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issues, and/or social embarrassment. In general, research subjects should not suffer undesirable effects from their research participation.³ Because all research involves some degree of risk, a researcher must justify the risk and assure that the prospective benefits of the research proposal outweigh the risks a participant may be exposed to. All measures taken to minimize risk should be defined within the study protocol.²⁹ Examples of minimizing risk may include use of a study design with adequate safeguards to protect the confidentiality of information collected, and inclusion of a data management plan. A data management plan could describe who is in control of collected data; where data will be securely stored; who will be authorized to access, use, or disseminate study data; how use of data will be disclosed to a study participant; whether personal identifiers will be used; and whether study results will be included in employee personnel files or patients' medical records. In addition, plans for the future uses of samples, identifiers, and data obtained from the samples must also be provided, along with a description of how long study data will be maintained and how study data will be destroyed. A researcher addresses these elements in the method, intervention (if applicable), data treatment, and risks and benefits sections of a protocol. The American Nurses Association Code of Ethics for Nurses–Provision 7 states that the nursing profession should engage in scholarly inquiry to identify, evaluate, refine, and expand the body of knowledge that forms the foundation of its discipline and practice.¹ Ongoing scholarly activities are essential to fulfilling a profession's obligations to society. Provision 7 identifies that nurses working alone or in collaboration with others can participate in the advancement of the profession through the development, evaluation, dissemination, and application of knowledge in practice. Magnet^® organizations deliberately integrate evidence-based practice (EBP) and research into clinical and operational processes and educate nurses about EBP and research to explore the safest and best practices for patients and to generate new knowledge. All nurses should learn the policies and procedures of their organization related to three areas: human subjects' protection (informed consent and the role of the IRB), requirements of study participation, and procedures for reporting conflicts between protection of a patient and requirements of study participation (see Clinical nurse's role: Four examples).²⁶ Remember that all proposed data collection from human subjects (including employee records and patients' medical records) should have some form of review. In addition to IRB approval, an organization may require other review processes for projects and studies that will be conducted by nurses or other employees. Nurses should identify the recognized body for determining if a proposal is research or QI within their practice setting and confirm that required human subjects review procedures were completed before data collection begins. When a patient is admitted, clinical nurses should ask whether the patient is currently a subject in a research study. If the patient responds yes, the nurse should confirm that the patient has signed a consent form and ask for a copy of the consent form to be included in the medical record. However, the nurse cannot obtain consent for a research study unless he or she is a part of the study team, has received education about the study, and has competed human subjects' protection training. In addition, nurses should not obtain informed consent to participate in research from their assigned patients to prevent patients from feeling coerced or compelled to participate in order to receive quality care.²⁶ Nurses must be aware that clinical care and research have different goals, procedures, and ethical considerations. The nurses' role when caring for a patient who is serving as a study participant is to recognize and report conflicts that can occur.³⁰ Examples include the incompatibility of planned treatment measures with study medications and/or interventions, adverse medication reactions, changes in mental status, breaches in confidentiality, coercion with recruitment or continued participation, or any identified healthcare risks. To learn more about human subjects' protection, consider completing online courses such as the Collaborative Institutional Training Initiative at h-hsr or the National Institutes of Health web-based Training Module at . Research is defined as a systematic or scientific investigation including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. Quality improvement (QI) is an organizational strategy involving analysis of process and outcomes data and systematic initiatives designed to improve performance in a particular healthcare setting. Both research and QI projects can involve data collection from human subjects; however, not all interactions with humans or data collected from humans is considered research under IRB rules. For example, purely QI projects such as data collection for internal administrative purposes do not require IRB approval. But because QI projects can overlap with research, many organizations require all project proposals to be submitted for IRB review. Nurses may receive email

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