{"id":1063363,"date":"2012-10-07T15:53:05","date_gmt":"2012-10-07T15:53:05","guid":{"rendered":"http:\/\/www.longevitymedicine.tv\/researcher-alert-california-stem-cell-agency-tightening-budget-oversight-on-grants\/"},"modified":"2024-08-17T20:29:00","modified_gmt":"2024-08-18T00:29:00","slug":"researcher-alert-california-stem-cell-agency-tightening-budget-oversight-on-grants-2","status":"publish","type":"post","link":"https:\/\/www.euvolution.com\/futurist-transhuman-news-blog\/stem-cell-therapy\/researcher-alert-california-stem-cell-agency-tightening-budget-oversight-on-grants-2.php","title":{"rendered":"Researcher Alert: California Stem Cell Agency Tightening Budget Oversight on Grants"},"content":{"rendered":"<p><a href=\"http:\/\/feedads.g.doubleclick.net\/~a\/HNF8fkle_nFoJFyMki6WG72aosY\/0\/da\"><img decoding=\"async\" src=\"http:\/\/www.longevitymedicine.tv\/wp-content\/plugins\/wp-o-matic\/cache\/1fd63_di\" border=\"0\" style=\"padding-left:10px; padding-right: 10px;\"><\/a><br><a href=\"http:\/\/feedads.g.doubleclick.net\/~a\/HNF8fkle_nFoJFyMki6WG72aosY\/1\/da\"><img decoding=\"async\" src=\"http:\/\/www.longevitymedicine.tv\/wp-content\/plugins\/wp-o-matic\/cache\/1fd63_di\" border=\"0\" style=\"padding-left:10px; padding-right: 10px;\"><\/a><\/p><p>Some of California's top stem cell<br>researchers are going to have to sharpen their spreadsheets if they<br>want to win money from the state's $3 billion stem cell agency.<\/p><div><\/div><div>The agency is moving to beef up<br>scrutiny of the high-profile, big-ticket grant applications<br>that it will consider during the next several years. The effort may well  extend to all grant programs. The move also makes<br>it clear to researchers that the CIRM staff is in the driver's seat<br>when it comes to budgeting on research projects.<\/div><div><\/div><div>The plan was<a href=\"http:\/\/cirm.ca.gov\/files\/meetings\/pdf\/2012\/100812_item_5_Budget.pdf\"> laid out this week in a memo<\/a> to directors of the <b>California Institute for Regenerative Medicine<\/b> (<b>CIRM<\/b>) by<b> Ellen Feigal<\/b>, the agency's senior vice<br>president for research and development.  She said,<\/div><blockquote><p>&ldquo;Increasing the importance of<br>budgetary review will encourage applicants to propose rigorous,<br>realistic and vetted budgets, and will further our mission to be good<br>stewards of taxpayer dollars.  These additions will not significantly<br>increase the workload burden on GWG members (grant reviewers) and<br>explicitly acknowledge that program&nbsp;goals, scientific plans, accurate&nbsp;budgeting and prudent spending are inextricably linked.&rdquo;<\/p><\/blockquote><div>The proposal comes before the CIRM<br>directors' <b>Science Subcommittee<\/b> <a href=\"http:\/\/cirm.ca.gov\/Agenda_2012-10-08\/science-subcommittee\">next Monday<\/a> and would alter the<br>closed-door grant review process in the following manner, according<br>to Feigal's memo.<\/div><blockquote><p>&bull; &ldquo;To assist GWG review,<br>appropriate expertise on budget and financial matters (e.g., this<br>could be in the form of a specialist reviewer, or can also be<br>assigned to a GWG reviewer with the appropriate background and<br>expertise), will review applications for sound budgeting and provide<br>comments or questions to the GWG for consideration by the reviewers<br>before the reviewer&rsquo;s final scores are entered.<br>&bull; &ldquo;If the financial\/budgetary<br>matter potentially directly impacts on the design or feasibility of<br>conducting the project, the GWG may consider this issue in the<br>scoring; otherwise, budgetary and financial issues and questions will<br>not contribute to the scientific score.<br>&bull; &ldquo;As appropriate, review summaries<br>sent to the ICOC (the CIRM governing board) will identify scientific<br>as well as budget or other issues.  