Practice Guidelines for the Ethical Recruitment of People into Clinical Trials - Essay Example

EVIDENCE BASED GUIDELINES Practice guidelines for the ethical recruitment of people into clinical trials Customer Inserts His/Her Name Customer Inserts Grade Course Customer Inserts Tutor’s Name 23, 05, 2011 Table of content Introduction 1 Background 1 Ethical and technical considerations 2 Guidelines for participant recruitment 4 Consent 6 Other considerations 7 Conclusion 8 Reference List 9 Introduction The purpose of these practice guidelines is to enable healthcare research centers apply appropriate procedures and come up with clinical trial recruitment programs that are highly successful and ethically acceptable. Background There is drastic growth in the health care field and at the same time development alongside new technologies. The new technologies in the field of medicine have elicited research on new vaccines and drugs. However, before these vaccines and drugs are approved, they have to undergo clinical trials. The health research professionals normally get involved with clinical trials of vaccines and drugs so that they can be approved. This involves recruitment of participants for clinical trials for new vaccines and drugs, dealing with the consequences of the trails (such as depression, adverse side effects, social implications, financial consequences and other outcomes). They also have to consider the ethical arena of the clinical trials being carried out (Hoffmann 2010). In the last couple of years, getting or recruiting participants into medical and clinical trials of new vaccines and drugs under research has proved quite challenging and has been identified as the most delaying stage of the discovery and drug development process. Once this stage in successfully implemented, the initiatives for clinical trials are considered successful. This is because the time-line for the process will be greatly reduced and the targets of the trail process can be easily met within or ahead of the target schedule. However, when coming up with a recruitment program for clinical trials, great care has to be taken. In this aspect, the program should highly put into consideration the ethical scrutiny for all initiatives as well as materials used for participant’s recruitment. For instance, the European commission set in the year 2002 released strict guidelines for all health research centers interested in carrying out clinical trails. The commission stated that consultations, patient advertisement and all initiatives involved in participant’s recruitment process be approved by a recognized ethical committee before implementation. If the ethical committee disapproves the initiatives for clinical trials proposed, then the researchers will have no otherwise but to cancel or review the whole recruitment and trial process until further approval by the committee (Hoffmann 2010). Therefore, the following practice guidelines have to be considered when recruiting people for clinical trials: Ethical and technical considerations There are a number of ethical considerations as well as practical issues that still surround carrying out of clinical trials. These issues are the main barriers of research in the medical fields. Any medical research that involves use of human beings as participants in the trial process must have the potential to benefit human beings, must be well designed and must prove to be necessary. The process of ethics review must be conducted and usually involves review of technical and specific ethical issues (Courtney 2010). The individual participating in the trials need to potentially benefit from the study especially in cases of pediatric studies (studies involving trials using children as participants). The main challenge in this area is to balance between exploitation of the participants and the need to get adequate data for use in other human beings so that they are not disadvantaged. It remains unethical and technically unprofessional to use drugs and vaccines for human beings without adequate testing using appropriate population with the required age range. If the study will not be able to adequately address its aims, then it will be considered unethical simply because the participants are likely to be exposed to potential harm or risks with no appropriate balance of group data (Hoffmann 2010). In order to make up a design for a study, the researchers need to carry out or indulge in extensive and conclusive review of the literatures behind the study. This involves reviewing of other related or similar studies carried out before. Studies that do not allocate enough time for literature review poses a great threat to the human participants and thus considered unethical and technically inappropriate. The best example here is a situation that involved hexamethonium asthma. In this incident, the researchers lost a twenty four year old human being (volunteer) in the year 2001 at Johns Hopkins after he inhaled hexamethonium which was meant to induce bronchoconstriction but instead caused bronchiolitis obliterans (Bryan-Brown 2005). This incident would not have probably occurred if the researchers had carried out adequate literature review. Adequate literature review would have alerted the researchers and the ethics committee on the potential fatal site effect of the drug and the whole scenario altered to a safer alternative. Studies involving children need to be carefully reviewed before implementation since children tend to be more vulnerable to fatal side effects than adults. When dealing with children, an expertise in drug actions for children is highly needed due to their vulnerabilities that may not be potential risks for medical trials involving adult participants (Grove and Goldenberg 2005). Guidelines for participant recruitment Recruitment of participants has proved to be the most challenging, time consuming and difficult stage in clinical trials. Issues that are considered here include potential benefit versus potential harm or inconvenience. When recruiting participants for medical or clinical trials, it is vital that effective communication be employed together with motivation. The participants to be recruited have to undergo medical examination to clear out any doubts to whether they may be suffering from any illnesses. This process of medical screening of participants is very essential since it helps when evaluating potential outcomes or side effects after the trial. Some participants may use this as a basis and can sue the researchers for causing harm to their health. