In October, Academy Fellows participated in a Discussion with the Health Research Authority which focussed on current opportunities and challenges in the regulation and governance of health research.
Professor Jonathan Montgomery (HRA Chair) and Dr Janet Wisely (HRA Chief Executive) summarised recent progress made by the HRA and outlined future directions. Attendees participated in a lively discussion, chaired by Sir Michael Rawlins FMedSci – chair of the Academy’s regulation and governance of health research working group, which focussed on a number of issues including implementation of the new HRA Approval Programme, data management and how to achieve public trust and understanding.
Additionally, the Academy has responded to the Health Research Authority’s consultation on proposed guidance on ‘Seeking informed consent for simple and efficient trials in the NHS’.
The Academy supports the move towards seeking consent in a proportionate manner from patients to take part in real-world, large-scale simple and efficient research trials of existing treatments within the NHS. This is consistent with recommendations made in the Academy’s 2011 report on health research governance.
In the submission our Fellows and other experts have provided a number of comments on the draft guidance that address:
- Avoiding coercion during patient recruitment.
- Specific guidance for obtaining consent during emergency care situations.
- Verification of informed consent.
- Clear feedback policy.
- Appropriate training for healthcare professionals.
- Clarification of health practitioners’ duty of care.
Further information on the HRA’s current progress is outlined in HRA Latest.
Discussion with the Health Research Authority meeting note