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Research nurse manager perceptions about research activities performed by non-nurse clinical research coordinators
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Nurs Outlook 63 (2015) 474e483
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Research nurse manager perceptions about research activities performed by non-nurse clinical research coordinators Carolynn Thomas Jones, DNP, MSPH, RNa,*, Clare Hastings, PhD, RN, FAANb, Lynda Law Wilson, PhD, RN, FAANa a
University of Alabama at Birmingham, School of Nursing, Birmingham, AL b National Institutes of Health Clinical Center, Bethesda, MD
article info
abstract
Article history: Received 2 October 2014 Revised 23 January 2015 Accepted 8 February 2015 Available online 14 February 2015
Objectives: There has been limited research to document differences in roles be-
Keywords: Clinical research Research nurse manager Nominal group process Clinical research coordinator Licensure Clinical research nurse
tween nurses and non-nurses who assume clinical research coordination and management roles. Several authors have suggested that there is no acknowledged guidance for the licensure requirements for research study coordinators and that some non-nurse research coordinators may be assuming roles that are outside of their legal scopes of practice. There is a need for further research on issues related to the delegation of clinical research activities to non-nurses. Methods: This study used nominal group process focus groups to identify perceptions of experienced research nurse managers at an academic health science center in the Southern United States about the clinical research activities that are being performed by non-nurse clinical research coordinators without supervision that they believed should only be performed by a nurse or under the supervision of a nurse. Results: A total of 13 research nurse managers volunteered to be contacted about the study. Of those, 8 participated in two separate nominal group process focus group sessions. The group members initially identified 22 activities that they felt should only be performed by a nurse or under the direct supervision of a nurse. Conclusions: After discussion and clarification of results, activities were combined into 12 categories of clinical research activities that participants believed should only be performed by a nurse or under the direct supervision of a nurse. Cite this article: Jones, C. T., Hastings, C., & Wilson, L. L. (2015, AUGUST). Research nurse manager perceptions about research activities performed by non-nurse clinical research coordinators. Nursing Outlook, 63(4), 474-483. http://dx.doi.org/10.1016/j.outlook.2015.02.002.
Introduction Clinical research coordination is a professional role for nurses who manage and implement clinical research protocols and provide care for pediatric or adult
patients who are enrolled in clinical trials. There is no standardization of job titles for individuals working in clinical research positions. Nurses working in this role have a variety of job opportunities and job titles ranging from study nurse, clinical research nurse, clinical research coordinator, and research nurse
* Corresponding author: Carolynn Thomas Jones, College of Nursing, The Ohio State University, 4317 Corinth Drive, Birmingham, AL 35213. E-mail address: [email protected] (C.T. Jones). 0029-6554/$ - see front matter Ó 2015 Elsevier Inc. All rights reserved. http://dx.doi.org/10.1016/j.outlook.2015.02.002
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manager, with titles varying based on the employer institution. Some nurses work in designated clinical research hospital or clinic units where study patients receive care related to their clinical research participation. Other nurses are employed by investigators or clinical research companies and are charged with coordinating single or multiple clinical research protocols. Castro et al. (2011) defined clinical research nursing practice as having “a focus on the care of clinical research participants and management of a clinical research protocol” (p. 8). Research nurse coordinators manage the operation of an average of six protocols and the care of 80 or more study patients annually (Getz, 2013; Getz, 2009). Mueller (2001) noted that the roles of nurses working in clinical research have evolved into independent roles following decades of task delegation by physician investigators (PIs) and that those independent roles constitute a unique specialization in nursing. Hastings, Fisher, and McCabe (2012) observed that nurses working in clinical research have made contributions to the research findings that support evidence-based practice through the key roles they perform in coordinating and managing research involving human subjects. Nurses at the National Institutes of Health Clinical Center represent the largest critical mass of nurses engaged in research support and coordination in the country. In 2007, nurses at the Clinical Center embarked on a project to systematically document and describe the roles of nurses in clinical research. An expert committee of clinical research nurses identified and validated five dimensions that constitute the domain of clinical research nursing practice: (a) clinical practice, (b) care coordination and continuity, (c) study management, (d) human subject protection, and (e) contributing to the science (CRN2010 Clinical Research Nurse Domain of Practice Committee, 2009). Castro et al. (2011) conducted a study to describe the specific role activities performed in each of these five domains. Bevans et al. (2011) further differentiated the role activities of nurses working as clinical research nurses, clinical research coordinators (CRCs), and nurse practitioners in clinical research settings. Nurses attending a national conference of clinical research nurses were surveyed to explore clinical research nurse perceptions about the activities of nurse clinical research coordinators (NCRCs) and nonnurse clinical research coordinators (NNCRCs), validated the nursing role delineation work of Bevans et al. (2011), and also raised concerns about the delegation of clinical activities typically requiring nursing licensure to unsupervised non-nurses (Jones & Wilson, 2014). Findings from this survey additionally suggested role conflict among the NCRC respondents and the need for further research on the delegation of clinical research activities to non-nurse research personnel (Jones & Wilson, 2013). PIs in clinical research sites, including academic medical centers, hire both NCRCs and NNCRCs. These individuals may or may not be academically educated
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in clinical research and may or may not hold certification in clinical research. There are two widely recognized mechanisms for clinical research professionals to obtain “certification” in clinical research coordination. The Association of Clinical Research Professionals (ACRP) offers certification of clinical research coordinators who have experience in conducting “essential duties” as a clinical research coordinator. Those duties are defined by ACRP as “documenting adverse events; prepare or review documents submitted to the IRB; protocol review or study procedures planning; participate in conducting subject visits; maintaining source document; prepare for and participate in study visits with monitor, sponsor, auditors, etc.; and participate in consent process.” Individuals graduating from an academic program may be eligible to take the certification examination with documentation of 1,500 hours of CRC experience. Those with an associate’s degree or bachelor’s degree or those who are registered nurses (RNs) can take the examination with documentation of 3,000 hours of CRC experience, and those with a high school diploma or registered as a licensed practical nurse or lab technician are eligible to take the examination with documentation of 4,500 hours of CRC experience (ACRP, 2014). The Society of Clinical Research Professionals (SoCRA) also has a certification examination for clinical research professionals. Eligibility for the certified clinical research professional examination requires 2 years of full-time experience as a clinical research professional or a 12-hour academic baccalaureate or graduate certificate or degree in clinical research with 1 year of full-time experience (SoCRA, 2014). Existing clinical research certifications offered exclusively for nurses working in this area of practice are lacking. There has been limited research related to delegation of clinical research activities, and many researchers who have studied the roles and experiences of clinical research coordinators have not differentiated the roles of nurses and non-nurses working in clinical research in their studies (Duane, Granda, Munz, & Cannon, 2007; Getz, 2012; Granda, Duane, Munz, & Cannon, 2009; Gwede, Johnson, Roberts, & Cantor, 2005; Kellen et al., 1994). The Department of Veteran Affairs (VA) Office of Inspector General (2007) released a report raising concerns about “unlicensed research assistants practicing medicine” in a South Texas Veterans Heath Care System in San Antonio. This led to a call for additional policies about the delegation of clinical research activities, documentation of delegation of tasks for clinical trial protocols, and scopes of practice. Multiple VA research institutions have published their policies for delegation of research activities on websites. For example, policies of the Institutional Review Boards (IRBs) of the San Francisco VA hospital elucidate the research activities that may be delegated by investigators to nurses and non-nurses (San Francisco VA Medical Center, n.d.). Similar policies from the VA Medical Center affiliated with the University of Texas Health Sciences Center at
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San Antonio (2013) and the Nebraska VA Medical Center (2014) have been disseminated online. Baer, Zon, Devine, and Lyss (2011) described tasks often assigned to research staff including “screening for potential study candidates, determining eligibility, coordinating the patient calendar, preparing documents for submission to institutional review boards, filing amendments, submitting safety data, conducting patient education, obtaining informed consent and assessing potential adverse events” (p. 188). Olson et al. (2012) studied role descriptions and research activity delegation practices for nurse and nonlicensed, nonnurse research personnel in a single-site study in Minnesota to determine whether scopes of practice violations existed. The findings from this study ultimately led the study site to develop new institutional policies to differentiate and describe specific training, roles, and restrictions for study personnel with different backgrounds at the institution. The Dana Farber Cancer Center has a delegation policy that includes both the Food and Drug Administration (FDA) guidance on clinical research investigator delegation and also the clinical research nurse competencies that are published by the Oncology Nursing Society (Oncology Nursing Society, 2010) to list specific clinical research activities that may be delegated from the PI to a physician’s assistant or nurse practitioner, a research nurse, or unlicensed and nonmedically qualified personnel (Dana Farber Medical Center, 2014). The U.S. FDA (2009) has drafted nonbinding recommendations on the delegation of clinical research activities by investigators citing numerous FDA inspection findings in which inappropriate delegation occurred. Examples of tasks that have been inappropriately delegated included “(a) screening evaluations, including obtaining medical histories and assessment of inclusion/exclusion criteria; (b) physical examinations; (c) evaluation of adverse events; (d) assessment of primary endpoints; and (e) obtaining informed consent” (p. 6). The FDA also provided guidance on the delegation of activities by PIs as follows: “The investigator should ensure that any individual to whom a task is delegated is qualified by education, training, and experience (and state licensure where relevant) to perform the delegated task. Appropriate delegation is primarily an issue for tasks considered to be clinical or medical in nature, such as evaluating study subjects to assess clinical response to an investigational therapy (e.g., global assessment scales, vital signs) or providing medical care to subjects during the course of the study. Most clinical/medical tasks require formal medical training and may also have licensing or certification requirements. Licensing requirements may vary by jurisdiction (e.g., states, countries). Investigators should take such qualifications/licensing requirements into account when considering delegation of specific tasks. In all cases, a qualified physician (or dentist) should be responsible for all
trial-related medical (or dental) decisions and care” (U.S. Department of Health and Human Services Food and Drug Administration, 2009, p. 3). There is a need for further research and policy statements on the delegation and supervision of clinical research activities from the PIs to clinical research nurses and other clinical research staff. Moreover, there is a need for the research to clarify the scope of practice of RNs and non-nurse research personnel. The American Nurses Association and National Council of State Boards of Nursing (2005) adopted a joint statement on delegation; however, this document does not comment on the delegation of clinical research protocol activities. The Alabama Nurse Practice Act (Alabama Board of Nursing, n.d.) discusses licensure and scope of practice but does not differentiate activities performed or delegated in clinical research settings from those activities performed in other clinical settings. The focus of this research was to identify perceptions of experienced research nurse managers (RNMs) at an academic health science center in the Southern United States about the clinical research activities that were being performed by NNCRCs without supervision, which they believed should only be performed by an RN or under the supervision of an RN. For the purposes of this article, an RNM was defined as an experienced RN clinical research coordinator who was managing research site operations including supervision of one or more nurse and non-nurse clinical research staff. This article defined a clinical research study as a physician investigatoreinitiated or sponsored research intervention in human subjects using pharmacologic agents (drugs or biologics) and/or devices and does not include nursing research studies on modes of care delivery or social science studies that focus on interviews or questionnaires.
