Medical Research Law & Policy Report® Index-Summary

CALIFORNIA

– Cord blood, state program, 588; UC collection bill, 628
– Informed consent emergency exemption, 457
– Mishandling body parts

– – Andre suit, no duty to families (Cal. Ct. App.), 562
– – Waters and Cohen suits, no duty to families (Cal. Ct. App.), 252

– Stem cell research

– – Acceptable research material rule, In Brief, 113
– – Bond measure, 760
– – Consolidating CIRM requirements, 83
– – Cooperation with Wis., 412
– – Donation of embryos, 113
– – Funding bills approved by panel, 180
– – Grants

– – – Early transaction awards, 694
– – – Investigator incentives, 286
– – – Status of institutions, CIRM report, 83

– – Loan, guidelines approval, 113
– – Outreach to industry, 790
– – Oversight of CIRM, Senate bill, 146; action suspended, 316; approved, 561
– – Pact with Md., 728
– – Strategic review, 626

CANADA

– Digital archive of published health research, 283
– Nanotechnology, interim policy, 225
– Ontario research funding, 282

CANCER

– Blood Brain Barrier Disruption, experimental treatment (D. Or.), 273
– Breast cancer

– – Australia, gene patent challenge (Fed. Ct. Austl.), 367
– – New clinical trial model, 212

– Capps research proposal, 207
– Cholesterol drugs link to cancer unlikely, 29
– Clinical trials

– – Beth Israel study enrollment suspension, 695
– – Iowa coverage mandate, 146
– – Merck global network, 378
– – Phase III trial design, 785

– Duke researcher resignation, 763
– Isolated DNA, patent challenge (S.D.N.Y.), 103; patents invalid, Special Report, 228; webinar, Special Report, 353; notice of appeal, 398; recusal sought (Fed. Cir.), 477; brief filed, 515; BNA Insights, 594; comments, 652; briefs (Fed. Cir.), Special Report, 705
– Medicare, PET scans for bone metastasis of cancer, 216
– NCI Cooperative Group Program, overhaul sought, 245
– Plagiarism and falsifying research, no federal jurisdiction (E.D. Pa.), 29
– Registries

– – La. tumor registry, 25
– – N.J. cancer registry, 762
– – Wash. registry, 492
– – Wis. registry, 492

– Texas

– – Cancer Prevention and Research Inst., 26; rules, 148
– – Funding, 84

– Univ. of Ill. cancer drug royalties (7th Cir.), 479
– Univ. of Miami halts cancer study, 566
– Univ. of Pittsburgh prostate cancer research dispute (W.D. Pa.), 12

CDC

See CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC)

CEFTOBIPROLE

– Skin infection drug application rejection, 21

CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC)

– Conflicts of interest, HHS IG report, 29
– Grassley questions travel costs, 150

CHILDREN'S HEALTH CARE

– Autism link to vaccines, U.K. MDs guilty, 85
– Bone cancer, “experimental treatment” coverage denial (S.D. Ohio), 73
– Brain damage study in newborns (D. Mass.), 608
– Ill. newborn screening, 84
– Me. birth defects, 761
– Pediatric research

– – Ethics and overseas research, 555
– – Experimental cardiac procedure blamed for death (3rd Cir.), 718
– – Medical device applications, 213; rule pulled, 454
– – Rare pediatric diseases, Senate hearing, 485
– – Toxic exposure and medical monitoring (3rd Cir.), 580

CIALIS

– ED drug inventorship (Fed. Cir.), 243; (U.S., rev sought), 658

CLINICAL TRIALS

– Adaptive designs, FDA draft guidance, 145
– Allergy treatment study, alleged breach of contract (S.D. Ill.), 206
– Alzheimer's trial database, 374
– Antibiotic noninferiority trials, 758
– Avandia trial halted, 478
– Bayesian statistical methods for medical devices, 111
– Biosimilar trials urged, 486
– Bone cement trials (E.D. Pa.), 794
– Cancer

– – Beth Israel study enrollment suspension, 695
– – Iowa coverage mandate, 146
– – Merck global network, 378
– – Phase III trial design, 785

– Children, high or unclear bias risk in trials, 49
– Compliance assessment sealed (N.J. Super. Ct. App. Div.), 380
– Coordinators move to competitor (D. Mass.), 445
– Duke researcher suspension, 493
– Flaws in clinical trials, CRO reports, 138
– Gays and lesbians, bias probe sought, 246
– HIV studies, women underrepresented, 621
– International developments

