Summary of responses received from individual Research Ethics Committees
| Research Ethics Committee | Paediatric flagged | Attended in person | Discussed on phone | Decision | Opt-out consent | Streamlined PIS | Inclusion benefit | Electronic healthcare data |
|---|---|---|---|---|---|---|---|---|
| 1 | Yes | No | No | Accept, with modifications | No concerns raised | No concerns raised | Initial judgement: “In the section ‘Are there any benefits for my baby’ please delete the third sentence starting ‘This non-evidence based approach …’” Subsequently accepted modified wording | No concerns raised |
| 2 | Yes | Yes | No | Accept, with modifications | No concerns raised | No concerns raised | Initial judgement: “Please amend the sentence ‘This non-evidence based approach to neonatal care may involve more risk than being in a study like WHEAT which involves a carefully designed protocol and consistent monitoring’ under the heading ‘Are there any benefits for my baby?’ as it could be considered coercive”. Subsequently accepted modified wording | No concerns raised |
| 3 | Yes | Yes | No | Accept, with modifications | Required the following to be added to the protocol “The person conducting the consent discussion should provide a clear, well written documentation in patient paper notes to document the entire consent process and clarifying the option taken (opt in/ opt out) by the parents” | No concerns raised | No concerns raised | No concerns raised |
| 4 | No | Yes | No | Reject—after further discussion | Judgement: “The REC remained unhappy with an opt-out process. They discussed the possibility of providing a consent form for parents to evidence they had opted out, but on reflection agreed if this was possible it should be possible to provide an opt-in consent form and change the process accordingly. … The Committee agreed it was essential parents were asked to sign an agreement (either opt-out or opt-in) to ensure they personally understood exactly what they were consenting their children to. The Committee felt the concept of an opt-out study would indicate to parents there was no risk involved in the study, which would influence their decision to participate. … They acknowledged there were justifications for opt-out studies, but did not believe they applied in this case. The REC require the consent process to be changed to an ‘opt in’ system, and a consent form provided for review. This should be provided to parents alongside the information sheet, and the protocol updated to reflect this” | Initial judgement: “The participant information sheet should be rewritten/reformatted in line with NRES guidance, to ensure all pertinent areas are covered”. Having demonstrated that there was nothing absent in the PIS that was suggested by NRES guidelines, abbreviated PIS was accepted | Initial judgement: “The sentence within the ‘Are there any benefits for my baby?’ section stating ‘This non evidence based approach to neonatal care may involve more risk than being in a study like WHEAT which involves a carefully designed protocol and consistent monitoring’ must be removed. Note: Giving this kind of information to potential participants by inclusion in a general information leaflet about research is considered to be reasonable, though the particular wording should be reviewed within the institution guidelines” Subsequently accepted modified wording | No concerns raised |
| 5 | No | No | Yes | Accept, with modifications | Initial judgement: “The Committee requests further justification for the proposed use of opt-out consent”. AND “The Committee requests clarification of the process should a parent decide to opt out of the study, and confirmation that no undue pressure or influence would be placed on them, even if unintentionally (for example, by asking them to sign a form to opt out, when this is not required at the time of initial consent)”. Subsequently accepted opt-out consent with condition we provided parents with a card to prove their participation and explaining the opt-out process | No concerns raised | Initial judgement: “Please remove the final sentence of the section ‘Are there any benefits for my baby?’. It is disingenuous to include this statement about “non-evidence based approach” in the PIS since evidence based care simply means care that is compatible with the current state of evidence”. Subsequently accepted modified wording | No concerns raised |
| 6 | Yes | No | Yes | Accept, with modifications | No concerns raised | No concerns raised | Initial judgement: “Removal of the following sentence in the Participant Information Sheet: “This non-evidence based approach to neonatal care may involve more risk than being in a study like WHEAT which involves a carefully designed protocol and consistent monitoring”. Subsequently accepted modified wording | No concerns raised |
| 7 | Yes | Yes | No | Reject—after further discussion | Initial judgement: “The Committee decided that, as there is an opportunity to do so, consent should be sought from parents. The design should be changed from opt out to opt in. Therefore, please submit a consent form for completion by parents” | No concerns raised | Initial judgement: “Please remove the last sentence from the section headed Are there any benefits for my baby? In the Participant Information Sheet”. Subsequently accepted modified wording | No concerns raised |
| 8 | No | No | Yes | Reject | “The Committee did not accept that it was appropriate for patients to be entered into this study without prior consent from parents. The ‘opt-out’ consent is not a concept that the Committee recognises; it is recruitment without consent. This raised many ethical issues which have not been addressed. The Committee also considered that written evidence of consent would protect researchers from future action by parents or authorities in the event of adverse outcomes, which are not rare in this very vulnerable patient population” | No concerns raised | “The Committee thought the Parent Information Sheet was coercive in places, stating it was better to be in the study than not” | No concerns raised |
| 9 | No | Yes | No | Accept, with modifications | No concerns raised | No concerns raised | Initial judgement: “Are there any Benefits…? Section—delete the last sentence”. Subsequently accepted modified wording | No concerns raised |
| 10 | No | Yes | No | Accept, with modifications | Initial judgement: “An opt out form should be included for parents to keep for their own records” | No concerns raised | No concerns raised | No concerns raised |
| 11 | Yes | Yes | No | Accept, with modifications | Initial judgement: “Please formally document the parents’ decision to not opt out of the study”. Subsequently accepted recording this in the electronic health record | No concerns raised | Initial judgement: “Please remove the last sentence of the ‘Are there any benefits to my baby?’ Section of the Patient Information and replace with ‘taking part in a research study may confer non-specific benefits’”. Accepted modified wording | No concerns raised |
| 12 | No | No | Accept, with modifications | Initial judgement: “The ‘opt out’ option is mentioned in the study does not seem to be ethical. With the ‘opt out’ there is always a subtle push towards taking part in the study. This should be changed to ‘opt in’ as usual”. Subsequently accepted, after committee were presented with further data supporting the use of opt-out consent in this setting. | “PIS as presented is bit complex and long, especially for parents in this situation. PIS could be made brief and be simplified with lay reader friendly language”. Subsequently accepted after demonstrating parent involvement in drafting | Initial judgement: “Since there are no real benefits for babies or parents for taking part in the study, any reference to benefits of taking part should be removed from the PIS, as it could be undue persuasion”. Subsequently accepted modified wording | No concerns raised |
NRES, National Research Ethics Service; PIS, Patient Information Sheet; REC, Research Ethics Committee; WHEAT, WithHolding Enteral feeds Around packed red cell Transfusion.