Human Subjects Issues

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Human Subjects Issues

• S005

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General principles

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

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Think for a moment about the things you would
want to know before you volunteer to participate
in a research study
Special Issues

• 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

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Things you would want to know (continued)
Special Issues

• 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?
• Unpleasant side effects?
• Disruption of normal schedule or activities?
• How participation might benefit you
• How your participation might benefit others if
  the research is successful

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You would also want to understand (continued)
Special Issues

• What will happen to your personal information or
  materials gathered in the study
• How your identity and privacy will be protected

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Special Issues

• Confidentiality refers to an agreement with an
  individual regarding the treatment of information
  obtained from or about that individual.

Data are confidential if they will not be
disclosed outside the context of the research
project in a way that reveals or implies a
subjects identity.
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Special Issues

• Anonymity refers to the complete absence of names
  or other identifying information.

Data are anonymous if it is impossible for the
investigator--or anyone else--to connect a
subject with the data they've provided.
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Special Categories of Subjects

• Vulnerable Populations
• Research Involving Children
• Research Involving Students

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

• Here are a few questions to ponder

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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

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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

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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

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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