Section 3 - Ethical Opinion Flashcards
What is the limit to When a final decision should be issued for a full review app?
60 calendar days… aim for 40 days…
Can be 90 if advanced therapy
What is the limit to When a final decision should be issued for a PR review app
21 calendar days
When should the CI be notified of a decision?
<10 Working days for full… <5 working days for PR by sub-committee
What are some of the standard conditions of an FO?
That the sponsor obtain approval from host organisations prior to the start of the research.
Approval from MHRA prior to research starting (CTIMPs and devices)
Registration of publically accessible database within 6 weeks of first participant getting recruited (CTs determined by the first 4 categories of IRAS Q2)
CI Undertaking GCP
Ensuring researchers trained in conducting study.
Ensuring data encryptions are in place
Registering participant on TOPS (phase 1 HV studies)
You have a CTIMP (or a device study). Want to give an UnFO due to safety concerns… can you?
Not at meeting… Should should give PO and ask them to consult the MHRA. (Section 14 SOP)
When can a REC give the responsibility of reviewing the response to HRA staff?
In cases where there is no technical information required and no questions of judgement are likely to rise.
If it’s bad enough can a REC request it be put to another REC meeting?
Yes… take note of clock and that the applicant is under no obligation to provide info by a specified date (as long as it’s within two months)… can create issues if they miss cut off date for the next meeting…
Can a REC raise new points after the decision is first issued?
No
How long do applicants have to respond?
Two months.
Send a reminder (SL12) at one month. At two months withdraw.
When further advice is needed from a referee, does the clock stop when SL8 (notification email) is sent to applicants?
No. Not till decision issues.
Who can act as a referee? Who contacts? Timeline for this? Who reviews advice?
A member of another REC… an external expert… AO contacts someone with no connection to researchers (using template on HRA hub).
The meter should be sent to the referee within 5 working days. Request response in writing within a further 10 days.
Sub-committee of members named at meeting reviews.
If REC believes they previously gave an opinion in error (e.g. further info after decision, misinteroreted legal/regulatory requirements) what can be done?
Variation of opinion… changes the decision.
Requests to vary should be considered by Chair and other members as appropriate… If varies, Issue a new letter clarifying terms in the letter amd stating former letter has been superseded and why (3.54)
Does FO mean activity at all sites can begin?
No… activity can begin when management at sites approve research beginning.
