This chapter from Business Administration for Clinical Trials: Managing Research, Strategy, Finance, Regulation, and Quality is
about cultivating good relationships with colleagues and research
subjects. Authors Cavalieri and Rupp discuss the "people part," one of
the most rewarding and challenging parts of research. The
chapter explains how to take unique perspectives and needs of colleagues
and subjects into consideration to overcome barriers to finding common
ground.
Chapter 4: Fostering Professional Relationships and a Productive Workplace Environment
The
most rewarding and challenging part of research is the “people part.”
An intimate understanding of human nature is at the heart of good
practices for managing professional research relationships between
supervisors and staff. There are, of course, many other factors
influencing the research professional’s work relationships, including
institution policies, the scope of practice, and state and federal laws,
but it’s the “people part” that is meaningful and memorable. This
chapter explores ways the research professional can foster relationships
with colleagues and research subjects, as well as provides some
suggestions on creating firewalls.
Finding common ground and understanding
Working with colleagues and research subjects is required. Doing it
well is an art. If you take the unique perspectives and needs of each
of your colleagues and subjects into consideration, you have overcome
the biggest barrier to finding common ground.
Research subjects
Research subjects have a relationship with research professionals
that is similar to their relationship with their medical providers.
There is a fundamental similarity between a patient and research subject
in the healthcare setting because both are involved in activities and
testing within a medical environment. But there are also a host of
differences.
Table 4.1 shows these similarities and differences
.
TABLE 4.1 The Similarities and Differences Between Patients and Research Subjects
Both Groups Are...
|
Patient
|
Research Subject
|
|---|
Vulnerable
|
Illness and care requirements may be creating stress and disruption of their normal lives.
They may feel too weak or ill to question or comparison-shop for medical services.
They may need to use preferred medical providers due to the requirements of their medical insurance plan.
|
They may feel stressed by their medical condition and care.
They may be desperate for treatment options.
The subject may not understand the difference between standard of care or optional research activities.
|
Dependent
|
They need professional medical treatment.
|
They may have exhausted available approved medical therapies.
|
Interacting With You Over a Period of Time
|
Outpatient clinical care is usually intermittent and ongoing.
Inpatient care is usually a short-term situation until the patient is medically stable and released from the hospital.
|
The relationship between research professionals
and research subjects is based on the research protocol and last for a
day, a week, or years.
|
Located
|
Treatment may take place in a medical clinic,
hospital ward in an acute care hospital, or a longterm care facility.
Medical professionals may provide services in the patient’s home.
|
The study may take place in a clinic, hospital
ward, long-term care facility, or community-based ward, medical office,
or in the community.
|
Simply put, patients need clinical care, but research subjects do
not need to participate in research. The importance of establishing
rapport and a positive working relationship with research subjects
cannot be overstated.
Why do patients agree to participate? Despite strict research
regulations to the contrary, some patients may feel pressured to
participate. They may want to “please” their physician or feel obligated
to go along with their family’s wishes.
What are the direct and indirect benefits a subject may receive
from participating in a clinical trial? Directly, they may be receiving
access to innovative medications or interventions. It is important for
research professionals to clarify the difference between clinical care
and research participation. Therapeutic misconception is when a
subject believes their research participation is medical therapy with a
medical provider following a treatment plan with interventions and
medications that have already undergone the scrutiny of the clinical
trial process. Sometimes subjects choose to participate and lose sight
of the research aspects of the study interactions and consider it a
social relationship.
Family members were participating in a research study in
which blood samples were collected for genetic analysis. The
investigator used a group consent process to thoroughly explain the
study and answer questions. Family members had as much time as they
needed to consider participation, and those individuals who agreed
proceeded from the conference room one by one to the clinic room, where a
blood sample was taken.
In the clinic room, one consented subject told the research
nurse how much he hated needle sticks and that, although he was
perfectly willing to participate in the study, he did not want a
phlebotomy procedure. “If I don’t do this, my family will be angry and
keep trying to convince me to do it. They are going to know I didn’t do
this.” The investigator spoke with the subject privately, supported the
subject’s right to privately decline to continue participation, and
provided the subject with an “out”—the option of placing a bandage on
his arm so that he appeared to have had a blood sample collected.
