SCI/TBI Advisory Council Meeting
Friday, April 29, 2005
Room 333
University of South Dakota School of Medicine – Sioux Falls
 

PRESENT: Leo Hallan, Dr. Barry Timms, Mary Pat Forsberg, Grady Kickul, and Chris Olson (with 5 voting Council Members in attendance a quorum exists)

ABSENT: Ryan Green and Jim Tesch

GUESTS: Dr. John Koch and Maria Kramer

CALL TO ORDER
Chairman Leo Hallan called the meeting to order at 11:05 a.m.

APPROVAL OF THE MINUTES
The February 28, 2005 minutes were unanimously approved as distributed.

ITEMS OF BUSINESS
Grady Kickul noted that Dr. Timms has been officially appointed to the Council to replace Dr. Morecraft.

Dr. Timms circulated the CVs of the three expert external reviewers. Dr. Timms spoke briefly about these reviewers. The first, Dr. Jonathan Geiger, is Chair of the Department of Pharmacology and Physiology at the University of North Dakota. The second reviewer was Dr. Gerlinde Metz from the University of Lethbridge in Canada. The final reviewer was Dr. Mark Rasenick from the University of Illinois at Chicago.

Review Process - Grady requested that the Council walk through the process that they intended to follow in the meeting. Leo described the process as follows: He (Leo) will introduce an application; Council will discuss it, go over the two expert reviewers summaries, and make a decision.

Grady felt further clarification was needed. He first requested that it be noted in the minutes that the Council was operating under authority granted to it through Governor’s Executive Order 2004-07 which in Section 6 states that: “The Council shall by majority vote have the authority to award grants with the stipulation that funding provided will be for a three year term.”

He then proposed the following structure for the grant review:
1. The Council discusses each application. This discussion to include ratings and comments from both the expert reviewers and the consumer advocates.
2. Next all Council Member score the applicants which have reached the 3.5 threshold via secret ballot.
3. The Council Member’s secret ratings will be averaged and these averages used as a guide for the final funding recommendation.
4. The Council takes final funding action

Grady’s opinion was that each application should have to meet a threshold score 3.5 or better first before the Council rates it. (3.6 to 5.0 is considered “unacceptable”) Basically, if the Council concurs with the reviewer’s ratings while discussing the proposals, the Council wouldn’t even score that proposal via secret ballot. Dr. Timms noted that the Council should use the expert reviewer’s recommendations as one major basis for making a decision. (The final priority scores guide the Council regarding the applications that are to be funded.)

Dr. Timms noted that that the standard procedure in any process is to have the reviewers give their scores and comments and then everyone on the Council knows what the rating for the application is. Then you hold a secret ballot for each application so that anyone who hasn’t reviewed the proposal can rate it based on the presentation.

Conflict of Interest - Grady noted that normally a Council Member may not be present for discussion and voting if they have a conflict of interest. Each of the Council Members declared whether or not they have a conflict of interest. The application speaks to this. “Areas of conflict of interest may arise when a review committee member holds an appointment at the applicant’s institution. “ Dr. Timms declared that he is employed at USD in the same division as one of the applicants, and, therefore, felt too close to the applicant to give an unbiased vote regarding these grants. Grady recommended that the Council have Dr. Timms give input and fully participate in discussions regarding the applications, but not vote. Mary Pat seconded the motion and the Council approved it. All other Council Members affirmed that they had no conflicts of interest.

Meeting Materials Security - The Council discussed what physical documents should be kept from the review process and meeting. Dr. Timms recommended that all review notes and materials be given back to Dr. Koch and then unnecessary items can be shredded. All grant applications will be kept on file. Funded applications are considered public documents and can be requested by members of the public. Reviewer’s scores should be in writing along with any summaries and kept on record. Grady noted that USD will be the repository of these official records.

Qualifications of Consumer Advocates - Grady suggested that the Council needs to agree on a statement relative to the qualifications of consumer advocate reviewers. He proposed that consumer advocate reviewers be individuals who currently have (or have had) an SCI/TBI condition, or are a family member of someone so afflicted. Dr. Timms suggested that this also be noted as an amendment in the written process as this is the first time it has been addressed. Chris seconded Grady’s motion and the Council approved it.

Attendance by Council Personal Assistants - Chris sought clarification relative to the appropriateness of his mother attending Council meetings in order to assist him. Dr. Timms noted that as long as there is strict confidentiality, it’s OK for “staff” helpers to be at the meetings. This particularly the case given the challenges a number of the Council members would face without such assistance.

Follow-on Activities - Dr. Koch reminded everyone that once the Council finishes the process and has made its decisions, a process of notification needs to be implemented. There will need to be at least two letters from the Council. The first will inform the applicants whether they have been funded or not. The second letter goes to the Governor’s Office informing him that the Council has made its decision under the authority granted by the Executive Order and requesting that that the money required to fund these projects be transferred to the University for management purposes. Dr. Koch volunteered to author draft award and notification letters for the Chairs’ consideration.
Grady moved that the Chair work with Dr. Koch on the letters. The award letters will also include the summary statements. Prior to the formal notification of award, Dr. Koch will supply the draft materials to Grady to present to the Governor’s Office for review. Chris seconded Grady’s motion. The Council approved it. The deadline for the Council to get back to the applicants is May 15, 2005 with the start date being June 1, 2005

Reviewer Comments to go with Notification - Dr. Timms suggested that the two consumer advocate reviewers can have a combined summary statement of their review added to the primary reviewer’s statements. Dr. Timms indicated that he would be willing to help the consumer advocate reviewers fuse these together. The applicants do not know who is reviewing their applications. Typically there is a list of the review panel that is public knowledge, but the applicants don’t know who within the panel actually reviewed their application. Dr. Timms noted that the Council can keep the panel list on record in case anyone asks.

