{"id":198,"date":"2019-08-29T19:00:44","date_gmt":"2019-08-29T19:00:44","guid":{"rendered":"https:\/\/www.socra.org\/blog\/?p=198"},"modified":"2019-08-29T19:00:45","modified_gmt":"2019-08-29T19:00:45","slug":"research-with-respect-advocacy-in-pediatric-clinical-trials","status":"publish","type":"post","link":"https:\/\/www.socra.org\/blog\/research-with-respect-advocacy-in-pediatric-clinical-trials\/","title":{"rendered":"Research with Respect:  Advocacy in Pediatric Clinical Trials"},"content":{"rendered":"\n<figure class=\"wp-block-image is-resized\"><img decoding=\"async\" loading=\"lazy\" src=\"https:\/\/www.socra.org\/blog\/wp-content\/uploads\/2019\/08\/pediatric-clinical-trials-1024x683.jpg\" alt=\"A pediatric clinical researcher meeting with a mother and child\" class=\"wp-image-199\" width=\"833\" height=\"555\" srcset=\"https:\/\/www.socra.org\/blog\/wp-content\/uploads\/2019\/08\/pediatric-clinical-trials-1024x683.jpg 1024w, https:\/\/www.socra.org\/blog\/wp-content\/uploads\/2019\/08\/pediatric-clinical-trials-300x200.jpg 300w, https:\/\/www.socra.org\/blog\/wp-content\/uploads\/2019\/08\/pediatric-clinical-trials-768x512.jpg 768w, https:\/\/www.socra.org\/blog\/wp-content\/uploads\/2019\/08\/pediatric-clinical-trials.jpg 1254w\" sizes=\"(max-width: 833px) 100vw, 833px\" \/><\/figure>\n\n\n\n<h3 style=\"text-align:center\">Lauren Bird, RN, BSN, CCRC<br><strong>Clinical Research Nurse<\/strong> <\/h3>\n\n\n\n<h3 style=\"text-align:center\"><strong>Mallory Rowell, MS, CCRC<\/strong><br><strong>Clinical Research Coordinator<br><\/strong><\/h3>\n\n\n\n<h3 style=\"text-align:center\">The Research Institute at Nationwide Children&#8217;s Hospital<\/h3>\n\n\n\n<p><strong><em>Abstract<\/em><\/strong><em>: Maintaining respect for the autonomy of families enrolled in pediatric clinical trials is a vital aspect in achieving the best outcomes. This article highlights ethical considerations in working with families enrolled in pediatric clinical trials, with a focus on appreciating the difficulty that families face in deciding whether to participate in a clinical trial as well as the importance of advocating for the special needs of family units. The significance of providing valuable resources to families and how this can positively affect recruitment and retention rates is also covered, along with the need to incorporate an ethical mindset into daily practice. <\/em><\/p>\n\n\n\n<!--more-->\n\n\n\n<h2><strong>Introduction<\/strong><\/h2>\n\n\n\n<p>It is normal for a parent to\nhave conflicting feelings about enrolling a child in a research study. Clinical\nresearch professionals must put themselves in the shoes of parents, and they\nmust ensure that they respect parents\u2019 decisions and make the parents comfortable\nwhen they are enrolling their child in a research study.<\/p>\n\n\n\n<p>Ethics impacts everything\nthat is done in pediatric clinical research. It is not an abstract concept. Ethics\nis ubiquitous in the day-to-day work of clinical research professionals who constantly\nface challenges that require them to use an ethical mindset. <\/p>\n\n\n\n<p>In practice, ethics is\ndynamic. Although there are many regulations and laws that require certain\nbehavior in certain situations, there are also an infinite number of situations\nthat are not covered by any regulation or law. Handling these situations\nrequires critical thinking and an ethical mindset. <\/p>\n\n\n\n<h2><strong>History of Human Subjects Research and the Era of\nBioethics<\/strong><\/h2>\n\n\n\n<p>Historically, there have been\nmany failures to inform, protect, and respect research participants. A great\ndeal of fear and mistrust of clinical research still exists today. Historic\nfailures have ranged from a complete disregard for human life to deception to\nissues as seemingly innocuous as failing to provide any benefit to the\ncommunity from which the participants are recruited. Ethical failures vary in\nthe degree of extremity. Clinical research professionals must continually be\naware of their obligation to the community, individuals, and society overall.<\/p>\n\n\n\n<p>Within the last 40 years,\nduring what is referred to as the era of bioethics, ethics in medicine has\nevolved significantly. This has been an important time for humanistic\nprinciples to take hold in medicine and research. Although the early idea of\nintroducing values into research may have seemed like a lofty goal, this\nremains a vital tool for conducting good research today.