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

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

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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

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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 that govern all research it. Justice requires that recruitment tion of Human Subjects Law was conducted in the US based on three and selection of research subjects be passed, providing the ethical stan- basic tenets: respect for persons, be- equitable, with all participants being dards followed in the US to this day.2 neficence, and justice.16,17 All per- treated fairly during the conduct of a The Belmont Report heavily influ- sons who serve in the role of a study study. The PI should distribute bur- enced the Federal Policy for the Pro- investigator are required to complete den and benefits among population tection of Human Subjects, known human subjects training, which in- groups by considering who bears the as the Common Rule, published in cludes a review of content from the burden and risk of research partici- 1991.15-17 This regulation added ba- Belmont Report.3 Understanding in- pation and who benefits from the sic protections for participation of terventions required to uphold these research findings. Study subjects pregnant women, fetuses, neonates, ethical principles when research is should be selected fairly and equita- children, and prisoners in research. conducted is another important ele- bly without exploiting a group that The Common Rule also established ment of nursing advocacy. will not benefit from the study requirements for voluntary consent The ethical principle of respect for results.2,3,17,18 for participation in research and ob- persons acknowledges the dignity Conducting research according to taining written consent from persons and freedom of every person and ethical and legal standards requires agreeing to participate in research on supports the requirement that volun- nurses to: a form to be approved by the IRB tary informed consent be obtained • protect vulnerable research par- during the review process. Awareness before involving a human subject in ticipants. Vulnerable participants are of the history that led to legal re- research. In relation to the conduct those with diminished autonomy quirements for conducting research of research, this principle addresses a who are less able to defend them- reminds us of how basic human person’s ability to independently and selves in a given setting or situa- rights were violated in the past and autonomously volunteer for partici- tion.17-20 In considering autonomy, how we can guard against similar pation in a study. It also supports the two elements must be addressed: events in the future. mandate that persons be fully in- mental capacity or the ability to The National Institutes of Health formed regarding study procedures understand and process informa- sets policies for human subjects re- and risks and benefits, and that they tion, and voluntariness or freedom search according to federal law.18 cannot be pressured or coerced to from the control or undue influence IRBs require evidence of current hu- participate in research. All study op- of others.17 When some or all par- man subjects protection training by portunities must include provisions ticipants are likely to be vulnerable all study team members to approve a that give research participants the to coercion or undue influence, www.Nursing2019.com July l Nursing2019 l 29

