Human Subjects Research 101 Revised January 2008. Presentation Goals. Discuss Human Subjects Research Definitions Historical Background Identify Ethical and Legal Requirements Belmont Report 45 CFR 46 – “The Common Rule” Describe Institutional Review Board Structure & Policies
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Federal definition of research
A systematic investigation, including research development, testing, and evaluation designed to develop or contribute to generalizable knowledge.
Federal definition of human subject
A living individual about whom an investigator (professional or student) conducting research obtains
Beginnings of the IRB
(Institutional Review Board)
Yes, if the research involves no more than minimal risk to subjects, no ethical concerns, does not involve vulnerable subjects, and meets at least one of the exempt research categories established by the government regulations. IRB chair can make this determination.
Dunn & Chadwick (1999), Protecting Study Volunteers in Research
Compensation for injury
Whom to contact re:
Study, subject’s rights, event of injury
Right to refuse or withdrawnEssential Basic Elements
Educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior, if minimal risk, no correlation between subjects/responses, and no vulnerable population included. (Category #2)
Research involving the collection or study of existing data, documents, records, or specimensif these sources are publicly available or the information is recorded in such a way that subjects cannot be identified, indirectly or through identifiers linked to the subjects. (Category #4)
Taste and food quality evaluation and consumer acceptance studiesifwholesome foods without additives are consumed or food contains ingredients approved by FDA, EPA, or USDA. (Category #6)