The ethical conduct of research with humans

Author(s): University of Washington, Human Subjects Division
Document type: Online material
Year: 2003
Pages: 39
Source: Faculty, university or academic institution: Indiana University, Poynter Center for the Study of Ethics and America Institutions
Language(s): English

Classification

National background: United States
Category: Non-EU Training Material for Research Ethics
Subject areas: Human experimentation
Content: Case studies; Important codes; Legal background; Normative reflections
Issues touched: Autonomy, respect, informed consent, subjects unable to consent, role representatives Beneficence, non-maleficence, risk for the subject Justice, benefits/burdens, research without benefit for the subject, placebos/standard therapy Protection of privacy, data protection, biological material; Vulnerable groups, soldiers, prisoners, pregnant women, elderly people; International research, research in developing countries; Ethics committees, research protocols
Audience: Students of natural sciences
Classification remarks: Collection of slides without further comments. These slides are used in tutorial sessions offered by the issuing institution, combined with a web-based training programme.

Estimation

Theoretical quality remarks: As the material is a collection of slides, it is only meant as support material in a greater didactic context. Thus, the "legal background" (stating some relevant US regulations) is only mentioned on the slides, leaving it to the tutor to comment on it. The "important codes" contain Nuremburg Code and the Helsinki Convention, but only the Belmont principles are given in detail and interpreted to some extent. The "normative reflections" are mainly restricted to this interpretation (e. g. that the "principle respect" is implemented in the form of "informed consent", which then in turn is further characterised in its content and procedural requirements). The focus of the prospective course is the researcher's responsibility in interacting with the IRB's. The three case studies are well-selected, but the slides provide only questions concerning the cases discussed, no answers (1: HIV-suspicion in random blood sample; 2: malaria study in Africa; 3: low number of research subjects).
Didactical quality: Didactically prepared material
Didactical quality remarks: Starts with cases of unethical research, enumerates important codes and US laws, states and interprets the Belmont principles, describes the role of IRB's, gives 3 case studies with questions (no answers)
Overall estimation: recommendable
Estimation remarks: The slides can provide medial support in teaching a course.