Why your registry needs a SAB
A well-constituted SAB is not a prestige accessory. It provides:
- Scientific validity: Ensures your data elements, study design, and analysis plans meet publishable standards
- Regulatory credibility: FDA and EMA look favorably on participant led research with independent scientific oversight
- Industry credibility: Pharma and biotech partners evaluate SAB composition when deciding whether registry data is worth licensing
- Academic credibility: Journal reviewers assess whether the registry was designed with appropriate scientific rigor
- IRB support: IRBs are more comfortable with participant led research when there is independent scientific oversight
- Endpoint development: Helps identify and validate clinically meaningful endpoints for future trials
SAB composition
Core roles to fill
Disease specific clinician scientists (2 to 4), Physicians or scientists with direct expertise in your disease. These are your most important members. They validate your data elements, interpret natural history findings, and connect you to the clinical research community.
Biostatistician (1), Essential for designing data collection that produces analyzable results. Without statistical input at the design stage, registries often collect data that cannot answer the scientific questions they were built to address.
Participant/caregiver representative (1 to 2), Ensures the registry captures outcomes that matter to participants, not just outcomes that are easy to measure. This is non-negotiable for a advocacy organization.
Clinical trial methodologist (1), Advises on how registry design can support future trial endpoints, comparator arms, and recruitment.
Bioinformatician or data scientist (1), Critical if you are collecting genomic, proteomic, or other high-dimensional data.
Regulatory scientist (1, optional but valuable), Advises on FDA/EMA guidance, natural history data acceptance, and the regulatory pathway from registry to trial support.
Ethicist (1, optional), Particularly valuable for registries collecting genomic data, pediatric data, or planning broad consent.
What to look for in members
- Active publishing record in your disease area
- No conflicts of interest that would compromise independence (industry employment is a common conflict, can be managed with disclosure and recusal policies, but must be explicit)
- Genuine interest in participant led research (not just a CV line)
- Willingness to commit meaningful time, quarterly meetings minimum, plus ad hoc consultations
Structure and operations
Charter
Every SAB needs a written charter covering:
- Mission and scope of the SAB's authority
- Composition requirements and term limits
- Meeting frequency and quorum requirements
- Conflict of interest disclosure and management policy
- Compensation policy (honoraria, travel)
- Relationship to the advocacy organization's board of directors
- Decision making process (advisory vs. binding)
Meeting cadence
- Full SAB meeting: Quarterly (90 minutes minimum), or semi-annually for very busy members
- Working groups: Monthly or as-needed for specific projects (e.g., data element committee, publication committee)
- Annual meeting: In-person or hybrid intensive; review registry progress, set annual priorities, discuss publications
Compensation
SAB members should be compensated. Uncompensated advisory roles lead to disengagement. Typical honoraria:
- Meeting attendance: $500, $1,500 per meeting
- Manuscript review/authorship work: $500, $2,000 per project
- Travel expenses reimbursed at cost
Compensation levels vary significantly by organization size and the seniority of advisors. Even small honoraria signal that you value their time.
SAB responsibilities specific to registries
Data element review
The SAB should formally review and approve your core data element set before data collection begins. This review should address:
- Are these elements sufficient to answer our scientific questions?
- Are these elements consistent with the literature and with other registries in this disease space?
- Are there validated instruments or scales we should use rather than custom questions?
- What are the minimum data elements required for a natural history analysis?
Publication oversight
Define clearly before the first publication:
- Who is eligible for authorship vs. acknowledgment when registry data is published?
- Does the advocacy organization have a right of review before submission?
- How are participant coauthors identified and supported?
- What is the embargo policy for data shared with industry partners?
Endpoint development
For rare diseases pursuing FDA approval, the SAB should actively participate in FDA meetings (e.g., Type B or C meetings, Natural History Workshop) and help develop clinically meaningful endpoints that regulatory agencies will accept.
How to recruit SAB members
- Start with your clinical network, Physicians treating your community are natural candidates. Ask your most engaged participants who their best doctor is.
- Conference outreach, Attend disease specific conferences and approach researchers whose work aligns with your registry's goals.
- NORD and Global Genes networks, Both organizations connect participant groups with scientific advisors.
- Reach out cold with a strong pitch, Many researchers are genuinely motivated by participant led science. A clear, compelling ask with defined time commitments gets more yeses than you expect.
Checklist
- [ ] Drafted SAB charter
- [ ] Identified required expertise areas
- [ ] Recruited disease specific clinician scientists
- [ ] Recruited biostatistician
- [ ] Included participant/caregiver representative(s)
- [ ] Established conflict of interest policy
- [ ] Defined compensation structure
- [ ] Scheduled inaugural meeting before data collection begins
- [ ] SAB has reviewed and approved data element set
- [ ] Defined publication policy with SAB input