Copyright © 2019 Wolters Kluwer Health, Inc. All rights reserved. additional safeguards must be in- the National Commission for the approves all research proposals included to protect their rights and Protection of Human Subjects of Bio- volving human subjects that will be welfare.17-20 Nurses have a role in medical and Behavioral Research.2 conducted within the organization. identifying vulnerable subjects and The Commission identified that all verifying that their rights are being research proposals involving human Understanding the role of IRBs protected when research is con- subjects should be based on ethical Which statement about an IRB is not ducted. principles and be approved in ad- true? Study participants may be vulner- vance by an IRB. The IRB is the rec- a. The primary responsibility of an IRB able because of age, legal or mental ognized authority for determining is to protect the welfare and rights of incompetence, terminal illness, or whether a project is research or a human subjects. confinement to an institution.17,20 quality improvement (QI) initiative b. Federal regulations require an IRB to Examples include infants and chil- (see Is it research or QI?). be comprised of a minimum of twelve dren, human fetuses, prisoners, preg- In the early 1980s, these regula- members from diverse occupations and nant women, physically or mentally tions were revised and published as backgrounds, with one member from disabled persons, economically or Title 45 Code of Federal Regulations outside the organization. educationally disadvantaged persons, Part 46, Protection of Human Sub- c. IRB members are responsible for re- and workers. The latter category jects (45CFR46), which includes a viewing a protocol to assess the balance may include employees of the facility category of Special Protection of of risks and benefits and determine that in which the research is being con- Children, Mentally Ill, or Special risks to subjects do not outweigh the ducted or any other participant who Populations.24 Nurses should be benefits or knowledge to be gained. may face employment-rated risks. aware that because research conduct- d. IRBs conduct an initial review of all IRB approval requires justification for ed in the US is subject to all federal proposed research studies, continuing the inclusion of vulnerable subjects regulations identified in 45CFR46, reviews, and quality assurance audits. as study participants and the protocol an organization can lose the right to should include a description of mea- conduct research if 45CFR46 re- Correct answer: b. The minimum sures taken to protect their rights.19,20 quirements are violated. number of members required for an Research involving special popula- Two government agencies oversee IRB is 5, not 12. tions should not exceed a minimal research conduct: the Office for Hu- An IRB’s primary responsibility is risk level. The US Department of man Research Protections and the to protect the welfare and rights of Health and Human Services and the FDA.24,25 Hospitals, universities, and human subjects. Many IRBs are insti- FDA provide additional guidance on other organizations receiving federal tutionally based programs. IRBs con- the concept of participant research research funding enter into an agree- duct an initial review of all proposed vulnerability.21-23 ment, called an assurance, regarding research studies and then conduct a • adhere to federal regulation of the ethical conduct of research. As continuing review, at least annually, research activity. In 1974, Congress discussed below, the agreement spec- for studies in progress for more than passed the National Research Act as ifies that an IRB functioning in accor- 12 months. The IRB also conducts Public Law 93-348 and established dance with 45CFR46 reviews and quality assurance audits.3 Federal regulations require an IRB Is it research or QI?31-33 to be comprised of at least five members from diverse occupations and Research is defined as a systematic or scientific investigation including research backgrounds, with one member from development, testing, and evaluation, designed to develop or contribute to gener- outside the organization. Typical IRBs alizable knowledge. Quality improvement (QI) is an organizational strategy involving analysis of process and outcomes data and systematic initiatives designed to are comprised of physicians, nurses, improve performance in a particular healthcare setting. Both research and QI proj- other healthcare specialists, chap- ects can involve data collection from human subjects; however, not all interactions lains, ethicists, and at least one com- with humans or data collected from humans is considered research under IRB munity member.3 IRB members are rules. For example, purely QI projects such as data collection for internal adminis- responsible for reviewing a research trative purposes do not require IRB approval. But because QI projects can overlap protocol to assess the balance of risks with research, many organizations require all project proposals to be submitted for and benefits, and to determine that IRB review. risks to subjects do not outweigh the The IRB is the recognized authority for determining whether a project is QI or benefits or knowledge to be gained. research. The IRB review process assures human subjects protection for all pro- IRB members also evaluate ethical posed project work. components to determine that basic

