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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
A list of all IRB Advisor articles published in 2002, organized by topic.
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