Research synthesis only; not medical or legal advice. Human research requires the applicable regulatory authorization, independent ethics review, informed consent, qualified oversight, and ongoing participant protection. Requirements vary by jurisdiction and study risk.
Research-use-only products and the ethical boundary
A “research use only,” “not for human use,” or laboratory-use label is not permission to test a material in people. It does not establish medicine authorization, clinical-trial authorization, manufacturing quality, sterility, endotoxin control, identity, or a lawful human-use supply chain.
An ethics committee does not replace regulatory authorization or product-quality requirements. Human exposure belongs within the applicable legal and ethical framework using appropriately controlled A clinical-stage candidate with scientific or public relevance. Investigation is not approval, and a studied exposure is not a recommendation. Sumber definisi: Scope and selection methodology · Glosarium or approved product, qualified investigators, and accountable sponsors.
Foundational documents
| Document | Year | Scope | Key provisions |
|---|---|---|---|
| Nuremberg Code | 1947 | Foundational international ethics | Voluntary consent; favorable risk–benefit; qualified investigators |
| Declaration of Helsinki | 1964; revised, including 2024 | Medical research involving humans | Participant welfare; independent review; special protection where vulnerability exists |
| Belmont Report | 1979 | US ethical principles | Respect for persons; beneficence; justice |
| CIOMS International Ethical Guidelines | 2016 | International health research | Consent; fair selection; community and low-resource context |
| ICH E6 Good Clinical Practice | 1996; R3 adopted 2025 | International clinical-trial standard | Rights and safety; reliable data; quality-by-design oversight |
Regulatory frameworks
United States
FDA rules include 21 CFR Parts 50, 56, and 312; HHS rules include 45 CFR Part 46 and additional protections for specified populations. Whether an investigation requires an IND or qualifies for an exemption is a regulatory determination. Applicable trials may also have ClinicalTrials.gov obligations.
European Union
Regulation (EU) 536/2014 governs medicinal-product clinical trials through the Clinical Trials Information System, with member-state and ethics review roles. Article 29 addresses informed consent.
United Kingdom
The Medicines for Human Use (Clinical Trials) Regulations 2004, as amended, govern medicine trials. HRA and research-ethics processes apply in relevant settings, and public registration may use recognized registries.
Other jurisdictions and global standards
Japan, Canada, and Australia have national authorization and ethics frameworks. WHO’s ICTRP and good-clinical-practice materials support registration and quality principles but do not replace national law.
See the jurisdiction pages for the United States, European Union / EEA, and United Kingdom.
Scientific question → protocol → independent ethics review → regulatory authorization where required → consent and enrollment → monitoring and reporting → results. Participant rights, risk-benefit review, and data integrity guard the whole study.
Institutional Review Board / Ethics Committee
An IRB, REC, or IEC is an independent body that reviews participant protection, scientific and ethical justification, risk–benefit, selection, consent, privacy, monitoring, and study conduct. Composition rules seek scientific, nonscientific, and independent perspectives; the exact rule depends on jurisdiction.
Review categories
| Category | Criteria | Neutral example | Who decides |
|---|---|---|---|
| Convened / full review | Greater-than-minimal risk or another criterion requiring committee review | A first-in-human medicinal-product trial | The competent ethics board under the applicable framework |
| Expedited review | Defined minimal-risk category eligible under the governing rule | Collection of a limited research sample from consenting adults | The ethics board or its authorized reviewer, not the researcher alone |
| Exempt determination | Fits a defined exemption under the applicable rule | Analysis of qualifying de-identified data | The institution or ethics process designated by the framework, not self-declaration |
Product status, intervention, population, data use, and risk can change the required pathway. “Minimal risk” and exemption are legal or regulatory concepts, not informal judgments.
Informed consent
Consent is a process for providing understandable information and supporting a voluntary decision. It continues when relevant information changes and does not waive participant rights or make an otherwise unacceptable study ethical.
Purpose and procedures
Research purpose, expected participation, study procedures, and A clinical-stage candidate with scientific or public relevance. Investigation is not approval, and a studied exposure is not a recommendation. Sumber definisi: Scope and selection methodology · Glosarium status should be described in understandable terms.
Risks and alternatives
Foreseeable risks, possible benefits, and relevant alternatives are addressed without overstating benefit or minimizing uncertainty.
Rights and contacts
Privacy, injury-related information where applicable, contacts for questions, voluntariness, and the right to withdraw without penalty are core protections. Significant new information that may affect willingness to continue belongs in the ongoing process.
Participant protection also includes monitoring, adverse-event communication, protocol compliance, privacy safeguards, and appropriate results reporting. See adverse events and reporting and dose-language boundaries.
Clear information → understanding → voluntary decision → ongoing updates → clear information. Participants retain the right to ask questions and withdraw. Consent alone does not make a study ethical.
Sources
US Department of Health and Human Services. Protection of Human Subjects (Common Rule). 45 CFR Part 46. 2018 revision. https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html
FDA. Protection of Human Subjects. 21 CFR Parts 50 and 56. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=50
FDA. Investigational New Drug Application. 21 CFR Part 312. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=312
ICH Harmonised Guideline. Good Clinical Practice (E6(R3)). Final version, adopted 6 January 2025. https://database.ich.org/sites/default/files/ICH_E6%28R3%29_Step4_FinalGuideline_2025_0106.pdf
World Medical Association. Declaration of Helsinki — Ethical Principles for Medical Research Involving Human Subjects. 2024. https://www.wma.net/hb-e-version-2024-2/
CIOMS. International Ethical Guidelines for Health-Related Research Involving Humans. 2016. https://cioms.ch/wp-content/uploads/2017/01/WEB-CIOMS-EthicalGuidelines.pdf
Regulation (EU) No 536/2014 of the European Parliament and of the Council on Clinical Trials on Medicinal Products for Human Use. 2014. https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014R0536
National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report. 1979. https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/index.html