– – Developing nations, need for local partners, 531
– – Foreign study data usage, 417
– – India, new restrictions, 111
– – Russian rules, 585

– Investigational device exemption, preemption, 752
– NCI Cooperative Group Program, overhaul sought, 245
– New clinical trial model, 212
– N.Y. medical research consortium, 413
– Non-inferiority trials, 145; FDA policy, 559
– Physician participation decline, 403
– Postmarket research

– – FDA report, 725
– – IOM report, 449

– Reimbursement for new technologies, 153
– Safety, FDA reporting rule, 612
– Stem cell research

– – Clearance from FDA, 750
– – Enrollment, 651
– – Trial enrollment, 651

– Suicide link, 346; assessing risk, 586
– Tax issues, Special Report, 733
– TOGA, investigational use exemption (E.D.N.Y.), 784
– Trovan clinical trial injuries (U.S., brief filed), 368; (rev den), 401
– Univ. of Rochester pain drug initiative, 691
– Unlawful clinical trials (E.D. Pa.), 664
– Warfarin, Medicare coverage, 16

CLONING

– Ohio, human cloning ban, 220

COLLEGES AND UNIVERSITIES

– Ariz. State, Havasupai blood samples settlement (Ariz. Super. Ct.), 271; informed consent, 444; HHS panel examines, 501
– Baylor conflict-of-interest compliance, NIH concerns, 86
– Columbia Univ. PET center, 459
– Conflicts of interest

– – Research projects and transfers to startups, 260
– – Specific colleges

See specific colleges, this heading

– – University research projects and transfers to startups, 260

– Cornell, DNA patent claims (D. Del.), 342
– Duke researcher suspension, 493; resignation, 763
– George Washington Univ. brain damage study in newborns (D. Mass.), 608
– Harvard

– – Biologist, misconduct in research probe, 565
– – Conflicts of interest, 491
– – Oncomouse patentability questioned, 364

– Household help subsidies and attracting women to science, 79
– Intellectual property ownership and Bayh-Dole, 651
– Johns Hopkins

– – Cellular proteins pact (Del. Ch.), 11
– – Montgomery County, Md., pact, 147

– Kan. Univ., primate mistreatment claims, 384
– Medical schools

See specific schools, this heading

– Minority disparities, HHS university awards, 623
– NIH grants, 247
– Northrop Grumman IT research, 175
– Ohio

– – Centers of Excellence in Biomedicine and Health Care, 147
– – Proctor & Gamble collaboration pact, 284

– Ohio State Univ.

– – Confidentiality of survey records (Ohio Ct. App.), 108
– – Misdiagnosis whistleblowing, retaliation claim (S.D. Ohio), 366; dismissal, 481

– Patents

– – Specific colleges

See specific colleges, this heading

– – Universities filings, survey, 170

– Portland State Univ., Or. biotech funding, 114
– St. Louis Univ., new medical research center, 113; ex-Pfizer staff, 148
– Stanford

– – AIDS therapy, rights assignment (Fed. Cir.), 13; patents and Bayh-Dole (U.S., briefs sought), 397
– – Conflicts of interest, continuing medical education program, 13

– Tech transfer, 659
– Tulane peptide analog patent suit (D.D.C.), 28
– UC Berkeley collection of freshman cell samples, 347; ban sought, 490; retooled, 522
– UC cord blood collection, 628
– UC Santa Cruz animal rights case (N.D. Cal.), 459
– UCLA

– – HIPAA violations, researcher sentencing (C.D. Cal.), 288
– – Mishandling body parts

– – – Andre suit, no duty to families (Cal. Ct. App.), 562
– – – Waters and Cohen suits, no duty to families (Cal. Ct. App.), 252

– Univ. of Ill.

– – Cancer drug royalties (7th Cir.), 479
– – SHARPS center, federal grant, 254

– Univ. of Medicine & Dentistry grant application (D.N.J.), 696
– Univ. of Miami

– – Cancer study halted, 566
– – Defamation claim by medical student (S.D. Fla.), 107

– Univ. of Minn.

