Barriers for recruitment

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• Module duration: 2½ – 3 hours
• Material:
• Theoretical report
• Research protocols
• Information sheet
• Consent check list
• References cited in the module are found in the theoretical report.

Reference number: 2020-1-SE01-KA202-077806

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Learning objectives
• Understand the differences between the three types of barriers
• Explain what a research protocol is
• Practical knowledge on how extract information from a research
protocol
• Practical knowledge about taking consent
• Understand why it is harder to involve vulnerable groups in research
• Explain what person-centred care is

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• It is of the most importance that researchers are able to include a
representative sample of the target population in their research in
order to ensure external validity and being able to generalize the
results (Bonevski et al., 2014).
• External validity is the extent to which you can generalize the findings of a
study to other situations, people, settings and measures. In other words, can
you apply the findings of your study to a broader context?
https://www.scribbr.com/methodology/external-validity/

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Recruitment
• We know that individuals that are hard to recruit to health research
are also under-represented in our health care systems (Kaiser et al.,
2017). Hence, being able to include vulnerable groups in health
research would more likely result in a better and more equitable
service delivery overall, because of the knowledge gained from also
including this segment of the population.

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 Barriers
• We will examine the barriers from three perspectives, that are partly
based upon the results in a study aimed at identifying barriers in
recruiting patients (Isaksson et al., 2019):
• Centre-related barriers
• Study-related barriers
• Patient-related barriers

Reference number: 2020-1-SE01-KA202-077806

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Centre-related barriers

Reference number: 2020-1-SE01-KA202-077806

This publication [communication] reflects the views only of the authors, and the Commission
cannot be held responsible for any use, which may be made of the information contained therein.
Exercise
• In groups discuss:
• What are potential centre-related barriers
• Give examples from your experience or work place that could be potential
barriers
• Provide suggestions on how to overcome them
• 15 – 20 min discussion in the groups
• 10 min feedback

Reference number: 2020-1-SE01-KA202-077806

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Centre-related barriers
• One of the biggest barriers it's the lack of time and resources to
facilitate the recruitment to the study (Isaksson et al., 2019, Zucchelli
et al., 2018) .
• This is especially disadvantageous for the recruitment of individuals
that belongs to socially disadvantaged groups, since it is necessary to
spend more time to explain the purpose of a study as well as obtain
informed consent

Reference number: 2020-1-SE01-KA202-077806

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Centre-related barriers
• Another influential factor is that a clinic might not have the
experience and organisation of implementing a research study in their
day-to-day work (Isaksson et al., 2019), which is a significant barrier.
• Therefore, it is paramount that the research team is available to
provide support to the staff involved in the recruitment (Zucchelli et
al., 2018).

Reference number: 2020-1-SE01-KA202-077806

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Centre-related barriers
• The first step in the support from the research (study) team is to
ensure that the staff understands why the research is important to
conduct and the potential benefits it can generate in the future for
the patient group

Reference number: 2020-1-SE01-KA202-077806

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Centre-related barriers
• Inclusion and exclusion criteria for eligibility for participation in the
study.
• In general, everyone can participate in a study. However, each
study has specific criteria regarding who is allowed to participate.
• These are called inclusion and exclusion criteria. Inclusion and
exclusion criteria can be based on factors such as the participant's
previous treatments, the type of illness or condition, the stage of
the disease, gender, age, educational level and whether the
participant uses certain medications.

Reference number: 2020-1-SE01-KA202-077806

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Centre-related barriers
• Therefore, the staff must ascertain if the individual is eligible to
participate in the study in relation to the specified inclusion and
exclusion criteria. If the individual meets all the inclusion criteria,
they can then be asked if they would like to participate in the study.

Reference number: 2020-1-SE01-KA202-077806

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Centre-related barriers
• Informed consent (will be discussed later on as well)
• Participation in a research project is voluntary. However, the person
asked to participate must receive such documentation as required to
submit a so-called informed consent, i.e. an acceptance to participate
based on clear and detailed information about what participation entails.

