Medical Research Law & Policy Report® Index-Summary

ILLINOIS

– Newborn screening, 84
– Stem cell research grants, 254

INDIA

– Clinical trials, new restrictions, 111

INFORMATION NETWORKS AND TECHNOLOGY

– Alzheimer's trial database, 374
– Clinical research and IT investment, 110
– E-health

– Medtronic MD payments, website, 377
– Northrop Grumman IT research, 175
– Safety Report Portal, FDA-NIH announce, 345
– Stem cell treatments, website, 375
– Univ. of Louisville clinical trial website breach, 381

INFORMED CONSENT

– Accuracy of forms at issue, 372
– AMA resolution, 411
– Cal. emergency exemption, 457
– Cancer center forged signatures, 565
– Comprehension of forms, 518
– Coroner's retaining body part without consent of family (Cal. Ct. App.), 412
– Decisionally impaired subjects, applicable state laws, 258
– Eye implant, noneconomic damage cap (S.D. Ohio), 400
– Genetic research issues, 618
– Havasupai tribe and Ariz. State Univ., 444; HHS panel examines, 501
– HIPPA, proposed changes, 441; agency support, 702
– 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

– Opt-in standard for biological materials, 798
– Opting out of health data collection, 789
– Posting of forms online suggested, 687
– Specific language, FDA proposed rule, 19
– Stent implant claims (3rd Cir.), 167
– Third-party gamete donor consent, 140
– Translated consent forms, 489
– U.K. unauthorized tissue and organ removal, 763

INSTITUTIONAL REVIEW BOARDS (IRBs)

– Fla. rules, 26
– Grants from NIH, 80
– Guidance

– – Conflicts of interest, NIH rules, 667
– – Draft guidance from FDA, 42
– – FAQs from OHRP, 209
– – Finalized guidance expected from OHRP, 187; final guidance issued, 784

– Multi-site studies, 645
– Protection of study subjects, data sought, 583
– Public access to reviews, 22

INTELLECTUAL PROPERTY

– Academic Inventors' Bill of Rights, 213
– Fabrazyme shortage, 551
– International developments, genetics and biodiversity, 691
– Malaria product development partnership, 521
– Patents

See PATENTS

– Plagiarism charges affirmed (3rd Cir.), 480
– Technology transfer, House hearing, 364
– Traditional knowledge and folklore, WIPO initiative, 521
– University ownership and Bayh-Dole, 651
– Written description requirement (Fed. Cir.), 203

INTERNATIONAL DEVELOPMENTS

– Clinical trials, foreign study data usage, 417
– HIV international patent pool, 613
– Intellectual property, genetics, and biodiversity, 691
– Traditional knowledge and folklore, WIPO initiative, 521

INTERNET

– Informed consent, posting of forms online suggested, 687

IOWA

– Cancer clinical trial coverage mandate, 146
– Epicor use by Ankeny, Iowa, workers, 729
– Genetic discrimination ban signed, 287

IPLEX

– Investigational drug, access (N.D.N.Y.), 695

IRBs

See INSTITUTIONAL REVIEW BOARDS (IRBs)