Because all results were confidential, the family members did
not find out that one of them did not participate. Could the
investigator have re-explained the optional nature of research to the
group? Sure, but some family members might have continued to pressure
the person who didn’t want the needle stick.
It is not unusual for us to hear subjects say that they consider
their study participation as beneficial from the standpoint of having an
extra set of eyes looking over their clinical condition. Some patients
and their families, facing teams of medical specialists, may see the
investigator and his research team as a stable resource.
EXAMPLE
A clinical trial for osteoporosis was conducted over a 4-year
period. The sponsor, wanting long-term efficacy and safety data, offered
the participants the opportunity to continue on in a 2-year extension
study. As the primary study neared completion, the subjects were offered
information about the extension study, and the informed consent process
was conducted. The investigator realized the subjects needed additional
reminders and explanations about the research when he saw that the
majority of participants had, over time, actually forgotten that they
were participating in a clinical research trial and regarded their
quarterly study visits as clinical care with a social benefit. They
looked forward to their interactions with the research staff just as
they looked forward to their aquatic exercise programs and their church
activities.
Their decision to participate may be based on a desire for more
medical attention. Because research visits can take much longer and
happen at more frequent intervals than clinical care appointments, this
extra time may mean additional education, reassurance, and
encouragement.
These days, when clinicians are so busy, patients may want
providers to slow down and explain (and re-explain) medical information
in more detail or provide reassurance about symptoms. Time and attention
may be the only “carrots” a research professional can provide.
Attaining access to medical caregivers and services in large
hospitals and clinic systems can take considerable effort and time
waiting for an open appointment time. During a research study, subjects
usually have direct access to the investigator and his team because they
are responsible for closely monitoring the subjects’ status. Subjects
can become very dependent on the research staff to help them navigate
the complex healthcare system and get quicker access to help.
Adverse events are assessed quickly, and the research team will
intervene when the subject has concerns or symptoms of an adverse event.
When their study participation ends, patients and family members
may still want to leverage their relationship with the clinical research
team to help them cut through red tape and schedule quicker visits and
medical attention. They may call to update the investigator on their
medical progress, notify the investigator when they have been admitted,
or simply drop by to visit. These actions can stem from a former
subject’s normal desire for assistance and attention. We have done many
studies and worked with wonderful research subjects, and we’re always
sorry to see a study end. We do frequently run into former subjects, and
they often ask about study outcomes.
Helping subjects to transition from their active to completed
status in the research relationship will need to be handled respectfully
and tactfully.
Strategies for working with subjects include:
- Regularly refer to their research participation and obtain and document their verbal assent to continue.
- Use dedicated research telephone numbers and cell phones for all
interactions. Never give out your personal cell phone or information
about your residence.
- Clearly identify what you can and cannot do for former subjects. For
example, say, “I am sorry to hear that (former subject) was admitted to
the hospital. The investigator is available if (former subject’s)
medical providers have any questions about the research.”
- Consider sending a study closure letter to subjects from the
investigator. This provides a final formal thank you to the subject for
their involvement in the study, clearly closes the formal study
relationship, and gives them a route to contact the investigator and
research personnel within the confines of study follow-up.
- Research offices and clinics should maintain controlled access at
all times in order to protect the integrity of the research records.
Front desk personnel should not grant access to these areas without
scheduled appointments or calling the research personnel to the front
desk.
Sponsors and their representatives
One of all sponsors’ cardinal priorities is to understand what is
happening at their research sites and make sure they are in compliance
with GCP and the research protocol (International Conference on
Harmonisation, 1996). It is the sponsor’s goal to develop a positive
working relationship with the investigator and the investigator’s
research staff. The days when they were permitted to bring in
refreshments and provide small gifts such as tote bags and office
supplies to research personnel are long gone due to federal
anti-kickback statutes (Burgess, 2014).
Industry sponsors and their representatives, contract research
organizations (CROs), may use standard business practices to provide
incentives and reward their own employees by using gifts of products,
financial bonuses, and paid expenses, but this is not the case for the
research sites. Sponsors and their representatives must build rapport
with the investigators and their research personnel without gifts. They
rely on establishing a firm connection with site personnel in order to
understand how the research site operates and will provide feedback and
liberally praise achievements in order to encourage performance.