Methods This was a single-site study performed at an academic medical center in the southern region of the United States and was approved by the IRB locally. Study inclusion criteria were as follows: 1. Clinical research nurse managers with experience managing RN and non-RN research staff 2. Agreement to participate and sign the study informed consent form 3. Greater than or equal to 3 years of clinical research nursing experience 4. Experience in managing one or more clinical research studies defined as interventional studies of new medicinal, device, biologic, genomic, or radiologic entities 5. Agreement to attend two, 2-hour nominal group process (NGP) meetings
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6. Agreement to maintain confidentiality of discussions by fellow participants E-mail invitations and flyers were sent to a list of participants who had previously attended research coordinator training programs at the study institution and also to the list of members of the local chapter of the ACRP. The e-mail invitation asked nurses who met study inclusion criteria to contact the study investigator authorizing future correspondence about the study. A total of 13 RNMs contacted the study investigator; however, one did not qualify for study participation. Of the 12 remaining qualifying participants, one was male, and the remaining 11 were female. The investigator sent a formal letter of invitation and informed consent forms to the 12 respondents who met the study inclusion criteria followed by a telephone call to answer questions about the study. Although all 12 participants expressed interest in the study, only eight agreed to participate in the study. The other four eligible participants opted not to participate because of time constraints or illness. A total of seven participants were available for the first NGP meeting. One participant was late because of a study patient issue; however, she participated in the second NGP meeting. This study used the NGP to generate a ranked list of activities being performed by NNCRCs that the participants believed should only be performed by an RN or under RN supervision. Van De Ven and Delbecq (1974) validated the NGP as an efficient, reliable, and valid method of documenting consensus and decision making that can be used with groups ranging from six to 12 participants. The NGP has been used in nursing and health sciences research as a basis for decision making and consensus building (Allen, Dyas, & Jones, 2004; Azziz-Baumgartner & Wilson, 2009; Cantrill, Sibbald, & Buetow, 1996; Gibson & Soanes, 2000; Jones & Hunter, 1995). The first step in the NGP is to provide participants with a description of the process and the study question to be addressed. Participants are then given time to think about the question and write a list of ideas and answers to the question that was posed. Participants then share their ideas in a “round-robin” discussion until the last idea is recorded, and the list of ideas is discussed and clarified. Participants are asked to rank the ideas based on specified criteria (such as level of importance), and the researcher then tallies the rankings. At a follow-up session, participants discuss and clarify the ranked ideas and develop a final list of ranked responses to the original research question (Florida State Department of Public Health, n.d.; Network for Improvement of Addiction Treatment, n.d.). Figure 1 illustrates the NGP used in this study. The dates and times for the focus group meetings were determined based on the results of an Internet survey tool (Doodle.com). The meetings were scheduled after work from 5:30 to 7:30 p.m. to avoid interference with work schedules. Light refreshments were
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provided to participants. At the first meeting, the investigator again explained the study procedures, answered any remaining questions, and invited participants to sign the informed consent forms. Participants also completed a demographic form that captured education and experience data. During the initial NGP meeting, the investigator oriented participants to the nominal group process using the following icebreaker question: “What are your four favorite ice cream flavors?” Participants were asked to create their list of favorite flavors silently for 2 minutes. Participants then shared their favorites aloud, one by one, and the investigator wrote the flavors on a dry-erase board until all favorites were listed. Participants discussed the list for clarification purposes followed by a 2-minute individual silent ranking of the favorites by assigning a point value between 0 and 100 (100 being most favorite) on the dry-erase board. The participants were asked to ensure that the sum of all of the rankings equaled 100. Collected rankings were tabulated on a whiteboard and summarized to demonstrate the NGP process to participants. After a short break, the investigator read the following IRB-approved script to the participants: “At this juncture, we are getting positioned to commence the nominal group process related to the study question. As explained in our practice session, you will first work silently to generate your ideas, this time over 10 minutes. The problem that I want you to think about is the conduct of clinical research by non-nurse study coordinators. Make a list, based on your personal experiences or observations to answer this question: “What are the activities that non-nurse research coordinators perform that you believe should only be performed by a nurse or under the direct supervision of a nurse?” When you generate your ideas, please be sure to list each idea as a separate item. Do not lump multiple ideas in one statement. Separate each individual issue in an item statement. You should work silently and not share with your neighbor. Avoid interruptions during this process. Cell phones and beepers should be turned off or on silent at this time. Remember there is no competition for ideas, this is a silent brainstorming session.” Immediately after the silent idea generation, individual participants shared their lists one “activity item” at a time in a round-robin until all activities from all participants were listed by the investigator on the dryerase board. The investigator facilitated a brief discussion to gain consensus and clarity of the individual activities that were listed to ensure that intended meanings were conveyed. The group was dismissed to meet again in 3 days. The investigator recorded the discussions on an iPhone (Apple, Cupertino, CA) using a transcription application (www.rev.com) for reference and documentation. A total of 21 activities were originally identified and listed in the round-robin with
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Figure 1 e Methods: Nominal group process.
an associated frequency score for the number of times the activity was listed. During the second NGP session, participants discussed the list of 21 activities. One activity statement was determined to really represent two activities and was split out for a sum of 22 total activities. Participants were distributed a handout with the list of the 22 activities transcribed from the whiteboard during session 1. The investigator read the following IRB script, which instructed them on the ranking process: “At this time, we are going to again shift into working silently. You will take the list of activities that has been distributed. You have 100 total points to distribute across the list of items. The highest number of points will go to the activities that you believe are the most problematic in terms of impacting study quality and research participant safety. The lowest number of points will go to the activities that you believe is least problematic in terms of study quality or research participant safety. You will rank each issue. Be sure to total the score to ensure that you only used 100 points total for all ranked issues combined. You will be given 10 minutes to accomplish the ranking. When we complete individual rankings, you will turn in your ranking scorecard and then we will take a break while I tabulate the rankings.” After collecting the ranking sheets from each participant, the investigator then recorded the scores on an Excel (Microsoft, Redmond, WA) spreadsheet and projected the summed ranks onto a screen. Participants reviewed the list of ranked activities on the spreadsheet and discussed the activities and their
ideas for revising the list. Some activities were consolidated under one theme. After discussion, the final revised list included 12 activities. The resulting list was printed and distributed, and the script for ranking activities was reread. Participants again worked silently and ranked each activity so that the sum of ranking scores equaled 100, with a score of 1 being the least problematic and 100 being the most problematic in terms of study quality and participant safety.
