Research News
Please see below for postings arranged by date regarding research news, local research information, postings on new guidance and worksheets provided by federal organizations, changes to local forms and p&ps, announcements for educational opportunities and conferences etc. If you have an item that you would like to have posted to this page, please email the information to the Research Institute at research.institute@phci.org
How does Milwaukee stand out?
This month's M Magazine features an article about stand-out health care programs in the Milwaukee area. Mentioned first in the article is Dr. Mike McCrea, executive director of ProHealth Care's Neuroscience Center and the Research Institute regarding ProHealth Care's TBI research and his work with the federal government on traumatic brain injury. The article also includes the MAKOplasty partial knee resurfacing surgery that is being done at Oconomowoc Memorial Hospital, the only hospital in southeast Wisconsin with the technology.
Read More: M Magazine "How does Milwaukee stand out?
Date of post: August 5, 2010
Minorities in Research
The Building Trust research project, led by faculty at the University of Pittsburgh, in collaboration with PRIM&R, has recently completed a 30-minute film about minority participation in research. The chief message of the film is that more minorities are needed to participate in medical trials to find cures for diseases and conditions affecting them, but to make that happen, both researchers and potential participants need to change their way of thinking. The film "Medical Research, Bioethics and Race: Where Do We Go From Here" was funded by the National Center on Minority Health and Health Disparities of the National Institutes of Health.
Read More: Post Gazette Article
Date of post: August 5, 2010
Area study suggests more caution with athletes' concussions
The Journal-Sentinel featured an article about a clinical research study regarding concussion which was conducted by researchers at the ProHealth Care Neuroscience Center & Research Institute at Waukesha Memorial Hospital in collaboration with researchers at New York University School of Medicine. Dr. Mike McCrea, lead researcher for the study and executive director of ProHealth Care's Neuroscience Center & Research Institute was interviewed for the article.
An article is also on the Green Bay NBC television station's web site.
Read more:
Journal Sentinel Article: http://www.jsonline.com/features/health/98352224.html
NBC Article: http://www.nbc26.com/Global/story.asp?S=12802152
Date of post: July 14, 2010
With the iPad, Apple may just revolutionize medicine
Steve Jobs got a new liver, the rest of us got an easier way to watch Hulu in bed, and the health-care industry just may have gotten the big break it needed to launch into the 21st century.
Read more: http://www.washingtonpost.com/wp-dyn/content/article/2010/04/09/AR2010040906341.html?referrer=emailarticle
Date of post: July 7, 2010
Evolution of consent forms
The Hastings Center has released a report on a study of the evolution of consent forms. "The authors' review of the consent forms revealed two trends: greater consistency in the description of risks and an increase in the length of the forms....Their findings demonstrate the dilemma in attempting to provide information in consent forms that is simultaneously accurate and concise, while not making the forms so long that individuals are less likely to read or understand them."
Read more: http://www.thehastingscenter.org/Publications/IRB/Detail.aspx?id=4673
Date of post: July 1, 2010
Information Sheet Guidance for Sponsors, Clinical Investigators, and IRBs; Frequently Asked Questions-Statement of Investigator
The FDA has announced the availability of a new guidance sheet titled "Information Sheet Guidance for Sponsors, Clinical Investigators, and IRBs; Frequently Asked Questions-Statement of Investigator (Form FDA 1572)" For more information please see the announcement in the Federal Register.
Read more: http://edocket.access.gpo.gov/2010/2010-13420.htm
Date of post: July 1, 2010
FDA and NIH Launch Electronic Safety Reporting Portal
"The Food and Drug Administration and the National Institutes of Health today launched a new website that, when fully developed, will provide a mechanism for the reporting of pre- and post-market safety data to the federal government. Currently the website can be used to report safety problems related to foods, including animal feed, and animal drugs, as well as adverse events occurring on human gene transfer trials. Consumers can also use the site to report problems with pet foods and pet treats. The new site, called the Safety Reporting Portal (SRP), provides greater and easier access to online reporting."
