Issues Raised by Ethics Committees Across the 8 Peers for Progress Studies
| Theme (No. sites affected) | Summary of IRB/REC Comments/Actions | Research Governance theme |
|---|---|---|
| Mapped to ethical framework (4+1) | ||
| Clinical care (3) | Non-malevolence: Peer-support volunteers must not compromise participant medical care. | |
| Clinical governance structures for support staff (2) | Beneficence: Provide further details regarding clinical governance structures to ensure that research nurses report significant clinical issues to a suitably qualified clinician. | OP |
| Emotional support for peer supporters (4) | Beneficence: How will the leaders be trained to provide emotional support for group members? | |
| Beneficence: Applicants should address the emotional issues likely to arise in peer support. | ||
| Beneficence: The well-being of the peer supporters should not be compromised by their activities as volunteer peer supporters. | ||
| Questionnaire finalization (3) | Non-malevolence: Researchers must provide a definitive questionnaire before approval can be granted. | SR |
| Confidentiality and privacy - not related to framework | ||
| Confidentiality (3) | Arrangements for how research nurses should deal with issues relating to confidentiality should be described. | OP |
| Recruitment constraints (1) | Prospective participants identified by clinic staff must sign a card indicating interest in participating before research staff contact prospective participant. | IG, OP |
| Protection of peer-supporter privacy (1) | For the protection of all concerned, volunteers should not be telephoning or visiting participants late at night. | HR |
| Peer-supporter characteristics/recruitment | ||
| Selection of peer supporters (3) | Details relating to the recruitment, selection, vetting, training, and support of peers should be given together with relevant approval time scales. | ?OP |
| Enhanced criminal and background checks must be conducted. | OP | |
| Matching peer supporters to peers (1) | The abilities and qualities of the peer supporters should be matched to the needs of those to be supported. | SR |
| Duration and suitability of peer-support training (2) | The training programs are inadequate in content and duration. | SR |
| Payment for peer support (3) | Peer supporters are being asked to give up a lot of time, and the researchers should consider remuneration for this. | HR |
| Practical safety: peers and supporters | ||
| Institutional protections for peer supporters (2) | How will adequate support be provided for peer supporters? | OP, HR |
| How will rescue mechanisms be provided? | OP, HR | |
| A contract should be provided for peer supporters. | OP | |
| Arrangements for how the nurse manages the peer supporters should be described, particularly where a peer supporter is not functioning adequately or appropriately. | OP, HR | |
| Risk to peer or participant from being alone together [at home] (1) | For 1:1 interventions, a home visiting policy is needed. | OP |
| Practical safety: intervention staff | ||
| Antisocial working hours (1) | Nurses supporting peers should have antisocial hours limited and working hours stated. | HR |
| Background checks (1) | Enhanced criminal and background checks should be required for nurses. | OP |
| Study design and evaluation relating to ethical review process | ||
| Separation of pilot and main study approval processes (2) | Researchers must complete the pilot study before applying for approval for a full trial. | OP |
| Study duration (1) | The study duration is insufficient due to the processes that will need to be followed. | OP |
| Inclusion of participant preference analysis (1) | A statistical analysis based on preference/personality of participants should be carried out. | SR |
| Choice of HbA1c as a primary outcome (1) | Is HbA1c a suitable primary outcome for the study? | SR |
| Consent form return process (1) | How will consent forms be returned to researchers? | OP |
HR = human resources; IG = information governance; OP = organizational policy; SR = scientific rigor