To the extent endorsed by the<br>GWG, the review summaries will also identify potential resolution<br>should the ICOC approve a given award with budget issues.<br>&bull; &ldquo;CIRM officers should be provided<br>explicit discretion to consider the budget comments, as well as<br>budget or other issues.  To the extent endorsed by the GWG, the<br>review summaries will also identify potential resolution should the<br>ICOC approve a given award with budget issues.&rdquo;<\/p><\/blockquote><div>Feigal's memo clearly indicates that<br>CIRM staff has experienced push-back from recalcitrant researchers<br>when efforts have been made to bring costs under control. She noted that<br>the agency's staff examines a research project's budget during the<br>&ldquo;prefunding&rdquo; review that follows board approval. However, Feigal<br>said, at that stage, &ldquo;It is often challenging to make substantive<br>changes to the budget, based on appropriateness of study activities<br>and costs, given the ICOC approval at a given budget amount.&rdquo;<\/div><div><\/div><div>The agency has already examined some<br>budgets prior to board approval. <a href=\"http:\/\/cirm.ca.gov\/ReviewSummary_DR2A-05309\">One grant review<\/a> in a $200<br>million-plus round this summer, for example, declared that costs to<br>prepare regulation packages had &ldquo;overlap&rdquo; and were &ldquo;excessive,&rdquo;<br>along with costs dealing with manufacturing and per patient expenses.<br>That was for a high-scoring application by <b>Antoni Ribas<\/b> of <b>UCLA<\/b>, and<br>he was not alone.<\/div><div><\/div><div>In her memo, Feigal listed other cases<br>of budgetary shortcomings in recent applications:,<\/div><blockquote><p>&bull; &ldquo;Budget does not align with the<br>program deliverables and milestones.  For example, the budget<br>includes activities not relevant to project objective(s) or that are<br>out of scope.<br>&bull;&rdquo;Budget does not contain adequate<br>expenses for known costs.  For example, an applicant may budget<br>$100,000 for a GMP manufacturing run of a biologic in which it is<br>generally accepted knowledge that the actual expenses are typically<br>much greater.<br>&bull;&ldquo;Budget item significantly exceeds<br>a known cost or seems excessive without adequate justification.  For<br>example, an applicant may propose a surgical expense of $100,000 per<br>patient for a procedure with Medicare reimbursement set at $15,000.<br>&bull;&ldquo;Cost allocations are not done<br>properly.  For example, an applicant is developing the same<br>therapeutic candidate for 3 indications, and is applying for CIRM<br>funding for 1 of the 3, but is charging CIRM for the cost of the<br>entire manufacturing run.&rdquo;<\/p><\/blockquote><div>Initially, the budgetary review would<br>be used in disease team, early translational, strategic partnership<br>rounds, and any new rounds &ldquo;as deemed appropriate.&rdquo; Feigal said,<br>however, that  &ldquo;all applications for CIRM awards should be<br>carefully examined for budgetary appropriateness.&rdquo;<\/div><div><\/div><div>Our take: This seems to be a<br>well-advised move, albeit one that is not likely to find favor with<br>researchers accustomed to loose oversight. It moves budgetary review<br>to an earlier stage and gives the CIRM directors a chance to weigh in<br>on those matters prior to approval of grants, instead of creating a<br>sense of entitlement on the part of recipients that may pop up<br>following board approval of their applications. Indeed, the plan<br>makes such good sense that it raises the question why it was not in<br>place years ago.