Sponsors are in the business of developing products. Investigators
are in the business of providing medical care, teaching, and publishing,
but there is common ground between the two. Sponsors have business
goals, and the investigators have professional goals. The common ground
is that both want subject safety, to reach study enrollment goals, to
maintain protocol compliance, and ultimately to have the research
question, the purpose of the study, answered.
Building a positive and productive relationship with the study
sponsor makes good business sense, but the integrity of the research
data must be maintained and the results must avoid any appearance of
influence from the sponsor.
Here are some important strategies you can put into practice:
- Use caution when the sponsor or their CRO offers to provide direct support for site activities.
- Do not allow the sponsor or CRO to prepare local IRB documents. The IRB submission process is the investigator’s responsibility.
- Refrain from releasing any prescreening information about the
investigator’s patients because these persons have not signed consent.
It would be a Healthcare Insurance Portability and Accountability Act
(HIPAA) violation to even report the sex or age of patients who were
evaluated for eligibility.
- Providing colleagues’ contact information for the sponsor to use for
study communication may seem like a supportive suggestion, but the
investigator’s IRB will need to be informed that this is part of the
study recruitment plan. Remember, after the contact information is
provided to the sponsor or CRO, there is nothing to stop them from
sending study-specific information as often as they choose to busy
colleagues who may view this as spam at best. In addition, there is
nothing to stop the sponsor from using the contact information for their
own purposes.
- Use caution when the sponsor or their CRO requests participation in
surveys comparing their systems with the systems other sponsors are
using. Investigators are required to maintain the confidentiality of
their studies.
- Use the dedicated research addresses, telephone numbers, and cell
phones provided as a part of the investigator’s institution for all
interactions.
- Check your institution’s and IRB’s policies on recruitment bonuses
and gifts. Expect them to be prohibited and be thoroughly familiar with
the institution and IRB policies. The IRB’s interpretation of bonuses
may include more than prohibiting direct payments. It may also prohibit
“educational grants” and “finders’ fees” for clinical personnel.
- Keep study documents in secure cabinets and maintain confidentiality
with all study information. Monitors know better than to ask for
details about other study commitments, but especially those who are
industry-sponsored will be keeping their eyes and ears open for evidence
of competing commitments at the sites.
- Keep meals and coffee breaks Dutch treat. Make sure the monitors know where the cafeteria and restrooms are located.
- There is no need to establish the expectation of continuously being
together during their entire visit. Their goal is to establish rapport,
and they will be maintaining a file with notes about the investigator
and site staff. Your goal is to establish a positive working
relationship. Always remember that you are in control of how much
personal information you want to share about yourself.
Clinical stakeholdersThe support and
engagement of clinical stakeholders who oversee the clinical and
ancillary areas in the institution are critical to the success of a
study. They will likely want to know about the results of the data
collection long before the research analysis is complete. Their clinical
world moves at breakneck speed, and their priority is the use of the
data for their reports and initiatives.
EXAMPLE
An investigator conducted a clinical trial for an investigational
device that evaluated levels of bioburden (essentially dirt, debris, and
germs) in patient rooms over a 2-year period. Although the clinical
staff was fully informed of the study plan and activities, over time,
they made assumptions about the reliability of the device’s data for the
cleaning status of the room. The investigator had to explain and
re-explain that the study results were not yet available—the study data
had not yet been analyzed and could not be used to make clinical
decisions (Smith et al., 2014).
Here are some strategies for working with clinical stakeholder:
- Include clinical stakeholders in planning, updating, and sharing results.
- Include support for them in a study budget where appropriate,
especially when the research disrupts their workflow or consumes some of
their resources such as staff time.
- Let them know that their involvement is appreciated and that
long-term success of the organization’s mission depends on their
goodwill and support.
Research colleagues
Adults are free to choose whether to establish personal
relationships with co-workers, when this is going to happen, and how
much of their life outside of work they are going to discuss. Colleagues
have a natural interest in each other and getting to know new
employees. New employees may be anxious to fit in as they start in their
new position. Co-workers will almost certainly ask them to talk about
themselves and their interests. A proactive strategy is to prepare an
“elevator speech” of some very general comments about yourself to use
for these early meetings with your new colleagues.
