This document summarizes a study that used focus groups of experienced research nurse managers to identify clinical research activities performed by non-nurse coordinators that the managers believed should only be performed by nurses or under nurse supervision. The focus groups identified 22 such activities initially, which were combined into 12 categories after discussion. The goal was to provide guidance on the appropriate delegation of clinical research duties between nurses and non-nurses. There is currently a lack of standardization and clarity around the roles and licensure requirements of nurses and non-nurses conducting clinical research.

1. 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
a r t i c l e i n f o
Article history:
Received 2 October 2014
Revised 23 January 2015
Accepted 8 February 2015
Available online 14 February
2015
Keywords:
Clinical research
Research nurse manager
Nominal group process
Clinical research coordinator
Licensure
Clinical research nurse
a b s t r a c t
Objectives: There has been limited research to document differences in roles be-
tween nurses and non-nurses who assume clinical research coordination and
management roles. Several authors have suggested that there is no acknowl-
edged 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 experiencedresearch nursemanagersatanacademichealthscience centerinthe
Southern United States about the clinical research activities that are being per-
formed 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 per-
ceptions 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: jones.5342@osu.edu (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
Available online at www.sciencedirect.com
N u r s O u t l o o k 6 3 ( 2 0 1 5 ) 4 7 4 e 4 8 3
www.nursingoutlook.org

2. 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 partici-
pation. Other nurses are employed by investigators or
clinical research companies and are charged with
coordinating single or multiple clinical research pro-
tocols. 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 co-
ordinators 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 man-
aging 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 non-
nurse clinical research coordinators (NNCRCs), vali-
dated the nursing role delineation work of Bevans
et al. (2011), and also raised concerns about the dele-
gation 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
in clinical research and may or may not hold certifi-
cation in clinical research. There are two widely
recognized mechanisms for clinical research pro-
fessionals to obtain “certification” in clinical research
coordination. The Association of Clinical Research
Professionals (ACRP) offers certification of clinical
research coordinators who have experience in con-
ducting “essential duties” as a clinical research coor-
dinator. Those duties are defined by ACRP as
“documenting adverse events; prepare or review doc-
uments 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, au-
ditors, etc.; and participate in consent process.” In-
dividuals 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 techni-
cian are eligible to take the examination with docu-
mentation 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 clin-
ical research professional examination requires 2 years
of full-time experience as a clinical research profes-
sional 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 delega-
tion of clinical research activities, and many re-
searchers who have studied the roles and experiences
of clinical research coordinators have not differenti-
ated 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, documenta-
tion of delegation of tasks for clinical trial protocols,
and scopes of practice. Multiple VA research in-
stitutions 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
N u r s O u t l o o k 6 3 ( 2 0 1 5 ) 4 7 4 e 4 8 3 475

