Introduction:
The people have the right and duty to participate individually and collectively in the planning and implementation of their health care (The Declaration of Alma Ata, WHO, 1978) [1]. The UK Clinical Research Network (UKCRN) believes that active patient and public involvement (PPI) is needed and essential if it is to deliver a program of research which directly reflects the priorities, needs and views of patients and the public (UKCRN, 2006) [2].
The PPI in healthcare service is thought to increase accountability to tax-payers, better identify, meet their needs, and broaden the value base underlying evaluation [3, 4]. And by participating in research has shown the equity in healthcare provision since there is evidence to suggest that people who take part in clinical trials have better health outcomes (Davis et al. 1985, Karjalainen & Palva 1989) [5, 6].
However, there are many barriers for the ethnic minorities to participate in research, such as historic, societal, educational, and economic reasons [7], which have resulted in trial findings being based on unrepresentative populations (Heiat et al. 2002) [8].
There is little empirical evidence to explain ethnic minority under-representation in clinical trials, little UK-based research on South Asian participation, who is the UK's largest ethnic minority (UK National census 2001) [9], and the effect this may have on trial results. The published literature also remains unclear as to the reasons underpinning their under-representation [10].
It is important that all groups participate in health research [37-40]. The low ethnic minority involvement in clinical research is a concern for both research and public health reasons. Without adequate minority enrolment into research, researchers cannot learn about difference among groups and cannot ensure the generalizability of results [11].
In addition, participation in research increases participants' access to 'state of the art' treatment for diseases, frequent follow-up consultations, and closer disease monitoring and management (Heiat et al. 2002) [8]. It is a critical factor in many ethnic minority communities that suffer disproportionately from cancer, for instance, particularly in terms of excess mortality [11].
The role of ethnicity in clinical research is also addressed by the International
Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (www.ich.org) as part of its efforts to standardize
clinical research in the US, Europe and Japan [10]
Having carried out diabetes research in an Asian population for many years, I have learned much that is necessary to better understand the etiology and pathogenesis of diabetes in the target population, which has in turn benefited from this knowledge. I believe that minority participation in clinical research is both essential and beneficial although there are numerous barriers.
In this paper, I present a narrative review of the available literature; highlight the importance of engaging ethnic minorities in research, the barriers affecting their involvement in research and the solutions we have used to overcome the barriers.
The importance of minority participation in diabetes research
There are several reasons why it is important that the ethnic minority population is included in research.
Firstly, there are ethnicity-related differences in disease, including hereditary diseases for which the incidence may vary in different ethnic populations, for instances, cystic fibrosis in whites of European descent and sickle cell anemia in people of African descent. [7] Hypertension is much more prevalent among Britain's 2.5 million Asian and African-Caribbean population than among the white population and is a major contributor to end stage renal failure [12].
Diabetes incidence, prevalence, and disease progression varies by ethnic group [13]. Type 2 Diabetes Mellitus has reached epidemic proportions in many minority populations [14]. It is up to six times more common in people of South Asian descent and up to three times more common among people of African and African-Caribbean origin [15]. According to the Health Survey for England 2004, doctor-diagnosed diabetes is almost four times as prevalent in Bangladeshi men, and almost three times as prevalent in Pakistani and Indian men compared with men in the general population. Among women, diabetes is more than five times as likely among Pakistani women, at least three times as likely in Bangladeshi and Black Caribbean women, and two-and-a-half times as likely in Indian women, compared with women in the general population [16].
We now know more about etiological factors that might be responsible for the high incidence [17]. The information gathered so far, and the additional information yet to be obtained, will be essential to the implementation of health policies and interventions which are ethnically specific [18].
Secondly, the health and economic consequences of this diabetes epidemic are huge and rising [19]. Diabetes is already a leading contributor to total health care expenditures in the UK [20]. It is currently estimated that 10 per cent of the NHS budget is spent on diabetes. This works out at around £9 billion a year (based on 2007/2008 budget for the NHS) [21].
Thirdly, minority participation in research is also desirable from a national perspective. The UK has one of the most ethnically diverse populations in the world, and minority groups have composed around 8% of this country's population (UK National census 2001) [22], please refer to figure 1 for the non-White population by ethnic group in UK (UK National census 2001) [22].
