Medical Research Law & Policy Report® Index-Summary

GENETIC INFORMATION NONDISCRIMINATION ACT (GINA)

– Ala. rules, In Brief, 532
– Clinical trial subjects protected against discrimination by employers and insurers, HHS issues guidance, 271
– Final rule expected from EEOC, 394; IRS, Labor Dep't, HHS issue interim rules, 663
– Ill. rules, In Brief, 532
– Nev. rules, In Brief, 532
– N.D. rules, In Brief, 532
– Survey calls for more protection from discrimination and false ads, 561
– Vt. rules, In Brief, 532
– Wyo. rules, In Brief, 532

GENETICS AND BIOTECHNOLOGY

– Antibiotic resistance, NIH guidelines at issue, 455
– Baylor, MD accuses IRB of not conducting proper investigation of claims about gene therapy experiments, remanded (S.D. Tex.), 11
– Biologics

See BIOLOGICS

– Biotech crops, EU panel predicts increase, 617
– Commercial applications of gene sequencing data no breach of agreement (N.D. Ill.), 485
– Death in gene therapy trial confirmed, 486
– Direct-to-consumer genetic tests

– – False security raises concerns, 627
– – Federal oversight sought, 488
– – IVDs, tests likely to be considered, 626

– Discrimination

– – EEOC proposes bias ban, 149; final rules expected, 370
– – GINA

See GENETIC INFORMATION NONDISCRIMINATION ACT (GINA)

– – La. genetic testing rule, In Brief, 497
– – N.M. rules, In Brief, 497

– DNA molecule research, NIH releases biosafety resources, 524
– Egg donor compensation, N.Y. panel approves, 496
– Engineered organisms, USDA revising rules, seeks comments, 192
– Net operating loss carryover tax break, industry group want one-time refund, 45
– Patents

– – Breast and ovarian cancer gene patents challenged (S.D.N.Y.), 358
– – Effect on research

– – – Comments sought by HHS, 236
– – – Dire predictions not realized, journal reports, 236

– – Exemption from infringement liability endorsed by HHS panel, 697
– – Gene sequencing patents challenged (S.D.N.Y.), 580
– – Heart disease gene patent awarded, 151
– – Univ. of Utah human gene patents challenged (S.D.N.Y.), 513

– Personalized medicine

See PERSONALIZED MEDICINE

– Plant management, USDA issues draft auditing standard, 423
– Recombinant DNA, NIH proposes expanded biosafety guidelines, 190
– Security at biosafety labs, GAO reports, 562
– Stanford accused of plagiarizing gene research, 484
– State developments

– – Ariz. plans virtual tissue bank, 160
– – Mich. creating biobank for newborns, 432

– Stimulus funding includes genome projects, 366
– Swiss biotech crop ban extended, 494
– Synthetic biology risks and benefits reviewed, 489
– Test results transmitted between health systems, 666
– Toxicogenomic data studied by EPA, 399
– Univ. of Wash. announces genome analysis strategy, 588
– Voluntary biotech quality management system, USDA launches pilot program to test, 83

GEORGIA

– Governor announces medical innovation center, 401

GERMANY

– Stem cell research collaboration with Cal., In Brief, 677

GIFTS

See CONFLICTS OF INTEREST

GINA

See GENETIC INFORMATION NONDISCRIMINATION ACT (GINA)

GRANTS

– Bayh-Dole Act authority non-use, GAO reports, 522
– Clinical and Translational Science Awards announced by NIH, 526
– Closeout dates, HHS IG says CDC must observe, 165
– Coronary revascularization, NIH awards grants to study effectiveness, 708
– Financial conflicts, NIH may expand regulations, 357
– Fraud

– – Duke research grant administrative and clerical overcharges reported by HHS IG, 129
– – Fabricated audits sent to NIH, biotech firm director sentenced (W.D. Wash.), 375
– – Internal controls at NIH, HHS IG reports, 680
– – Omeros denies false claims charges (W.D. Wash.), 714
– – Weill Medical College settles grant fraud charges (S.D.N.Y.), 208
– – Yale settles false claims allegations over federal grants, 24

– Grant.gov web site revised by HHS, 527
– Health informatics grants awarded by CDC, 671
– Management a top issue for HHS IG in 2009, 57
– Natl. Joint Replacement Registry, AHRQ awards grants, 527
– Orphan drug clinical trials, FDA grants to fund, 17
– Pediatric devices, In Brief, 675
– Recovery Act grants awarded by NIH, 649
– Small businesses

See LEGISLATION, FEDERAL, HR 2965

– State developments

– – Cal. fair political practices agency issues warning, 54
– – New Jersey

– – – Brain injury research grants, In Brief, 402
– – – Cancer research grants, In Brief, 593
– – – Developmental disabilities research grants, In Brief, 593
– – – Spinal cord research, In Brief, 287; announced, In Brief, 712

– – Wash. issues grants for R&D, 55

– Stem cell research

See generally STEM CELL RESEARCH

– Stimulus package includes funding, 188; subject of briefing, 238
– Univ. of R.I. gets NIH grant, 401
– Web application system, GAO reports, 520
– Web tool announced by NIH, 614