3. 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 po-
tential study candidates, determining eligibility, coor-
dinating the patient calendar, preparing documents for
submission to institutional review boards, filing
amendments, submitting safety data, conducting pa-
tient 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, non-
nurse research personnel in a single-site study in
Minnesota to determine whether scopes of practice
violations existed. The findings from this study ulti-
mately 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 in-
cludes 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 recom-
mendations on the delegation of clinical research ac-
tivities by investigators citing numerous FDA
inspection findings in which inappropriate delegation
occurred. Examples of tasks that have been inappro-
priately delegated included “(a) screening evaluations,
including obtaining medical histories and assessment
of inclusion/exclusion criteria; (b) physical examina-
tions; (c) evaluation of adverse events; (d) assessment
of primary endpoints; and (e) obtaining informed con-
sent” (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 educa-
tion, 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 re-
quirements into account when considering delega-
tion 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 clin-
ical 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 state-
ment on delegation; however, this document does not
comment on the delegation of clinical research proto-
col activities. The Alabama Nurse Practice Act
(Alabama Board of Nursing, n.d.) discusses licensure
and scope of practice but does not differentiate activ-
ities performed or delegated in clinical research set-
tings from those activities performed in other clinical
settings.
The focus of this research was to identify percep-
tions 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 in-
terviews 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 in-
clusion 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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4. 6. Agreement to maintain confidentiality of discus-
sions 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 investi-
gator authorizing future correspondence about the
study. A total of 13 RNMs contacted the study inves-
tigator; however, one did not qualify for study partic-
ipation. 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 tele-
phone 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 partic-
ipants 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 ques-
tion 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 rank-
ings. 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 sched-
uled after work from 5:30 to 7:30 p.m. to avoid inter-
ference with work schedules. Light refreshments were
provided to participants. At the first meeting, the
investigator again explained the study procedures,
answered any remaining questions, and invited par-
ticipants to sign the informed consent forms. Partici-
pants also completed a demographic form that
captured education and experience data. During the
initial NGP meeting, the investigator oriented partici-
pants 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. Partici-
pants 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 dis-
cussed 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 dur-
ing 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 brain-
storming session.”
Immediately after the silent idea generation, indi-
vidual 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 dry-
erase board. The investigator facilitated a brief dis-
cussion 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 refer-
ence and documentation. A total of 21 activities were
originally identified and listed in the round-robin with
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5. an associated frequency score for the number of times
the activity was listed.
During the second NGP session, participants dis-
cussed 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. Partici-
pants were distributed a handout with the list of the 22
activities transcribed from the whiteboard during ses-
sion 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 num-
ber 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 com-
bined. 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. Partici-
pants 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
Figure 1 e Methods: Nominal group process.
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6. 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 co-
ordinators perform that you believe should only be per-
formed 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, partic-
ipants discussed the activities and determined that
“documentation of health history” should be split into two
activities: “assessing health history” and “determining in-
clusion 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 dis-
cussion. The participants then discussed the rankings and
determined further grouping of activities that better rep-
resented 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 dis-
plays them from the highest ranked score to the
lowest. Table 4 represents the consensus of the par-
ticipants 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 1 e Supervisory Experience of Participants (n [ 8)
Supervise Currently Supervise Supervised in the Past
Range Mean Range Mean
Nurse clinical research coordinators 0e9 3.88 0e20 5.13
Other registered nurses 0e3 0.75 0e3 0.38
Non-nurse clinical research coordinators 0e4 1.38 0e5 1.88
Other non-nurse staff 1e7 3.38 0e8 3.0
Number of studies supervised 0e100 32 0e200 43.13
Number of studies coordinated themselves 0e20 4.0 0e50 16.63
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
4
Assessing changes in clinical status,
adverse events
4
Consenting research participants 3
Dispensing research medications 3
Presenting test results to patients 2
Administering medication (research
and nonresearch medications))
2
Coordinating, obtaining, interpreting,
and documenting laboratory results
2
Grading of adverse events 2
Collecting and documenting concomitant
medications
1
Writing a consent form 1
Performing nursing skills and physical
examination skills (without certification)
1
Coordinating phase I or II trials with
hospitalized patients or complex trials
1
Coordinating setup of research visit
procedure scheduling
1
Overseeing randomization 1
Writing orders in a hospital chart 1
Recognizing and documenting end points 1
Performing patient care or case management 1
Documenting health histories 1
Assessing follow-up of adverse effects or
events
1
Performing special protocol procedures
proficiently
1
Educating patients (related to disease,
side effects of drugs)
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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7. studies. The list is ranked by participants with 1 being
the least problematic and 100 being the most prob-
lematic 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 clarifica-
tion 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 non-
nurse, non-licensed staff. Several research in-
stitutions in VA facilities have published institutional
policies for the delegation of clinical research activ-
ities. Some policies require a delegation of authority log
for clinical research activity; however, others are more
granular about which activities should only be
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
Assessing changes in clinical
status/adverse events
69.00
Coordinating phase 1 or 2 trials,
trials with hospitalized patients,
or complex trials
60.00
Performing nursing skills and physical
examinations without certification
47.00
Administering medications (research
and nonresearch medications)
44.00
Determining inclusion and exclusion
criteria
42.00
Performing patient care/case
management
41.88
Dispensing study drug 41.00
Consenting research participants 38.00
Completing serious adverse event
documentation forms
34.00
Performing follow-up of adverse
effects
33.00
Presenting test results to patients 33.00
Educating patients (related to disease,
side effects of drugs)
32.00
Coordinating, obtaining, interpreting,
and documenting laboratory tests
and results
28.88
Performing special protocol procedures
proficiently
28.00
Assessing health histories 25.62
Collecting and documenting
concomitant medications
20.38
Recognizing and documenting
end points
20.00
Overseeing randomization 17.80
Writing orders in a hospital
chart
14.88
Grading adverse events 10.88
Coordinating setup of research
visit procedure scheduling
10.80
Writing a consent form 7.88
Total 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.
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
Coordinating phase 1 or 2 trials, trials
with hospitalized patients, or
complex trials
98
Managing of adverse event/serious
adverse event assessment,
documentation, and reporting
87
Administering and dispensing medication 76
Performing nursing skills and
physical examinations without
certification
72
Assessing inclusion/exclusion
criteria, concomitant medications,
and health histories
72
Providing patient care, case management,
and education
71
Coordinating, obtaining, interpreting,
and documenting labs (including
presenting test results to patients)
63
Overseeing randomization and
maintaining study blind
56
Performing special protocol procedures
proficiently
53
Writing orders in a hospital chart
(including verbal orders)
53
Recognizing and documenting
endpoints
51
Developing and performing
informed consent
48
Total 800
N u r s O u t l o o k 6 3 ( 2 0 1 5 ) 4 7 4 e 4 8 3480

