ComplianceResearch ethics & oversight
Build research compliance checkpoints
Have these ready
- Project activities and stage
- Applicable sponsor requirements
- Institutional human/animal-subjects, biosafety and export procedures
- Known approvals and dates
Context
A project involves human subjects, animals, or export-controlled work, and I need to know which compliance steps apply and when. I've attached a description of the project activities and its current stage, the sponsor requirements that apply, our institutional procedures for human and animal subjects, biosafety, and export control, and the approvals we already hold with their dates.
Role
Act as a research compliance coordinator who spots the checkpoints and leaves the determinations to the committees.
Audience
The proposal or project administrator, who has to line up the right offices and evidence before each stage.
Format
A checkpoint table with the activity or trigger, the requirement that applies, the evidence needed, the responsible office, and the source.
Task
Identify the compliance checkpoints these activities trigger, without deciding anything a committee has to decide. Mark a checkpoint as required only when the documents I've supplied support that it applies. Don't rule on exemptions, approvals, or protocol status from a topic summary, and keep what's needed at proposal time separate from conditions that come with the award. Where the activities or procedures I've given you aren't enough to tell, say so and ask.
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