Requiring Consent vs. Waiving Consent for Medical Records Research: A Minnesota Law vs. the U.S. (HIPAA) Privacy Rule

The use of medical records in research can yield information that is difficult to obtain by other means. When such records are released to investigators in identifiable form, however, substantial privacy and confidentiality risks may be created. These risks become more common and more serious as medical records move to an electronic format. In 1996, the state of Minnesota enacted legislation with respect to consent requirements for the use of medical records in research. This legislation has been widely criticized because--it is claimed--it creates an unnecessary impediment to research. In this article, we show that these arguments rest upon misinterpretation and/or misrepresentation of the 1996 legislation. A consent requirement had actually been present in Minnesota since 1976 (though codified in a patient rights statute rather than a privacy statute). The 1996 law does not require specific consent, as often claimed, but rather only a general authorization. The campaign against the Minnesota legislation appears to have been motivated by concern with respect to the then impending federal privacy rule. The HIPAA rule, as enacted, is in fact less stringent with respect to consent than the Minnesota consent law. On the other hand, the Minnesota consent law has not been effectively applied or enforced. As we change the way we manage sensitive medical information, new efforts are needed to provide protection against the confidentiality risks in research. Patient consent is an important tool in this regard. New instrumentalities are needed to solicit and document consent.     

Total and free tissue factor pathway inhibitor in pregnancy hypertension.

OBJECTIVE: To clarify the role played by tissue factor pathway inhibitor (TFPI) in pregnancy hypertension. METHODS: Using enzyme-linked immunosorbent assays, hemostatic measurements were obtained for women with pre-eclampsia (n=51), nonproteinuric hypertension of pregnancy (n=62), postpartum pre-eclampsia 24 h after childbirth (n=31), and no hypertension (healthy pregnant controls, n=100). RESULTS: There was a significant increase in circulating free TFPI levels in women with pre-eclampsia (9.7+/-6.2 ng/mL) or nonproteinuric hypertension of pregnancy (8.3+/-5.3 ng/mL) compared with healthy controls (5.3+/-2.1 ng/mL). In women with pre-eclampsia the levels remained elevated after placental delivery (10.6+/-4.0 ng/mL). Free protein S levels were significantly higher in women with pre-eclampsia (40.0%+/-10.7%), nonproteinuric hypertension of pregnancy (37.1%+/-12.5%), or postpartum pre-eclampsia (39.3%+/-9.1%) than in healthy pregnant controls (32.2%+/-8.5%). CONCLUSION: Increased levels of the physiologically active free forms of TFPI and free protein S, 2 coagulation inhibitors, may protect women with pregnancy-induced hypertension from the risks of hemostatic activation.     

腺病毒介导的P16／CDKN2基因对TJ899细胞系活性的影响

（1）目的 研究5型腺病毒载体（Ad5)携带P16基因对恶性脑胶质瘤细胞系TJ899生长状态的影响。（2）方法 免疫组化（SP法）测定P16蛋白表达，MTT（methly thiazolyl tetrazolium,MTT)法测定恶性脑胶质瘤细胞系生长状态，克隆形成实验。（3）结果 重组体腺病毒能介导P16外源基因在恶性脑胶质瘤细胞系TJ899细胞中阳性表达，6d时肿瘤细胞生长抑制率为93%，并且能显地抑制肿瘤细胞的克隆形成能力。（4）结论 腺病毒介导P16基因能在肿瘤细胞中表达。并能明显抑制肿瘤细胞生长的状态。     

外阴尖锐湿疣人乳头瘤病毒感染的检测与分型

目的 了解患外阴尖锐湿疣人乳头瘤病毒(HPV)6型和11型的感染情况及PCR方法对尖锐湿疣诊断与分型的临床意义。方法 采用PCR方法测定160例尖锐湿疣患病题组织或分泌物中HPV6／11型及HPVl6／18型的感染率。结果 HPV6／11型感染率为95％(152／160)，HPVl6／18型感染率为5％(8／160)，HPV6／11型 HPVl6／18型混合感染率为1．3％(2／160)。结论 外阴尖锐湿疣患以HPV6型和11型感染为主。PCR方法是一种比较适合临床HPV检测与分型的极为敏感和特异的诊断方法。     

微血管密度和p16基因表达对判定肾癌生物学行为的意义

目的 :探讨肿瘤内的微血管密度 (IMD)和 p1 6基因表达与肾细胞癌 (RCC)生物学行为的关系。 方法 :采用免疫组织化学方法 ,对 76例RCC患者的根治性肾切除标本 ,检测第Ⅷ因子相关抗原和 p1 6基因表达 ,分析IMD、p1 6基因表达与RCC分期、分级及预后的相关性。 结果 :IMD随临床分期升高而增加 (P <0 .0 5 ) ,而与分级无明显相关性 (P >0 .0 5 ) ,随访 5年内死亡者IMD明显升高 (P <0 .0 1 ) ;癌旁组织中 p1 6阳性率 (75 .0 % )显著高于RCC组织 (4 8.7% ) ,p1 6阳性表达随临床分期、病理分级升高而降低 (P <0 .0 5 ) ,而与IMD呈负相关性。结论 :IMD是预测RCC恶性行为的一个有用指标 ,IMD和p1 6基因表达可为RCC的疗效和预后判定提供重要的资料。     

