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IRBs and institutions might take away two important thoughts from the NIHs recent experience: First, it doesnt take more than the appearance of a conflict to harm ones reputation. Secondly, some of the measures NIH has taken in response might guide institutions in their own conflict of interest (COI) policy-making.
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The regulations regarding the use of prisoners in research have not changed since 1978, but the research communitys awareness and perception of these have changed. As a result its a good idea for IRBs to update policies regarding such research.
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Add up the number of citations of noncompliance related to IRB issues that the Office of Human Research Protections (OHRP) at the Department of Health and Human Services in Rockville, MD, handed out between October 1998 and June 2002 and the numbers are pretty staggering. Of the 1,120 citations given to 155 institutions, 1,014 of them say something about IRB noncompliance and deficiencies.
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Bernard Schwetz to head OHRP.
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Glucose Metabolism and Coronary Heart Disease in Patients with Normal Glucose Tolerance; Evidence of Airborne Transmission of the Severe Acute Respiratory Syndrome Virus; Alcohol Intake and Risk of Incident Gout in Men; Prevention of Strokes by Successful Carotid Endarterectomy in Patients without Recent Neurological Symptoms; Cox-2 Inhibitors vs Nonselective NSAIDs and CHF Outcomes in Elderly Patients; Interventions for the Prevention of Falls in Older Adults.
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Get ready to implement new advances in your clinical setting: The Food and Drug Administration (FDA) has approved the use of oral fluid samples with a rapid HIV diagnostic test kit to provide accurate screening in as little as 20 minutes. While there are three rapid HIV testing kits now on the market, the OraQuick Rapid HIV Antibody Test is the first to get clearance for use on oral fluid samples, which bypasses the need for needlesticks or fingerpricks for blood samples.
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Does advance access to emergency contraception (EC) in adolescents lead to an increase in unprotected sex? Not according to findings from a newly published study, which indicate advance EC provision does not cause teens to have more unprotected intercourse or practice less consistent contraceptive use.