Date of post: July 1, 2010
New Videos Reveal How NIH Identifies the Most Promising Research Applications
The NIH's Center for Scientific Review released two videos to help new grant applicants better understand how the application process works. The first, titled NIH Peer Review Revealed, "provides an inside look at the dynamic way reviewers evaluate NIH grant applications." In the second, NIH Tips for Applicants, "reviewers and NIH staff members featured in the NIH Peer Review Revealed video provide advice to new applicants."
Read more: http://www.nih.gov/news/health/jun2010/csr-16.htm
Watch the videos: http://cms.csr.nih.gov/ResourcesforApplicants/InsidetheNIHGrantReviewProcessVideo.htm
Date of post: July 1, 2010
Request for Information (RFI) on the NIH Plan to Develop the Genetic Testing Registry
NIH "is seeking input and feedback on its plan to develop the Genetic Testing Registry (GTR); a centralized public resource that will provide information about the availability, scientific basis, and usefulness of genetic tests. Submission of test information to the GTR will be voluntary, and the NIH expects to receive wide interest and participation from researchers, test developers, and manufacturers." Comments should be submitted by July 12, 2010.
Read more: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-10-101.html
Date of post: July 1, 2010
Notice of Proposed Rule-Making: Responsibility of Applicants for Promoting Objectivity in Research for Which Public Health Service Funding Is Sought and Responsible Prospective Contractors
The Department of Health and Human Services has posted a notice of a proposed rule related to financial conflicts of interest. The proposed rule "would expand and add transparency to investigator disclosure of significant financial interests, enhance regulatory compliance and effective institutional oversight and management of investigators' financial conflicts of interests, as well as NIH's compliance oversight." Public comments must be submitted by July 20, 2010. In a related article, Dr. Francis Collins and Sally Rockey of NIH authored a commentary on the proposed rule that was posted in JAMA on May 24.
Read more: http://jama.ama-assn.org/cgi/content/full/jama.2010.774
Concern over foreign trials for drugs sold in US
"Medical ethicists have worried for years about the growing share of new drugs whose human trials took place in foreign countries where federal auditors could not make sure patients were protected, but no one knew how big the potential problem was. But according to a report by Daniel R. Levinson, the inspector general of the Department of Health and Human Services, 80 percent of the drugs approved for sale in 2008 had trials in foreign countries, and 78 percent of all subjects who participated in clinical trials were enrolled at foreign sites...Ten medicines approved in 2008 were tested entirely abroad with not a single test patient in the United States, the report said."
Read more: http://oig.hhs.gov/oei/reports/oei-01-08-00510.pdf
Date of post: July 1, 2010
New effort launched for clinical drug trials
The Wall Street Journal reports that "New York state medical centers and drug makers are launching an initiative to address a nettlesome problem for clinical drug trials: getting patients to sign up. More than 3,000 clinical trials are actively recruiting in New York state, and an additional 8,000 trials involving New York are already running or were recently completed, according to the government clinical trials registry. Patient recruitment is one of the top reasons that clinical trials are delayed or fail, according to the Tufts Center for the Study of Drug Development."
Read more: http://online.wsj.com/article/SB10001424052748703280004575309051186276456.html
Date of post: July 1, 2010
FDA seeks to ban Chicago HIV doctor from research: Regulators say his clinic submitted phony data, forms with forged signatures
The Chicago Tribune reports, "In a rare move, federal regulators are seeking to disqualify a prominent Chicago HIV doctor from future drug studies after they discovered his clinic committed one of the most grievous sins of medical research: submitting fictitious data in a drug trial."