Results The participants in this study were representative of highly educated and experienced research nurse managers. Highest degrees ranged from bachelor of science in nursing (n ¼ 3), master of science in nursing (n ¼ 3), and PhD (n ¼ 2). The mean number of years working as a nurse not in clinical research was 8.6 years (range, 5e17 years). The mean number of years working in clinical research was 11.75 years (range, 3.5e19 years). Participants identified the mean number of years working in the position of “research nurse manager” was 5.71 years (range, 1.5e14 years). One participant identified her job title as “research nurse manager” for only 1.5 years at the time of the study; however, she clarified that before that she worked as the only study coordinator for a cardiologist and was managing all aspects of over 10 studies, including the supervision of a non-nurse staff member, but with the job title of “study coordinator.” The mean age of participants was 46 years (range, 37e55 years). All participants were female. The participants had
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Table 1 e Supervisory Experience of Participants (n [ 8) Supervise
Nurse clinical research coordinators Other registered nurses Non-nurse clinical research coordinators Other non-nurse staff Number of studies supervised Number of studies coordinated themselves
Currently Supervise
Supervised in the Past
Range
Mean
Range
Mean
0e9 0e3 0e4 1e7 0e100 0e20
3.88 0.75 1.38 3.38 32 4.0
0e20 0e3 0e5 0e8 0e200 0e50
5.13 0.38 1.88 3.0 43.13 16.63
extensive supervisory experience, summarized in Table 1 . Professional memberships in clinical research organizations by participants included ACRP (n ¼ 4), SoCRA (n ¼ 1), Southern Nursing Research Society (n ¼ 1), and Sigma Theta Tau International (n ¼ 3). One participant was certified by ACRP. During the first NGP session, participants identified 21 activities in response to the following study question: “What are the activities that non-nurse research coordinators perform that you believe should only be performed by a nurse or under the direct supervision of a nurse?” Table 2 lists the activities and the frequency of the listing of each of these activities. During session 2, participants discussed the activities and determined that “documentation of health history” should be split into two activities: “assessing health history” and “determining inclusion and exclusion criteria.” This resulted in a list of 22 activities for ranking. The investigator distributed score sheets to participants that included the list of 22 activity items, and then each participant was instructed to assign point values to the individual activities so that the total score for the 22 activities on each participant’s score card equaled 100 points. Table 3 lists the activities from highest ranking score to lowest ranking score and presents the sum total ranking score attributed to each activity. The activities and associated summed ranks were put into an Excel table and projected on a screen for viewing and discussion. The participants then discussed the rankings and determined further grouping of activities that better represented consolidated activities. For instance, in the initial ranking, there were two activities related to medications: “administering medications (research and non-research medications) and “dispensing study drugs.” The group consensus was that those two activities should be grouped together as “administering, dispensing medication (all).” Another example of grouping of activities was merging the terms “completing serious adverse event documentation forms,” “assessing changes in clinical status and adverse events,” “follow-up of adverse events,” and “grading of adverse events” into one activity term: “management of adverse event and serious adverse event assessment, documentation and reporting.” The discussion ultimately reduced the list of 22 activities to a final list of 12 activities. A second score card was distributed listing the 12 resulting activities, and again participants were instructed to assign values to the activities so that the total score for activities summed 100 points. The final
scores are summarized in Table 4, which lists the total score from all participants for each activity and displays them from the highest ranked score to the lowest. Table 4 represents the consensus of the participants about 12 activities that non-nurse research coordinators perform but that the participants believed should only be performed by a nurse or under the direct supervision of a nurse in clinical research
Table 2 e Round-robin Results: Activities That Participants Believed Should Only Be Performed by a Nurse or Under the Direct Supervision of a Nurse (n [ 8) Activities Frequency Completing serious adverse event documentation forms Assessing changes in clinical status, adverse events Consenting research participants Dispensing research medications Presenting test results to patients Administering medication (research and nonresearch medications)) Coordinating, obtaining, interpreting, and documenting laboratory results Grading of adverse events Collecting and documenting concomitant medications Writing a consent form Performing nursing skills and physical examination skills (without certification) Coordinating phase I or II trials with hospitalized patients or complex trials Coordinating setup of research visit procedure scheduling Overseeing randomization Writing orders in a hospital chart Recognizing and documenting end points Performing patient care or case management Documenting health histories Assessing follow-up of adverse effects or events Performing special protocol procedures proficiently Educating patients (related to disease, side effects of drugs)
4 4 3 3 2 2 2 2 1 1 1 1 1 1 1 1 1 1 1 1 1
NOTE. The table lists the actual activities stated from the participants during the round-robin and how often those activities were stated (frequency).
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Table 3 e Ranked List of Activities that Participants Believed Should Only Be Performed by a Nurse or Under the Direct Supervision of a Nurse (n [ 7) Activity (22 Activities) Ranking Sum Score 1
Table 4 e Final Ranked Activities that Participants Believed Should Only Be Performed by a Nurse or Under the Direct Supervision of a Nurse (n [ 8) Activity (12 Activities) Ranking Sum Score 2
Assessing changes in clinical status/adverse events Coordinating phase 1 or 2 trials, trials with hospitalized patients, or complex trials Performing nursing skills and physical examinations without certification Administering medications (research and nonresearch medications) Determining inclusion and exclusion criteria Performing patient care/case management Dispensing study drug Consenting research participants Completing serious adverse event documentation forms Performing follow-up of adverse effects Presenting test results to patients Educating patients (related to disease, side effects of drugs) Coordinating, obtaining, interpreting, and documenting laboratory tests and results Performing special protocol procedures proficiently Assessing health histories Collecting and documenting concomitant medications Recognizing and documenting end points Overseeing randomization Writing orders in a hospital chart Grading adverse events Coordinating setup of research visit procedure scheduling Writing a consent form Total
Coordinating phase 1 or 2 trials, trials with hospitalized patients, or complex trials Managing of adverse event/serious adverse event assessment, documentation, and reporting Administering and dispensing medication Performing nursing skills and physical examinations without certification Assessing inclusion/exclusion criteria, concomitant medications, and health histories Providing patient care, case management, and education Coordinating, obtaining, interpreting, and documenting labs (including presenting test results to patients) Overseeing randomization and maintaining study blind Performing special protocol procedures proficiently Writing orders in a hospital chart (including verbal orders) Recognizing and documenting endpoints Developing and performing informed consent Total
69.00 60.00
47.00 44.00 42.00 41.88 41.00 38.00 34.00 33.00 33.00 32.00 28.88
28.00 25.62 20.38
98
87
76 72
72
71 63
56 53 53 51 48 800
20.00 17.80 14.88 10.88 10.80 7.88 700.00*
* One of the study participants was late to the first ranking and was not able to participate so the total number of participants was seven for the first ranking.
studies. The list is ranked by participants with 1 being the least problematic and 100 being the most problematic in terms of study quality and participant safety.