Matters can become very personal if family members are employed at
the same institution or research professionals are receiving healthcare
services at the institution where they work. Family may work at the same
institution; however, there are usually policies that prohibit their
working in the same department or supervising relatives.
Research professionals may work and receive healthcare services at
academic medical centers. Their privacy is protected by HIPAA privacy
laws, and there are strict policies on how and when medical records can
be accessed. Surveillance and audits are conducted to ensure every
patient’s, employee or not, privacy.
It is not uncommon for clinical personnel to participate in
clinical research. Clinical personnel may have a better fundamental
understanding and, in general, a greater trust of research. They may be
curious and altruistic and see their participation as an avenue to
contribute to medical knowledge. Strive to maintain the
employee–subject’s confidentiality, especially during testing and study
visits.
Expect the employee–subject to experience some role confusion. They
may be uncomfortable with the role reversal. Do not assume that the
employee–subject already knows anything at all about the disease process
under study or the mechanics of daily research activities.
Often investigators and institutions have policies prohibiting
family members or direct employees from participating in their clinical
trials in order to avoid or avoid the appearance of coercion and breach
of privacy. Research protocols may also include enrolling family members
or employees as exclusion criteria.
Strategies for working with colleagues include:
- It is important to block potential conflicts of interest or
breaches in confidentiality before they happen. Check your institution
for policies related to enrolling relatives into trials. Institutional
review boards (IRB) and the principal investigator’s research enterprise
usually have a standard operating procedure (SOP) and policies in place
addressing issues related to members of the research team or their
family members participating.
- If such policies do not exist, draft a policy for the research enterprise to address this.
Facing the grim realities of life
The mission of research professionals is to find answers to treat
and mitigate the effects of illness, better understand ways to prevent
illness, and provide a measure of hope that what we learn can help ease
the suffering of others. The passion and compassion of research
professionals can lead to the very real effects of sadness, depression,
and feeling burned out over time as they face the needs and loss of so
many medically ill people.
Because a significant number of waking hours are spent with
colleagues, these relationships are important and valuable and can be a
source of tremendous joy and pain. The change in relationships with our
colleagues due to career moves, retirement, or illness is inevitable.
These changes can also lead to feelings of sadness and loss.
Here are some strategies you can use for taking care of yourself:
- Appreciate today. Remind yourself that today, what you are
working on now, and the people you are working with are a part of “the
good old days” you will look back on in the future.
- Work on the coping skills necessary for facing death and dying. We
should recognize the signs of burnout in ourselves and colleagues and
take steps to cope.
- A change in research specialty may be in order. Not all clinical
trials are working with seriously ill subjects. There are many research
roles, and some involve no patient contact.
Be (almost) indispensable
The people within a research enterprise, like people in any
business, need to work at building productive working relationships.
Productive research relationships are grounded in communication, team
effort, and compliance, and this chapter has presented some
research-specific ideas to consider. How are productive relationships
built? One way to look at working relationships at an academic research
site is to recognize that everyone, even the principal investigator, has
a boss and is expected to contribute to the success of the research
enterprise. Adopting the strategy of becoming (almost) indispensable to
your boss and your colleagues benefits everyone on the team.
Why is indispensable status risky? First, you should never be truly
indispensable because this can hold you back from developing and taking
on new opportunities. People may also ask you to do unreasonable things
because you are the supposedly the only one who can do them. Being
indispensable is a sign of poor planning on the part of all parties
involved. Having indispensable people will backfire when they have an
illness or family emergency, as everyone does at some point. Finally,
people with “indispensable” labels can get a falsely elevated impression
of themselves.
No one is indispensable.
That said, here are some ways to be (almost) indispensable:
- Consider ways to work collaboratively and build a strong study
team. Mentoring the less-experienced members of the research team or
coaching a colleague through the research certification process helps to
reduce the frequency and seriousness of mistakes and improve
efficiency. Supporting and advising a peer while they prepare for
research certification creates a sense of shared accomplishment and
fosters the spirit of teamwork.