抑癌基因P16在膀胱移行细胞癌中的表达及临床意义

目的　探讨抑癌基因P16蛋白在膀胱移行细胞癌中的表达。方法　采用S -P放射免疫法检测 3 2例膀胱移行细胞癌、10例正常膀胱粘膜中P16蛋白的表达。结果　 3 2例膀胱移行细胞癌中 ,P16蛋白表达总阳性率为 40 .63 % ;在膀胱移行细胞癌Ⅰ、Ⅱ、Ⅲ级中分别为 63 .64 %、3 3 .3 3 %、2 5 .0 0 %。P16蛋白表达的阳性率随病理分级增高而降低 ,Ⅰ级与Ⅱ级、Ⅲ级比较差异无显著性 (P >0 .0 5 )。结论　P16蛋白检测有助于对膀胱移行细胞癌的诊断 ;P16蛋白的缺失与膀胱移行细胞癌的发生、发展和预后有关。     

长链核酸扩增技术评价病毒灭活效果的研究

目的:探讨用长链核酸扩增技术评价病毒灭活效果的可行性.方法:针对伪狂犬病毒(pseudorabies virus,PRV)糖蛋白gD基因前后的保守区设计预计产物长短不一的5对引物,用半巢式PCR技术扩增经低pH法(4.0±0.1)、巴氏消毒法[(60±1.0)℃]和s/D法(有机溶剂/洗涤荆)处理后的PRV核酸,同时以细胞感染法做平行对照.结果:低pH对PRV核酸有破坏作用,处理时间越长,核酸损伤程度越明显,处理60 min时,6.62 lgTCID50的PRV完全被灭活.5条不同长度PCR扩增产物中,只有3.9 kb的长片段检出与细胞培养结果一致.7.25 lgTCID50的PRV经(60±1.0)℃处理20 min后即被完全灭活,7.13 lgTCID50的PRV经s/D法处理1 h后被完全灭活,但各长度核酸片段扩增均为阳性,与细胞感染试验结果不符.结论:低pH对PRV核酸的损伤程度随处理时间的延长而增加;用长链PCR(3.9 kb)技术来评价经低pH法灭活病毒的效果是可行的,而该法不适合评价巴氏消毒法和S/D法灭活病毒的效果.     

Co-segregation of the PROS1 locus and protein S deficiency in families having no detectable mutations in PROS1.

Inherited deficiency of protein S constitutes an important risk factor of venous thrombosis. Many reports have demonstrated that causative mutations in the protein S gene are found only in approximately 50% of the cases with protein S deficiency. It is uncertain whether the protein S gene is causative in all cases of protein S deficiency or if other genes are involved in cases where no mutation is identified. The aim of the current study was to determine whether haplotypes of the protein S gene cosegregate with the disease phenotype in cases where no mutations have been found. Eight protein S-deficient families comprising 115 individuals where previous DNA sequencing had failed to detect any causative mutations were analyzed using four microsatellite markers in the protein S gene region. Co-segregation between microsatellite haplotypes and protein S deficiency was found in seven of the investigated families, one family being uninformative. This suggests that the causative genetic defects are located in or close to the protein S gene in a majority of such cases where no mutations have been found.     

不同性别飞行学员人格特征的比较

目的 :探讨男女飞行学员人格特征的差别 ,为选拔战斗机女飞行员提供心理选拔方法的参照 .方法 :女学员组为某飞行学院 2 2名女飞行学员 ,男学员组为同一飞行学院 4 3名男飞行学员 .采用卡特尔 16种个性因素测验 (16PF) ,应用DXC多项心理测评仪进行集体测试 .结果 :在 16PF的 2 4个分析项目中 ,情绪的稳定性 (C)、兴奋性 (F)、敢为性 (H)、怀疑性 (L)、紧张性 (Q4)、适应与焦虑、内向与外向等 7个因子分男学员和女学员有显著差异 (P <0 .0 5或P <0 .0 1) ,其中在稳定性、兴奋性、敢为性和外向性等 4个因素上 ,女学员的分数显著高于男学员 (P <0 .0 5或P <0 .0 1) ;而在怀疑性、紧张性、焦虑性等 3个因子分上则是男学员显著高于女学员(P <0 .0 5或P <0 .0 1) .结论 :女飞行学员的个性特点是情绪稳定 ,轻松兴奋 ,冒险敢为 ,适应环境 ,趋于外向 ,紧张困扰和焦虑较少 .本调查结果表明 ,女飞行学员的人格特征基本符合战斗机飞行员人格结构的要求