<\/div><div><\/div><div>A final note: Feigal's memo is an<br>excellent example of the type of information that clarifies issues<br>and helps CIRM directors make the best possible decisions. It<br>provides some history, good evidence for a change and an explanation<br>of benefits. Additionally, the memo is timely, having been posted on<br>the CIRM website sufficiently in advance of next week's meeting to give affected parties and others time to comment<br>and make constructive suggestions. The memo is also far superior to<br>the Power Point presentations that are often submitted to the board<br>minus any nuanced, written discussion of the issue at hand.<\/div><div><\/div><div>Next week's meeting will be based in<br>San Francisco but also has teleconference locations in Irvine (2), La<br>Jolla, Stanford, Pleasanton, Oakland and Los Angeles where the public<br>and researchers can participate. The specific addresses <a href=\"http:\/\/cirm.ca.gov\/Agenda_2012-10-08\/science-subcommittee\">can be found on the agenda. <\/a><\/div><div><\/div><div><\/div><div><img loading=\"lazy\" decoding=\"async\" width=\"1\" height=\"1\" src=\"http:\/\/www.longevitymedicine.tv\/wp-content\/plugins\/wp-o-matic\/cache\/1fd63_10000891-2248614655671161886?l=californiastemcellreport.blogspot.com\" alt=\"\" style=\"padding-left:10px; padding-right: 10px;\"><\/div><p><img loading=\"lazy\" decoding=\"async\" src=\"http:\/\/www.longevitymedicine.tv\/wp-content\/plugins\/wp-o-matic\/cache\/1fd63_30DY8fml4zE\" height=\"1\" width=\"1\" style=\"padding-left:10px; padding-right: 10px;\">Source:<br><a href=\"http:\/\/feedproxy.google.com\/~r\/blogspot\/uqpFc\/~3\/30DY8fml4zE\/researcher-alert-california-stem-cell.html\">http:\/\/feedproxy.google.com\/~r\/blogspot\/uqpFc\/~3\/30DY8fml4zE\/researcher-alert-california-stem-cell.html<\/a><\/p>","protected":false},"excerpt":{"rendered":"<p>Some of California's top stem cellresearchers are going to have to sharpen their spreadsheets if theywant to win money from the state's $3 billion stem cell agency.The agency is moving to beef upscrutiny of the high-profile, big-ticket grant applicationsthat it &hellip; <a href=\"https:\/\/www.euvolution.com\/futurist-transhuman-news-blog\/stem-cell-therapy\/researcher-alert-california-stem-cell-agency-tightening-budget-oversight-on-grants-2.php\">Continue reading <span class=\"meta-nav\">&rarr;<\/span><\/a><\/p>\n","protected":false},"author":64,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"limit_modified_date":"","last_modified_date":"","_lmt_disableupdate":"","_lmt_disable":"","footnotes":""},"categories":[25,1246878],"tags":[],"class_list":["post-1063363","post","type-post","status-publish","format-standard","hentry","category-stem-cell-therapy","category-stem-cells"],"modified_by":null,"_links":{"self":[{"href":"https:\/\/www.euvolution.com\/futurist-transhuman-news-blog\/wp-json\/wp\/v2\/posts\/1063363"}],"collection":[{"href":"https:\/\/www.euvolution.com\/futurist-transhuman-news-blog\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.euvolution.com\/futurist-transhuman-news-blog\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.euvolution.com\/futurist-transhuman-news-blog\/wp-json\/wp\/v2\/users\/64"}],"replies":[{"embeddable":true,"href":"https:\/\/www.euvolution.com\/futurist-transhuman-news-blog\/wp-json\/wp\/v2\/comments?post=1063363"}],"version-history":[{"count":0,"href":"https:\/\/www.euvolution.com\/futurist-transhuman-news-blog\/wp-json\/wp\/v2\/posts\/1063363\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.euvolution.com\/futurist-transhuman-news-blog\/wp-json\/wp\/v2\/media?parent=1063363"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.euvolution.com\/futurist-transhuman-news-blog\/wp-json\/wp\/v2\/categories?post=1063363"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.euvolution.com\/futurist-transhuman-news-blog\/wp-json\/wp\/v2\/tags?post=1063363"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}