8. performed by the PI or the clinical research nurse and
which may be delegated to non-nurse study staff. Pol-
icies and procedures for institutions conducting clin-
ical 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 labora-
tory data, and reviewing patient diary data and other
medical records is often performed by study co-
ordinators, 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 delin-
eate 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 FDA-
approved 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 rec-
ommendations from the FDA (2009), which reported
that research tasks that had been inappropriately
delegated included screening evaluations, physical
examinations, evaluation of adverse events, assess-
ment 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
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). More-
over, 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 po-
sition. It also did not include members of research
teams who were nonlicensed non-nurses, and, there-
fore, 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 in-
vestigators delegate in the complex conduct of clinical
research protocols. Academic and nonacademic med-
ical centers hire nurse and non-nurse study co-
ordinators to perform those delegated activities in both
the inpatient and outpatient setting. Because of
financial constraints, an increasing number of non-
nurse 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 co-
ordinators 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 electro-
cardiograms 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 let-
ter. However, the work of personnel in clinical
research can also occur in smaller, isolated, autono-
mous, 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
N u r s O u t l o o k 6 3 ( 2 0 1 5 ) 4 7 4 e 4 8 3 481

9. of practice for research personnel with nursing and
non-nursing backgrounds. Such policies and guide-
lines are essential in order to ensure the protection of
clinical research participants and the quality of clin-
ical 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 ac-
tivities 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.
r e f e r e n c e s
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_NCSBN-
ANA.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/study-
coordinator-landscape/?utm_source¼linkedin&utm_
medium¼social&utm_content¼9c27ae0c-b8c1-470b-8449-
32d0905715d0.
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
N u r s O u t l o o k 6 3 ( 2 0 1 5 ) 4 7 4 e 4 8 3482

10. 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.
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. 07-01219-
194). Retrieved from http://www.va.gov/oig/54/reports/VAOIG-
07-01219-194.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.
N u r s O u t l o o k 6 3 ( 2 0 1 5 ) 4 7 4 e 4 8 3 483