The non-White population: by ethnic group, April 2001
Figure 1: The non-White population: by ethnic group, April 2001, UK
The growth of minority populations (Figure 2, 3)[23] will contribute significantly to this anticipated increase in total costs attributable to diabetes since these are the populations that have the greatest number of affected and at-risk individuals. Greater minority participation in all aspects of diabetes research will help in learning more about how to reverse this trend [18].
Figure 2: the growth of minority populations
Figure 3: the growth of minority populations
Last but not least, not including ethnic minorities in research undermines the UK government's NHS plan for tackling inequalities, and its core principle of providing culturally appropriate and accessible care for different groups and individuals (Department of Health 2000) [24]. It also potentially fails to meet statutory provisions in the amendments to The Race Relations Amendment Act (2000), in which all public agencies in the UK are charged with promoting diversity and tackling institutional racism within their organizations [25].
Since there can be no scientific basis for excluding this group of people from clinical trials, exclusion suggests a form of institutional racism in which minority ethnic populations are denied the same opportunities as the general population[26].
Barriers and solutions:
Working in minority populations is challenging, even for the most experienced clinical investigators. [18] Personally, I believe the barriers to recruiting minority participants fall into five general categories.
Barrier No. 1: logistical barriers
According to Giuliano [11], structural factors such as study duration, treatment or intervention schedule, cost, time, follow-up visits, and side effects represent more of a barrier to participation among the ethnic minority groups compared with whites.
From our experience, apart from the above few factors which may affect potential suitable subjects taking part into research, they are also concerned about the missing meals, child or elder care, transportation etc…
However, most of the logistical barriers can be overcome by careful planning. In our own research, the main barrier has been the inconvenience of scheduled study visits, which we have managed to adjust to meet the participants' needs. This involves scheduling procedures to fit into participants' busy life styles, such as running the research clinic in the unsocial hours, seeing the subjects before or after their work, or if they prefer, during weekends or holidays.
In addition, as our study cohort tends to be senior citizens, transportation to and from the research clinic has become an increasingly important barrier.
There is considerable research to show that older minority adults tend to have more health problems and to be more disabled (Haney & Gear, 1991; Hildreath & Saunders, 1991) [27, 28] than older White adults. Additionally, cultural and racial barriers may dampen an older minority person's interest in traveling to a non-ethnic neighborhood for fear of the potential for becoming a victim of racially motivated crime [29].
Therefore, many older ethnic minority adults may be less motivated to come to a centre that is not in their neighborhood. Moreover, some older adults are caring for their own aging parents or spouses and often do not have the financial resources to hire home care staff to watch the spouse or parent (Ballard et al.; Henderson et al., 1993) [30, 31]. Many south Asian women have custody of their grandchildren as well as their extensive family. There are a number of ways to address this problem.
One immediate solution is to provide free transportation to and from the research site (Ballard et al., 1993) [31]. This can often be costly for studies with limited budgets, as transportation is often expensive, especially when it involves picking up the frail or disabled older clients. Moreover, this method does not address the concerns an older and minority person may have about being in a foreign neighborhood [29].
A sound method to overcome the above concern is to conduct the study in the target community. This method substantially increases the likelihood that older minority adults as well as the young who have child care or elder care issues are able to access the research clinic.
There are two reasons: First, the site is more conveniently located and should result in less travel time and expense; second, if the study site is in the community or provided in a community centre, then potential participants may be less distrustful of the research. Arean et al. (1993) [29], Ballard et al., (1993) [31] Gallagher-Thompson et al. (1994) [32], and Henderson et al., (1993) [30] have used this approach successfully. For instance, Ballard et al. (1993), in recruiting older African- American adults into their Alzheimer's disease support project, were able to double the number of people in their study by providing services in the community. From our experience, we have managed to reach our recruitment target by sending out the relevant information through a local mosque where most of our target population would visit, and we held temporary research clinics in the local community to minimize the potential subjects' travel time and expense.
Where is not feasible to set up a temporary research clinic, we have tried various solutions, including providing a clear description of how to travel to the research clinic, a map and contact person's telephone number; use of a special service available to elderly individuals through volunteer organizations to help them access transport; use of taxi vouchers; and provision of rides by staff.
Barrier No. 2: Cultural barriers
The issue of cultural competence is the most important issue to consider when researching an ethnic minority population [18]. From our own experience, we realized that attempting to recruit a group of ethnic minority adults without considering cultural factors can result in a failed research project.
