Article Figures & Data
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Site Number Lead Investigator Country Region Project Description Setting Ethical Review Structure (National Bodies/Local Committee 1. Ayala17 United States, southern California Peer-support intervention with emphasis on volunteer model and navigating family, community, and clinical environments, among Mexican and Mexican-American adults along US-Mexico border Community and clinical setting; coordinated by a university-based research team FDA, DHHS, OHRP, University Ethics Committee 2. Bodenheimer18 United States, San Francisco Integration of peer supporters and peer coaching into nurse/doctor treatment teams among clinics serving Latino, Caucasian, and African American populations Community setting with telephone and clinical links; coordinated by a university-based research team FDA, DHHS, OHRP, University Ethics Committee 3. Chan19 China, Hong Kong SAR Peer support, empowerment, and web-based disease management linked by telephone information technology Telephone and web-based peer support with community components; coordinated by a university-based research team Chinese University of Hong Kong-NTEC, CREC 4. Knox20 United States, Texas Application of a peer-support intervention shown to be effective among low-income, Latino populations in Los Angeles, California to an older, insured, mixed-race, middle-class population Peer-defined settings combined with technology-based interaction; coordinated by a national research network in partnership with community groups FDA, DHHS, OHRP, Academy Ethics Committee 5. Oldenburg21 Australia, Victoria Revision of existing NGO peer-support program to focus on improved daily management, linkages to care, and implications for national dissemination Non-clinical, community-based, rural and urban groups; coordinated by a university-based research team NHMRC, AHEC, University Ethics Committee 6. Safford22 United States, rural Alabama Community-based peer advisors delivering one-on-one telephone coaching for patient-driven self-management support emphasizing empowerment. Predominantly African American communities in rural Alabama; coordinated by a university-based research team FDA, DHHS, OHRP, University Ethics Committee 7. Simmons and Graffy23 United Kingdom, Cambridgeshire and bordering areas Peer-facilitated support delivered in group, 1:1 or group, and 1:1 format (with control group) in rural England Non-clinical, community-based, rural and urban groups; coordinated by a hospital-based research team NHS, NRES, Regional REC 8. Tang and Heisler24,25 United States, Michigan Peer-led self-management support in “real-world” clinical and community settings among Latinos and African Americans, respectively Clinical and community settings; coordinated by a university-based research team FDA, DHHS, OHRP, University Ethics Committee AHEC = Australian Health Ethics Committee; CREC = Clinical Research Ethics Committee; FDA = US Food and Drug Administration; DHHS = US Department of Health and Human Services; NHMRC: Australian National Health and Medical Research Council; NHS = UK National Health Service; NRES = UK National Research Ethics Service; NTEC = New Territories East Cluster; OHRP = US Office for Human Research Protection; REC = Research Ethics Committee
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
Honoring the dignity of persons: Any relationship between persons must be premised on an understanding and acceptance that all people have an inherent dignity that has been variously codified in international documents. Peer-support relationships must be founded on mutual respect. Selection and training of peer supporters: This will be determined by the setting and may be through an open call for expressions of interest and/or an approach involving a person (eg, a health care professional) who is acquainted with the potential peer supporter. Information governance principles need to be adhered to in this process. The selection process for those with or without given characteristics needs to be transparent, justifiable, and fair. Peer supporters need to be trained in confidentiality. Peers have the right to confidentially refuse a given peer supporter; this may be more or less common with friends, relatives, or neighbors. Professional-Lay boundaries: Standard professions have delineations for boundaries within which relationships may be ethically practiced. While peer supporters are not professionals, support relationships are breeched when there are conflicting roles that compete with the primary goals of peer support. This means that peer supporters need to carefully negotiate the kinds of contacts and activities they enter into with their peers. Simplified informed consent: Implied consent may constitute an appropriate standard in two contexts: intervention and the surrounding research. Agreeing to pair up with a peer or attend a group within an IRB-approved framework should imply consent. Similarly, in certain research activities, an individual’s actions imply consent (eg, completing an IRB-approved questionnaire). More intrusive research activities, however, (eg, measurements, recording of activities, and blood sampling) should require standard consent processes. Medical-record review needs to follow standard information-governance procedures. Documentation of peer relationship and its activities: Formalizing peer relationships will require establishing some basic standards of documentation of the peer relationship and of the activities and outcomes of such a relationship. While documentation in standard professions is elaborate, standards and scope of peer documentation are not well defined. Certain critical cross-cutting issues, such as ensuring completeness and accuracy, confidentiality, avoiding falsifying of records, and truth telling, must be adhered to. Confidentiality and privacy of personal records and information: The freedom to be left alone should extend to all peer support relationships. Patients do not have to document a written release in order to voluntarily share their own personal health information with a peer supporter. They can assume that it will be treated confidentially. They can freely choose whether to have a peer supporter and whether to share any personal health information. Involvement in illegal activities: Parties involved in peer relationships should not abet or foster crime, including involvement with illegal drugs. Helping a peer partner in crime and covering it up is immoral and should be discouraged. Non-licensure to practice medicine: Peer supporters are neither qualified nor licensed to diagnose, give medical advice, or recommend medications. Their interventions involve support that in many aspects aids the implementation of the licensed medical practitioner’s recommendations. Payment/Volunteerism: Any payments made to peer supporters must be carefully considered. A tension exists between the benevolence of volunteers and the capacity for health systems to exploit this benevolence which might undermine evidence-based (but more costly) structures and system changes. If a health system finances peer supporters, the system is obligated to provide adequate training and support for their work. IRB = institutional review board
