文章： Ethical, legal, and social considerations in conducting the Human Microbiome Project 杂志：Genome Research 讨论了HMP计划的伦理、法律等方面的问题； 样品收集，用了排除法，原则是有可能影响肠道菌群稳定的情况进行了排除： 1） taking specific medications (e.g., antibiotics, immunosuppressive agents) 2） major dietary changes 3） history of cancer (exception of certain skin cancers) 4） chronic immune-mediated disorders (e.g., inflammatory bowel disease, psoriasis) 5） history of chronic candidiasis (yeast infection) 6） active sexually transmitted diseases (e.g., gonorrhea) within the previous 2 mo for females 7） Children under the age of 18 and adults beyond the age of 40 will be excluded because of the need for a relatively uniform human population 知情同意书： 1）鉴于未来的研究是不可预期的，为此知情同意书应当是动态的； 2）为了特殊研究目的进行研究时，需要告知参与者签订特定的知情同意书； 研究结果的告知： 对参与者的结果反馈是HMP颇为纠结的问题，为此 Current policy leaves it up to the primary investigator and local institutional review board (IRB) to decide whether or not to return research results to participants 对于 HIV and other sexually transmitted infections。如果是HIV， In the context of HIV, if test results are associated with personal identifiers, then federal policy requires that individuals be informed of their test results and that pre- and post-test counseling be provided (Department of Health and Human Services, Office for Protection from Research Risks , Policy on Informing Those Tested About HIV Serostatus; http://www.hhs.gov/ohrp/humansubjects/guidance/hsdc88jun.htm )。对于 sexually transmitted infection，各个州的要求不完全相同 数据分享和隐私保护： 在HGP计划中，针对数据分享，NIH制定了相关的policy。随着技术的发展，此policy也做了些调整。 As the HMP is initiated, researchers are once again faced with the decision of whether to adopt data sharing policies that allow public access. The current plan is to deposit all human microbial DNA into publicly accessible databases (Office of Portfolio Analysis and Strategic Initiatives. NIH Roadmap for Medical Research: Human Microbiome Project—Overview; http://nihroadmap.nih.gov/hmp )。 取样的风险： 原则需要减少取样的风向 多样性： 尽可能做到人群的多样性增加，同时尽量保证民族与种族的多样性。
标签: HMP
