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A newsletter for those involved in clinical trials. Published 20 times a
year by Canary LtdEthics committees/IRBs
The following articles on this topic have been published in
CRAdvisor (CRA) – the year, issue number
and starting page number for each are listed below:
Back to index |
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2007 |
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| CRA 2007; 185:1 |
New SSI form for UK ethics review. |
| CRA 2007; 185:3 |
COREC revises approval conditions for trials. |
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CRA 2007; 185:6 |
Guidance on consent and information sheets. |
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CRA 2007; 185:8 |
Model conditions for review of Research Tissue Banks. |
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CRA 2007; 188:7 |
IRB fails to provide adequate subject protection. |
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CRA 2007; 189:2 |
UK launches new National Research Ethics Service and announces plans for
central R&D approval. |
| CRA 2007; 190:1 |
New guidance: US adverse event reports. |
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CRA 2007; 190:5 |
Oklahoma IRB violates federal regulations. |
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CRA 2007; 190:8 |
New report on protecting subjects. |
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CRA 2007; 191:6 |
FDA warning to IRB about working procedures. |
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CRA 2007; 192:4 |
FDA advises on adverse event reporting. |
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2006 |
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CRA 2006; 163:5 |
IRB review of clinical trial websites. |
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CRA 2006; 165:2 |
UK's NPSA launches consultation on the future of NHS research ethics
committee services. |
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CRA 2006; 165:3 |
Summary of the proposals for change in the UK ethics committee system. |
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CRA 2006; 168:1 |
Centralised IRB review for multicentre trials. |
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CRA 2006; 168:1 |
EU revises Detailed Guidance on ethics committee applications. |
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CRA 2006; 169:2 |
EC issues revised Detailed Guidance on ethics committee applications. |
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CRA 2006; 169:4 |
FDA finalises guidance on centralised IRB review. |
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CRA 2006; 171:5 |
IRBs violate FDA regulations. |
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CRA 2006; 174:2 |
New arrangements for the ethics committee review of device studies. |
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CRA 2006; 174:7 |
Consultation on the implementation of UK REC changes. |
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CRA 2006; 174:8 |
Phase I trials under precautionary measures. |
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CRA 2006; 177:4 |
IRB breaches regulations on operation and responsibilities. |
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CRA 2006; 177:6 |
IRB ownership and conflicts of interest. |
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CRA 2006; 178:2 |
Changes to UK ethics system to go ahead. |
| CRA 2006; 178:8 |
New law relating to ethics committees in Italy. |
| CRA 2006; 181:2 |
New 'Memorandum of Understanding' between MHRA, COREC and
GTAC. |
| CRA 2006; 181:8 |
New REC application for UK trials. |
| CRA 2006; 182:1 |
Launch of business plan for UK ethics service. |
| CRA 2006; 182:12 |
Review of reasons for provisional REC opinions. |
| CRA 2006; 182:12 |
Ethics committees in Europe - how to work with diversity. |
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2005 |
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CRA 2005; 144:3 |
Not just investigators! IRB receives FDA warning about its conduct. |
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CRA 2005; 146:5 |
Revised documents for IRB registration. |
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CRA 2005; 147:7 |
Reporting adverse events to IRBs. |
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CRA 2005; 149:1 |
European Commission Directive on GCP 2005/28/EC now published. |
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CRA 2005; 149:5 |
New FDA guidance on centralised IRB review. |
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CRA 2005; 150:6 |
Investigator fails to impress inspectors. |
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CRA 2005; 151:7 |
New Brazilian trial regulations. |
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CRA 2005; 152:7 |
Conference examines future of EU RECs. |
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CRA 2005; 154:5 |
Research ethics committees summer school in Denmark. |
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CRA 2005; 157:7 |
UK recommendations on RECs. |
| CRA 2005; 158:5 |
Alabama IRB continues to violate regulations. |
| CRA 2005; 158:7 |
ABPI updates information for REC members. |
| CRA 2005; 158:7 |
COREC update. |
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CRA 2005; 160:4 |
Identifying the most frequent violations of FDA regulations. |
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CRA 2005; 161:2 |
Conflicts of interest for National Cancer Institute Pediatric Central IRB
members. |
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2004 |
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CRA 2004; 126:6 |
New documentation for UK ethics applications. |
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CRA 2004; 127:4 |
Warning letter for IRB that violates regulations. |
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CRA 2004; 127:8 |
Mock application for a fictitious biotechnology product. |
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CRA 2004; 128:1 |
IRB halts enrolment in trial after subject suicide. |
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CRA 2004; 133:1 |
What is the impact of EU Directive 2001/20/EC on clinical research? |
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CRA 2004; 133:3 |
Institutional review boards just do not learn - more inspection
findings. |
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CRA 2004; 135:1 |
Long-awaited Commission Directive on GCP released for consultation. |
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CRA 2004; 135:6 |
Registration of IRBs. |
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CRA 2004; 137:3 |
FDA proposes establishment of IRB database. |
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CRA 2004; 141:8 |
OHRP updates human subject regulations decision charts. |
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CRA 2004; 142:4 |
Sponsors would be wise to adhere to conditions set by IRBs. |
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2003 |
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CRA 2003: 102:1 |
WHO updates international ethical guidelines for clinical studies. |
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CRA 2003; 102:8 |
No local ethics approval needed in Germany. |
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CRA 2003; 103:4 |
Governance arrangements for RECs 'a move away from the principles of the
Declaration of Helsinki'. |
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CRA 2003; 103:6 |
New IRB accreditation programme. |
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CRA 2003;107:4 |
Update on UK arrangements for Ethics Committees. |
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CRA 2003; 110:1 |
EU releases final versions of five Detailed Guidance documents. |
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CRA 2003; 110:3 |
FDA continues to punish IRBs that fail to comply with regulations. |
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CRA 2003; 111:6 |
Final Detailed Guidance on applications to Ethics Committees. |
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CRA 2003; 114:7 |
First IRB accreditation by AAHRPP. |
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CRA 2003; 117:1 |
Lawsuits issued to investigators, study co-ordinator ,hospital, sponsor
and IRB. |
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CRA 2003; 118:2 |
New ethics guidance: Council of Europe's draft Additional Protocol on
Biomedical Research. |
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CRA 2003; 119:7 |
Only recognised RECs to be accepted. |
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CRA 2003; 120:1 |
IRBs continue to violate regulations. |
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CRA 2003; 120:5 |
COREC updates interim arrangements. |
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CRA 2003; 121:5 |
UK Ethics Committees in line for major shake-up. |
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2002 |
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CRA 2002; 84:1 |
Delay to parallel submission in UK. |
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CRA 2002; 84:6 |
New 'red book' on Internet. |
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CRA 2002; 85:6 |
IRBs are scared!