Discussion The purpose of this study was to identify perceptions of experienced RNMs at an academic health sciences center in the Southern United States about specific clinical research activities that are being performed by NNCRCs without supervision that they believe should
only be performed by a nurse or under the supervision of a nurse. The identification of activities that “should not be delegated to or performed by unsupervised study staff” can lead to additional debate, research, and policy formation for clinical research operations and the clarification of job descriptions. Such demarcations can prevent violations in institutional policies, federal regulations, and guidelines and in licensure scopes of practice. Ultimately, defining role boundaries can help to mitigate risks related to the safety of participants, study validity, or institutional liabilities. The clarification of clinical research role assignments can also support PIs’ commitments to adhere to regulations such as those specified in the FDA Statement of the Investigator, Form 1572 (U.S. FDA, 2012). This study supports the findings from the study by Olson et al. (2012), which led to the development of institutional policies that clearly illustrated the clinical activities that could be delegated to a NCRC or nonnurse, non-licensed staff. Several research institutions in VA facilities have published institutional policies for the delegation of clinical research activities. Some policies require a delegation of authority log for clinical research activity; however, others are more granular about which activities should only be
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performed by the PI or the clinical research nurse and which may be delegated to non-nurse study staff. Policies and procedures for institutions conducting clinical research should include detailed delegation of authority guidelines such as those shared by Dana Farber Medical Center that includes differentiation of clinical research nurse and nonlicensed personnel and is validated with the findings of this nominal group study (Dana Farber Medical Center, 2014). Activities that were identified by participants in this study that are performed by NNRCs include clinical research activities that are typically restricted to licensed personnel in hospital and clinical settings such as administering and dispensing (study) drugs; performing nursing skills and physical examinations; providing patient care; coordinating, obtaining, and documenting laboratory tests; and writing orders in a hospital chart. In clinical research settings, licensure requirements are also important boundaries that require clarification and adherence. The FDA (2009, 2012) requires supervision and insurance of adequate education and training of clinical research personnel; however, the FDA does not define specific education or licensure requirements for study-related activities. The assignment of causality for adverse events is restricted to the PI, but the collection of adverse event data derived from patient histories, reviewing laboratory data, and reviewing patient diary data and other medical records is often performed by study coordinators, many of whom are not RNs. State boards of nursing define and have jurisdiction over the scope of practice in nursing and the delegation of nursing activities to non-nurses. Glazer (2000) argued that there is a need for nursing to better delineate nursing functions from non-nursing functions. There is a lack of regulation or licensure requirements for clinical research activities. For instance, there are state licensing restrictions on the dispensing of FDAapproved medications; however, the regulations are silent about delegation of dispensing of investigational agents by non-RN study coordinators. It could be argued that RNs nurses are uniquely trained and licensed to perform these clinical research activities that use “a great deal of judgment to make decisions and systematically adapt nursing activity to the client and the situation” (Glazer, 2000, p. 1). Findings from the current study support the recommendations from the FDA (2009), which reported that research tasks that had been inappropriately delegated included screening evaluations, physical examinations, evaluation of adverse events, assessment of primary end points, and obtaining informed consent. The FDA identified a need for a broader binding policy in defining the delegation of research activities to clinical research personnel, thus requiring those activities only be delegated to nurses. A limitation of the present study was that it was a small single-site study and represented professional judgments of the experienced participants about what was occurring within their settings, thus limiting
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generalizability of the findings. However, the small number of participants was in keeping with NGP methodology, which usually includes between six and 12 participants (Van De Ven & Delbecq, 1974). Moreover, because the study was focused on perceptions of research nurse managers as experienced experts, it did not include other less experienced nurse coordinators or research nurses who were not in a supervisory position. It also did not include members of research teams who were nonlicensed non-nurses, and, therefore, there may be a bias in favor of nursing. Despite the study limitations, findings from this study support the need for future studies on clinical research roles of nurses and non-nurse research personnel. There are specific activities that investigators delegate in the complex conduct of clinical research protocols. Academic and nonacademic medical centers hire nurse and non-nurse study coordinators to perform those delegated activities in both the inpatient and outpatient setting. Because of financial constraints, an increasing number of nonnurse study coordinators are being hired to perform these coordination functions, replacing nurses who are more costly. Nurses contribute unique and pivotal functions in performing, managing, and supervising delegated clinical research activities. In some cases, the nurse may perform the activity or manage its delegation to specialty practitioners (such as nurse practitioners and pharmacists) and may also supervise non-nurse staff in performing the activities. Often, multiple coordinators must work as a team to carry out complex operations in phase I and II studies, which require rapid collection of clinical samples, while also infusing titrated doses and collecting simultaneous and serial clinical measurements (such as electrocardiograms and vital signs). Having a team of nurse and non-nurse staff to assist in those activities can ensure efficiency in following the protocol to the letter. However, the work of personnel in clinical research can also occur in smaller, isolated, autonomous, and unsupervised settings. The lack of clear regulations and policies that guide delegation of clinical research activities creates risks to research participants and the quality of clinical research. Excellence in clinical research requires quality and safety assurances to protect the research participants and the integrity of study protocols.
Conclusion This study provides a first look at research nurse manager perceptions of those delegated clinical research activities that should be the responsibility of licensed nurses. Further research is needed with a broader sample of research nurse managers and experienced research nurses in order to guide the development of policies and guidelines for the scopes
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of practice for research personnel with nursing and non-nursing backgrounds. Such policies and guidelines are essential in order to ensure the protection of clinical research participants and the quality of clinical research studies. There is a need for further research on this topic, including larger samples from multiple research sites. It would be useful to assess perceptions of appropriate delegation of research activities by NCRCs, NNCRCs, and by PIs and also to gather data about the roles and activities of NCRCs and NNCRCs in different settings in the United States and globally.
references
Alabama Board of Nursing. (n.d.). Alabama nurse practice act. Retreived from http://www.abn.alabama.gov/ UltimateEditorInclude/UserFiles/docs/nurse-practice-act/ ARTICLE-1.pdf Allen, J., Dyas, J., & Jones, M. (2004). Building consensus in health care: A guide to using the nominal group technique. British Journal of Community Nursing, 9(3), 110e114. American Nurses Association & National Council of State Boards of Nursing. (2005). Joint Statement on Delegation. Retrieved from https://www.ncsbn.org/Delegation_joint_statement_NCSBNANA.pdf. Association of Clinical Research Professionals (ACRP). (2014). Eligibility for the CCRC Program. Retrieved from http://www. acrpnet.org/MainMenuCategory/Certification/ CRCCertification/eligibility-for-the-CCRC-Program.aspx. Azziz-Baumgartner, C., & Wilson, L. L. (2009). Applying a model of program adaptation to the familias fuertes parent/adolescent educational intervention for Latino immigrant families in the rural south. Southern Online Journal of Nursing Research, 9(3). Retrieved from http://www.resourcenter.net/images/snrs/ files/sojnr_articles2/vol09num03art07.html. Baer, A. R., Zon, R., Devine, S., & Lyss, A. P. (2011). The clinical research team. Journal of Oncology Practice, 7(3), 188e192. http:// dx.doi.org/10.1200/JOP.2011.000276. Bevans, M., Hastings, C., Wehrlen, L., Cusack, G., Matlock, A. M., Miller-Davis, C., . Wallen, G. R. (2011). Defining clinical research nurse practice: Results of a role delineation study. Clinical and Translational Science, 4(6), 421e427. http://dx.doi. org/10.1111/j.1752-8062.2011.00365.x. Cantrill, J. A., Sibbald, B., & Buetow, S. (1996). The Delphi and nominal group techniques in health services research. International Journal of Pharmacy Practice, 4, 67e74. http://dx.doi. org/10.1111/j.2042-7174.1996.tb00844.x. Castro, K., Bevans, M., Miller-Davis, C., Cusack, G., Loscalzo, F., Matlock, A., & Hastings, C. (2011). Validating the clinical research nursing domain of practice. Oncology Nursing Forum, 38(2), E72eE80. http://dx.doi.org/10.1188/11.ONF.E72-E80. CRN2010 Clinical Research Nurse Domain of Practice Committee. (2009). Building the foundation for clinical research nursing: Domain of practice for the specialty of clinical research nurse. Retrieved from http://www.cc.nih.gov/nursing/crn/DOP_document.pdf. Dana Farber Medical Center. (2014). Guidance on delegation of tasks. Retrieved from http://www.dfhcc.harvard.edu/fileadmin/ DFHCC_Admin/Clinical_Trials/QACT/Policies_and_ Procedures/10.1.14.Guidance_on_Deleg_of_Tasks.pdf. Duane, C. G., Granda, S. E., Munz, D. C., & Cannon, J. C. (2007). Study coordinators’ perceptions of their work experiences. The Monitor, 21(5), 39e42. Retrieved from http://216.30.191.162/ Monitor/2007September/duane.pdf.
