2002 Index

When looking for information on a specific topic, back issues of IRB Advisor newsletter, published by Thomson American Health Consultants, may be useful. To obtain back issues, contact our customer service department at P.O. Box 740060, Atlanta, GA 30374. Telephone: (800) 688-2421 or (404) 262-7436. Fax: (800) 284-3291 or (404) 262-7837. E-mail: customerservice@ahcpub.com.

Audits

  • FDA audit surprise? What to expect, how to prepare, JAN:4
  • IRBs can implement and adapt own auditing programs, depending on need, APR:37
  • Pre-Audit Interview Standard Operating Procedure form, APR:sup
  • Stay one step ahead even after the audit, JAN:6
  • The ins and outs of Pitt’s IRB monitoring program, APR:39

Bioterrorism

  • Vaccine, drug development link IRBs and researchers, MAR:28

Board members

  • Public opinion counts when it comes to human subjects, MAY:56

Conflicts of interest

  • Before they sign, ensure that subjects understand, JUL:76
  • Elements of informed consent, JUL:77
  • IRB review may include financial connections, NOV:130
  • Key finance question: Is relationship covered, MAR:31
  • Questions to assist in evaluating financial conflicts of interest, NOV:131
  • Regulations weren’t meant for protection, FEB:21

Education/Training

  • Have book, will study, AUG:93
  • Human subject protections ed goes on-line at UM (University of Miami), JUN:67
  • On-line conference trains researchers, AUG:92
  • UM (University of Miami) takes proactive training approach, APR:43

Ethics

  • Children in research trials: Have we gone too far? AUG:89
  • In a nutshell: Facts about Dryvax (smallpox vaccine) study, DEC:135
  • IRBs handle religious, ethical conflicts, FEB:17
  • IRB review of smallpox vaccine study receives national public scrutiny, DEC:133
  • Poor countries may not benefit from research (international research guidelines), DEC:140
  • Privacy rules, advancing technology raise tissue procurement questions, MAR:25
  • Recent clinical trial deaths suggest imbalances, NOV:127
  • Under scrutiny: IRB shopping, JUL:75

Guidance

  • Adverse event reporting often creates confusion, conflicts over when and how, AUG:85
  • AE protocol helps clarify what should be reported, AUG:87
  • A risk-benefit matrix should ask the right questions, OCT:113
  • ASSERT checklist table, NOV:126
  • ASSERT statement offers guidance in trial design, NOV:125
  • Assessing a clinical trial’s risks and benefits requires closer IRB attention, OCT:109
  • Beyond HIPAA: Protect sensitive information, OCT:117
  • COE: Don’t panic! Review compliance guidelines, APR:46
  • Continuing review: Revisit the study at least annually, SEP:105
  • Feds consider legislation that would tighten research, IRB regulations, JUL:73
  • Here are CIOMS research guidelines in a nutshell (international research guidelines), DEC:142
  • IOM’s recommendations call for new name and more focused role for IRBs, NOV:121
  • New rules proposed for IND exemptions, JUN:64
  • OHRP offers primer on IRB procedures, JUL:77
  • Points to consider during continuing review, SEP:106
  • Poor countries may not benefit from research (international research guidelines), DEC:140
  • Report offers guidance in protection subject privacy, FEB:16
  • Risks and benefits must be evaluated separately, NOV:123
  • The common rule and the IRB, FEB:19
  • Third-party status gets further revision, MAR:33
  • Two eyes are better than one: Secondary reviews improve protocol review process, SEP:97

HIPAA (Health Insurance Portability and Accountability Act)

  • CMS proposes changes to privacy rules, but critics say more still are needed, JUN:61
  • Does anybody really know what HIPAA is? OCT:114
  • Frequently asked questions about HIPAA, OCT:115
  • Hospital system and IRBs: Get started on HIPAA regs, JUN:63

Informed consent

  • Determining subjects’ mental capacity is essential for true informed consent, MAY:49
  • Egg donors may not be fully aware of risks, JAN:7
  • Elements for obtaining ART (assisted reproduction technology) consent, JAN:8
  • Informed consent checklist, MAY:53
  • Legal land mine: Informed consent goes on trial, SEP:103
  • Lengthy consent form still needs adjustments (smallpox vaccine study), DEC:136
  • Obtaining consent can be multistep process, MAY:52
  • When protocol changes, updated consent needed, SEP:104

Internet

  • For you consideration: Internet research issues, JAN:3
  • Recruiting etiquette in cyberspace is different from conventional methods, FEB:13
  • Virtual human subjects need just as much privacy as conventional subjects, JAN:1

IRB software

  • e-Documentation system (PRAMS) cuts most paperwork, SEP:100
  • Georgia Tech designs on-line software (IRBWISE) for IRBs, APR:44
  • Here’s how an IRB uses iMedRIS software, JUL:82
  • ProIRB may be convenient system for mid-sized IRBs, MAY:58
  • Software (IRB Navigator) can be adapted to suit small IRBs, SEP:102
  • Software used by Texas IRB (iMedRIS) handles entire process, JUL:80

Payments to subjects

  • Should IRBs standardize payments to subjects? APR:41

Quality

  • It’s not enough to follow rules, get a new attitude, MAY:54
  • OHRP QA (quality assurance) Self-Assessment Tool, JUN:69
  • QA sell-assessment tool now on-line, JUN:68
  • Shift in philosophy was outgoing director’s goal, DEC:137

Sample forms/charts

  • ASSERT checklist table, NOV:126
  • Informed consent checklist, MAY:53
  • IRB’s protocol summary form queries INDs, IDEs, JUN:66
  • OHRP QA (quality assurance) Self-Assessment Tool, JUN:69
  • OLOLRM Institutional Review Board Annual Review, JAN:sup
  • Pre-Audit Interview Standard Operating Procedure form, APR:sup
  • Questions to assist in evaluating financial conflicts of interest, NOV:131
  • Sample renewal letter, JAN:sup

Spotlight on Compliance

  • COE: Don’t panic! Review compliance guidelines, APR:46
  • Improved clinical care or medical research? NOV:129
  • Key finance question: Is relationship covered? MAR:31
  • Legal land mine: Informed consent goes on trial, SEP:103
  • Maryland legislation could be model for other states, JUL:79
  • New legislation will change human research oversight, DEC:139
  • Off-label use differs from investigational use, AUG:94
  • PHS works with biotech company on stem-cell use regs, JUN:70
  • The common rule and the IRB, FEB:19
  • Whistle-blowers: They can sue, and they could win, MAY:57

Tissue research

  • PHS works with biotech comp on stem-cell use regs, JUN:70
  • Privacy rules, advancing technology raise tissue procurement questions, MAR:25