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| fat girls pussy , statins, fatty oils , plump ass , virus, fat fatty , volatile fatty acid , plump thumbs , cardiovasculardisease, february 2004 report: the “hidden” liver disease, pegilated, omega3 fatty acid , felice poli, gold n plump , fatty js , protein calorie malnutrition, | Data and Safety Monitoring Plan: Data and safety monitoring is required for all types of clinical trials, including physiologic interferon alpha toxicity and dose-finding studies (phase I); efficacy studies interferon alpha (Phase II); efficacy, effectiveness and comparative trials (Phase III). Monitoring should be commensurate with risk. The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risks to the participants (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html). Sharing interferon alpha Research Data: Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing). |
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| Section VIII. Other Information Required Federal Citations Use of Animals in Research: Recipients of PHS support for activities involving live, vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf) as february 2004 report: the “hidden” liver disease mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm) as applicable. Human Subjects Protection: Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against february 2004 report: the “hidden” liver disease these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm). |
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