TIP
Research
professionals can contribute to developing orientation processes and
tools, create an intranet site for research resources, or hold periodic
meetings for education and fellowship.
Helping a new colleague can be as simple as an experienced
coordinator taking a new coordinator under her wing and mentoring her
through her first weeks and months as a study coordinator. Explaining,
identifying references, and listening in these early days can be the
difference for successfully acclimating to the new position.
If the principal investigator needs some backup on study
activities, having the secondary investigator assume responsibility from
beginning to end on the next subject being enrolled is an excellent
orientation to the study. It will become much easier for them to step in
and out of the process for backing up the study activities going
forward.
Recognize that recruitment and retention of subjects is
everyone’s job. Subject recruitment and retention are prime examples of
the value of teamwork. Each member of the research team has a part to
play, from the investigator administering informed consent to the
research coordinator handling the logistics and education to the
research assistant who efficiently collects and processes specimens. If a
subject doesn’t understand what they have consented to, if parking or
finding the research office is too frustrating, or they have to return
for a repeat blood collection, study retention is in jeopardy.
EXAMPLE
Consider the impact of a friendly receptionist, a research
assistant who provides clear directions to the study visit location, and
the value of updates on study progress to clinical personnel in
ancillary areas. Your subjects as well as the study coordinator and
investigator will have regular interaction with them. Completed subjects
and even patients who do not qualify for study participation can become
ambassadors. We consider it high praise when qualifying medical
professionals choose to participate in our clinical trials.
Thorough pre-study and ongoing targeted education makes a
difference in retaining research subjects. Telling a subject that there
are 13 study visits as a part of the informed consent discussion may be
honest, but he may consider this too much of a commitment. If the
information is presented as five study visits and eight telephone study
visits over 3 months, the subject may find this less daunting. With so
many visits over several months, providing a simple calendar with
appointments plotted out or a list of appointments can help the subject
stay organized.
At each study visit, be sure to remind the subject of where they
are on the study timeline. For example, reference the study visit
calendar and tell the subject, for example, that today is study visit
three, and that his next study visit is a telephone visit that should be
done either Thursday or Friday. Ask if it would be convenient for you
to telephone him in the morning on Thursday, for example.
- Go the extra mile. Successful research professionals look for ways around, over, or through obstacles.
EXAMPLE
Interactive systems (historically called interactive
voice-recognition systems or IVRS) are commonly used in research for
managing investigational product and supplies. They have been in place
for more than a decade and have evolved from telephone and fax to
web-based systems. These systems efficiently track inventory and study
milestones such as screening visits and may be a tool for implementing
the randomization process of subjects for multisite trials. Research
professionals receive training on how to use the system, but should be
prepared to think and work through logistical glitches.
During the final months in a recent clinical trial, the
remaining amount of limited investigational product was being
redistributed among sites and several boxes were removed from our site’s
stock. Shortly after this transfer, a system error in the IVRS was
discovered at an early morning study visit. One of the redistributed
boxes of investigational product was still listed as our site’s stock,
and the IVRS assigned it to our subject. Our dilemma was to reschedule
the subject’s study visit or attempt to work around an automated system.
Rescheduling subjects for study visits is a risk to their
compliance. Will the inconvenience cause the subject to consider
withdrawing from study? Will the subject return for a repeat study visit
within the protocol-mandated schedule? Will the delay result in a delay
of the study drug start or a protocol deviation due to the timing of
doses?
The study visit was scheduled for 7:00 a.m. Central time
because the subject and her parent needed to get to school and work on
time. Telephone calls to the IVRS are usually done after a subject
arrives for the visit because this centralized system is working with
dozens of study sites and is designed to take global and site variables
into consideration for study drug assignment.
The study sponsor was based in the Pacific time zone. The
investigator was in route and unavailable by telephone. Calls to the
IVRS help line and study monitor were unanswered. With minutes left to
decide whether this issue could be resolved to salvage the study visit
or reschedule the study visit, the research coordinator made a call to
the sponsor’s project leader. This person was available and had the
authority to provide immediate authorization to assign an alternate
investigational product kit, and the study visit was completed.