Florida State Department of Public Health. (n.d.). Basic tools for process improvement: Nominal group process. Decision-Making tools. Retrieved from http://www.doh.state.fl.us/hpi/pdf/ NominalGroupTechnique.pdf Getz, K. (2013). Has the study coordinator landscape reached a tipping point?. Retrieved from http://forteresearch.com/news/studycoordinator-landscape/?utm_source¼linkedin&utm_ medium¼social&utm_content¼9c27ae0c-b8c1-470b-844932d0905715d0. Getz, K. (2012). Flying blind on CRA workload, time demands. Applied Clinical Trials, 21. Retrieved from http://www. appliedclinicaltrialsonline.com/appliedclinicaltrials/Articles/ Flying-Blind-on-CRA-Workload-Time-Demands/ ArticleStandard/Article/detail/781681. Getz, K. A. (2009). Assessing the downstream impact of protocol design complexity. Touch Briefings, 93e95. Retrieved from http:// www.touchbriefings.com/pdf/3322/kenneth-a-getz.pdf. Gibson, F., & Soanes, L. (2000). The development of clinical competencies for use on paediatric oncology nursing course using a nominal group technique. Journal of Clinical Nursing, 9, 459e469. Glazer, G. (2000). Legislative: “What makes something a nursing activity or task”. Online Journal of Issues in Nursing, 5(3). Retrieved from www.nursingworld.org/MainMenuCategories/ ANAMarketplace/ANAPeriodicals/OJIN/Columns/Legislative/ LegNursingActvityorTask.aspx. Granda, S. E., Duane, C. G., Munz, D. C., & Cannon, J. C. (2009). A study of factors leading to turnover intentions in clinical research coordinators. The Monitor, 23(5), 55e60. Gwede, C. K., Johnson, D. J., Roberts, C., & Cantor, A. B. (2005). Burnout in clinical research coordinators in the United States. Oncology Nursing Forum, 32(6), 1123e1130. Hastings, C., Fisher, C. A., McCabe, M. A., & The National Clinical Research Nursing Consortium. (2012). Clinical research nursing: A critical resource in the national research enterprise. Nursing Outlook, 60(3), 149e156. http://dx.doi.org/ 10.1016/j.outlook.2011.10.003. Jones, J., & Hunter, D. (1995). Qualitative research: Consensus methods for medical and health services research. British Medical Journal, 311(7001), 376e380. http://dx.doi.org/10.1136/ bmj.311.7001.376. Jones, C. T., & Wilson, L. L. (2014). Clinical research nurse perspectives on unsupervised, non-nurse clinical research coordinators. The Monitor, 28(1), 12e19. Jones, C. T., & Wilson, L. L. (2013). Role perceptions of nurse clinical research coordinators. Nursing Research Review, 3, 133e139. http://dx.doi.org/10.2147/NRR.S47579. Kellen, J. C., Schron, E. B., McBride, R., Hale, C., Campion, J., Handshaw, K., . Ettinger, A. (1994). A survey of clinical trial coordinators: Factors influencing job satisfaction and turnover. Cardiovascular Nursing, 30(4), 25e31. Mueller, M. (2001). From delegation to specialization: Nurses and clinical trial co-ordination. Nursing Inquiry, 8(3), 182e190. Nebraska Veteran Affairs Medical Center. (2014). Scope of practice for research personnel. Retrieved from http://www.google.com/ url?sa¼t&rct¼j&q¼&esrc¼s&source¼web&cd¼8&cad ¼rja&uact¼8&ved¼0CFEQFjAH&url¼http%3A%2F%2Fwww. nebraska.va.gov%2Fservices%2FResearch%2Fadmin% 2Fcredentialing%2FScope_of_Practice_for_Research_ Personnel.docx&ei¼QwR5VPXUD6TuiALIpYHADQ&usg¼AF QjCNEZw5HXX3v5Qm7VL_sU2Cx84o3vDg&sig2 ¼QNmw0UE8KbRO45qxOC6_wA&bvm¼bv.80642063,d.cGE. Network for Improvement of Addiction Treatment. (n.d.). How to use the nominal group technique. Retrieved from http://www. niatx.net/Content/ContentPage.aspx?NID¼147 Olson, R. E., Boisjolie, C., Goldman, J. A., Jorgenson, B., Pink, V., Williams, K. A., . Cosico, J. N. (2012). Scope of practice in
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clinical research: A cardiovascular research institute’s approach. The Monitor, 26(6), 23e30. Oncology Nursing Society. (2010). Oncology Clinical Trials Nurse Competencies. Retrieved from https://www.ons.org/sites/ default/files/ctncompetencies.pdf. San Francisco Veteran Affairs Medical Center. (n.d). Scope of practice for clinical research employees. Retrieved from www. research.ucsf.edu/chr/VA/Scope.doc Society of Clinical Research Associates (SoCRA). (2014). Candidate eligibility. Retrieved from http://www.socra.org/certification/ ccrc-certification-exam/candidate-eligibility/. U.S. Department of Health and Human Services Food and Drug Administration (FDA). (2009). Guidance for industry, investigator reponsibilitiesdProtection of the rights, safety and welfare of study subjects. Retrieved from http://www.fda.gov/downloads/ drugs/guidancecomplianceregulatoryinformation/guidances/ ucm187772.pdf.
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U.S. Department of Health and Human Services Food and Drug Administration (FDA). (2012). Statement of Investigator, 21 CFR 312.53(c). Retrieved from http://www.fda.gov/ downloads/AboutFDA/ReportsManualsForms/Forms/ UCM074728.pdf. Veteran Affairs Office of Inspector General. (2007). Healthcare inspection alleged practice of medicine by unlicensed research assistants South Texas Health Care System (Report No. 07-01219194). Retrieved from http://www.va.gov/oig/54/reports/VAOIG07-01219-194.pdf. University of Texas Health Sciences Center. (2013). Health Science Center handbook of operating policies: Policy 7.2.3. Research scope of practice for study personnel. Retrieved from http://uthscsa.edu/ hop2000/7.2.3.pdf. Van De Ven, A. H., & Delbecq, A. L. (1974). The effectiveness of nominal, Delphi and interacting group decision making processes. Academy of Management Journal, 17(4), 605e621.
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www.nursingoutlook.org
Research nurse manager perceptions about research activities performed by non-nurse clinical research coordinators Carolynn Thomas Jones, DNP, MSPH, RNa,*, Clare Hastings, PhD, RN, FAANb, Lynda Law Wilson, PhD, RN, FAANa a
University of Alabama at Birmingham, School of Nursing, Birmingham, AL b National Institutes of Health Clinical Center, Bethesda, MD
article info
abstract
Article history: Received 2 October 2014 Revised 23 January 2015 Accepted 8 February 2015 Available online 14 February 2015
Objectives: There has been limited research to document differences in roles be-
Keywords: Clinical research Research nurse manager Nominal group process Clinical research coordinator Licensure Clinical research nurse
tween nurses and non-nurses who assume clinical research coordination and management roles. Several authors have suggested that there is no acknowledged guidance for the licensure requirements for research study coordinators and that some non-nurse research coordinators may be assuming roles that are outside of their legal scopes of practice. There is a need for further research on issues related to the delegation of clinical research activities to non-nurses. Methods: This study used nominal group process focus groups to identify perceptions of experienced research nurse managers at an academic health science center in the Southern United States about the clinical research activities that are being performed by non-nurse clinical research coordinators without supervision that they believed should only be performed by a nurse or under the supervision of a nurse. Results: A total of 13 research nurse managers volunteered to be contacted about the study. Of those, 8 participated in two separate nominal group process focus group sessions. The group members initially identified 22 activities that they felt should only be performed by a nurse or under the direct supervision of a nurse. Conclusions: After discussion and clarification of results, activities were combined into 12 categories of clinical research activities that participants believed should only be performed by a nurse or under the direct supervision of a nurse. Cite this article: Jones, C. T., Hastings, C., & Wilson, L. L. (2015, AUGUST). Research nurse manager perceptions about research activities performed by non-nurse clinical research coordinators. Nursing Outlook, 63(4), 474-483. http://dx.doi.org/10.1016/j.outlook.2015.02.002.
