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people become research subjects and/or are exposed to research treatment without their knowledge or when participants are misinformed about the purpose of the research. Nurses engaged in research must address all five of these basic human rights as they develop a study protocol.²⁷• The right to self-determination addresses freedom to choose without external control and is founded on the ethical principle of respect for persons.²⁸ When conducting research, participants must be treated as autonomous agents with the right to choose to participate or to not participate, and the freedom to withdraw from a study at any time without penalty. Potential violations can result when participants perceive a threat of harm or when excessive rewards are offered to ensure study participation. Other violations would occur when people become research subjects without their knowledge or when participants are misinformed about the purpose of the research. A researcher includes information in the informed consent and data collection procedures of a protocol to describe how this basic right is being protected.• The right to privacy and dignity addresses freedom of a person to determine the time, extent, and circumstances for sharing private information and is based on the ethical principle of respect for persons.²⁸ When conducting research, the PI must inform participants that they may choose to decline to answer questions and decline to allow measurements, such as vital signs or lab specimens, to be collected by the researcher. The PI must also tell participants how their study data will be managed and shared. Violations may occur if invasive questions are asked that may result in loss of job, friendships, or dignity, or that may create embarrassment or emotional distress. A violation could also occur if participants are not notified that their study information will be shared with others. The researcher includes information to explain how this basic right is being protected in the intervention (if applicable), instrument description, consent, data collection, data treatment, and dissemination sections of a protocol submitted for IRB review. • The right to anonymity and confidentiality involves measures to assure that a subject's identity cannot be linked, even by the researcher, with his or her individual responses. Individual identities of subjects cannot be linked to research responses and cannot be publicly divulged. This right is based on the ethical principle of respect for persons.²⁸A researcher must describe how study data will be deidentified or collected in a manner that will protect the identity of all study participants. Violations can occur when the researcher, by accident or direct action, allows an unauthorized person to gain access to study data that contains identifiers or creates a harmful situation. The researcher includes descriptions of all measures taken to protect anonymity and confidentiality in the instrument, data collection, data treatment, and risks and benefits sections of a protocol. • The right to fair treatment, which means that all persons should be treated fairly and should receive what they are due/owed, is based on the ethical principle of justice.²⁸ The PI makes plans to ensure equitable selection of subjects and their treatment when conducting research, confirms that subject selection is directly related to the research question, and assures that risks and benefits are distributed fairly. Potential violations may involve injustices with subject selection that occur as a result of social, cultural, racial, and/or gender biases. The researcher addresses these elements in the sample, setting, eligibility (inclusion/exclusion criteria), and risks and benefits sections of a protocol. • The right to protection from discomfort and harm requires the researcher to take an active role to promote good and prevent harm; this aligns with the ethical principle of beneficence.²⁸ The researcher must design a study to minimize risks for social, physical, economic, or psychological discomfort or other harm. Violations may occur if the researcher knows in advance that harm, death, or disabling injury will occur and/or that the benefits do not outweigh the risks. Violations also can occur when measures are not included to minimize or manage potential study risks.Safety of human participants in research involves addressing categories of risk exposure during study participation. Which statement about risk exposure in research is true? Correct answer: c. Because all research studies involve some level of risk, the safety of human participants in research involves addressing categories of risk exposure during study participation. The term risk is used to describe potential injury or damage that may result from study procedures. In the US, control of research risk is centered within federal law When developing a protocol, nurses sometimes mistakenly assume that no risk will be involved with certain research projects. Nurses need to be aware that all research studies involve some level of risk because risk in research is defined broadly and is not limited to physical injury. Examples of research-related physical injury may be associated with an investigational device, experimental procedure, or medication. Nonphysical injury may involve loss of confidentiality, psychological distress, legal implications, employment

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