Reviewer’s Honorarium - Leo noted that, per an e-mail from Carmen Hammond at USDSM, USDSM will pay the primary reviewers. Dr. Timms believes that it would be nice to have the Chair send a letter and enclose an honorarium as appreciation for the reviewer’s time. Dr. Timms stated he would be happy to help draft the letter. Timms observed that the Council may want to suggest that the primary reviewers donate back their honorariums. Dr. Koch reminded everyone that the honoraria will be paid directly from USDSM operational funds, therefore, any refusal of an honorarium might logically be considered simply an expense USDSM does not have to incur rather than a gift to the Council.

Executive Session – The Council moved into executive session for the purposes of review and discussion of the two grant applications received. During this session comments of the external reviewers and consumer advocate reviewers was received by the Council and comment from individual Council Members invited. Each submission was reviewed individually and full discussion took place.

Returning from Executive Session – Noting that each application had some areas which require additional clarification and re-consideration, Mary Pat asked Chris and Leo to draft a letter explaining the need for the two applicants to refocus their proposals. Dr. Koch recommended that some Council Members speak directly to the applicants. Grady noted that the Council should start by sending a letter to the applicants. This would be a letter extending the application consideration period as the notification dates are only target dates. It should also inform them that Chris Olson and Leo Hallan have been designated by the Council to personally follow up with the applicants via a conference call on a scheduled date to address the questions and concerns about the proposal. The questions and concerns can either be addressed in the letter or during the conference call. Then give the applicant two weeks to respond in writing to the questions and issues that were discussed during the conference call.

Mary Pat liked Grady’s first thought and recommended the letter with the questions and concerns mentioned so the applicants could formulate their answers. Then the applicants would give their responses during the conference call and still send a written copy of their responses. Chris and Leo would give the benefit of technical assistance to the applicants over the telephone in putting together their responses. Chris noted that he would like a written letter back to the Council along with a revised application.

Grady Kickul expressed his enthusiasm for the work of the Council indicating that there aren’t a lot of Councils like this one around the country. He feels councils with individuals with disabilities haven’t had a lot of impact on researchers and haven’t been really listened to by researchers. This Council is on the cutting edge because it will be directing these researchers in what they want to see from them.

Dr. Koch observed that the National Institute of Health (NIH) has established a new Roadmap within their grants programs. They want to see much more “translational research” - projects that take basic scientific knowledge and move it from bench to bedside. NIH has already put out revised criteria for the review of Basic Biomedical Sciences grants which put more emphasis on applicability. This Council can use this to drive more applications research by being open to pilot funding of such work.

Council Funding Action - Grady officially moved that the Council authorize the Executive Committee to do the following:
1. Notify the researchers in writing of concerns/questions/needed revisions
2. Have a conference call with each researcher addressing the concerns/questions/ needed revisions
3. Direct the researchers to follow-up in writing
4. Authorize the Executive Committee to decide whether to fund and at what levels based on these communications. The Executive Committee will then inform the full Council of its actions.

The Executive Committee will also require that a resubmission of the application be sent in for the Council’s records and grants administration purposes. Mary Pat seconded the motion. The Council approved this motion.

Grady recommended that: (1) from the award date, the researchers each come before the Council to give them a 6-month progress report (in layman’s language) and (2) encouraged the Executive Committee to hold Researcher 1 to a higher standard during the consultation/revision process since Researcher 1’s score was not as competitive as that for Researcher 2’s submission.

Grady suggested that when the Executive Committee makes the decision, it will work with Dr. Koch regarding the notification because the Council has to do this according to Hoyle. Dr. Koch will help the Council set this up and then get a draft copy to Grady so he can run it by the Governor’s office. Grady also encouraged the Council not to commit to more than one year so the Council can see where the research is going.

Discussion Relative to Council Authority and Application Process – Grady observed that the Council’s authority is only limited by the Executive Order. The Council can go any direction they choose to go and has the flexibility to do mini-grants or whatever. The Council can give money out at the next meeting (or any meeting) if need be. There is particular flexibility right now since the Council is about to enter a new fiscal year. Thus, even if the Council funded these two proposals as requested, it would still have the ability to authorize another $300,000 as early as the next meeting. He emphasized that he sees this Council as truly a consumer-based Council that operates from within, and even has the authority in terms of practical research to go out and simply identify a project and find a researcher or clinician interested in doing it.

Chris felt we were learning some valuable lessons from this first round and believes the guidelines can be a tool to steer the research to what the Council would like to see.

Dr. Timms noted that the Council has time and an opportunity to re-address the relevance of this support. If the Council restricts the research to in-state research, the Council will limit themselves to a very small number of individuals that are doing this sort of neurological research. Dr. Timms noted that if the Council expands the research to allow some individuals to have some outside collaboration or exploratory projects for individuals who are doing research in another area with application to this, the more molecular approaches for example, then the Council might open up an opportunity for people to get some pilot study money to test this out. Leo noted that the Council could entice South Dakota researchers to work with outside resources in collaborative efforts in a narrowed focus.

Re-structuring of Application Process and Materials - Dr. Koch encouraged the Council to talk about what has happened with this process so they can start looking at how they take their next steps. Grady agreed that at the next meeting the Council should discuss mini-grants and planning/pilot projects as well as re-examine the application process priorities.

USD Foundation Account - Leo asked Dr. Koch about the account with the USD Foundation which was being sought as a place to hold donations to the Council. Koch replied that they are still in discussions with the Foundation as to some of the specifics of this. The Foundation has indicated that they would be willing to do this, but they don’t have the account set up yet.

NEXT MEETING
The next meeting will be on Friday, June 10, 2005 at 11:00 a.m. in the Health Science Center, Room 333.

Meeting adjourned at 3:55 p.m.