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Copyright © 2019 Wolters Kluwer Health, Inc. All rights reserved. human rights are not being compro- • The right to privacy and dignity instrument, data collection, data mised, selection of subjects is fair and addresses freedom of a person to treatment, and risks and benefits equitable, informed consent will be determine the time, extent, and sections of a protocol. obtained, and confidentiality of study circumstances for sharing private • The right to fair treatment, which data will be protected.26 information and is based on the ethi- means that all persons should be cal principle of respect for persons.28 treated fairly and should receive Five basic human rights When conducting research, the PI what they are due/owed, is based Which basic human right is violated must inform participants that they on the ethical principle of justice.28 when people become research subjects may choose to decline to answer The PI makes plans to ensure and/or are exposed to research treat- questions and decline to allow mea- equitable selection of subjects and ment without their knowledge or when surements, such as vital signs or lab their treatment when conducting participants are misinformed about the specimens, to be collected by the research, confirms that subject purpose of the research? researcher. The PI must also tell par- selection is directly related to the a. self-determination ticipants how their study data will be research question, and assures that b. privacy and dignity managed and shared. Violations may risks and benefits are distributed c. anonymity and confidentiality occur if invasive questions are asked fairly. Potential violations may in- d. fair treatment that may result in loss of job, friend- volve injustices with subject selec- e. protection from discomfort and harm ships, or dignity, or that may create tion that occur as a result of social, embarrassment or emotional distress. cultural, racial, and/or gender bi- Correct answer: a. The right to A violation could also occur if par- ases. The researcher addresses these self-determination is violated when ticipants are not notified that their elements in the sample, setting, people become research subjects study information will be shared eligibility (inclusion/exclusion crite- and/or are exposed to research treat- with others. The researcher includes ria), and risks and benefits sections ment without their knowledge or information to explain how this basic of a protocol. when participants are misinformed right is being protected in the inter- • The right to protection from discom- about the purpose of the research. vention (if applicable), instrument fort and harm requires the researcher Nurses engaged in research must description, consent, data collection, to take an active role to promote address all five of these basic human data treatment, and dissemination good and prevent harm; this aligns rights as they develop a study sections of a protocol submitted for with the ethical principle of benefi- protocol.27 IRB review. cence.28 The researcher must design • The right to self-determination ad- • The right to anonymity and confiden- a study to minimize risks for social, dresses freedom to choose without tiality involves measures to assure physical, economic, or psychological external control and is founded on that a subject’s identity cannot be discomfort or other harm. Viola- the ethical principle of respect for linked, even by the researcher, with tions may occur if the researcher persons.28 When conducting research, his or her individual responses. Indi- knows in advance that harm, death, participants must be treated as auton- vidual identities of subjects cannot or disabling injury will occur and/ omous agents with the right to choose be linked to research responses and or that the benefits do not outweigh to participate or to not participate, cannot be publicly divulged. This the risks. Violations also can occur and the freedom to withdraw from right is based on the ethical principle when measures are not included to a study at any time without penalty. of respect for persons.28 minimize or manage potential study Potential violations can result when A researcher must describe how risks. participants perceive a threat of harm study data will be deidentified or or when excessive rewards are offered collected in a manner that will Risk exposure in research to ensure study participation. Other protect the identity of all study Safety of human participants in research violations would occur when people participants. Violations can occur involves addressing categories of risk become research subjects without when the researcher, by accident exposure during study participation. their knowledge or when participants or direct action, allows an unau- Which statement about risk exposure in are misinformed about the purpose thorized person to gain access to research is true? of the research. A researcher includes study data that contains identifiers a. Research risk does not include non- information in the informed consent or creates a harmful situation. The physical injury, such as concerns about and data collection procedures of a researcher includes descriptions of loss of confidentiality, psychological protocol to describe how this basic all measures taken to protect ano- distress, legal implications, employment right is being protected. nymity and confidentiality in the issues, or social embarrassment. www.Nursing2019.com July l Nursing2019 l 31

