Patients Perceptions of Interventional Clinical Trials - Case Study Example

IMPACTS OF RECRUITMENT INTO INTERVENTIONAL CLINICAL TRIALS ON PATIENTS’ PERCEPTIONS OF RESEARCH AND QUALITY OF CARE By Presented to Introduction Thispaper explores patients’ views and opinions following being approached for participation into a qualitative research study after previous recruitment into interventional clinical research trials when they were critically ill in Intensive Care Unit (ICU) and how this affects their perception of research and quality of care offered. It explores how being recruited into such trials while critically ill subsequently affects their attitudes towards research. The researcher will explore the legal, regulatory, ethical, epistemological, and practical issues that would arise from being recruited into such a qualitative study in the wake of another enrolment into a study in their critical condition. While the implications of inclusion of any form of subjects in any research is a critical matter that attracts authorities’ attention, legal, regulatory, and ethical issues have mainly formed the basis for constant re-evaluation of how researchers engage subjects, including seeking to understand what can be done better to make the experience more fulfilling for all parties involved (Carlson, Boyd and Webb, 2004). Recruitment into clinical trials helps to evaluate whether unofficial drugs/ treatment methods about to be launched in the market are viable for use and whether they add any more value to the existing treatment methods. Whenever there is adequate time to begin trials, researchers test new interventional methods using less sensitive subjects, such as volunteers whose health and mental capabilities are regarded good enough to make sound decisions (Cook et al, 2008). However, this is not always possible. Eruption of contagious, highly infectious diseases that significantly shorten the lives of those infected needs urgent measures; sometimes including use of new procedures and unverified drugs on trial from established and reputable manufacturers. Some of the participants who are enrolled into such trials are people already in critical stages of illness, a contested move since most targeted respondents can hardly decide for themselves whether to participate or not (based on their weakening mental and physical health statuses). Despite the obvious frown towards this practice, inclusion of critically ill patients in clinical trials remains one of the dominant practices in clinical research today (Chlan, Guttormson, Tracy and Bremer, 2009). With the increasing inclusion of critically ill patients in clinical research trials, the researcher aims to establish the impacts of the kind of engagement they had while in the critical condition and how involvement in subsequent research (qualitative research) could breach legal, ethical, regulatory, and epistemological and practical expectations. For the anticipated research, the researcher will seek information from patients who were critically ill, were admitted to intensive care and were approached and recruited to Interventional Clinical research trial. Interviewing will happen upon successful discharge from the health facility. Qualitative interviews and qualitative research methods will be utilised. This is based on the researcher’s aim of analysing views, which are best collected and analysed qualitatively. The research is expected to bring up issues on when and how to approach patients, and how to deal with issues that might arise in the interview (complaints, trauma, and post intensive care). Patients are still vulnerable since they are still hospitalised with ongoing treatment; some have slightly recovered from life threatening experience; they are affected by change of environment; they have experienced trauma, received invasive procedures while in Intensive Care Unit; or are adjusting to the normal way of life. The three researchers taking part in the present research are expected to be assigned different roles that will help make the process smooth. One researcher will be in charge of clearing possible hurdles that may prevent possible execution of the research plan. This includes collaborating with the medical team that initially oversaw participation of subjects in clinical trials while critically ill, identifying participants who could be easier to approach, seeking consent from authorities among other administrative roles. The other two will directly engage the participants, explain the research and its scope to them, seek their consents, and conduct the interviews. This will help save time in the process. Issues to be Considered When Recruiting Participants Who Were Initially Enrolled into Interventional Clinical Trials While Critically Ill Legal Issues and Regulation As earlier indicated, many of the critically ill patients lack the mental competence to consent to various issues. This could extend for long periods after the main procedures are over, sometimes even after discharge. The Mental Capacity Act 2005 provides a suitable framework that together with other regulatory frameworks and laws establishes the basis for engagement for the mentally incapacitated to be included in clinical research trials. The framework is founded along the conflicting principles of lack of capacity to consent (also defined as inability to make decisions), acting in the best interests of the individual, (acting in connection with care or treatment scope), and binding limitations to the authority of the researchers carrying out the research (U.K. Parliament, 2005). The Act defines what has to be regarded as mental incapacitation, providing for exhaustion of all practical steps that should establish whether the subject is of sound mental capacity, and not merely dismissing them because they have appeared to make ‘unwise’ decisions. Similarly, the legislation protects the subject from being restricted of their rights and freedoms of action (U.K. Parliament, 2005). The above provisions of the Mental Capacity Act 2005 have great implication on the process of recruitment of persons considered to be of unsound mental capacity into clinical research trials. For instance, based on Section (3) of the Act, a person who has not been established to be mentally incapacitated is automatically deemed as mentally sound. Any decisions they make or any consents they give are therefore binding. In this state, they can freely make suitable decisions that will advise on their willingness to participate in the qualitative interviews. The main aim of the subsequent research study is to follow up on issues that arose from the first study (involving clinical trials). Of particular interest is how the clinical trials could have positively or negatively impacted the subjects, thereby affecting their willingness to cooperate in future. Without a doubt, such subsequent follow-ups are subject to critical evaluation based on their legality. It has to be understood that the research team is acting in the best interest of the patient. One common factor of concern with the ability to consent based on mental competence is the rate at which other illnesses often deprive (temporarily or permanently) the patient the ability to consent freely. This is explained under Section 3 (1) which defines what should be considered as loss of capacity to make binding consent based on mental incapacitation. The factors deemed necessary for such establishment include being unable to: a) Understand the information relevant to the decision, b) Retain that information, c) Use or weigh that information as part of the process of making the decision, or d) Communicate his decision (whether by talking, using sign language or any other means) (U.K. Parliament, 2005). In fact, the issues raised in the Act stipulate situations under which the patient could be deemed to have consented to participate in the research study. Weldring, Carungcong and Braidford (2013) advised that obtaining a consent from any patient cannot be dismissed as an easy task. According to the authors, obtaining consent is preceded by detailed explanation of the role at hand, why the trial is important, why the consent is necessary, the patient’s power to refuse participation, and why the trial could be different from other trials (for instance, why the clinical trials have to be followed up with another research study targeting subjects’ views). Effective completion of these steps marks the beginning of the cooperation between the recuperating patient and the researcher. In the common world of research, it is paramount that each participant grants their signed consent and that proof for such granting of permission remains available for such a period as the consent issue may be disputed (Myles, Williamson, Oakley and Forbes, 2014). These issues form grounds for regulation of research activities. Ethical, Epistemological and Practical Issues Ethical factors of research are of great importance to all parties involved. One of the defining documents that has provided guidelines for ethical conduct of parties to a research is the Nuremburg Code. Part one of the code states: This latter element (having sufficient knowledge and comprehension of the elements of the subject matter involved) requires that, before the acceptance of an affirmative decision by the experimental subject, there should be made known to him the nature, duration, and purpose of the experiment; the method and means by which it is to be conducted; all inconveniences and hazards reasonably to be expected; and the effects upon his health or person, which may possibly come from his participation in the study (Shuster, 1997). This section alone outlines important factors that have great significance on engagement in research. Considering the qualitative research to be conducted, including terms on the possible timeline for the engagement between the researcher and the subjects. Yet, it is sometimes impossible to really define a timeframe. For instance, in circumstances where a review committee may discredit the content of interviews and order a fresh data collection exercise, it would be easier for the researcher to revisit the earlier engaged subjects since starting afresh may be infeasible based on available resources and time. So, would it be prudent to tell the subjects that it is likely that they will be recalled for further engagement? Attempts to answer this question must disregard the notion that some participants were friendly in the initial engagement, despite the fact that they may be easier to contact (Rensik, 2009). In this case, the ethical resolution would be to briefly discuss with the subjects any emerging issues that may have influenced the current requirement for further data collection. This may not guarantee positive attitudes towards further engagement, but the sincerity of the researcher would be paramount regardless of the possible cost of being truthful. Again, some former participants may not be able to engage the researcher once more for the research owing to personal reasons, and the researcher is bound to consider deleting any of their initial information in full. Another important factor raised by Part 1 of the Nuremburg Code is the need to communicate the hazards that may be involved in participating in the research. As noted earlier, the population in question is a vulnerable one, and some of the respondents may not have recovered to recommended levels of satisfaction to participate in difficult physical activities. For instance, persons who developed physical disabilities before or at the point of treatment in the ICU could be unable to dedicate enough time to share their views