PROTECTING THE RIGHTS OF STUDY PARTICIPANTS
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Because nursing research usually involves humans, a major nursing responsibility is to be aware of and to advocate on behalf of clients’ rights. Before any research on humans can be started, the researcher must obtain approval from the relevant committee designated to protect human subjects’ rights. This includes research that does not require direct involvement of the person, only access to data about the client. This committee is often called the Institutional Review Board (IRB). The IRB ensures that all clients are informed of and understand the consequences of consenting to serve as research participants (Figure 2–3 •). The specific elements that comprise informed consent are listed in Box 2–7.
The client needs to have enough information to be able to assess whether an appropriate balance exists between the risks and inconvenience of participating in a study and the potential benefits, either to the client or to the development of knowledge that may benefit others.
For many years, adults have been the focus of much health care research conducted on human subjects. The American Academy of Pediatrics has identified the need to conduct pediatric research so that children can benefit from advances in medical science. At the same time, because children are so vulnerable, extra precautions must be taken to ensure their rights are upheld and they are not harmed. It is critical to have pediatric expertise on panels that review prospec- tive research studies and in research development. All nurses who practice in settings where research is being conducted with human subjects or who participate in such research play an important role in safeguarding the rights discussed next.