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Service-Learning Research Primer (PDF)
Informed Consent
Federal regulations require that certain information must be provided to prospective research participants in an informed consent document. According to Pimple (2006), the basic requirements are:
- A statement that the study involves research
- An explanation of the purposes of the research.
- The expected duration of the subject's participation
- A description of the procedures to be followed
- Identification of any procedures that are experimental
- A description of any reasonably foreseeable risks or discomforts to the subject
- A description of any benefits to the subject or to others that may reasonably be expected from the research
- A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject
- A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained
- For research involving more than minimal risk, an explanation as to whether any compensation, and an explanation as to whether any treatments are available, if injury occurs and, if so, what they consist of, or where further information may be obtained
- An explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights, and whom to contact in the event of research-related harm to the subject
- A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time (pp. 21-22)
Additionally, the informed consent statement must be written at a level understandable by most of the population (not the study's sample), must include the number of other research participants in the study, the possible ways that the study can be terminated by the researcher, and the penalties (if any) for the subject voluntarily withdrawing from the study (Pimple, 2006, p. 22). There are some exceptions to the requirement for informed consent in research involving humans, such as archival research on previously-collected documents, or naturalistic observation in which researchers do not interact with participants. Parental consent may be required for studies involving minor children. In all cases an IRB must review the research protocol to determine if and how informed consent will be handled.
