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12 Cards in this Set

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  • Back
The current standards for ethics in research were derived in response to the research done by:
Nazi scientists during WWII. These scientists used captives, including concentration camp prisoners, to conduct painful and damaging medical research (which often resulted in the death of the participants), all without the consent of the participants.
After the Nuremberg Trials, where many of these scientists were convicted of war crimes because of their actions, responsible scientists began to develop official guidelines and requirements for ethical research.
The Nuremberg Code
These guidelines included that research participation must be completely voluntary, that researchers must disclose the nature of the research (activities to be engaged in, possible risks) to the participants, that risks to participants must be minimized and participants protected against risk, and that if the research threatens the welfare of participants it must be terminated.
The Belmont Report
In 1979 the National Institutes of Health issued a report that detailed national standard for ethics in behavioral and biomedical research involving human participants. These broad guidelines for ethics in research reiterate some of the issues from the Nuremberg Code in addition to bringing some new issues to the forefront. They delineated three principles for ethical research: (1) The Principle of Respect for Persons, (2) The Principle of Beneficence, (3) The Principle of Justice.
The Belmont Report
(1) The Principle of Respect for Persons
This principle suggests that we should inform participants of risks associated with research, and respect their decisions about participation and its limits. It also suggests that people who cannot make informed decisions about their own participation (due to issues such as age or illness) should be protected to ensure that research participation is truly voluntary and that they are not being exploited or harmed.
(2) The Principle of Beneficence
This principle suggests that researchers have a twofold obligation while conducting their research. First, they must endeavor to do no harm to their participants. Second, they must attempt to maximize benefits of the research while minimizing risks. The practical outcome of this principle is that researchers must ensure that their research is designed to minimize risk, and ensure that the anticipated benefits, either to individuals or society, are sufficient to warrant the level of risk.
(3) The Principle of Justice
This principle suggests that both the risks and benefits of research should be distributed across the population in ways that are fair and justified. Vulnerable populations, including the young, the sick, or the disenfranchised, should not be exploited because they are easy to co-opt into participation. Participants should be drawn from the groups that will benefit, so that the people who bear the potential risks of research are also the ones who benefit. Additionally, we have an obligation to ensure that our findings do apply to the population broadly, such that our research benefits are not disproportionately geared toward a particular group.
Research and Risk
All participation in research involves some risk to the participants. It may be very small risk, like discomfort with the questions being asked, or it may be very substantial risk, like possible long-term psychological or physical impact. The lowest level of risk identified by APA’s standards is minimal risk. There is no research that is “no risk.”
Because all research involves some risk to participants, we are required to ensure a few things. These issues are clear outgrowths of the Nuremberg Code and Belmont Report. Among them are:
• we must minimize risk where possible
• we must give participants enough information about the research before they participate so that they understand what they will be doing and what the risks might be
• we must allow participants to decide, at any point during the research, that they no longer wish to participate
• we must make sure that at the end of the study participants understand the purposes of the study and have the opportunity and resources to work through any questions or distress
Institutional Review Board (IRB)
This is a committee that exists in most institutions that do research. It is made up of people from that institution and people from the community, and its job is to review research and ensure that risks are minimized, participants are going to be treated ethically, and the research is of good enough quality to warrant any risk incurred.
Informed Consent
When a participant arrives to engage in a study, we always present that person with a document that explains the study, explains the risks involved, and explains the participant’s right to withdraw from the study at any point without penalty. This document should be clear and understandable. The participant reads the document and signs it. The consent to participate is described as “informed consent” because the participant is consenting to be studied based on an informed understanding of the possible risks of participating in the research.
Sometimes in research is it necessary to conceal temporarily the true purpose of the research or to deceive participants otherwise about elements of the research process. If this is truly the only way to conduct the study effectively, researchers may use deception. They cannot, however, deceive the participants about the risks involved. All risks must be delineated in advance in order to obtain informed consent. When deception is used, participants must be informed afterward about the nature of the deception (see next topic).
Debriefing involves revealing any deception that was going on, inquiring after the participant’s experience, and answering any questions the participant might have about the experience or the study. This allows participants to obtain yet more information about the study and its purposes. It also allows researchers to get feedback from the participants about any unanticipated issues or effects.