• It is important that the research person's information is given in

straightforward language and does not contain words that can be
perceived as an emphasis or overword on the possible value of the study.

Reference number: 2020-1-SE01-KA202-077806

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Centre-related barriers
• Research protocol
• A research protocol informs an individual about the purpose of the
study and how to proceed.
• The protocol must state which methods are to be used and how
many participating patients are expected to answer the questions.
• As described earlier, the protocol also contains the inclusion and
exclusion criteria for eligibility for participation in the study.
Furthermore, the protocol should include a summary of the
existing research.

Reference number: 2020-1-SE01-KA202-077806

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Centre-related barriers
• The optimal scenario would be to incorporate a study as part of the
regular routine clinical practice (Zucchelli et al., 2018).
• This, however, is not as easy as it sounds since, in reality, clinical
practice encounters various situations from day to day and could be
involved in recruiting for other studies, which influences the
recruitment of study participants.

Reference number: 2020-1-SE01-KA202-077806

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Study-related barriers

Reference number: 2020-1-SE01-KA202-077806

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Study-related barriers
• The individuals responsible for designing the study need to be aware
of the challenges of implementing a research protocol in clinical
settings, especially to ensure that vulnerable groups have the same
opportunity to be included like everyone else.
• Therefore, it is crucial to address any potential recruitment problems
early in the process, which means at the stage of writing the protocol
and planning the study (Isaksson et al., 2019).

Reference number: 2020-1-SE01-KA202-077806

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Study-related barriers
• An optimal way to prevent the creation of barriers is to meet and talk
with the people that will be doing the recruitment at that particular
clinical site (Donovan et al., 2016).
• It is essential to understand that one specific model of the
recruitment process does not fit all clinical settings; hence, if involving
several recruitment locations, the individuals designing the study
must engage with all the sites so local requirements can be addressed
(Berge et al., 2016).

Reference number: 2020-1-SE01-KA202-077806

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Study-related barriers
• The study team also need to speak with the representatives from the
patient groups to elicit their views and suggestions for the design of the
study.
• It is paramount that the researchers ensure that the patient group
engaged in the consultation represents all segments of society to ensure
that unintentional discrimination does not occur .
• Many researchers find it challenging to access vulnerable groups in our
society and one approach could be to liaise with different organisations
in various communities.

Reference number: 2020-1-SE01-KA202-077806

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Study-related barriers
• At that stage it is essential to provide clear and unambiguous
information about (Hanley et al., 2003):
• Why this study is important
• Why you are approaching them
• What you are asking from them
• Their level of involvement and time commitment
• The benefit of the research
• Any potential risks

Reference number: 2020-1-SE01-KA202-077806

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cannot be held responsible for any use, which may be made of the information contained therein.
 Group exercise
• Read a study protocol Duration:
• https://pilotfeasibilitystudies.biomedcentral.com
• https://www.researchprotocols.org • 45 min to answer questions and
• Instructor hands out copies of research protocols prepare a short presentation
• The group answers the following questions
• Why this study is important • Each group present 5 -10 min
• Why you are approaching them
• What you are asking from them
• Their level of involvement and time
commitment
• The benefit of the research
• Any potential risks

Reference number: 2020-1-SE01-KA202-077806

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cannot be held responsible for any use, which may be made of the information contained therein.
Reference number: 2020-1-SE01-KA202-077806
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cannot be held responsible for any use, which may be made of the information contained therein.
Study-related barriers
• Other useful factors that can facilitate the recruitment of patients are
the following:
• Plan and ensure that the study team is available to support on
regular basis the different recruitment sites by visiting on regular
intervals (Isaksson et al., 2019).
• Depending on the scale of the research project, it would be
advisable to have a dedicated webpage with information about the
study and contact details to the research team.

