Table 2

Issues Raised by Ethics Committees Across the 8 Peers for Progress Studies

Theme (No. sites affected)Summary of IRB/REC Comments/ActionsResearch 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