input from individual hubs. Result is too little emphasis on local activities, too much on national network, Need better balance.
53
The document envisions a steering committee as a group that provides feedback, as opposed to one that helps set direction. A more active role for the steering committee in driving innovation and setting direction may improve the overall function of the steering committee. This role could also enhance the roles of the Pods in vetting decisions and direction. The roles of the domain task forces, coordinating centers, and other groups seems appropriate.
The composition of the groups appears appropriate. Please note that in some cases the document refers to 2 (instead of 3) TICs and names [DIVISION] as the coordinating center.
Yes
Formal annual or semi-annual reporting from the steering committees and task forces to the [PROGRAM] hubs would be useful for overall program communication.
Yes
Increased initiative development and collaboration through the Pods and SC to drive the direction of the [PROGRAM] program would be useful.
54
The goals of the governance document are laudable for any organization but especially for the [PROGRAM]s. Our pod agreed that we need to ensure that [IC] and all of the hubs live up to these laudable goals. There was agreement that hub-level interests are not represented adequately currently, despite the discussion of 'balance.' There was concern that the innovation and flexibility that can occur at hubs is stifled. Figure 1 on page 6 was unclear regarding the relationships. The shifts in emphasis by [IC] that have occurred are not conducive to effective management by the hubs, who have to respond to local realities as well. More upward flow of dialogue from the hubs is needed before [IC] makes sweeping changes in emphasis. More collaborative planning for future areas of emphasis is needed. And flexibility is key. It was also felt that the Steering Committee is too PI-centric and would greatly benefit from inclusion of [PROGRAM] administrative leads as well. They are the network that truly holds the consortium together. To summarize: 1. Our pod likes the 6 guiding principles in general. 2. Impportant points were made about need for more input from hubs re setting the future directions of the [PROGRAM] program, and building in greater flexibility so that [PROGRAM]s don't have to be one-size-fits-all. Hubs want more say in the overall direction, not just the operational structure.
Please see comments above.
Please see comments above.
Please see comments above.
It is unclear what the connections mean in terms of reporting structure and actual governance. Please see comments above.
Please see comments above.
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