Read more: http://www.aegis.org/news/ct/2010/CT100602.html
Date of post: July 1, 2010
NIH Director says new rules on conflicts may need to be toughened further
The director of the National Institutes of Health, Francis S. Collins, is considering making some quick revisions to his long-awaited plan for toughening NIH conflict-of-interest regulations, following a Chronicle article highlighting his agency's handling of one of the most prominent examples of a researcher who failed to fully disclose payments from industry. The Chronicle reported that Thomas R. Insel, while leading a just-concluded yearlong NIH effort to bolster the agency's policies against financial conflicts of interest, was also working to help the tainted researcher, Charles B. Nemeroff, land a new job at the University of Miami.
Addressing his agency's advisory board Thursday, Dr. Collins said the proposed new rules, which are nearing final implementation, may now need to be changed to ensure that any penalties or sanctions against a researcher remain in effect if the researcher moves to another institution.
Read more:
May 20, 2010 article: http://chronicle.com/article/NIH-Proposes-Tougher-Rules-/65636
June 6, 2010 article: http://chronicle.com/article/While-Revising-Ethics-Rules/65800/
June 10, 2010 article: http://chronicle.com/article/NIH-Director-Says-New-Rules-on/65905/
Date of post: July 1, 2010
CISCRP, Pfizer pilot program to provide volunteers with study results
The Center for Information and Study on Clinical Research Participation (CISCRP) partnered with Pfizer to pilot a project to provide participants in clinical research with summaries of research results presented in scholarly journals. The summaries were written in "plain English" and both participants and research staff responded favorably to the project. CISCRP and Pfizer are now conducting a larger-scale study to incorporate the feedback they received in the pilot.
Read more: http://www.ciscrp.org/professional/participant/newsletters/may10/ParticipantMay2010-p1.pdf
Date of post: July 1, 2010
MMR doctor struck off medical register
"The doctor who first suggested a link between MMR vaccinations and autism has been struck off the medical register. The General Medical Council found Dr Andrew Wakefield guilty of serious professional misconduct over the way he carried out his controversial research. It follows a GMC ruling earlier this year that he had acted unethically."
Rease More: http://news.bbc.co.uk/2/hi/health/8700611.stm
Date of Post: July 1, 2010
ProHealth hoping research center will bring in more grants
ProHealth Care hopes its new research institute at Waukesha Memorial Hospital positions the parent company to compete with larger health systems, while bringing in millions of dollars in research grants.
Read more: ProHealth hoping research center will bring in more grants - The Business Journal of Milwaukee
Date of Post: 5/7/2010
WMH Regional Cancer Center Receives $2.7 Million National Cancer Institute Grant
Funding Will Expand Cancer Research and Care For Underserved
The ProHealth Care Regional Cancer Center at Waukesha Memorial Hospital is among 14 hospitals to receive a grant from the National Cancer Institute (NCI), part of the National Institutes of Health, to expand its cancer research program, supportive care services and provide state-of-the-art cancer care to underserved populations.
http://www.prohealthcare.org/whats-new/regional-cancer-center-receives-.aspx
Date of Post: 4/23/2010
Access to Investigational Drugs - Webinar Materials
Expanded access, sometimes called "compassionate use," is the use of an investigational drug outside of a clinical trial to treat a patient with a serious or immediately life-threatening disease or condition who has no comparable or satisfactory alternative treatment options.
http://www.fda.gov/AboutFDA/Basics/ucm200769.htm
Date of Post:4/5/2010
FDA MedWatch Mobile Text Messaging
The FDA recently launched a new MedWatch Safety Information mobile text message program. The content of the text messages will consist of alerts that provide timely new safety information on human drugs, medical devices, and related safety topics. The messages contain actionable information that may impact both treatment and diagnostic choices for healthcare professional and patient. To subscribe to the pilot, text FDA to 87000. Subscribers can expect to receive approximately three to five text messages a week during the six-month pilot. Standard text messaging rates will apply.
Date of Post:4/5/2010
US health bill promises changes for biomedical researchers
http://www.nature.com/news/2010/100323/full/464479a.html
Date of Post: 3/31/2010
Published online 23 March 2010 | Nature 464, 479 (2010)