<\/p>\n\n\n\n<p>Focusing on the vast\nphilosophical opinions that surround bioethics sometimes makes bioethics seem\nless accessible to those who are not bioethicists. There is sometimes a\ndisconnect between the philosophical and practical aspects of bioethics. For\nexample, how do healthcare providers such as nurses and physicians align their\nactions to the code of ethics, or philosophy, which includes principles such as\nbeneficence and autonomy? This article focuses on respect as well as some of\nthe challenges clinical research professionals face in their work in upholding\nthis ideal. Situations where being able to act ethically is critical are\nhighlighted.<\/p>\n\n\n\n<h2><strong>Special Considerations and Current Issues in Pediatric\nClinical Research <\/strong><\/h2>\n\n\n\n<p>Table 1 highlights special\nconsiderations in pediatric clinical research at Nationwide Children\u2019s Hospital.\nChildren are considered a vulnerable group and have special protections under\nthe law. The institutional review board (IRB) at Nationwide Children\u2019s Hospital\nis especially careful in deciding which studies should or should not be undertaken.\nMost IRBs include a variety of different experts and laypersons to ensure that\ndifferent interests are represented. Nationwide Children\u2019s Hospital has a\npediatric expert on the IRB. <\/p>\n\n\n\n<p>The IRB at Nationwide\nChildren\u2019s Hospital also assigns risk levels from 1 to 4 to pediatric research\nstudies. The risk levels are related to requirements for enrollment, consent,\nand study conduct. <\/p>\n\n\n\n<p>Another special consideration\nwhen enrolling a child into a study is that the entire family is essentially\nbeing enrolled. In some instances, only one parent and the child come to the\nstudy visits. Many times, however, extra family members come to the study\nvisits. This can place an incredible burden on families when they are deciding\nwhether to enroll in a study. Clinical research professionals must be sensitive\nto this.<\/p>\n\n\n\n<p>The last special\nconsideration is maintaining the balance between not wanting to put children\nthrough pain and discomfort and the obligation to continue conducting research.\nChildren are still considered therapeutic orphans for many drugs, devices, and other\ntherapies, which means that there is no good research to tell physicians how to\ntreat their pediatric patients. As much as clinical research professionals might\nstruggle emotionally with their role in working with children in research, it\nis their duty to help ensure that adequate research is available to safely\ntreat children. <\/p>\n\n\n\n<h2><strong>Prevalent Ethical Dilemmas in Pediatric Clinical\nResearch<\/strong><\/h2>\n\n\n\n<p>There are four areas that\nhave especially prevalent ethical dilemmas:<\/p>\n\n\n\n<ul><li>Informed consent<\/li><li>Therapeutic misconception<\/li><li>Spectrum of health status (healthy control versus chronically ill)<\/li><li>Social media and technology.<\/li><\/ul>\n\n\n\n<p>Table 2 highlights each of\nthese areas.<\/p>\n\n\n\n<p>The issues around informed\nconsent have been well documented in the literature. This is an area where continual\nimprovements are likely to be needed. Appropriate informed consent requires a\nstrong understanding of the practicality of ethics. When clinical research\nprofessionals at Nationwide Children\u2019s Hospital conduct the informed consent\nprocess, they look at things such as who is deciding to participate and whether\nthey understand what is involved in the research study.<\/p>\n\n\n\n<p>In pediatric research, the\nparent or guardian signs the consent form, which can lead to complications. For\nexample, what happens if the parent wants the child to participate in the study\nbut the child does not want to participate? At Nationwide Children\u2019s Hospital,\nassent starts at age nine. If a child age 9 or older does not sign the assent\nform, clinical research professionals do not enroll the child in the study.<\/p>\n\n\n\n<p>The following situation,\nwhich occurred at Nationwide Children\u2019s Hospital, illustrates this ethical\nissue. A parent and child came in to enroll in a device study for an\ninvestigational product. The device had been shown to be helpful in providing patients\nand their families with feedback about the child\u2019s illness. The child is seven\nyears old, which is old enough to generally understand the study but not old\nenough to provide assent. The mother is very excited about the study and\nreadily signed the informed consent form; however, the child does not want to\nwear the device for a few days. Based on the regulations, the mother\ntechnically has the right to enroll the child into the study. This is the type\nof situation that clinical research professionals face regularly.