Reference number: 2020-1-SE01-KA202-077806

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Study-related barriers
• Provide information and reminders about the study via posters
and leaflets at the recruiting sites.
• It is essential that there are available resources to arrange
meetings and training for those that will do the recruiting at the
sites. Furthermore, it is advisable if tokens of appreciation can be
offered for those that are recruiting and obtaining consent for
encouragement (Berge et al., 2017).

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Study-related barriers
• If the study requires that a participant needs to answer
questionnaires, it would be advisable that the design of the study
is so it can be completed at the clinic (Zucchelli et al., 2018).
Especially, for those participants that needs additional support
with the questionnaires it is vital they can receive that.
• If the participant is sent home with the questionnaire, they cannot
receive additional support if needed. Also, it will increase the risk
of them not completing the questionnaire, even if they have
agreed to participate in the study.

Reference number: 2020-1-SE01-KA202-077806

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cannot be held responsible for any use, which may be made of the information contained therein.
Patient-related barriers

Reference number: 2020-1-SE01-KA202-077806

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cannot be held responsible for any use, which may be made of the information contained therein.
Patient-related barriers
• Individuals that come from socially marginalised groups are usually a
more of a challenge to recruit into healthcare research (Bonevski et
al., 2014, Zucchelli et al., 2018).
• These individuals can be for example (but not limited to), individuals
who are unemployed, elderly, have a disability, experience mental
health problems, migrants or refugees.

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Patient-related barriers
• These individuals can be for example (but not limited to), individuals
who are unemployed, elderly, have a disability, experience mental
health problems, migrants or refugees.
• Being a member of a socially marginalised group also increases the
risks of health inequalities, poverty and social exclusion and currently
in Europe 21.1% of the European population (92.4 million people)
lived in households at risk of poverty or social exclusion
https://ec.europa.eu/eurostat/web/products-eurostat-news/-/edn-20201016-2 [Accessed 9 June 2021].

Reference number: 2020-1-SE01-KA202-077806

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Reference number: 2020-1-SE01-KA202-077806
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cannot be held responsible for any use, which may be made of the information contained therein.
Patient-related barriers
• Data shows for children living with parents that has only obtained at
most lower secondary level education have a risk of poverty or social
exclusion by 50.8% in contrast to children whose parents had the
highest level education at the tertiary level the risk was only 7.5%
• https://ec.europa.eu/eurostat/statistics-explained/index.php?title=Children_at_risk_of_poverty_or_social_exclusion#The_highest_risk_of_poverty_or_social_excl
usion

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Patient-related barriers
• If a person works or not also influence the risk for poverty or social
exclusion. Currently in the EU, 1 in 12 people lives in households with
very low work intensity. This means that eight and a half percent of
the population aged less than 60 years worked less than 20% of their
total work potential during the past year. Again, there is vast
differences between countries, for example on Greece 13.8% was in
the very low work intensity in contrast to the 4.2% in Czechia.
• https://ec.europa.eu/eurostat/web/products-eurostat-news/-/edn-20201016-2

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Patient-related barriers
• Coming from a different culture, living in a different country from
where you were brought up in (language problems), and having poor
health literacy skills are also influential barriers when recruiting
participants into health care research.
• In one study there were concerns about the difficulties in gaining
informed consent from non-native speakers, especially those with
limited literacy. This also raises concerns about the ethical stance that
only true informed consent should be pursued (Zucchelli et al., 2018).

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Patient-related barriers
• Research shows that one of the most challenging aspects in recruitment and
the cause for not gaining informed consent from potential study subjects was
due to insufficient interactions and communication (Franklin et al., 2012,
Reynolds et al., 2013).
• It also needs to be emphasized that if an individual does not completely
understand all the information given by the healthcare professional, then in
reality true informed consent is not attained. Therefore it is essential that
adequate time is provided for obtaining informed consent in order to ensure
a representative sample of the population is included in the study (Nurmi et
al., 2015).

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Informed consent
• It means that an individual are able to make to decisions for
themselves.
• They can understand what is involved and can think clearly about
the advantages and disadvantage of different actions.
• They must be given enough information and they should be
allowed to make up their own mind without pressure from other
people.