The take-away message is that technology is great, but clinical
trials call for sharp critical-thinking skills to keep subjects engaged
and maintain protocol compliance. Technology will keep up with the
clinical trial needs, but cannot always anticipate all of the real-life
challenges that arise. Several years have gone by, and our latest
clinical trial IVRS system has an automated choice for kit replacement
to address lost or damaged kits.
EXAMPLE
Study monitors, the sponsors’ representatives, are responsible for
supervision of the overall conduct of the trial. Their visits to the
study site are part of these responsibilities. They will send
confirmation letters for scheduled study visits and provide a
description of what they plan to review. The monitor will interact with
the investigator and study coordinator during the visit and works to
clarify and resolve any data discrepancies. They may also provide
additional protocol and GCP-related education.
Our investigators rely on email or verbal updates on the
progress of a site visit from the research coordinator. Emails are a
handy documentation tool for the research coordinator to use. Formal
meetings with the investigator are customarily done toward the end of
the monitor’s visit. By remaining in close contact with their study
staff, the investigator can intervene in a more timely manner and as
needed.
Monitoring visits are a significant investment of coordinator
time. The coordinator will prepare for the visit, making sure that the
items listed in the monitor’s confirmation letter are ready for their
review.
Action items presented at the final meeting with the
investigator and listed in the follow-up monitor letter will need to be
addressed.
The dilemma for the research professional is that the monitor’s
follow-up letter may be 4 to 6 weeks in coming. The solution for the
research coordinator is to use the investigator’s update emails to
create a short summary of the activities and create a punch list (a
to-do list of items commonly used in construction or project management)
so that the needed items are not forgotten. Site personnel should
carefully review the monitor’s follow-up letter to make sure all of the
noted items are addressed. On the rare occasion that the monitor’s
letter does not arrive, is misdirected, or is very tardy, the
investigator can rely on their documentation.
It is essential that research professionals understand their study
responsibilities and regularly review GCP guidelines to ensure
compliance (U.S. Department of Health and Human Services, 1996).
- Understand that research professionals on the front lines often have the best perspective on improving operations.
EXAMPLE
A clinical trial for a new drug to treat osteopenia (low
bone-density) needed participants. Because most women have never had a
bone-density measurement (a low-risk radiology procedure), their bone
density was usually unknown.
Because the investigator had been conducting these types
of trials for many years, the experienced team of research professionals
at an academic research site had efficient processes in place for
conducting outpatient osteoporosis clinical trials.
Their standard recruitment plan was to inform potential
subjects of the study and then filter qualifying subjects from a large
pool of interested women. The dedicated recruitment nurse was
responsible for managing all outreach efforts, including giving
community-based presentations, arranging the advertising and public
relations messages, phone triage, and scheduling screening visits. The
recruitment nurse frequently used staggered advertising strategies to
achieve 50 to 75 telephone calls per week and, of these, an average of
10 screening study visits were scheduled, with the goal of scheduling
them within a few days of the telephone call. The research nurse
coordinator was responsible for conducting the screening visits,
enrollment, and study visits.
As enrollment steadily increased, the research coordinator’s
schedule was quickly filled, and the processes needed improvement. The
original thinking was that a positive working relationship between the
research coordinator and a subject is established at the time of the
screening visit. When we analyzed our screen-fail ratio, it became clear
that only one to two subjects out of every 10 scheduled visits
qualified for the study. The 30-minute screen visits for the other eight
screen failures were a poor investment of the research nurse
coordinator’s limited time. She needed to spend her time working with
the subjects who qualified and chose to continue on in the study.
The recruitment nurse and research nurse coordinator
re-examined their usual tasks and formulated a process change to let the
recruitment nurse assume responsibility for the conduct of the
screening visits. After study eligibility was confirmed, the research
nurse coordinator stepped in to complete the visit and move forward with
the study activities. The recruitment nurse completed the screen visits
for the subjects who, based on their bone-density results, did not
qualify to participate. After a brief trial, the investigator agreed to
this plan. Subjects were more accepting of this process than we had
anticipated.
- Strengthen your research team by understanding your weaknesses and working together to bridge the gaps.