Copyright © 2019 Wolters Kluwer Health, Inc. All rights reserved. b. Study participants are not exposed to Examples of minimizing risk may All nurses should learn the policies risk when research procedures involve include use of a study design with and procedures of their organization data collection using surveys/question- adequate safeguards to protect the related to three areas: human sub- naires or retrospective data collection confidentiality of information col- jects’ protection (informed consent from medical records. lected, and inclusion of a data man- and the role of the IRB), requirements c. All research studies involve some level agement plan. A data management of study participation, and proce- of risk. plan could describe who is in control dures for reporting conflicts between d. A researcher does not need to define of collected data; where data will be protection of a patient and require- measures taken to minimize risk within securely stored; who will be autho- ments of study participation (see the study protocol if a study is catego- rized to access, use, or disseminate Clinical nurse’s role: Four examples).26 rized as “minimal risk.” study data; how use of data will be Remember that all proposed data disclosed to a study participant; collection from human subjects Correct answer: c. Because all re- whether personal identifiers will be (including employee records and search studies involve some level of used; and whether study results will patients’ medical records) should risk, the safety of human participants be included in employee personnel have some form of review. In addi- in research involves addressing cat- files or patients’ medical records. In tion to IRB approval, an organization egories of risk exposure during study addition, plans for the future uses of may require other review processes participation. The term risk is used to samples, identifiers, and data ob- for projects and studies that will be describe potential injury or damage tained from the samples must also be conducted by nurses or other em- that may result from study proce- provided, along with a description of ployees. Nurses should identify the dures. In the US, control of research how long study data will be main- recognized body for determining if a risk is centered within federal law tained and how study data will be proposal is research or QI within 45CFR46.24,28 destroyed. A researcher addresses their practice setting and confirm When developing a protocol, these elements in the method, inter- that required human subjects review nurses sometimes mistakenly assume vention (if applicable), data treat- procedures were completed before that no risk will be involved with ment, and risks and benefits sections data collection begins. certain research projects. Nurses of a protocol. When a patient is admitted, clini- need to be aware that all research cal nurses should ask whether the studies involve some level of risk Key takeaways for nurses patient is currently a subject in a re- because risk in research is defined The American Nurses Association search study. If the patient responds broadly and is not limited to physical Code of Ethics for Nurses–Provision yes, the nurse should confirm that injury. 7 states that the nursing profession the patient has signed a consent form Examples of research-related should engage in scholarly inquiry and ask for a copy of the consent physical injury may be associ- to identify, evaluate, refine, and form to be included in the medical ated with an investigational de- expand the body of knowledge that record. However, the nurse cannot vice, experimental procedure, or forms the foundation of its discipline obtain consent for a research study medication. Nonphysical injury and practice.1 Ongoing scholarly unless he or she is a part of the study may involve loss of confidentiality, activities are essential to fulfilling a team, has received education about psychological distress, legal implica- profession’s obligations to society. the study, and has competed human tions, employment issues, and/or Provision 7 identifies that nurses subjects’ protection training. In social embarrassment. working alone or in collaboration addition, nurses should not obtain In general, research subjects with others can participate in the informed consent to participate in should not suffer undesirable effects advancement of the profession research from their assigned patients from their research participation.3 through the development, evalua- to prevent patients from feeling co- Because all research involves some tion, dissemination, and application erced or compelled to participate in degree of risk, a researcher must of knowledge in practice. Magnet® order to receive quality care.26 justify the risk and assure that the organizations deliberately integrate Nurses must be aware that clinical prospective benefits of the research evidence-based practice (EBP) and care and research have different proposal outweigh the risks a par- research into clinical and operational goals, procedures, and ethical con- ticipant may be exposed to. All processes and educate nurses about siderations. The nurses’ role when measures taken to minimize risk EBP and research to explore the caring for a patient who is serving as should be defined within the study safest and best practices for patients a study participant is to recognize protocol.29 and to generate new knowledge. and report conflicts that can occur.30

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Copyright © 2019 Wolters Kluwer Health, Inc. All rights reserved. Clinical nurse’s role: Four examples Review these clinical scenarios and choose the correct responses based on the discussions in this article.

