Medical Research Law & Policy Report® Index-Summary

HEALTH AND HUMAN SERVICES DEPARTMENT (HHS)

– Appointments

– – Comparative effectiveness panel members named by HHS, 242
– – Daschle withdraws name, Baucus (D-Mont) and Kennedy (D-Mass) remain committed to health reform, 123; Sebelius nominated, 150; Senate action delayed, 280; Sebelius approved, 312
– – Health IT coordinator named, 244
– – Surgeon General nominated, 494; Senate panel approves, 708

– CDC

See CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC)

– Civil rights unit revises web site, 125
– FDA

See FOOD AND DRUG ADMINISTRATION (FDA)

– Funding

See LEGISLATION, FEDERAL, HR 3293

– Innovations, HHS seeks to encourage, 13; biomedical innovation, outgoing HHS official comments, 82
– NIH

See NATIONAL INSTITUTES OF HEALTH (NIH)

– OHRP

See OFFICE OF HUMAN SUBJECT PROTECTION (OHRP)

– Regulatory agenda released, 359
– Terrorism countermeasures funding, GAO reports, 522

HEALTH CARE REFORM, FEDERAL

– Daschle pledges to work with both parties on reform, 48
– Effectiveness research

See COMPARATIVE EFFECTIVENESS

– Research role, In Brief, 373

HEALTH INSURANCE PORTABILITY AND ACCOUNTABILITY ACT (HIPAA)

– BNA plans audioconference, 201
– Privacy rule

– – Enforcement by HHS civil rights office announced, 537
– – Guidance on health information networks offered by HHS, 21
– – Inadequate and impediment to research, Institute of Medicine panel says, 112
– – Invasions of privacy and security breaches remain obstacles, study finds, 279

HEMOPURE

– Blood substitute, proposed trial may be off, 12

HHS

See HEALTH AND HUMAN SERVICES DEPARTMENT (HHS)

HIPAA

See HEALTH INSURANCE PORTABILITY AND ACCOUNTABILITY ACT (HIPAA)

HORMONE REPLACEMENT THERAPY (HRT)

– Ghostwriting by maker, documents unsealed (E.D. Ark.), 559

HUMAN SUBJECT PROTECTION

– Criteria for enrollment, MDs and RNs favor patient benefits, 706
– Decisionally impaired research subjects

See INFORMED CONSENT

– Draft guidelines, OHRP developing, 541
– Economic recession and White House could change goals of OHRP, 172
– Exempt research, OHRP posts FAQs, 704
– GAO says system is vulnerable to ethical manipulation, 227; ramifications of GAO probe, Special Report, 294
– Harmonizing rules, federal panel to study, 541
– Heart risk guidance issued by FDA, 19
– India, unethical human experiments, new laws to address, 316
– Multi-agency jurisdiction, OHRP offers guidance, 716
– Noncompliance list updated by OHRP, 163
– Obama dissolves bioethics council, 454
– Oversight, new administration plans policy changes, 214
– Pfizer seeks accreditation for human research protection program, 172; program accredited, 278
– Pulmonary sickle-cell study halted due to safety issues, 518
– Russian convicts, use in clinical trials banned, 529
– State developments

– – Minn. considers ban on clinical trial participation by subjects in mental health commitment process, 127; bill signed, 374
– – N.H. proposal, In Brief, 621
– – Va. rules, In Brief, 532

– Trends

– – Ethical protection of human study participant becoming major issue, 407
– – Outlook 2009, top issue, 5

HUMIRA

– Univ. of Iowa sues Abbott over Humira patents (S.D. Iowa), 484