TRAINING GRANTS FOR CLINICAL RESEARCHERS. The Association for Patient Oriented Research has a useful listing of fellowships and other training grants provided by foundations and the NIH for fellows and faculty involved in clinical research (http://www.mc.vanderbilt.edu/gcrc/apor/html/research.htm).
 

TROUBLE IN DOT.COM LAND. Clinmark, Inc., which last year renamed itself Clinmark Dotcom, has ceased operations. The company had developed a web based database of investigators and investigative sites used by industry to place clinical trials. The database is for sale.
 

CLINICAL TRIALS AND THE FDA. Having two sets of human subjects guidelines, one from Health and Human Services and one from the FDA, is often confusing. The FDA has organized its human subjects protection activities in the Office for Human Research Trials (OHRT). The office’s web site (http://www.fda.gov/oc/ohrt/default.htm) is the place to go for information about FDA regulations, guidelines, policy proposals, FDA contacts, and educational material. An interesting list compares FDA and HHS human subjects regulations (http://www.fda.gov/oc/ohrt/comparison.html).
 

CLINICAL TRIALS IN DEVELOPING COUNTRIES. The National Bioethics Advisory Commission has issued recommendations for international clinical trials aimed at preventing exploitation of research participants in developing countries. Major issues are ensuring that clinical trials are responsive to the country’s needs and that the research products are available in that country after product approval. The report can be viewed at www.bioethics.gov.
 

ACCREDITATION OF IRBs?. The Institute of Medicine initiated a vocal debate last month when it issued its report ” Preserving Public Trust: Accreditation and Human Research Participant Protection Programs.” The committee recommended adopting a program developed by the National Committee for Quality Assurance (NCQA) for the VA system. The report favored the NCQA program over a competing plan proposed by Public Responsibility in Medicine and Research (PRIM&R). Many critics, including the Association of American Medical Colleges, feel it is premature to select one accreditation standard over the other. The IOM report addressed issues other than the accreditation of research programs, and can be read at http://www.nap.edu/books/0309073286/html.
 

ONLINE TRAINING FOR CLINICAL RESEARCH. The NIH has just made available an interactive course teaching the essential principles and processes of conducting clinical research. Topics
Covered are ethical issues in human subjects research, roles and responsibilities of the investigator, roles and responsibilities of the institution, regulatory issues, and clinical investigators and the mass media.  The program can be accessed at www.cc.nih.gov/ccc/cr/training.html.