Levine & Padilla (1980) [33] stated" in research that provides services that are culturally sensitive, a study must meet the following prerequisites: (a) The setting must be embedded in the cultural community, (b) staff administering the research protocols and intervention packages must be bilingual-bicultural, and (c) the staff must be sensitive to the cultural nuances within the ethnic group so that information about the subgroups that make up a culture can be fed back to the researchers and service staff to improve recruitment and retention." (P21-4) As stated in other articles on this subject, using research and clinical staff drawn from ethnic groups from which one wants to recruit may help overcome the fear and distrust that the population may have of research.
According to Valle (1989) [34], the use of bilingual and bicultural staff is imperative for any outreach methods to be successful. In the Gallagher-Thompson et al. (1994) [32] study mentioned earlier, recruiting older Mexican Americans was highly successful because of the use of Spanish-speaking staff that were also bicultural. This staff not only conducted research interviews and treatments but also acted as the research representatives to the community. In the Arean et al. (1993) study [29] the research and clinical staff were also multiethnic.
It is important to assure that staffs that interact with participants do so in a manner that is appropriate to the participants [18].
From our experience, we conducted a study aiming to recruit the south Asian community into a Diabetes prevention program. At the initial phase of the study, we have had only one part time researcher who is bilingual, speaking both Hindu and English. However, with the study's progression, we found it is too hard to cope with the oncoming telephone calls and unplanned appointments without this part time researcher's presence. We then recruited two trained advocators and another bilingual researcher to work part-time pattern to cover the study, all with the same ethnic background as the target population. The study was completed successfully.
Barrier No. 3: Researcher's attitude
Previous assessments of researchers' opinions about minority recruitment have identified barriers, such as a perception of lower interest in clinical trials among minority patients and a lack of investigator confidence in explaining clinical trials in culturally appropriate terms [35].
As Henley & Clayton (1982)[36] suggests, we must all understand that we have racial prejudices and realize that ethnic minority Britons have as much right to health care as white, English speaking Britons.
As United Kingdom Central Council (UKCC, 1992) [37] states in the code of professional conduct that nurses must: "Recognize and respect the uniqueness and dignity of each patient and client, and respond to their needs of care, irrespective of their ethnic origin, religious beliefs, personal attributes, and the nature of the health problem or any other factor".(P3)
Ways to overcome these barriers include, hiring appropriate staff, arranging for the research staff to undertake cultural sensitivity training and community involvement to ensure appropriate language and literacy levels are used in dealing with the minority population. Poor health literacy is a growing concern in a number of communities, as it is related to poorer health status [41]. It is important to assure that staffs that interact with participants do so in a manner that is appropriate to the participants. In some studies, this may be facilitated by having at least some of the staff of the same ethnic background as the target population [18].
Barrier No. 4: Overcoming Fear and Distrust
Even more difficult to address are attitudes, beliefs, and inadequate knowledge. There may be fear or distrust of research [18] .There may be unfamiliarity with research procedures such as randomization, blinding, and placebo controls [7]. There often are concerns about interference with primary care or with continuity of care.
Approaches to meet these barriers include having credible spokespeople, communication with and endorsement by community leaders, avoidance of jargon, and emphasis on both personal and ethnic group benefits from participation [7].
Other approaches include making sure that investigators', community and participants' agendas are clarified, and maintaining credibility by not promising more than can be delivered or endorsing activities before they are ready, for instance, not guaranteeing a full physical examination unless prepared to do one [18].
Barrier No. 5: Feedback to the Community
This issue is a vital part of the entire process of conducting research with an ethnic minority population, particularly if researchers expect to continue conducting research in the community [1, 18].
In the Arean (1996) study [29], providing feedback to the medical clinics that referred patients about the preliminary findings increased referral rates by 50%. However, to maintain the flow of referrals from the physicians, repeated presentations and collaboration with the medical clinic is crucial, so that physicians do not forget that the study is in place. We have found that, by using this method, the referral parties often provide useful insights into our findings and consistently report that they are made to feel part of the research process.
Conclusions
Inclusion of minorities in clinical research is not only a legal requirement, but is also highly desirable. Type 2 diabetes has reached epidemic proportions in many minorities [42]. Information gathered from research in these populations will be essential to implementation of appropriate health policies and interventions. To foster minority participation in research, however, investigators must recognize the obstacles to minority participation and develop specific approaches to overcome them.
