Archive for March, 2009
The system created to review and monitor clinical trials involving humans is vulnerable to “unethical manipulation,” and government officials admit they don’t assess whether some parts of the system are adequate or even factual.
In a recent investigation of the Institutional Review Board (IRB) system, the Government Accountability Office (GAO) created a fake company with a fake review board, received approval to test a nonexistent medical device, and falsified documents—all with the approval of federal agencies.
An IRB is an entity formally designated to review and monitor research involving human subjects. IRBs have traditionally been part of large research universities, but private companies have started playing a greater role in creating IRBs to oversee clinical trials. The Department of Health and Human Services’ Office for Human Research Protections and the Food and Drug Administration are responsible for overseeing the IRB system.
In its undercover investigation, GAO created a “bogus” company and IRB. It appeared so real that a private research company contacted the GAO’s IRB about reviewing its surgical procedures. In addition, GAO filed an assurance statement with HHS, promising to protect human subjects. That HHS assurance application, which was approved, would have allowed the fake company to receive HHS research funding. And the last part of the investigation? GAO was able to get approval from an actual IRB to test a fake medical device.
In response to GAO’s investigation, the director of the Office of Human Research Protections said when reviewing assurance applications, HHS does not consider whether the IRBs listed are “adequate” nor does it review applications to determine whether the information is true.
The results of GAO’s investigation were presented recently in testimony before the House Subcommittee on Oversight and Investigations, Committee on Energy and Commerce.
To read the full GAO report, click here.
The American Recovery and Reinvestment Act specifically prohibits funds from being used to support any gambling establishment, aquarium, zoo, golf course, or swimming pool. But according to President Obama and Vice President Biden, similar projects also will be on the forbidden list. Speaking to members of the National Conference of State Legislatures, Obama said “whenever a project comes up for review, we will ask a few simple questions: Does it advance the core mission of the Recovery Act? Does it jumpstart job-creation? Does it lay the foundation for lasting prosperity?” Biden added, “There is the letter of the law and then there is the spirit of the law. And we intend to make sure the spirit of the law is what’s actually followed here, in addition to the letter.”
So, no Recovery Act funding for dog parks or skateboard parks. And no funding for new lights in the White House. The president went on to provide an example of what he considers an imprudent project. He said the East Wing, where the first family lives, needs repairs to the electrical and heating systems. However, the work would not meet the economic recovery goals of the new law, so Recovery Act funding will not be used for the project.
Obama issued a memo to the heads of federal agencies on March 20, outlining specific steps that should be taken when reviewing and funding Recovery Act projects. It requires the creation of merit-based review criteria and outlines agencies’ and grantees’ responsibilities for ensuring funds are not used for imprudent or prohibited projects. But it goes even further: recipients who use funds for excluded projects and activities face specified penalties such as additional reporting and oversight requirements, rescission of funds, and even possible suspension and debarment.
To view the memo, click here.
Management Concepts’ Federal Grants Update 2009 course offers a discussion of the Recovery Act and its impact on grants management. For information about upcoming sessions, click here.
Looking for a quick, easy way to track funding opportunities from the National Institutes of Health? Try Twitter.
In mid-March NIH began using the social networking and blogging service to provide information about funding opportunities. Using Twitter, NIH will post links to Funding Opportunity Announcements in a condensed format, about the size of a typical text message. The Institute will “tweet” announcements once a week. (Twitter enables users to send and read other users’ updates known as tweets. Tweets are text-based posts that can be accessed via the Twitter website, RSS feeds, cell phone text message systems, and similar services.) NIH is also using Twitter to post general health news updates.
To learn more and to sign up for Twitter, visit the NIH Twitter page at http://twitter.com/NIHforFunding.
Welcome to Management Concepts’ Grants Blog.
We created this site as a tool to help you stay up to date on the latest information that affects the administration of federal grants and assistance programs. You’ll find posts about new governmentwide policies and directives, congressional activities, federal awarding agency issuances, answers to common grants management questions, and much more. We’ll also be passing along grants management tips, helpful resources, interesting facts and news briefs, and other tidbits that can help you in your daily work. And occasionally you’ll find a posting by a grants management subject matter expert who will share some real-life experiences, thoughts about current developments, and insights into federal grants management issues.
A little bit about me…
My name is Lisa Hayes, and I’ll be posting most of the entries for the Management Concepts Grants Blog. I’m a curriculum developer in Management Concepts’ Grants division – which basically means I help write and update our training materials. One of my responsibilities is to constantly monitor developments affecting federal grants management, and this blog will offer me an opportunity to share some of that information with you. As we developed this blog, I envisioned that its contents would span three c’s: current, constructive, and casual. If you have questions or comments about anything you read on the blog, please feel free to email me at email@example.com. For more information about Management Concepts, visit us online at http://www.managementconcepts.com