Medical Research Law & Policy Report® Index-Summary

ILLINOIS

– Autism, In Brief, 433
– GINA rules, In Brief, 532

IN VITRO DIAGNOSTIC DEVICES (IVDs)

See MEDICAL DEVICES

INDIA

– Clinical trial registration required, 367
– Unethical human experiments, new laws to address, 316

INFLUENZA

– Swine flu

– – Funding sought by White House, 315
– – Respirators, Institute of Medicine recommends, 616

– Vaccine

– – H1N1, In Brief, 529
– – New method to make, HHS contracts to develop, 459

INFORMATION NETWORKS AND TECHNOLOGY

– Better, faster research due to data sharing predicted by NCI official, 240
– BNA plans audioconference on health IT funding, 201
– Genetic test results transmitted between health systems, 666
– Grants for health informatics award by CDC, 671
– Internet

See INTERNET

INFORMED CONSENT

– Blindness blamed on implant trial, suit dismissed (S.D. Ohio), 655
– Cancer trial consent form evaluated, 523
– Experimental stent implant, heart patient's claims dismissed (E.D. Pa.), 76; reconsideration denied, 420
– Heart valves

– – Repair, clarification, 22
– – Unapproved heart valve marketing, Grassley (R-Iowa) queries FDA, 376

– Human tissue product documents, attorney-client privilege waived in suit over illegal use of body parts (D.N.J.), 16
– Impaired decisionmaking, recommendations approved by HHS panel, 215
– Pacemaker implanted as part of NIH experiment, failure-to-warn claim may proceed (D. Del.), 389
– Unfair competition and consumer remedies claims dismissed (S.D. Cal.), 609
– VA, one-third of consent forms non-compliant, 403

INSTITUTIONAL REVIEW BOARDS (IRBs)

– Accountability remains an issue at OHRP, 707
– Assurances and registration, HHS clarifies policy, 364
– Clinical trials

– – Fraudulent clinical trial, IRBs claims House panel conducted illegal sting, 207
– – Guidance on reporting released by FDA, 39

– Conflicts of interest, many IRBs lack clear policies, study finds, 273
– External IRBs, In Brief, 156
– Fake study, Coast Independent shut down, 333
– Fla. rule, In Brief, 496
– GAO says system is vulnerable to ethical manipulation, 227; ramifications of GAO probe, Special Report, 294
– Liability for violations, OHRP seeks comments, 189
– Registration

– – Database, FDA suggests updates, 667
– – Final rule issued by FDA and OHRP, 41; deadline, In Brief, 589

INTELLECTUAL PROPERTY

– Access limited by institutional material transfer agreements, 47
– Government-funded articles

See LEGISLATION, FEDERAL, HR 801

– Ischemia research, Pfizer to appeal trade secrets verdict (Cal. Super. Ct.), 26
– Obstetrics journal article authorship dispute, summary judgment granted for defendant (E.D. Mich.), 78
– Patents

See PATENTS

– Stem cell research, In Brief, 23
– Trademarks, mouse strain for human cell engraftment, infringement alleged (N.D. Cal.), 77
– Traditional knowledge, WIPO endorse compromise, 709

INTERNATIONAL DEVELOPMENTS

See also specific countries
– Clinical trials, globalization raises issues, 153
– Russia-U.S. cooperation pact, In Brief, 495

INTERNET

– BNA Convergence launched, 401
– CMS launched health IT website, 459
– HHS civil rights unit revises web site, 125
– NIH social science, In Brief, 53
– Tech transfer, In Brief, 399

IOWA

– Physician gifts ban approved by Senate, 248

IPLEX

– ALS patients get access, 195

IRBs

See INSTITUTIONAL REVIEW BOARDS (IRBs)

IVDs (IN VITRO DIAGNOSTIC DEVICES)

See MEDICAL DEVICES