500 signatures reached
To: Minister for Health, Department of Health
Centralise ALL health research ethics NOW!
As a matter of urgency, Minister for Health Stephen Donnelly must expedite amending and enacting all relevant legislation for Centralised National Research Ethics and increase ethical review capacity for all health research in Ireland.
Why is this important?
Issues:
1. Capacity
• Since a network of 12 hospital Research Ethics Committees (REC) was established around the turn of the century, the number of health research applications has dramatically increased – without a corresponding increase in REC capacity to assess these applications.
2. Uncertainty
• It is now the case that many RECs can no longer guarantee a timeline for review/approval – even where submissions are made by deadline, which creates uncertainty for trial/study planning.
• Any uncertainty in the Irish health research environment makes Ireland a less attractive location for opening clinical trials and undertaking health research.
• Consistency: Different RECs may respond to the same application in different ways, or place different demands on researchers.
• REC efforts to standardise application forms between 2010-2015 appear to have faltered with the introduction of GDPR and the Health Research Regulations.
3. Drug vs. non-drug studies
• While drug trials (interventional trials) only need approval from a single REC to open a study at any sites, non-interventional studies (translational - TM) must submit a separate application for every single site.
4. Research guidance
• There is no central location where guidance can be sought on how to progress research. Clear and consistent direction on e.g. patient consent is required to navigate an evolving research environment.
In summary:
• Reduce the burden on researchers
• Standardise ethics reviews, which are paramount for guarding patient safety
• Streamline approval and guidance
Note:
This petition was created by Cancer Trials Ireland as one element of the organisation’s Just Ask 2020 campaign to raise public awareness of clinical trials and issues relating to clinical trials.
The Just Ask 2020 campaign is supported by unrestricted grants from Pfizer Healthcare Ireland; Novartis; AbbVie; MSD; Roche; Bayer.
1. Capacity
• Since a network of 12 hospital Research Ethics Committees (REC) was established around the turn of the century, the number of health research applications has dramatically increased – without a corresponding increase in REC capacity to assess these applications.
2. Uncertainty
• It is now the case that many RECs can no longer guarantee a timeline for review/approval – even where submissions are made by deadline, which creates uncertainty for trial/study planning.
• Any uncertainty in the Irish health research environment makes Ireland a less attractive location for opening clinical trials and undertaking health research.
• Consistency: Different RECs may respond to the same application in different ways, or place different demands on researchers.
• REC efforts to standardise application forms between 2010-2015 appear to have faltered with the introduction of GDPR and the Health Research Regulations.
3. Drug vs. non-drug studies
• While drug trials (interventional trials) only need approval from a single REC to open a study at any sites, non-interventional studies (translational - TM) must submit a separate application for every single site.
4. Research guidance
• There is no central location where guidance can be sought on how to progress research. Clear and consistent direction on e.g. patient consent is required to navigate an evolving research environment.
In summary:
• Reduce the burden on researchers
• Standardise ethics reviews, which are paramount for guarding patient safety
• Streamline approval and guidance
Note:
This petition was created by Cancer Trials Ireland as one element of the organisation’s Just Ask 2020 campaign to raise public awareness of clinical trials and issues relating to clinical trials.
The Just Ask 2020 campaign is supported by unrestricted grants from Pfizer Healthcare Ireland; Novartis; AbbVie; MSD; Roche; Bayer.