Research ethics governance exists because of historical episodes in which research caused serious harm to participants who were not adequately protected — the Nuremberg trials, the Tuskegee syphilis study, and the thalidomide tragedy among them. The frameworks that emerged from these failures — the Nuremberg Code, the Belmont Report, the Declaration of Helsinki — and the institutional structures that implement them (IRBs, Research Ethics Committees) are not regulatory obstacles to scientific progress. They are the systems that ensure research participants’ rights and welfare are protected, that research data has not been fabricated or selectively reported, that conflicts of interest are disclosed, and that research with potential dual-use applications is assessed for biosecurity risk. For corporate R&D, the ethics dimension is increasingly significant: GDPR and CCPA govern personal data used in research; clinical trial ethics requirements affect pharmaceutical and medical device development; and research integrity failures create reputational and regulatory consequences that dwarf the cost of the ethics review. A structured R&D ethics compliance checklist addresses this comprehensively: from the initial ethics risk assessment through IRB submission, informed consent, ongoing monitoring, and research integrity maintenance. This free checklist gives researchers, R&D teams, and research compliance officers a structured framework for the full ethics compliance lifecycle.
Individuals should be treated as autonomous agents capable of making their own decisions. Those with diminished autonomy — children, prisoners, individuals with cognitive impairments — are entitled to additional protection.
In practiceInformed consent — the process of ensuring participants understand the research, its risks and benefits, their right to withdraw, and that they are voluntarily agreeing to participate.
Researchers must maximise the possible benefits and minimise the possible harms of research, and must not harm participants to benefit others.
In practiceRisk–benefit assessment — are the risks to participants proportionate to the potential knowledge gains? Are all risks minimised to the lowest practicable level?
The benefits and burdens of research should be distributed fairly. Vulnerable or disadvantaged populations should not bear a disproportionate burden of research risk while advantaged populations receive the benefits.
In practiceFair participant selection — selection criteria justified by scientific need, not by convenience or the vulnerability of the population.
Six phases covering the full ethics compliance lifecycle — from initial risk assessment through informed consent design, IRB submission, approval, ongoing compliance monitoring, and research integrity management.
Informed consent is not a signature on a form. It is an ongoing process of ensuring participants understand what they are agreeing to, what risks they are accepting, and that their participation is genuinely voluntary. The form documents the process — it is not the process itself.
This checklist is available as a free, runnable template in CheckFlow — with IRB approval as a required gate before data collection can begin and continuing review reminders tracked automatically.
Use This Template FreeExempt review applies to research that presents no more than minimal risk and falls within specific regulatory categories — such as research using existing data that is publicly available or properly de-identified, or research conducted in established educational settings using normal educational practices. Critically, the researcher does not determine whether their research qualifies for exemption. The IRB makes this determination. Research must not proceed without either an exemption determination or IRB approval.
Expedited review applies to research involving no more than minimal risk that meets specific regulatory criteria — such as voice or video recordings, or the collection of data through non-invasive procedures. Expedited reviews are conducted by the IRB chair or a designated reviewer rather than by the full board.
Full board review is required for all research involving greater than minimal risk that does not qualify for expedited review. The full IRB convenes to review, discuss, and vote on the protocol. This is required for most clinical trials, research with vulnerable populations, and studies involving sensitive topics or significant risks to participants.
The most serious research ethics violation — beginning human subjects data collection without IRB approval — occurs when the data collection workflow is not dependent on ethics approval. CheckFlow makes IRB approval receipt a required phase gate: the data collection workflow cannot be initiated until the ethics approval phase is marked complete.
Template DesignerAn IRB approval that expires mid-study because continuing review was not filed invalidates all data collected after the expiry. CheckFlow tracks the IRB approval expiry date and triggers the continuing review submission task 60 days in advance — preventing the lapse that invalidates the study.
AutomationsJournal submissions, grant reports, and regulatory filings require evidence of ethics compliance: approval number, approval date, informed consent documentation, and any protocol amendments. CheckFlow’s ethics compliance record contains all of this — built automatically as the compliance process runs.
Analytics & ReportingEthics approval is a prerequisite for human subjects data collection. CheckFlow’s R&D Data Collection Process Checklist covers the data collection methodology that follows ethics approval. See the R&D Data Collection Process →
Ethics compliance is a required component of research proposals and should be addressed at proposal stage. CheckFlow’s Research Proposal Submission Checklist covers the full proposal development process. See the Research Proposal Submission Checklist →
An R&D ethics compliance checklist covers six phases: ethics risk assessment (IRB review requirement determination, applicable framework identification, risk level assessment, vulnerable population identification, data privacy requirements), informed consent design (plain language form, all required elements, vulnerable population adaptations, consent process documentation), IRB/ethics committee submission (full protocol, supporting documents, institutional submission, review pathway, query responses), IRB approval and study initiation (approval before any data collection, documentation filed, study conducted as approved), ongoing compliance (annual continuing review, adverse event reporting, protocol deviation reporting, emerging risk monitoring), and research integrity and conflict of interest (COI disclosure, data integrity procedures, authorship criteria, dual-use review).
Informed consent requires that participants receive and understand: the purpose of the research; all procedures they will be asked to undergo; all foreseeable risks and discomforts; any potential benefits; disclosure of alternatives to participation; how confidentiality will be maintained; compensation arrangements if any; contact information for questions; a statement that participation is voluntary; and confirmation that they can withdraw at any time without penalty. Informed consent is an ongoing process — not a one-time event at enrolment. If new information emerges during the study that might affect participants’ willingness to continue, the consent process must be repeated.
A protocol amendment is a planned, prospective modification to an approved protocol that must be submitted to and approved by the IRB before implementation. A protocol deviation is an unplanned departure from the approved protocol that has already occurred — it is reported to the IRB after the fact. Protocol deviations are often inadvertent (equipment failure, participant misunderstanding) and do not necessarily affect the validity of the study or participant safety, but they must be reported so the IRB can assess their significance. Protocol deviations that do affect participant safety are treated as unanticipated problems and require immediate reporting.
In the US, certain categories of research may be eligible for exemption from IRB review under 45 CFR 46. Exemptions apply to research in categories such as research conducted in established educational settings using normal educational practices, research involving surveys or interviews of adults on non-sensitive topics where confidentiality is maintained, and research involving solely secondary analysis of de-identified data. Critically, the researcher does not determine whether their research qualifies for exemption — the IRB makes this determination. Research should not proceed without either an exemption determination or IRB approval.
You can start a free 14-day trial with no credit card required, giving you full access to all features including this template. The Business plan is $10 per user per month after the trial. Full details at checkflow.io/pricing.
