HRA Ethics Officer Pilot HRA Ethics Officer Pilot
Published on 17 October 2012
The Health Research Authority is conducting a pilot to consider whether the introduction of ethics officers, experienced representative of the NRES, will increase the proportionate of favourable opinions at first review, improve the timelines of review and reduce the administrative burden on RECs, through the provision of advice and support to the researcher and committee.
Where is the pilot taking place?
East Midlands:
- Nottingham 1
- Nottingham 2
- Derby
- Leicester
North East:
- York
- Sunderland
Who are the ethics officers?
Experienced REC Chairs are fulfilling the ethics officer function during the pilot. An evaluation will be undertaken to consider who will provide this function in the longer term, if the pilot is successful.
What is involved in the pilot?
If the REC the researcher applies to is taking part in the pilot, the researcher will be asked to email their study documentation to the coordinator at the time of booking. This will be forwarded to the ethics officer who will consider the application and associated documentation prior to the REC meeting. The ethics officer will contact the researcher prior to the meeting for some or all of the following reasons:
- To discuss any relevant issues with the researcher and flag any areas which require greater consideration. The researcher may therefore be better prepared to answer the RECs queries at the meeting.
- To discuss any changes to the Participant Information Sheet (PIS) or Consent Form (CF). The ethics officer will identify any areas of the PIS or CF which may require modification as they are inconsistent with the protocol or other parts of the application, incorrect or an addition is required. No changes are allowed to be made to the documentation prior to the REC meeting however these changes may be accepted by the REC at the time of the meeting to allow a favourable opinion with conditions rather than a provisional opinion to be given. Please note the REC will have the final decision on any changes to the documentation.
- To consider the attendance of the researcher at the REC meeting. The ethics officer will review the application and determine if attendance is required in person or if attendance by telephone would be suitable.
- For all applications, the ethics officer will contact the researcher and determine whether any advice was received prior to the researcher submitting their application and specifically whom or where this was from.
During the REC meeting an ethics officer will be present however there will be no difference to the normal procedure when attending a REC meeting.
After the meeting, the researcher will be sent an email from the ethics officer, thanking them for taking part in the pilot and asking them to complete an anonymous, online questionnaire to provide feedback on their experiences.
What if the ethics officer is unable to contact the researcher?
In the event the ethics officer is unable to contact the researcher, the ethics officer may attempt to contact another researcher listed on the application form. If no response is received, the ethics officer will continue with the parts of the pilot which do not require a conversation with the researcher.