1. When admitting a patient, the nurse learns that the 3. Which of the following statements about clinical nurses’ patient is currently participating in a research study. participation in research is true? What steps should the nurse take? (Choose all that a. IRB review and approval of a research study proposal is not apply.) required when data are collected from nurses employed in a. Confirm that the patient has signed a research consent form a hospital setting. and ask for a copy of the consent form to include in the b. Study opportunities can provide a way for nurses to con- medical record. tribute information that can be used to improve nursing b. Confirm that the study’s PI knows about the hospital admis- practice and/or patient outcomes. sion so he or she can provide information about the study c. It is acceptable to forward an email study invitation to procedures and any requirements that may have bearing on others to help the researcher reach the targeted sample the patient’s treatment plan. size. c. Obtain information from the PI on all study requirements d. A review process is not required before collecting data from and any changes in the standard of nursing care (for patients’ medical records as long as the data collector is a example, additional vital sign measurements, phlebotomy, hospital employee. or patient teaching). Correct answer: b. Study opportunities can provide a way for d. Notify the patient’s healthcare provider and unit manager/ clinical nurses to contribute information that can be used to director/supervisor. improve nursing practice and/or patient outcomes. Correct answers: a,b,c,d. The admitting nurse should take all Nurses may receive email invitations to participate in a of these steps. study being conducted within in their work setting. Nurses should never forward such an email study invitation to others 2. A nurse coworker on the unit is the PI for a study she because by doing so, the nurse would be engaging in study plans to conduct as part of her graduate program re- recruitment. Only members of the research team are eligible quirements. She asks all nurses on the unit to let their to recruit study participants after the IRB has reviewed the patients know about the study and obtain consent from proposed recruitment and data collection procedures and patients who want to participate. The clinical nurse has granted permission for the PI/study team to recruit should: participants. a. Support the PI conducting the study so she can fulfill her school program requirements. 4. A nurse’s role in human subjects’ protection involves b. Recruit only those patients who are directly assigned to which of the following? (Choose all that apply.) the nurse. a. Learning the policies and procedures of their organization c. Tell the PI that a nurse cannot obtain consent for a research related to three areas: human subjects’ protection (in- study unless the nurse is a part of the study team, has formed consent and role of the IRB), requirements of study received education about the study, and has competed participation, and procedures for reporting conflicts be- human subjects’ protection training. tween protection of a patient and requirements of study d. Discuss the study opportunity with patients, have patients participation. sign the research consent form if they agree to participate b. Serving as a patient advocate to uphold patient rights and in the study, and place the signed consent form in the ensure that research is conducted in an ethical, scientifically medical record. valid manner. Correct answer: c. Nurses should not participate in recruit- c. Assessing patients’ ability to provide informed consent. ment unless they are authorized to do so as members of the d. Confirming patients’ knowledge regarding procedures and research team. Nurses authorized to recruit should not recruit risks and benefits of the study they are participating in. patients in their care to protect patients from feeling coerced Correct answers: a,b,c,d. Nurses must fulfill all these respon- by a caregiver. sibilities to protect human subjects engaged in research.

Examples include the incompatibility To learn more about human web-based Training Module at of planned treatment measures with subjects’ protection, consider https://phrp.nihtraining.com/ study medications and/or interven- completing online courses such users/login.php. ■ tions, adverse medication reactions, as the Collaborative Institutional REFERENCES changes in mental status, breaches in Training Initiative at https:// 1. American Nurses Association Code of Ethics for confidentiality, coercion with recruit- about.citiprogram.org/en/series/ Nurses. The 9 Provisions. 2016. https://anacalif. memberclicks.net/assets/Events/RNDay/2016%20 ment or continued participation, or human-subjects-research-hsr or code%20of%20ethics%20for%20nurses%20-%20 any identified healthcare risks. the National Institutes of Health 9%20provisions.pdf. www.Nursing2019.com July l Nursing2019 l 33

Copyright © 2019 Wolters Kluwer Health, Inc. All rights reserved. 2. Miracle VA. The Belmont Report: the triple 14. Centers for Disease Control and Prevention. 25. US Food and Drug Administration. FDA policy crown of research ethics. Dimens Crit Care Nurs. The Tuskegee timeline. 2015. www.cdc.gov/ for the protection of human subjects. 2015. 2016;35(4):223-228. tuskegee/timeline.htm. www.fda.gov/science-research/clinical-trials-and- 3. Yoder LH. The basics of human subjects 15. US Department of Health and Human Services. human-subject-protection/fda-policy-protection- protection. Medsurg Nurs. 2006;15(2):95-98. Federal policy for the protection of human subjects human-subjects. 4. US Department of Health and Human Services. (“Common Rule”). 2016. www.hhs.gov/ohrp/ 26. Connelly LM. Staff nurses’ responsibilities Office for Human Research Protections (OHRP). regulations-and-policy/regulations/common-rule/ when caring for patients in a research study. 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