– – Conflict of interest policy, 284; implemented, 523
– – Death of participant, 791
– – Melanoma study, 348

– Univ. of Mo. life sciences startup funding, 114
– Univ. of N.C. standardized licensing pact, 285
– Univ. of Pittsburgh prostate cancer research dispute (W.D. Pa.), 12
– Univ. of Rochester pain drug initiative, 691
– Univ. of Wis. conflict of interest probe, 524
– Vanderbilt databank of de-identified DNA samples, 47

COLORADO

– AIDS reporting, 26
– Physicians, disclosures for license renewals, 381

COMPARATIVE EFFECTIVENESS

– Academic detail funding, 249
– Appropriate comparators, industry strategies, 153
– Balanced views urged, 653
– Cost control and comparative effectiveness research, 406
– Drug access, 452
– Federal infrastructure changes urged, 451
– Health reform

See LEGISLATION, FEDERAL, HR 3590

– Impact of research, issues, 215
– National clinical research infrastructure, 757
– NIH grants, 172
– Nonpharmacological interventions compared with drugs, 173
– Patient participation, 487
– Premier health alliance, 788
– RAC auditing deferrals, 552
– Relevancy to all patient populations, 371
– Scientific basis for research, 406
– Stakeholder comments, 516; participation, 725
– Task force, HHS future activity, 120
– Tracking database, 759
– Unresolved issues, 453

CONFERENCES AND MEETINGS

– Ass'n for the Accreditation of Human Research Projects, 259; 259
– Center for Business Intelligence

– – Fourth Annual Forum on Tracking State Laws and Aggregate Spend, 557
– – “Reimbursement Strategies for Medical Devices and Diagnostics,” 153

– Friends of Cancer Research, 407
– NIH, Does Your Research Raise Security Concerns?, 615
– Public Responsibility in Medicine & Research

– – Advancing Ethical Research: Uniting, People, Principles, and Practices, 798
– – Conflicting Interest and Conflicting Expectations: Challenges Presented by NIH's New Rule, 667

– Research!America forum, 756
– Seventh Annual Pharmaceutical Compliance Conf., 88
– Sharing Convergent Strategies for Comparative Effectiveness Research, 406
– Tax Council Policy Institute, 143
– WIPO Intergovernmental Comm. on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore, 23

CONFLICTS OF INTEREST

– Academia-industry ties, webinar, 18
– Academic medical center policies, 755
– AMA resolution, 411
– Baylor compliance, NIH concerns, 86
– CDC management, HHS IG report, 29
– Development of drugs affected, 689
– Discipline for NIH ethics officer, 698
– Enforcement issues, HHS IG plans, 93
– Enhanced federal regulation sought, 486
– Fair market value and documentation, 425
– FDA, CRS report, 177
– Federal reporting law, effects, 376
– Grassley questions NIH travel costs, 150; discipline for ethics officer, 698
– Harvard, 491
– Journal editors, disclosure form, 401
– Medical devices, Grassley queries FDA, 697
– Natl. Ass'n on Mental Illness drugmaker donations, 288
– Outlook 2010, 5
– Partnerships seen as essential, 408
– Pfizer payment disclosure, 216
– Physicians

– – Decline in MD-industry ties, 723
– – Ethics code for medical specialty societies, 279
– – Initiative in addressing conflicts, 20
– – Orthopedic devices, payments to MDs, 583
– – Positive attitudes toward industry ties, 408
– – Psychiatry, transparency in industry ties sought, 214
– – Streamlining disclosure, FDA action sought, 724
– – Teaching hospitals and MD-industry ties, 407

– Public support for disclosure, study, 278
– Semiannual agenda for NIH, 272; proposed rule, 335; discussed, 499; HHS panel comments, 503; speakers comment, 667
– Senate report on “ghostwriting,” 415
– Stanford continuing medical education program, 13
– State rules

– – Mass. gift disclosure law, 760
– – Tex. rules, 26

– Stricter disclosure by researchers, 452
– Univ. of Minn.

– – Melanoma study, 348
– – Policy, 284; implemented, 523

– Univ. of Wis. probe, 524
– University research projects and transfers to startups, 260
– VA advisor and Medtronic, 794

CONGRESS, U.S.

– Ed. Note: This heading is used for administrative actions only. For coverage of legislation by bill number, see LEGISLATION, FEDERAL. For information on measures not yet assigned bill numbers see specific subject headings.
– Hill Watch, 219

CONNECTICUT

– Grants for Alzheimer's and diabetes, 347

CRIMINAL PROSECUTIONS

– Body parts valuation (Cal. Ct. App.), 660
– Bone cement trials (E.D. Pa.), 794
– Hedge fund insider trading (S.D.N.Y.), 731
– Sweden, destruction of data by researcher, 731
– Unlawful clinical trials (E.D. Pa.), 664