Teaching and sharing
educational resources can help make the research team well rounded.
Investigators who make an educational investment in their staff by
explaining the medical condition and related testing will reap the
benefits of personnel who are better equipped to support the screening,
recruitment, and study visit processes. They have a better understanding
of what to report and can identify options and solutions for process
improvements.
Colleagues can use “teaching moments” to explain software programs
and share documentation tools and tips. It can be uncomfortable to admit
that you aren’t an expert at creating graphs or aren’t familiar with
the medical symptoms or tests associated with the study’s disease
process. Keeping abreast of dynamic regulations and the latest ethical
issues is a challenge every research professional faces. Subject safety
is promoted in a work environment where research professionals are
encouraged to ask questions and share mistakes.
- Understand that knowledge and information is power.
- Operations can be slowed or halted when key personnel are absent or knowledge is hoarded by insecure members of the team.
EXAMPLE
All of the members of the research team can contribute to
centralized references for resources such as organizational charts
listing key contact personnel, detailed standard operating procedures
(SOPs), policies, and crisis plans. This is essential for both a small
research enterprise and the campus-wide research community.
- Maximize available resources. Research teams may have limited
surge capacity, ability to suddenly handle significant increases in the
workload such as multiple eligible subjects at the same time, as
investigators balance funding and personnel logistics. There are times
when redirecting efforts and working as a team can make a significant
impact on recruitment efforts and coverage for personnel illness and
family events. For example, investigators may work collaboratively with
other investigators within their department or other specialties. Their
research coordinators may serve as secondary personnel for multiple
investigators. It is critical to clarify delegation and define the
expectations and SOPs for this collaborative work.
- Set and reach stretch goals. When the question is, “How much effort
is enough?” the answer becomes, “Just a little bit more.” Setting a
study enrollment goal is a good idea. Setting a stretch goal, one that
requires extra effort, is a standard performance practice that
supervisors implement. The research professional may be able to enjoy
some flexibility with their schedule, which can sometimes translate into
a little downtime during an investigator meeting in Miami during
January, or coming into the office a little later or leaving a little
early to balance out some unavoidably long days.
EXAMPLE
It is common for a sponsor to designate the date when study
enrollment will close. At that point, the priority focuses on a final
push to enroll subjects. For a recent study, the final enrollment date
was on a Friday. A potentially eligible subject was contacted on
Thursday afternoon, and a message was left using the call-back phone
number for the dedicated research cell phone instead of the research
office phone.
When the potential subject returned the call at 6 p.m., the
research coordinator was walking from the office into the parking
garage. The potential subject was willing to come in the following
morning for a screening visit to learn more about the study, qualified
for participation, consented, and was the final subject enrolled in the
study.
- Recognize that appreciation, optimism, enthusiasm, and the
willingness to take on new challenges can be as infectious as pessimism.
We are human and need recognition for our ideas, contributions, and
achievements. The best recognition doesn’t have to be a trumpet
fanfare.
A handwritten note is a quiet acknowledgement of a job well done or
milestone achieved and can go a long way toward building morale. A
“wall of fame” in the research offices can display certificates for
milestone service anniversaries, the names of certified research
professionals, and internal publications. Employee-of-the-month awards
may not be appropriate for very small research enterprises and may
result in unintended consequences such as resentment and disappointment
for those who are not recognized. Customizing ways to recognize and
reward team effort makes sense in most settings.
Quality Connection
So let’s look at a risk the investigator might identify, which
involves a scenario of working with multiple personnel at multiple
research sites:
What exists: An
experienced investigator has just learned that a federal research
proposal has been funded. This multiyear, multisite protocol will
involve more than a dozen specialized team members.
The risk: Assuring regulatory compliance and maintaining required documentation across three study sites.
First, the investigator can create some quality objectives to address the risk:
1. Assign study
regulatory responsibilities and accountabilities for supporting the
approval and reporting processes.Assign study regulatory
responsibilities and accountabilities for supporting the approval and
reporting processes.
2. Assure compliance with sponsor-mandated progress and financial
reports and regulatory approvals from federal and local IRB groups.