with the researcher (Rensik, 2009). Clearly, it is unethical to attempt to engage such subjects, since engaging them only exposes them to greater possibilities of getting more ill. Furthermore, a subject cannot be coerced or threatened to participate in any clinical trials. Section Two of the Nuremburg Code stipulates that a method of research shall be effected for the good of society and there must not be other better means known to approach the issue. This means that only the best known methods can be used in the research procedure. The data collection methods must not appear to hurt the patients. The Code provides important guidelines, some of which have subsequently been taken to form regulatory and legal frameworks upon which authorities engage researchers with respect to their treatment of subjects. Some of the important ethical aspects of consenting are based on whether the researchers (or their funders) have vested interests in the research outcome. For instance, in a case where a drug manufacturing company has conspired with researchers to provide favourable results for future approval of the drug simply puts the entire project at doubt since the outcome, whether really favourable or not, can hardly be trusted. Such interests put researchers at conflict with the values that they ought to espouse, and could jeopardise the entire mission of a research project. Where such is exercised, there is high chance that human health may be affected by the unverified and underhandedly endorsed drug, violating Part B (10) of the principles of medical research as provided in the Declaration of Helsinki (World Health Organisation, 2001). Besides the mentioned ethical considerations, it is important to consider how engaging the vulnerable subjects who have been through traumatising experiences before and after being sent to the ICU could affect their psychological wellbeing. It is unethical to engage subjects in discussions that may make them excessively emotional and which may traumatise them. This is because such a research would have outdone the legal mandate of ‘doing the research for the benefits of the subjects’, as established in the Mental Capacity Act 2005 (UK Parliament, 2005). In fact, any actions that would trigger psychological trauma for subjects can be treated as an attempt to thwart the subject’s recovery process. Practical hurdles may prevent seeking consent from recuperating subjects who were initially critically ill from being achieved. The biggest practical impediment is their likely inability to respond properly, due to deteriorating mental or physical health status (Corti, Day and Backhouse, 2008). Where such a case applies, it is apparent that the input of a third party is required, especially if the incapacitation is expected to last for relatively prolonged periods of time. Besides practical issues, epistemological issues may be difficult for patients to understand. These issues may be viewed from two angles: whether the recovering patient may lose confidence in their treatment so far; and whether the need to carry out the review of experiences should best be handled as proposed. Good communication will at this point earn the research some credit from the potential subjects, whose disapproval could impede on any intended progress of the study. While continued research forms the basis for future success in providing optimal services upon demand, driving such points at such critical stages of patients’ recovery process (when they thought what they got in form of treatment was the best there can be) may be difficult and impractical (Myles et al, 2014). The researchers may have to spend unnecessarily long periods of time trying to convince the patient and the family about the possibility of bettering whatever services are already in use, making the patient spend even more time that they should have been resting for quicker recovery. Equally important is the Belmont Report, which sets out important principles; including maximization of benefits for subjects while reducing chances of risk during and after treatment (where such risk may be the result of the treatment procedures) (DeLanda, 2009). The report places human life high beyond any other aspect of treatment, including monetary gains and personal fulfilment (where the researcher may be primarily driven by the desire to accomplish certain research goals at the expense of the health/ life of the patient). Impacts of Recruitment into Interventional Clinical Trials on Patients, Researchers, and the Wider Research Family Persons who have recently been critically ill and are still recuperating (whether from disease or accident) are at a significantly sensitive stage in their lives. They need significant amount of attention; possibly round-the-clock attention. Their treatment is expected to utilise the most efficient methods and drugs as far as that objective is feasible. However, in moments that it is infeasible, medical teams are free to provide the patient and their family the relevant information regarding the state of available treatment options. Consequently, medical/ clinical teams may have enrolled such persons in clinical trials while they were still critically ill to establish whether they are receptive of treatment. Such subjects are already in doubt whether the hospital could have failed to utilise other viable means of treatment to try a different model. It raises a question of efficacy of the existing drugs/ methods, and need for justification towards superiority of new methods or drugs. The fact that they are on trial means that they are not certified, and they could fail to offer the required solution to the patient (Cook et al, 2008). Their trust in the hospital’s/ medical facility’s capability to treat them remains dented and they could fail to cooperate since they may feel that they