Introduction Clinical research coordination is a professional role for nurses who manage and implement clinical research protocols and provide care for pediatric or adult
patients who are enrolled in clinical trials. There is no standardization of job titles for individuals working in clinical research positions. Nurses working in this role have a variety of job opportunities and job titles ranging from study nurse, clinical research nurse, clinical research coordinator, and research nurse
* Corresponding author: Carolynn Thomas Jones, College of Nursing, The Ohio State University, 4317 Corinth Drive, Birmingham, AL 35213. E-mail address: [email protected] (C.T. Jones). 0029-6554/$ - see front matter Ó 2015 Elsevier Inc. All rights reserved. http://dx.doi.org/10.1016/j.outlook.2015.02.002
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manager, with titles varying based on the employer institution. Some nurses work in designated clinical research hospital or clinic units where study patients receive care related to their clinical research participation. Other nurses are employed by investigators or clinical research companies and are charged with coordinating single or multiple clinical research protocols. Castro et al. (2011) defined clinical research nursing practice as having “a focus on the care of clinical research participants and management of a clinical research protocol” (p. 8). Research nurse coordinators manage the operation of an average of six protocols and the care of 80 or more study patients annually (Getz, 2013; Getz, 2009). Mueller (2001) noted that the roles of nurses working in clinical research have evolved into independent roles following decades of task delegation by physician investigators (PIs) and that those independent roles constitute a unique specialization in nursing. Hastings, Fisher, and McCabe (2012) observed that nurses working in clinical research have made contributions to the research findings that support evidence-based practice through the key roles they perform in coordinating and managing research involving human subjects. Nurses at the National Institutes of Health Clinical Center represent the largest critical mass of nurses engaged in research support and coordination in the country. In 2007, nurses at the Clinical Center embarked on a project to systematically document and describe the roles of nurses in clinical research. An expert committee of clinical research nurses identified and validated five dimensions that constitute the domain of clinical research nursing practice: (a) clinical practice, (b) care coordination and continuity, (c) study management, (d) human subject protection, and (e) contributing to the science (CRN2010 Clinical Research Nurse Domain of Practice Committee, 2009). Castro et al. (2011) conducted a study to describe the specific role activities performed in each of these five domains. Bevans et al. (2011) further differentiated the role activities of nurses working as clinical research nurses, clinical research coordinators (CRCs), and nurse practitioners in clinical research settings. Nurses attending a national conference of clinical research nurses were surveyed to explore clinical research nurse perceptions about the activities of nurse clinical research coordinators (NCRCs) and nonnurse clinical research coordinators (NNCRCs), validated the nursing role delineation work of Bevans et al. (2011), and also raised concerns about the delegation of clinical activities typically requiring nursing licensure to unsupervised non-nurses (Jones & Wilson, 2014). Findings from this survey additionally suggested role conflict among the NCRC respondents and the need for further research on the delegation of clinical research activities to non-nurse research personnel (Jones & Wilson, 2013). PIs in clinical research sites, including academic medical centers, hire both NCRCs and NNCRCs. These individuals may or may not be academically educated
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in clinical research and may or may not hold certification in clinical research. There are two widely recognized mechanisms for clinical research professionals to obtain “certification” in clinical research coordination. The Association of Clinical Research Professionals (ACRP) offers certification of clinical research coordinators who have experience in conducting “essential duties” as a clinical research coordinator. Those duties are defined by ACRP as “documenting adverse events; prepare or review documents submitted to the IRB; protocol review or study procedures planning; participate in conducting subject visits; maintaining source document; prepare for and participate in study visits with monitor, sponsor, auditors, etc.; and participate in consent process.” Individuals graduating from an academic program may be eligible to take the certification examination with documentation of 1,500 hours of CRC experience. Those with an associate’s degree or bachelor’s degree or those who are registered nurses (RNs) can take the examination with documentation of 3,000 hours of CRC experience, and those with a high school diploma or registered as a licensed practical nurse or lab technician are eligible to take the examination with documentation of 4,500 hours of CRC experience (ACRP, 2014). The Society of Clinical Research Professionals (SoCRA) also has a certification examination for clinical research professionals. Eligibility for the certified clinical research professional examination requires 2 years of full-time experience as a clinical research professional or a 12-hour academic baccalaureate or graduate certificate or degree in clinical research with 1 year of full-time experience (SoCRA, 2014). Existing clinical research certifications offered exclusively for nurses working in this area of practice are lacking. There has been limited research related to delegation of clinical research activities, and many researchers who have studied the roles and experiences of clinical research coordinators have not differentiated the roles of nurses and non-nurses working in clinical research in their studies (Duane, Granda, Munz, & Cannon, 2007; Getz, 2012; Granda, Duane, Munz, & Cannon, 2009; Gwede, Johnson, Roberts, & Cantor, 2005; Kellen et al., 1994). The Department of Veteran Affairs (VA) Office of Inspector General (2007) released a report raising concerns about “unlicensed research assistants practicing medicine” in a South Texas Veterans Heath Care System in San Antonio. This led to a call for additional policies about the delegation of clinical research activities, documentation of delegation of tasks for clinical trial protocols, and scopes of practice. Multiple VA research institutions have published their policies for delegation of research activities on websites. For example, policies of the Institutional Review Boards (IRBs) of the San Francisco VA hospital elucidate the research activities that may be delegated by investigators to nurses and non-nurses (San Francisco VA Medical Center, n.d.). Similar policies from the VA Medical Center affiliated with the University of Texas Health Sciences Center at
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San Antonio (2013) and the Nebraska VA Medical Center (2014) have been disseminated online. Baer, Zon, Devine, and Lyss (2011) described tasks often assigned to research staff including “screening for potential study candidates, determining eligibility, coordinating the patient calendar, preparing documents for submission to institutional review boards, filing amendments, submitting safety data, conducting patient education, obtaining informed consent and assessing potential adverse events” (p. 188). Olson et al. (2012) studied role descriptions and research activity delegation practices for nurse and nonlicensed, nonnurse research personnel in a single-site study in Minnesota to determine whether scopes of practice violations existed. The findings from this study ultimately led the study site to develop new institutional policies to differentiate and describe specific training, roles, and restrictions for study personnel with different backgrounds at the institution. The Dana Farber Cancer Center has a delegation policy that includes both the Food and Drug Administration (FDA) guidance on clinical research investigator delegation and also the clinical research nurse competencies that are published by the Oncology Nursing Society (Oncology Nursing Society, 2010) to list specific clinical research activities that may be delegated from the PI to a physician’s assistant or nurse practitioner, a research nurse, or unlicensed and nonmedically qualified personnel (Dana Farber Medical Center, 2014). The U.S. FDA (2009) has drafted nonbinding recommendations on the delegation of clinical research activities by investigators citing numerous FDA inspection findings in which inappropriate delegation occurred. Examples of tasks that have been inappropriately delegated included “(a) screening evaluations, including obtaining medical histories and assessment of inclusion/exclusion criteria; (b) physical examinations; (c) evaluation of adverse events; (d) assessment of primary endpoints; and (e) obtaining informed consent” (p. 6). The FDA also provided guidance on the delegation of activities by PIs as follows: “The investigator should ensure that any individual to whom a task is delegated is qualified by education, training, and experience (and state licensure where relevant) to perform the delegated task. Appropriate delegation is primarily an issue for tasks considered to be clinical or medical in nature, such as evaluating study subjects to assess clinical response to an investigational therapy (e.g., global assessment scales, vital signs) or providing medical care to subjects during the course of the study. Most clinical/medical tasks require formal medical training and may also have licensing or certification requirements. Licensing requirements may vary by jurisdiction (e.g., states, countries). Investigators should take such qualifications/licensing requirements into account when considering delegation of specific tasks. In all cases, a qualified physician (or dentist) should be responsible for all
trial-related medical (or dental) decisions and care” (U.S. Department of Health and Human Services Food and Drug Administration, 2009, p. 3). There is a need for further research and policy statements on the delegation and supervision of clinical research activities from the PIs to clinical research nurses and other clinical research staff. Moreover, there is a need for the research to clarify the scope of practice of RNs and non-nurse research personnel. The American Nurses Association and National Council of State Boards of Nursing (2005) adopted a joint statement on delegation; however, this document does not comment on the delegation of clinical research protocol activities. The Alabama Nurse Practice Act (Alabama Board of Nursing, n.d.) discusses licensure and scope of practice but does not differentiate activities performed or delegated in clinical research settings from those activities performed in other clinical settings. The focus of this research was to identify perceptions of experienced research nurse managers (RNMs) at an academic health science center in the Southern United States about the clinical research activities that were being performed by NNCRCs without supervision, which they believed should only be performed by an RN or under the supervision of an RN. For the purposes of this article, an RNM was defined as an experienced RN clinical research coordinator who was managing research site operations including supervision of one or more nurse and non-nurse clinical research staff. This article defined a clinical research study as a physician investigatoreinitiated or sponsored research intervention in human subjects using pharmacologic agents (drugs or biologics) and/or devices and does not include nursing research studies on modes of care delivery or social science studies that focus on interviews or questionnaires.