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Informed consent
• They can give consent only if they can understand the information
they are given, make a decision, remember their decision and tell
other people about their decision.
• If they cannot do all these things, it’s called into incapacity.

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Informed consent
1. Provide information:
a. The person reflects on the information provided.
b. They are under no pressure to respond to the researcher immediately.

2. Obtaining consent:
a. The researcher reiterate the terms of the research
i. As separate bullet points or clauses
b. The person agrees to each term before agreeing to take part in the project
as a whole.

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 “When vulnerable individuals and groups are considered for
recruitment in research, researchers and research ethics
committees must ensure that specific protections are in place
to safeguard the rights and welfare of these individuals and
groups in the conduct of the research. “
Council for International Organizations of Medical Sciences, 2017. International ethical guidelines
for health-related research involving humans. International ethical guidelines for health-related
research involving humans. Page 57.
https://cioms.ch/wp-content/uploads/2017/01/WEB-CIOMS-EthicalGuidelines.pdf

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Assent

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Assent
• Assent refers to the process of children’s, adolescents’ and adults
incapable of giving consent, participate in the decision-making on being
involved in research.
• If an adult become capable of giving consent during the research, consent has
to be obtained before continuing research
• It is not regulated by law as consent is. However, it is considered good
practice to involve the them the process, event though it is the legal
guardian that give consent.
https://www.who.int/immunization/programmes_systems/policies_strategies/consent_note_en.pdf
https://cioms.ch/wp-content/uploads/2017/01/WEB-CIOMS-EthicalGuidelines.pdf

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Informed consent
Right to withdraw
• An ethical principle meaning that any participant in a research study
has the right to withdraw from (leave) the study at any time without
having to explain why and without any implications for her/his clinical
care.

Reference number: 2020-1-SE01-KA202-077806

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Group exercise
• In a group of three people, you role play the • Scenario
process of taking consent. • One act as the patient
• Patient • Ensure that you represent
• Individual obtaining consent different types of participants
• Observer – using the consent check list • Use the information sheet
• Use the provided • One as the individual taking consent
• Information sheet
• Use the information sheet
• Consent check list
• One as the observer
• Time
• Use the consent check list to
• 30 –45 min ensure that everything is
covered.
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Group exercise
• The observer gives feedback upon the process of obtaining
consent
• Ensuring that everything is covered in accordance to the
checklist
• Give feedback upon the communication skills
• After everyone has had a turn, the group discuss what are
the key aspects to think about when obtaining consent

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Person-centred care
• Person-centred care means focusing on the whole person, with
unique needs, resources and experiences, not just on the disease.
• Person-centred care is based on information about the person's life
and values, which aims to make the provision of care more personal.

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Person-centred care
• Part of person-centred care is that the person is authenticated,
accepted, and encouraged to talk about themselves and their life.
• Person-centred care also means special attention to needs associated
with a different cultural or linguistic background.

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Person-centred care
• Treats the person (patient) • Sees the person as a
based on their experiences, self- collaborative partner
esteem and rights • Validates the person's
• Strives to understand what is experience of the world
best for the person from their • Strives to involve the person's
perspective social network (family and
• Protects the person's self- friends) the health and social
determination and their right to care.
influence decisions in their care
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Person-centred care
• Research has shown that person-centred care is particularly beneficial
for patients with low education after an acute coronary syndrome
event, which can result in improvement of the equity of care (Fors et
al., 2016).
• Hence, it would be a viable assumption by implementing a person-
centred care approach for recruiting patients would contribute to a
more equal representation of individuals in our diverse population
across Europe.

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Exercise
• In a group, discuss how to obtain consent from people in relation to these
aspect while incorporating a person-centred care approach.
• Centre-related barriers
• Study-related barriers
• Patient-related barriers

• Duration
• 20 – 25 min group work
• Feedback: 10 – 15 min

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