<\/p>\n\n\n\n<p>Therapeutic misconception is\nalmost as pervasive in the bioethics literature as informed consent. This occurs\nwhen research participants are unable to fully understand the difference\nbetween medical care and research. Typically, these families believe that they\nwill be given special treatment or that the child will benefit from participating\nin a study. It is very important for the family and child to understand the\ndifference between standard medical care and research. The goal of standard\nmedical care is to treat the individual and resolve the illness, whereas the\ngoal of research is to learn something and hopefully provide generalizable\ninformation to the broader population.<\/p>\n\n\n\n<p>Clinical research\nprofessionals must understand the factors that contribute to therapeutic\nmisconception in order to determine the changes that they can make to daily\npractice. One factor is the person who explains the research to the patient. If\nthe investigator is also the patient\u2019s physician, the family might confuse the\nroles of doctor and researcher. The information covered in the discussion is\nanother contributing factor. The discussion should include an explanation of\nthe difference between standard clinical care and research and what the patient\nand family can expect from the research process. If the enrollment takes place during\na clinical visit in the clinic room, this can send mixed signals and contribute\nto therapeutic misconception.<\/p>\n\n\n\n<p>Nationwide Children\u2019s\nHospital enrolls patients who range from healthy controls to the chronically\nill. Different approaches are needed to enroll healthy controls and chronically\nill participants. Enrolling healthy controls can be challenging, as the research\nprovides no direct benefit to them, and typically, clinical research\nprofessionals do not have a long-term relationship with the family. With rare\ndiseases on the other hand, the families typically seek out research and are\noften desperate to enroll in these studies. They form relationships with study\ncoordinators because they are often enrolled in studies for years.<\/p>\n\n\n\n<p>There may be different\nethical issues depending on when and where patients are enrolled. For example,\nenrolling patients in the Emergency Room (ER) setting can be difficult and\nchallenging. One study at Nationwide Children\u2019s Hospital required obtaining\nconsent from children who were coming into the ER in cardiac arrest. What\nworked best was having one of the clinical investigators who was an attending\nphysician in the ER go in and consent the family, since the principal\ninvestigator had already formed relationships with that family.<\/p>\n\n\n\n<p>Children enrolling in \u201ccompassionate\nuse\u201d clinical trials usually have a fatal diagnosis, and the study is the only\nhope that they have left. The families are often desperate to get the child into\nsuch a study. Clinical research professionals must inform them that the study\nhas risks even though the study drug may be the only treatment that can treat\nthe child.<\/p>\n\n\n\n<p>Typically, chronically ill children\nand their families have tried everything that is available clinically, and they\nsee clinical research as their last hope. It is heartbreaking to see what these\nfamilies go through, especially when conducting research in rare diseases. Choosing\nwhich children with rare diseases to enroll in clinical trials is difficult. At\nNationwide Children\u2019s Hospital, clinical research professionals and the clinical\ninvestigators review the list of patients and families who would like to participate,\nand they evaluate which patients will be most compliant with the requirements\nof the study. Open and honest communication with the parents that their child\nmay not be selected for a study is crucial.<\/p>\n\n\n\n<p>When parents are sharing\ntheir stories, such as moving from another country to the city where the\nchildren\u2019s hospital is located in the hope of enrolling in the trial, it can be\ndifficult to separate emotion from the role of researcher. Clinical research professionals\nmust treat every family equally, and they must adhere to the protocol in order\nto obtain the necessary unbiased high-quality data. <\/p>\n\n\n\n<p>Social media and technology\ncan sometimes be a hot topic in research. Parents are networking online through\nsocial media, and clinical research professionals must ensure that this does\nnot affect the study data. At Nationwide Children\u2019s Hospital, for example,\nparents of twelve children participating in a double-blind study had created a\nprivate Facebook group and were sharing information such as the side effects\nthat they were seeing in their children, the color of the drug dripping off the\nIV pole, and physical therapy data. The clinical investigator had to talk to\neach of the parents and explain about how sharing these data could have a\nnegative outcome on the study. <\/p>\n\n\n\n<p>For high-profile studies at Nationwide\nChildren\u2019s Hospital, the informed consent form includes a paragraph about not\ndiscussing details of the study with anyone outside the family, and it mentions\nFacebook and Twitter. It states that the child could be removed from the study at\nthe clinical investigator\u2019s discretion if the family does this. <\/p>\n\n\n\n<p>Technology is ever changing, and clinical research professionals must learn to adapt. It is important to always be aware of potential problems related to social media and technology, to share ideas for dealing with this within the institution, and to have policies in place to protect the institution.