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Protecting the Rights of Patients, Nurses, and Others Participating in Research

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Protecting the Rights of Patients, Nurses, and Others Participating in Research 1.5 ANCC CONTACT HOURS Protecting the rights of patients, nurses, and others participating in research BY JOANN MICK, PhD, RN, NEA-BC Abstract: Clinical nurses are in a unique CLINICAL NURSES are in a unique position to support research that studies position to support research on the the effects of interventions, symptom effects of nursing interventions, management, education, and treatment plan symptom management, education, adherence in their patients. Nurses may also and treatment plan adherence in participate in research studies that aim to their patients. Nurses may also par- advance professional nursing practice. Using ticipate in research studies that aim a quiz format, this article addresses clinical nurses’ role in research, the history of federal to advance professional nursing regulation of research, basic human rights practice. and potential violations during the conduct A fundamental principle of nurs- of research, and specific nursing actions ing practice is respect for the inher- required when research is conducted in the ent dignity, worth, unique attributes, practice setting. and human rights of all individuals.1 Nurses who understand legal and Keywords: Belmont Report, Common Rule, ethical protections for human sub- Declaration of Helsinki, Good Clinical jects can contribute to research by Practice guidelines, human rights, human serving as advocates for their patients subjects protection, Kefauver-Harris and helping to ensure that studies Amendments, Nuremberg Code, thalidomide, Tuskegee study, Willowbrook are conducted in an ethical, legal, State School study and scientifically valid manner. ISTOCK Test your knowledge of the clini- / cal nurse’s role in research by taking ASISEEIT 26 l Nursing2019 l Volume 49, Number 7 www.Nursing2019.com Copyright © 2019 Wolters Kluwer Health, Inc. All rights reserved. Copyright © 2019 Wolters Kluwer Health, Inc. All rights reserved. the following quiz, then review the statement specifically identifying the quently, thousands of babies were discussion that follows each item to proposed activity as “research” along born with severe birth defects due to update your knowledge of basic with an explanation of the study’s prenatal thalidomide exposure.8 This human rights, potential violations intent and procedures. Informa- tragedy spurred development of the during the conduct of research, and tion about the study’s purpose, the Kefauver-Harris Drug Amendments specific nursing actions required amount of time required for study to the federal Food, Drug, and Cos- when research is conducted in the participation, all procedures (both metics Act. Enacted in 1962, these practice setting. experimental and standard of care) amendments required companies to involved in the study, descriptions of conduct clinical trials to establish a Historical events shaping foreseeable risks or discomforts that drug’s effectiveness before marketing protections for human subjects may be experienced, and any antici- and gave the FDA greatly expanded Knowing why federal laws were estab- pated benefits for study participants oversight authority. It also required lished and what requirements must be must be disclosed. Other elements that subjects of clinical trials provide met when conducting research can give required for informed consent in- informed consent.9 nurses insight into the importance of clude descriptions of any alternative • The Willowbrook State School their role in human rights advocacy. procedures or treatments available, study. Beginning in 1955, mentally Which of the following events led to an explanation of how confidentiality disabled children living at the federal regulation of research in the US? of records will be maintained, and Willowbrook State School in Staten (Choose all that apply.) information about measures available Island, N.Y., were intentionally in- a. the Nuremberg trials to study participants if any harm re- fected with hepatitis virus as part of b. the thalidomide tragedy sults from research participation. The an ongoing experiment to test the c. the Willowbrook State School study name of the principal investigator effectiveness of various vaccines and d. the Tuskegee study (PI) and his or her contact informa- treatments.10,11 Public knowledge tion must also be provided to study of the event led to development of Correct answers: a,b,c,d. All these participants. federal regulations for research in- historical events helped shape Clarifying statements include that volving children, including informed protection of the rights of human study participation is voluntary, that parental/guardian consent. subjects when they participate in the participant will experience no Legally, only competent adults can research. loss of rights or benefits if he or she provide informed consent. However, • The Nuremburg trials. Some of the chooses not to participate, and the the American Academy of Pediatrics earliest established practice standards participant can withdraw from a recommends obtaining assent from resulted from evaluation of evidence study at any time without penalty. children as young as 7 years depend- during the Nuremberg trials (1949– The consent signature line should ing on the child’s age, maturity, and 1953) regarding research performed include a statement that the partici- psychological state.10,12,13 Assent is by Nazis on prisoners of war during pant’s signature indicates his or her an ongoing process involving the World War II. A result of this forum decision to voluntarily participate child, parents, and members of the was the Nuremberg Code, which after having read and discussed in- healthcare team in which, with pa- outlined essential principles for re- formation within the consent with a rental consent, the team tells the search involving human subjects.2 study team member.3,4 child about the research in terms the One element of the Nuremberg The Declaration of Helsinki child can understand and encourages Code specified that persons must be (1961) and Good Clinical Practice the child to ask questions. When the able to freely volunteer for research (GCP) guidelines are other docu- team believes the child understands participation without coercion and ments developed to outline ethical his or her role in the research, the must have knowledge that they are principles regarding human experi- child is asked to assent or dissent volunteering to participate in re- mentation and provide public as- from participation. Unlike informed search. Consent documents were surance that the rights, safety, and consent, assent is not required by required to include specific elements well-being of research participants law, although it may be required for of informed consent and to be writ- are protected.2,5-7 institutional review board (IRB) ten at an appropriate reading level • The thalidomide tragedy. In the approval, which will be discussed and language for the population late 1950s and early 1960s, thalido- below.13 being studied. mide was prescribed to many preg- • The Tuskegee study. The Tuskegee Today, the law requires that nant women to prevent morning Study of Untreated Syphilis in the research consent forms provide a sickness and promote sleep. Subse- Negro Male, commonly called the 28 l Nursing2019 l Volume 49, Number 7 www.Nursing2019.com Copyright © 2019 Wolters Kluwer Health, Inc. All rights reserved. Tuskegee study, was conducted from research project. Renewal of human freedom to withdraw from a study at 1932 to 1972. In this study, re- subjects protection knowledge is re- any time without penalty.2,3,17,18 searchers from the Public Health Ser- quired every 3 years so researchers The principle of beneficence re- vice and the Tuskegee Institute in remain current on new laws that are quires researchers to maximize ben- Alabama withheld penicillin, a developed as history evolves (for ex- efits and minimize risks for research known effective treatment, from ample, laws and regulations involv- subjects. PIs must weigh the benefits study participants with syphilis in ing new technology and internet use). and risks of a research project by order to observe the disease’s natural conducting a risk assessment that course. The participants were not Ethical principles that considers both physical and non- informed about the study’s purpose govern research physical harm. Minimal risk is de- and did not receive treatment for Which document defines the ethical fined as the probability that harm or their syphilis, even after penicillin principles that govern all research con- discomfort will not be greater than became the treatment of choice in ducted in the US based on three basic that experienced in ordinary daily 1947.14 tenets: respect for persons, beneficence, life. Study participants may not di- When this research came to light and justice? rectly benefit from study participa- in 1972, the public outcry led to an a. the Nuremberg Code tion; however, future benefits may be inquiry by the National Commission b. the Common Rule described as those that may be gained for Protection of Human Subjects of c. the Belmont Report by society as a result of knowledge Biomedical and Behavioral Research. d. the Kefauver-Harris Amendments gained through research.2,3,17,18 The Commission examined human Finally, the principle of justice rights issues of experimentation with Correct answer: c. The Belmont requires a PI to develop a valid re- humans and published the Belmont Report (1979) defines the ethical search protocol and fairly administer Report in 1979. In 1981, the Protec- principles
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