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Service-Learning Research Primer (PDF)
Institutional Review Boards (IRBs)
Although research on service-learning outcomes may be exempt from this code because it usually involves non-medical research (see 45 CFR 46.101(b)), it is up to specific Institutional Review Boards (IRBs) to determine the exemption status (see 45 CFR 46.101(a)). Currently IRBs are the gate keepers on whether or not research in which humans will be utilized as subjects can be conducted by an investigator. According to Pimple (2006), the IRB assumes many important roles in the protection of human subjects in research.
- IRB review assures that:
- risks to subjects are minimized;
- risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result;
- selection of subjects is equitable; and
- there is proper informed consent and documentation of informed consent.
- In some instances, IRB review can also require that:
- the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects;
- there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data; and
- additional safeguards are included to protect the rights and welfare of any subjects likely to be vulnerable to coercion or undue influence.
- Once research is initiated, IRBs have continuing responsibilities. These include:
- the conduct of continuing review at intervals appropriate to the degree of risk, and in any event, not less than once per year;
- authority to observe or have a third party observe the informed consent process and the research;
- receipt of prompt reports from investigators of any unanticipated problems involving risks to subjects or others, or any serious or continuing noncompliance with the IRB's requirements or determination, or with the regulations; and
- authority to suspend or terminate IRB approval of research that is not being conducted in accord with the IRB's requirements or that has been associated with unexpected serious harm to subjects. (Pimple, 2006, pp. 13-14)