<\/p>\n\n\n\n<h2><strong>Respect in Clinical Research and Good Ethical\nStandards <\/strong><\/h2>\n\n\n\n<p>Respecting children and\nfamilies in clinical research includes remembering that every patient is unique.\nClinical research professionals must adapt to different personalities in order\nto form better relationships with patients, and they must remember that children\nare capable of making some decisions. For example, when working with small\nchildren, the study coordinator can ask the child to choose a type of Band-Aid\nor which arm the IV will go in. This makes the child feel important and\nempowered, shows respect, and embraces the child\u2019s autonomy. It shows the\nparents that clinical research professionals are respecting their child\u2019s\nwishes and gives them a sense of having some control over the situation.&nbsp; <\/p>\n\n\n\n<p>Part of practicing respect in\nresearch is ensuring that participants are fully informed. Clinical research\nprofessionals must ensure that the family has the information necessary to make\nthe best decision for the child and the family. This includes answering all of\ntheir questions, giving the family ample time to review the informed consent\nform, and informing the family that participation is voluntary and they can\nwithdraw at any time. Participants must be protected from unnecessary harm by\nfollowing all aspects of the protocol and having strong oversight by the clinical\ninvestigator.<\/p>\n\n\n\n<p>Treating participants and\ntheir families as collaborators in the research process helps show that clinical\nresearch professionals value them and that they are an important part of the\nprocess. When clinical research professionals and families work together as a\nteam toward the same goal, families feel more involved and invested in a study.<\/p>\n\n\n\n<p>By ingraining good ethical\nstandards into the way every situation is viewed, ethical standards become part\nof everyday practice. In order to empathize with patients, clinical research\nprofessionals must focus on humanizing, advocating, empowering, and educating pediatric\nresearch participants and their families. Clinical research professionals\nshould empower the children and their families to be their own advocates, and clinical\nresearch professionals should also ensure that the children and their families\nunderstand what participating in the study involves. Clinical research\nprofessionals should also learn as much about the study as possible so that\nthey can answer questions and convey confidence. Having an open mind and a\nquestioning attitude is important. <\/p>\n\n\n\n<p>The benefits of treating\nfamilies with respect include better compliance and retention rates for clinical\ntrials and developing a positive reputation in the community. If families feel\nvalued, they will continue to come back and will be compliant. Clinical research\nprofessionals should show that they will go the extra mile for the families. At\nNationwide Children\u2019s Hospital, small things, such as using good distraction\ntechniques for painful procedures, help put the parents at ease and establish\ntrust. Doing all of this helps the families develop a long-term relationship\nwith research. Families share good experiences, and the clinical research site\ndevelops a positive reputation in the community. <\/p>\n\n\n\n<h2><strong>Conclusion<\/strong><\/h2>\n\n\n\n<p>Most clinical research\nprofessionals may never face the specific ethical quandaries covered in this\narticle. The key takeaway messages about conducting pediatric clinical research\nwith respect (Table 3) are relevant for all clinical research. Ethics is not\njust something for the theoretical world to debate. It affects everything that\nclinical research professionals do, and it is a responsibility that they must\nembrace.