Methods This was a single-site study performed at an academic medical center in the southern region of the United States and was approved by the IRB locally. Study inclusion criteria were as follows: 1. Clinical research nurse managers with experience managing RN and non-RN research staff 2. Agreement to participate and sign the study informed consent form 3. Greater than or equal to 3 years of clinical research nursing experience 4. Experience in managing one or more clinical research studies defined as interventional studies of new medicinal, device, biologic, genomic, or radiologic entities 5. Agreement to attend two, 2-hour nominal group process (NGP) meetings
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6. Agreement to maintain confidentiality of discussions by fellow participants E-mail invitations and flyers were sent to a list of participants who had previously attended research coordinator training programs at the study institution and also to the list of members of the local chapter of the ACRP. The e-mail invitation asked nurses who met study inclusion criteria to contact the study investigator authorizing future correspondence about the study. A total of 13 RNMs contacted the study investigator; however, one did not qualify for study participation. Of the 12 remaining qualifying participants, one was male, and the remaining 11 were female. The investigator sent a formal letter of invitation and informed consent forms to the 12 respondents who met the study inclusion criteria followed by a telephone call to answer questions about the study. Although all 12 participants expressed interest in the study, only eight agreed to participate in the study. The other four eligible participants opted not to participate because of time constraints or illness. A total of seven participants were available for the first NGP meeting. One participant was late because of a study patient issue; however, she participated in the second NGP meeting. This study used the NGP to generate a ranked list of activities being performed by NNCRCs that the participants believed should only be performed by an RN or under RN supervision. Van De Ven and Delbecq (1974) validated the NGP as an efficient, reliable, and valid method of documenting consensus and decision making that can be used with groups ranging from six to 12 participants. The NGP has been used in nursing and health sciences research as a basis for decision making and consensus building (Allen, Dyas, & Jones, 2004; Azziz-Baumgartner & Wilson, 2009; Cantrill, Sibbald, & Buetow, 1996; Gibson & Soanes, 2000; Jones & Hunter, 1995). The first step in the NGP is to provide participants with a description of the process and the study question to be addressed. Participants are then given time to think about the question and write a list of ideas and answers to the question that was posed. Participants then share their ideas in a “round-robin” discussion until the last idea is recorded, and the list of ideas is discussed and clarified. Participants are asked to rank the ideas based on specified criteria (such as level of importance), and the researcher then tallies the rankings. At a follow-up session, participants discuss and clarify the ranked ideas and develop a final list of ranked responses to the original research question (Florida State Department of Public Health, n.d.; Network for Improvement of Addiction Treatment, n.d.). Figure 1 illustrates the NGP used in this study. The dates and times for the focus group meetings were determined based on the results of an Internet survey tool (Doodle.com). The meetings were scheduled after work from 5:30 to 7:30 p.m. to avoid interference with work schedules. Light refreshments were
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provided to participants. At the first meeting, the investigator again explained the study procedures, answered any remaining questions, and invited participants to sign the informed consent forms. Participants also completed a demographic form that captured education and experience data. During the initial NGP meeting, the investigator oriented participants to the nominal group process using the following icebreaker question: “What are your four favorite ice cream flavors?” Participants were asked to create their list of favorite flavors silently for 2 minutes. Participants then shared their favorites aloud, one by one, and the investigator wrote the flavors on a dry-erase board until all favorites were listed. Participants discussed the list for clarification purposes followed by a 2-minute individual silent ranking of the favorites by assigning a point value between 0 and 100 (100 being most favorite) on the dry-erase board. The participants were asked to ensure that the sum of all of the rankings equaled 100. Collected rankings were tabulated on a whiteboard and summarized to demonstrate the NGP process to participants. After a short break, the investigator read the following IRB-approved script to the participants: “At this juncture, we are getting positioned to commence the nominal group process related to the study question. As explained in our practice session, you will first work silently to generate your ideas, this time over 10 minutes. The problem that I want you to think about is the conduct of clinical research by non-nurse study coordinators. Make a list, based on your personal experiences or observations to answer this question: “What are the activities that non-nurse research coordinators perform that you believe should only be performed by a nurse or under the direct supervision of a nurse?” When you generate your ideas, please be sure to list each idea as a separate item. Do not lump multiple ideas in one statement. Separate each individual issue in an item statement. You should work silently and not share with your neighbor. Avoid interruptions during this process. Cell phones and beepers should be turned off or on silent at this time. Remember there is no competition for ideas, this is a silent brainstorming session.” Immediately after the silent idea generation, individual participants shared their lists one “activity item” at a time in a round-robin until all activities from all participants were listed by the investigator on the dryerase board. The investigator facilitated a brief discussion to gain consensus and clarity of the individual activities that were listed to ensure that intended meanings were conveyed. The group was dismissed to meet again in 3 days. The investigator recorded the discussions on an iPhone (Apple, Cupertino, CA) using a transcription application (www.rev.com) for reference and documentation. A total of 21 activities were originally identified and listed in the round-robin with
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Figure 1 e Methods: Nominal group process.
an associated frequency score for the number of times the activity was listed. During the second NGP session, participants discussed the list of 21 activities. One activity statement was determined to really represent two activities and was split out for a sum of 22 total activities. Participants were distributed a handout with the list of the 22 activities transcribed from the whiteboard during session 1. The investigator read the following IRB script, which instructed them on the ranking process: “At this time, we are going to again shift into working silently. You will take the list of activities that has been distributed. You have 100 total points to distribute across the list of items. The highest number of points will go to the activities that you believe are the most problematic in terms of impacting study quality and research participant safety. The lowest number of points will go to the activities that you believe is least problematic in terms of study quality or research participant safety. You will rank each issue. Be sure to total the score to ensure that you only used 100 points total for all ranked issues combined. You will be given 10 minutes to accomplish the ranking. When we complete individual rankings, you will turn in your ranking scorecard and then we will take a break while I tabulate the rankings.” After collecting the ranking sheets from each participant, the investigator then recorded the scores on an Excel (Microsoft, Redmond, WA) spreadsheet and projected the summed ranks onto a screen. Participants reviewed the list of ranked activities on the spreadsheet and discussed the activities and their
ideas for revising the list. Some activities were consolidated under one theme. After discussion, the final revised list included 12 activities. The resulting list was printed and distributed, and the script for ranking activities was reread. Participants again worked silently and ranked each activity so that the sum of ranking scores equaled 100, with a score of 1 being the least problematic and 100 being the most problematic in terms of study quality and participant safety.
Results The participants in this study were representative of highly educated and experienced research nurse managers. Highest degrees ranged from bachelor of science in nursing (n ¼ 3), master of science in nursing (n ¼ 3), and PhD (n ¼ 2). The mean number of years working as a nurse not in clinical research was 8.6 years (range, 5e17 years). The mean number of years working in clinical research was 11.75 years (range, 3.5e19 years). Participants identified the mean number of years working in the position of “research nurse manager” was 5.71 years (range, 1.5e14 years). One participant identified her job title as “research nurse manager” for only 1.5 years at the time of the study; however, she clarified that before that she worked as the only study coordinator for a cardiologist and was managing all aspects of over 10 studies, including the supervision of a non-nurse staff member, but with the job title of “study coordinator.” The mean age of participants was 46 years (range, 37e55 years). All participants were female. The participants had
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Table 1 e Supervisory Experience of Participants (n [ 8) Supervise
Nurse clinical research coordinators Other registered nurses Non-nurse clinical research coordinators Other non-nurse staff Number of studies supervised Number of studies coordinated themselves
Currently Supervise
Supervised in the Past
Range
Mean
Range
Mean
0e9 0e3 0e4 1e7 0e100 0e20
3.88 0.75 1.38 3.38 32 4.0
0e20 0e3 0e5 0e8 0e200 0e50
5.13 0.38 1.88 3.0 43.13 16.63
extensive supervisory experience, summarized in Table 1 . Professional memberships in clinical research organizations by participants included ACRP (n ¼ 4), SoCRA (n ¼ 1), Southern Nursing Research Society (n ¼ 1), and Sigma Theta Tau International (n ¼ 3). One participant was certified by ACRP. During the first NGP session, participants identified 21 activities in response to the following study question: “What are the activities that non-nurse research coordinators perform that you believe should only be performed by a nurse or under the direct supervision of a nurse?” Table 2 lists the activities and the frequency of the listing of each of these activities. During session 2, participants discussed the activities and determined that “documentation of health history” should be split into two activities: “assessing health history” and “determining inclusion and exclusion criteria.” This resulted in a list of 22 activities for ranking. The investigator distributed score sheets to participants that included the list of 22 activity items, and then each participant was instructed to assign point values to the individual activities so that the total score for the 22 activities on each participant’s score card equaled 100 points. Table 3 lists the activities from highest ranking score to lowest ranking score and presents the sum total ranking score attributed to each activity. The activities and associated summed ranks were put into an Excel table and projected on a screen for viewing and discussion. The participants then discussed the rankings and determined further grouping of activities that better represented consolidated activities. For instance, in the initial ranking, there were two activities related to medications: “administering medications (research and non-research medications) and “dispensing study drugs.” The group consensus was that those two activities should be grouped together as “administering, dispensing medication (all).” Another example of grouping of activities was merging the terms “completing serious adverse event documentation forms,” “assessing changes in clinical status and adverse events,” “follow-up of adverse events,” and “grading of adverse events” into one activity term: “management of adverse event and serious adverse event assessment, documentation and reporting.” The discussion ultimately reduced the list of 22 activities to a final list of 12 activities. A second score card was distributed listing the 12 resulting activities, and again participants were instructed to assign values to the activities so that the total score for activities summed 100 points. The final
scores are summarized in Table 4, which lists the total score from all participants for each activity and displays them from the highest ranked score to the lowest. Table 4 represents the consensus of the participants about 12 activities that non-nurse research coordinators perform but that the participants believed should only be performed by a nurse or under the direct supervision of a nurse in clinical research
Table 2 e Round-robin Results: Activities That Participants Believed Should Only Be Performed by a Nurse or Under the Direct Supervision of a Nurse (n [ 8) Activities Frequency Completing serious adverse event documentation forms Assessing changes in clinical status, adverse events Consenting research participants Dispensing research medications Presenting test results to patients Administering medication (research and nonresearch medications)) Coordinating, obtaining, interpreting, and documenting laboratory results Grading of adverse events Collecting and documenting concomitant medications Writing a consent form Performing nursing skills and physical examination skills (without certification) Coordinating phase I or II trials with hospitalized patients or complex trials Coordinating setup of research visit procedure scheduling Overseeing randomization Writing orders in a hospital chart Recognizing and documenting end points Performing patient care or case management Documenting health histories Assessing follow-up of adverse effects or events Performing special protocol procedures proficiently Educating patients (related to disease, side effects of drugs)
4 4 3 3 2 2 2 2 1 1 1 1 1 1 1 1 1 1 1 1 1
NOTE. The table lists the actual activities stated from the participants during the round-robin and how often those activities were stated (frequency).