are not getting the best (Kleiderman et al, 2012). Consequently, such subjects have higher odds of failing to cooperate with researchers in the present study. Their loss of trust in the facilities and level of care given at the ICU could also lead them to provide ‘unjustified’ negative reviews of the initial research, even when the outcome was positive. Basically, every information provided in research (pertaining to participants’ personal or residential information) must be treated with confidentiality and records rendered anonymous to prevent identification of individual participants and consequently violate their privacy entitlement (Kleiderman et al, 2012). Credibility of research results could be at stake if the researcher has vested interests in the research, or if they are working under coercion from their funders. Upon learning of such developments, the recovering patients will feel cheated and it may lead to withdrawal of their consents of participation in the present research study. The preceding relationship between the patient who just recovered from a critical illness and the researchers who sought to recruit them into clinical trials when in that state could carry on, or even define their relationship with the current study. This could jeopardise the work of the researcher, who could be misunderstood on the basis of misconceptions borne from the previous enrolment into clinical trials. Consequently, in the present research, the researcher anticipates to have to deal with non-receptiveness, low morale, and negative attitudes towards research. Unavoidably, we have to consider situations in which the interventional clinical trials could yield the unexpected results, and the patient has to undergo further treatment to erase impacts of this last treatment. Such patients are most unlikely to participate in such trials in the future. Their trust in the way trials are handled is difficult to restore, and they may become unapproachable for similar exercises in future. This means that the cooperation of researchers with this patient is indefinitely cut off, and they could likely influence or advise other potential participants to keep away from such important exercises. In such case, the work of researchers appears to gain negative reviews which impact the willingness of some to recruit individuals into similar exercises. Such a situation could negatively affect the morale of the researchers participating in the present qualitative research. Conversely, a positive outcome of an interventional clinical trial could be a huge boost to the research community’s ambitions of providing securing cooperation of the participants at every subsequent trial. In the same way an irked initially critically ill individual would discourage other potential participants from engaging recruiters after an awful experience, the satisfied ones are a great inspiration to potential future participants. Where positive influence is sustained, the researcher will be guaranteed of considerable levels of cooperation from the participants. Failure to fully disclose some important issues that should have been communicated to the participant could also trigger withdrawal from the research study. Where the scope of the research changes within the engagement process, the researcher has a duty to inform the participants and seek to enlist their cooperation once more by requiring them to consent afresh at their own will. Breach of protocol with regards to changed scope could affect subjects’ enrolment and willingness to cooperate. Consequently, their data may not be helpful to the researcher as negative attitudes arising from enrolment issues affects quality of information given. References Carlson, R. V., Boyd, K. M. and Webb, D. J. 2004. The revision of the Declaration of Helsinki: Past, present and future. British Journal of Clinical Pharmacology. 57(6): 695-713. Chlan, L., Guttormson, J., Tracy, M. and Bremer, K. L. 2009. Strategies for overcoming site and recruitment challenges in research studies based in intensive care units. American Journal of Critical Care. 18(5): 410-417. Cook, D. J., Blythe, D., Rischbieth, A., Hebert, P. C., Zytaruk, N., Menon, K…and Meade, M. O. 2008. Enrolment of intensive care unit patients into clinical studies: A triational survey of researchers’ experiences, beliefs, and practices. Critical Care Medicine. 36(7): 2100-2105. Corti, L., Day, A. and Backhouse, G. 2008. Confidentiality and informed consent: Issues for consideration in preservation of and provision of access to qualitative data. Forum: Qualitative Social Research. 1(3): Article 7. DeLanda, B. 2009. The Belmont Report: History, principles and application. Leland Stanford Junior University. Kleiderman, E., Avard, D., Black, L., Diaz, Z., Rousseau, C. and Knoppers, B. M. 2012. Recruiting terminally ill patients into non-therapeutic oncology studies: Views of health professionals. BMC Medical Ethics. 13(33): 1-12. Myles, P. S., Williamson, E., Oakley, J. and Forbes, A. 2014. Ethical and scientific considerations for patient enrolment into concurrent clinical trials. Journal of Animal Science and Biotechnology. 15(1): 470-479. Rensik, D. B. 2009. Re-consenting human subjects: Ethical, legal and practical issues. Journal of Medical Ethics. 35(11): 656-657. Shuster, E. 1997. Fifty years later: The significance of the Nuremberg Code. The New England Journal of Medicine. 337(20): 1436-1440. U.K. Parliament. 2005. Mental Capacity Act 2005. London: The Stationery Office. Weldring, T., Carungcong, J. and Braidford, L. 2013. Recruitment of critically ill patients into a multi-centre randomised control trial – A local perspective. London: Royal College of Nursing. World Health Organisation. 2001. Declaration of Helsinki: World Medical Association Declaration of Helsinki. Bulletin of the WHO. 79(4): 373-374. Read More