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Human Subjects Issues S005. General principles Avoid risk of unreasonable harm Informed consent (prior to data collection) Risks, benefits, procedures,

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Presentation on theme: "Human Subjects Issues S005. General principles Avoid risk of unreasonable harm Informed consent (prior to data collection) Risks, benefits, procedures,"— Presentation transcript:

1 Human Subjects Issues S005

2 General principles Avoid risk of unreasonable harm Informed consent (prior to data collection) Risks, benefits, procedures, sponsorship, etc. Risks, benefits, procedures, sponsorship, etc.Confidentiality/anonymity Avoid coercion Freedom to withdraw Avoid deception

3 Think for a moment about the things you would want to know before you volunteer to participate in a research study: That it is a research project What the purpose of the project is What the experience of participation is going to be like How long participation will take What compensation you will receive Special Issues

4 Things you would want to know (continued) What (if any) are the risks of injury or other distress, and what will happen if you are injured What else might happen to you Embarrassment? Embarrassment? Unpleasant side effects? Unpleasant side effects? Disruption of normal schedule or activities? Disruption of normal schedule or activities? How participation might benefit you How your participation might benefit others if the research is successful Special Issues

5 You would also want to understand (continued): What will happen to your personal information or materials gathered in the study How your identity and privacy will be protected Special Issues

6 Confidentiality refers to an agreement with an individual regarding the treatment of information obtained from or about that individual. Confidentiality refers to an agreement with an individual regarding the treatment of information obtained from or about that individual. Special Issues Data are confidential if they will not be disclosed outside the context of the research project in a way that reveals or implies a subject’s identity. Smith, John

7 Anonymity refers to the complete absence of names or other identifying information. Anonymity refers to the complete absence of names or other identifying information. Special Issues X Data are anonymous if it is impossible for the investigator--or anyone else--to connect a subject with the data they've provided.

8 Vulnerable Populations Research Involving Children Research Involving Students Special Categories of Subjects

9 When children are involved as subjects of research, the researcher must ordinarily obtain both the assent Research Involving Children of the child and the permission of the parent. Special Categories of Subjects

10 Clicker question coming next! Here are a few questions to ponder

11 Adults are interviewed via telephone for a study of their attitudes toward education. In explaining the study, you should promise... 1.Anonymity 2.Confidentiality 3.Neither

12 Students are interviewed by a researcher in a quiet room just next to the regular classroom. They are asked about their favorite games. 1.Assent from the students 2.Active consent from parents 3.Passive consent 4.None 5.Other

13 Students in grade 4 are observed in their classrooms, and the types of questions they ask are recorded. Do we need... 1.Assent from the students 2.Consent from the parents 3.Only teacher permission is required 4.Other

14 You ask adults to complete a written questionnaire and return it to you. No special identifying information is collected. 1.No consent required 2.Have them sign a separate consent form 3.Other


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