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| 31 March 2009 |
FDA's HSP/BIMO Initiative Accomplishments - Update published
As part of the report, FDA discloses the number of Bioresearch Monitoring (BIMO) inspections performed in the FY 2008: 675 Clinical Investigators, 179 Institutional Review Boards (IRBs), and 109 Sponsors/Monitors/CROs were inspected.
Of the 705 Clinical Investigators which were classified by FDA in FY2008, 9 % ended up in the 'Official Action Indicated' (OAI) category and 41 % in the 'Voluntary Action Indicated' (VAI) category.
Of the 90 Sponsors/Monitors/CROs, 19 % were classified OAI and 20 % VAI in FY2008.
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| 25 March 2009 |
International Compilation of Human Research Protections
The Office for Human Research Protections (OHRP) of the U.S. Department of Health and Human Services published the 2009 edition of the 'International Compilation of Human Research Protections'. This compilation lists the approximately 1100 laws, regulations, and guidelines that govern human subjects research in 92 countries, as well as standards from a number of international and regional organizations. This compilation was developed for IRBs/Ethics Committees, researchers, sponsors, and others who are involved in international research. Its purpose is to help these groups familiarize themselves with the laws, regulations, and guidelines where the research will be conducted, to assure those standards are followed appropriately.
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| 24 December 2008 |
Merry Christmas and a Happy New Year!
Wishing you a good start into 2009! ... and for each day of the New Year sufficient humor to enjoy the surprises that each day may hold and serenity in turbulent times. Our best wishes for a prosperous New Year!
Instead of sending presents and mailings at the end of the year, we have decided to support the Theodora Foundation (www.theodora.ch). Since 1993, this Swiss foundation has organized professional training for clown doctors (aka 'clinic clowns') and managed their visits to children in hospitals. The clown doctors dispense doses of fun and laughter and help children forget for a moment that they are ill. After all, laughter is the best medicine ... and the extra smile does not require a prescription!
Clown doctors work in close cooperation with physicians and health care staff. Our contribution to this foundation will help children in 46 hospitals across Switzerland and 60 hospitals in Belarus, China, France, Italy, Spain, Turkey and the UK to better cope with their time in hospital and to speed up their recovery.
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