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Table 3 e Ranked List of Activities that Participants Believed Should Only Be Performed by a Nurse or Under the Direct Supervision of a Nurse (n [ 7) Activity (22 Activities) Ranking Sum Score 1
Table 4 e Final Ranked Activities that Participants Believed Should Only Be Performed by a Nurse or Under the Direct Supervision of a Nurse (n [ 8) Activity (12 Activities) Ranking Sum Score 2
Assessing changes in clinical status/adverse events Coordinating phase 1 or 2 trials, trials with hospitalized patients, or complex trials Performing nursing skills and physical examinations without certification Administering medications (research and nonresearch medications) Determining inclusion and exclusion criteria Performing patient care/case management Dispensing study drug Consenting research participants Completing serious adverse event documentation forms Performing follow-up of adverse effects Presenting test results to patients Educating patients (related to disease, side effects of drugs) Coordinating, obtaining, interpreting, and documenting laboratory tests and results Performing special protocol procedures proficiently Assessing health histories Collecting and documenting concomitant medications Recognizing and documenting end points Overseeing randomization Writing orders in a hospital chart Grading adverse events Coordinating setup of research visit procedure scheduling Writing a consent form Total
Coordinating phase 1 or 2 trials, trials with hospitalized patients, or complex trials Managing of adverse event/serious adverse event assessment, documentation, and reporting Administering and dispensing medication Performing nursing skills and physical examinations without certification Assessing inclusion/exclusion criteria, concomitant medications, and health histories Providing patient care, case management, and education Coordinating, obtaining, interpreting, and documenting labs (including presenting test results to patients) Overseeing randomization and maintaining study blind Performing special protocol procedures proficiently Writing orders in a hospital chart (including verbal orders) Recognizing and documenting endpoints Developing and performing informed consent Total
69.00 60.00
47.00 44.00 42.00 41.88 41.00 38.00 34.00 33.00 33.00 32.00 28.88
28.00 25.62 20.38
98
87
76 72
72
71 63
56 53 53 51 48 800
20.00 17.80 14.88 10.88 10.80 7.88 700.00*
* One of the study participants was late to the first ranking and was not able to participate so the total number of participants was seven for the first ranking.
studies. The list is ranked by participants with 1 being the least problematic and 100 being the most problematic in terms of study quality and participant safety.
Discussion The purpose of this study was to identify perceptions of experienced RNMs at an academic health sciences center in the Southern United States about specific clinical research activities that are being performed by NNCRCs without supervision that they believe should
only be performed by a nurse or under the supervision of a nurse. The identification of activities that “should not be delegated to or performed by unsupervised study staff” can lead to additional debate, research, and policy formation for clinical research operations and the clarification of job descriptions. Such demarcations can prevent violations in institutional policies, federal regulations, and guidelines and in licensure scopes of practice. Ultimately, defining role boundaries can help to mitigate risks related to the safety of participants, study validity, or institutional liabilities. The clarification of clinical research role assignments can also support PIs’ commitments to adhere to regulations such as those specified in the FDA Statement of the Investigator, Form 1572 (U.S. FDA, 2012). This study supports the findings from the study by Olson et al. (2012), which led to the development of institutional policies that clearly illustrated the clinical activities that could be delegated to a NCRC or nonnurse, non-licensed staff. Several research institutions in VA facilities have published institutional policies for the delegation of clinical research activities. Some policies require a delegation of authority log for clinical research activity; however, others are more granular about which activities should only be
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performed by the PI or the clinical research nurse and which may be delegated to non-nurse study staff. Policies and procedures for institutions conducting clinical research should include detailed delegation of authority guidelines such as those shared by Dana Farber Medical Center that includes differentiation of clinical research nurse and nonlicensed personnel and is validated with the findings of this nominal group study (Dana Farber Medical Center, 2014). Activities that were identified by participants in this study that are performed by NNRCs include clinical research activities that are typically restricted to licensed personnel in hospital and clinical settings such as administering and dispensing (study) drugs; performing nursing skills and physical examinations; providing patient care; coordinating, obtaining, and documenting laboratory tests; and writing orders in a hospital chart. In clinical research settings, licensure requirements are also important boundaries that require clarification and adherence. The FDA (2009, 2012) requires supervision and insurance of adequate education and training of clinical research personnel; however, the FDA does not define specific education or licensure requirements for study-related activities. The assignment of causality for adverse events is restricted to the PI, but the collection of adverse event data derived from patient histories, reviewing laboratory data, and reviewing patient diary data and other medical records is often performed by study coordinators, many of whom are not RNs. State boards of nursing define and have jurisdiction over the scope of practice in nursing and the delegation of nursing activities to non-nurses. Glazer (2000) argued that there is a need for nursing to better delineate nursing functions from non-nursing functions. There is a lack of regulation or licensure requirements for clinical research activities. For instance, there are state licensing restrictions on the dispensing of FDAapproved medications; however, the regulations are silent about delegation of dispensing of investigational agents by non-RN study coordinators. It could be argued that RNs nurses are uniquely trained and licensed to perform these clinical research activities that use “a great deal of judgment to make decisions and systematically adapt nursing activity to the client and the situation” (Glazer, 2000, p. 1). Findings from the current study support the recommendations from the FDA (2009), which reported that research tasks that had been inappropriately delegated included screening evaluations, physical examinations, evaluation of adverse events, assessment of primary end points, and obtaining informed consent. The FDA identified a need for a broader binding policy in defining the delegation of research activities to clinical research personnel, thus requiring those activities only be delegated to nurses. A limitation of the present study was that it was a small single-site study and represented professional judgments of the experienced participants about what was occurring within their settings, thus limiting
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generalizability of the findings. However, the small number of participants was in keeping with NGP methodology, which usually includes between six and 12 participants (Van De Ven & Delbecq, 1974). Moreover, because the study was focused on perceptions of research nurse managers as experienced experts, it did not include other less experienced nurse coordinators or research nurses who were not in a supervisory position. It also did not include members of research teams who were nonlicensed non-nurses, and, therefore, there may be a bias in favor of nursing. Despite the study limitations, findings from this study support the need for future studies on clinical research roles of nurses and non-nurse research personnel. There are specific activities that investigators delegate in the complex conduct of clinical research protocols. Academic and nonacademic medical centers hire nurse and non-nurse study coordinators to perform those delegated activities in both the inpatient and outpatient setting. Because of financial constraints, an increasing number of nonnurse study coordinators are being hired to perform these coordination functions, replacing nurses who are more costly. Nurses contribute unique and pivotal functions in performing, managing, and supervising delegated clinical research activities. In some cases, the nurse may perform the activity or manage its delegation to specialty practitioners (such as nurse practitioners and pharmacists) and may also supervise non-nurse staff in performing the activities. Often, multiple coordinators must work as a team to carry out complex operations in phase I and II studies, which require rapid collection of clinical samples, while also infusing titrated doses and collecting simultaneous and serial clinical measurements (such as electrocardiograms and vital signs). Having a team of nurse and non-nurse staff to assist in those activities can ensure efficiency in following the protocol to the letter. However, the work of personnel in clinical research can also occur in smaller, isolated, autonomous, and unsupervised settings. The lack of clear regulations and policies that guide delegation of clinical research activities creates risks to research participants and the quality of clinical research. Excellence in clinical research requires quality and safety assurances to protect the research participants and the integrity of study protocols.
Conclusion This study provides a first look at research nurse manager perceptions of those delegated clinical research activities that should be the responsibility of licensed nurses. Further research is needed with a broader sample of research nurse managers and experienced research nurses in order to guide the development of policies and guidelines for the scopes
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of practice for research personnel with nursing and non-nursing backgrounds. Such policies and guidelines are essential in order to ensure the protection of clinical research participants and the quality of clinical research studies. There is a need for further research on this topic, including larger samples from multiple research sites. It would be useful to assess perceptions of appropriate delegation of research activities by NCRCs, NNCRCs, and by PIs and also to gather data about the roles and activities of NCRCs and NNCRCs in different settings in the United States and globally.
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