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CRA 2002; 85:6 |
Consortium for subject protection.
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CRA 2002; 90:5 |
IRB inefficiency criticised.
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CRA 2002; 91:1 |
US Department of Health proposes new rules to expose IRB shopping. |
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CRA 2002; 93:1 |
Ethics Committees to become Internet recruitment watchdogs? |
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CRA 2002; 93:8 |
MCA not to inspect Ethics Committees. |
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CRA 2002; 93:8 |
Change in Scottish Ethics Committee application procedures.
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CRA 2002; 94:2 |
Guidance for Ethics Committee applications. |
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CRA 2002; 97:2 |
Application for Ethics Committee opinion. |
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CRA 2002; 98:6 |
OHRP initiative to improve quality. |
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CRA 2002; 99:1 |
UK ethics rearrangement still in transition. |
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CRA 2002; 99:6 |
Guidance for IRBs. |
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CRA 2002; 100:6 |
An overview of US regulations contained in the Code of Federal
Regulations. |
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2001 |
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CRA 2001; 63:3 |
Changes for ethics review in Italy. |
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CRA 2001; 64:3 |
Single office to oversee all human research in USA. |
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CRA 2001; 64:6 |
Improve your REC applications. |
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CRA 2001; 68:6 |
Directive may increase ethics rejections. |
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CRA 2001; 70:4 |
Making successful REC submissions. |
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CRA 2001; 70:5 |
Do LRECs hinder research? |
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CRA 2001; 71:1 |
New governance for UK Ethics Committees. |
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CRA 2001: 72:2 |
New requirements for IRB review of paediatric trials. |
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CRA 2001; 80:8 |
NHS to implement Research Governance Framework. |
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2000 |
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CRA 2000; 41:1 |
Trials in the USA? Sponsors beware.
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CRA 2000; 42:4 |
Regulatory authorities and IEC meetings.
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CRA 2000; 42:6 |
Certification for IRB members.
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CRA 2000; 43:2 |
Certification of IRB members on the horizon.
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CRA 2000; 43:3 |
Italian Ethics Committee look forward to GCP Directive.
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CRA 2000; 47:2 |
Role of local Ethics Committee in Germany.
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CRA 2000; 49:2 |
Central office for Ethics Committee review.
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CRA 2000; 49:3 |
Poor communication with Ethics Committees leads to GCP violations:
inadequate letters of approval.
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CRA 2000; 51:1 |
Ethics Committee approval requirement slips back to 60 days.
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CRA 2000; 51:6 |
Ethics proposals for South Africa.
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CRA 2000: 52:1 |
IECs must consider protocol amendments in 35 days.
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CRA 2000; 52:4 |
Deficient contact with Ethics Committees: lack of annual reports.
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CRA 2000; 56:1 |
Improvements for ethics system in UK underway.
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1999 |
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CRA 1999; 19:3 |
Sponsors push their IEC luck.
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CRA 1999; 19:5 |
European ethics system close to requirements of Directive.
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CRA 1999; 24:6 |
Extensions for Ethics Committees review to be reduced from 30 to 15
days?
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CRA 1999; 27:1 |
Patient information sheet may eliminate Ethics Committee delays.
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CRA 1999; 28:3 |
Latest on Ethics Committees in Scandinavia.
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CRA 1999; 28:4 |
Review of Ethics in Europe.
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CRA 1999; 30:2 |
No changes to proposed ethics approval process.
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CRA 1999; 31:3 |
IRBs must know all trial locations.
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CRA 1999; 35:6 |
FDA inspects University IRBs.
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CRA 1999; 37:4 |
New Dutch law concerning human related research.
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CRA 1999; 37:6 |
University of Illinois suspended by OPRR.
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CRA 1999; 37:6 |
FDA denies targeting IRBs.
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1998 |
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CRA 1998; 2:1 |
Reform planned for research Ethics Committee in the UK.
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CRA 1998; 2:3 |
LREC policies have their differences.
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CRA 1998; 2:3 |
EU directive to shake up ethics approval in Europe.
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CRA 1998; 8:3 |
Two systems regulate trials in Denmark.
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CRA 1998; 9:3 |
The powers of the LRECs in the MREC system.
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CRA 1998; 12:1 |
Internal IRB audits may be required in the USA.
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CRA 1998; 13:1 |
Damning report on IRBs.
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CRA 1998; 15:1 |
IRBs must acknowledge their responsibilities.
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