3. Create and conduct surveillance and monitoring plans.Create and conduct surveillance and monitoring plans.
Next, fill in the details of how these quality objectives will be measured and the set up the QC processes:
1. Assign study regulatory responsibilities and accountabilities for supporting the approval and reporting processes.
- The regulatory specialist is responsible for daily document and
file management. Quality indicators include checking the contents of the
files against a standard checklist of “essential file documents,” dated
communication demonstrating study activities such as meetings and
instructions from the investigator, and evidence that the documents are
maintained securely, such as document storage in rooms accessible only
to the investigator’s designated personnel.
2. Assure compliance
with sponsor-mandated progress and financial reports and regulatory
approvals from federal and local IRB groups.
- Under the direction of the principal investigator, the
regulatory specialist is to create schedules, report templates, and
checklists. Quality indicators include a comparison of the schedule and
report submissions.
- The regulatory specialist is responsible for drafting reports and
correspondence for the principal investigator. Quality indicators
include investigator and sponsor satisfaction with report contents.
3. Create and conduct surveillance and monitoring plans.
- A written monitoring plan will be included in the
study-specific manual of procedures (MOP) and the research enterprise’s
SOPs. Quality indicators include verification of the presence of the MOP
and SOPs.
- Principal investigator oversight will consist of formal and informal
contact with all participating research sites on a quarterly, monthly,
weekly, and as-needed basis with the hospital and research personnel at
each participating research site. Quality indicators include review of
the documentation of written, electronic, and notes to file on telephone
conversations between the principal investigator and the site
personnel.
- The principal investigator will visit each participating research
site to conduct a site monitoring visit on a quarterly schedule. Quality
indicators may include a review of the monitoring report for each
visit.
- The principal investigator will conduct “for cause” visits without
prenotification as needed. Quality indicators may include a review of
the documentation of the circumstances associated with triggering the
visit.
Again, these objectives contain some very general descriptions of the
QC activities and quality indicators for a typical clinical trial
scenario.
Key take-aways
- The research environment is not immune to the dynamics of unprofessional behavior, personal differences, conflict, and ambition.
- General principles of managing people are relevant to the research environment.
- Research professionals can benefit from firewalls
- Quality control and quality assurance activities are directly
connected to the work performed by multiple members of the research
team. RNL
If you liked this article, you may also want to read:
References
International Conference on Harmonisation. (1996, June). ICH harmonised tripartite guideline: Guideline for good clinical practice. Retrieved from http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/
Guidelines/Efficacy/E6/E6_R1_Guideline.pdf
Smith, P. W., Beam, E., Sayles H., Rupp, M. E., Cavalieri, R. J., Gibbs, S., & Hewlett A. (2014). Impact
of adenosine triphosphate detection and feedback on hospital room
cleaning. Infection Control and Hospital Epidemiology, 33(5), 564-569.
U.S. Department of Health and Human Services, U.S. Food and Drug
Administration, Center for Drug Evaluation and Research, Center for
Biologics Evaluation and Research (1996, April). Guidance for industry E6 good clinical practice: Consolidated guidance. Retrieved from http://www.fda.gov/downloads/Drugs/Guidances/ucm073122.pdf
During
my years as a nursing student, civility was not formally addressed in
our classroom or clinical settings. It was implied that we were to treat
professors and fellow students with respect, but we were not taught
skills to deal with matters of incivility. It is important that nursing
students and recent graduates recognize incivility and learn skills to
deal with these issues because, although it can be very challenging to
confront professors, co-workers, and managers about such matters, it is
crucial to successful practice of our profession. 
I
remember very vividly the first day I cried on the job. The morning
started out quietly but, just before lunch, the calm was shattered with
screams, shouts, and threats. What had been a relatively quiet setting
suddenly crumbled around me and, to my surprise, I found that it was
prompted by my manager’s actions. For some unknown reason, he purposely
antagonized some of the patients, then walked off the unit and left me
to deal with the aftermath. 
Rite No. 4: Engage and commit to personal and organizational change 
Shortly
after my meeting with my manager, the hospital implemented a
“new-graduate meeting” every other week in which we are encouraged to
discuss concerns, fears, and issues we are facing. I soon realized that
several other new grads had the same concerns I did, and we now had a
voice to make changes.