<\/p>\n\n\n\n<p>Along with considering\npossible ethical situations that could occur, an ethical mindset is necessary\nin daily practice. Clinical research professionals should also know the\nresources that are available in the event of an ethical dilemma, such as who to\nturn to for help when faced with an ethical issue. <\/p>\n\n\n\n<p>The essence of conducting pediatric research with respect is to try to understand the difficulties that the participants and their families face and to serve as an advocate for them. Clinical research professionals must also help give clinical research a good name. They have the power to positively influence relationships with participants and their families and with the community, thereby helping to advance research.<\/p>\n\n\n\n<hr class=\"wp-block-separator\"\/>\n\n\n\n<h2 style=\"text-align:center\"><strong>TABLE 1<\/strong><\/h2>\n\n\n\n<p><strong>Special\nConsiderations in Pediatric Clinical Research at Nationwide Children\u2019s Hospital<\/strong><\/p>\n\n\n\n<ul><li>Vulnerable group:<ul><li>Special protections<\/li><\/ul><\/li><li>Internal IRB: <ul><li>Must have a pediatric expert<\/li><li>Assign a risk level (1-4) to each study<\/li><\/ul><\/li><li>Consideration of the family unit:<ul><li>How will participation affect the family as a whole?<\/li><\/ul><\/li><li>Therapeutic orphans:<ul><li>U.S. Food and Drug Administration pediatric rule <\/li><\/ul><\/li><\/ul>\n\n\n\n<h2 style=\"text-align:center\"><strong>TABLE 2 <\/strong><\/h2>\n\n\n\n<p><strong>Current\nIssues in Pediatric Clinical Research<\/strong><\/p>\n\n\n\n<ul><li>Consent:<ul><li>Who decides to participate?<ul><li>Parent or child? <\/li><\/ul><\/li><li>Does the child understand what he\/she is signing?<ul><li>Some institutions begin assent at age 5 <\/li><\/ul><\/li><li>If the parent consents and child declines, where is the line       drawn?<\/li><\/ul><\/li><li>Therapeutic misconception:<ul><li>Parent or participant believes that the participant will directly       benefit from trial participation<\/li><li>Lack of understanding of the different goals of therapeutic       medicine and research<\/li><li>How do clinical research professionals know if a patient\/family       is experiencing this misconception?<\/li><\/ul><\/li><li>Spectrum of health status (healthy control vs. chronically ill):<ul><li>Spectrum of health status at consent<\/li><li>Different approaches:<ul><li>Healthy control: <ul><li>No long-term relationship and no direct benefit <\/li><\/ul><\/li><li>Rare disease: <ul><li>Families seek out research and may be enrolled for years<\/li><\/ul><\/li><\/ul><\/li><li>Different ethical issues:<ul><li>Enrolling from the ER (consenting under stress)<\/li><li>Compassionate use (fatal diagnosis)<\/li><\/ul><\/li><\/ul><\/li><li>Social media and technology:<ul><li>Parents networking through social media<\/li><li>Use of technology to quickly and easily obtain private study       information<\/li><\/ul><\/li><\/ul>\n\n\n\n<h2 style=\"text-align:center\"><strong>TABLE 3<\/strong><\/h2>\n\n\n\n<p><strong>Key\nTakeaway Messages About Conducting Pediatric Clinical Research with Respect<\/strong><\/p>\n\n\n\n<ul><li>Be aware that ethics affects everything clinical research\n     professionals do (big and small):<ul><li>An ethical mindset is necessary in daily practice<\/li><\/ul><\/li><li>Know the available resources in the event of an ethical dilemma<\/li><li>Understand what the participant and family is facing: <ul><li>Imagine how difficult decisions about pediatric clinical research\n      can be<\/li><li>Consider the possible struggles of the individual or family <\/li><\/ul><\/li><li>Help give research a good name<\/li><\/ul>\n","protected":false},"excerpt":{"rendered":"<p>Lauren Bird, RN, BSN, CCRCClinical Research Nurse Mallory Rowell, MS, CCRCClinical Research Coordinator The Research Institute at Nationwide Children&#8217;s Hospital Abstract: Maintaining respect for the autonomy of families enrolled in pediatric clinical trials is a vital aspect in achieving the best outcomes. This article highlights ethical considerations in working with families enrolled in pediatric clinical &hellip; <\/p>\n<p><a href=\"https:\/\/www.socra.org\/blog\/research-with-respect-advocacy-in-pediatric-clinical-trials\/\" class=\"more-link\">Continue reading <span class=\"screen-reader-text\">Research with Respect:  Advocacy in Pediatric Clinical Trials<\/span> &rarr;<\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"om_disable_all_campaigns":false,"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0},"categories":[52],"tags":[53,54],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v15.6.2 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Research with Respect: Advocacy in Pediatric Clinical Trials - SOCRA Blog<\/title>\n<meta name=\"description\" content=\"Maintaining respect for the autonomy of families enrolled in pediatric clinical research trials is a vital aspect in achieving the best outcomes. 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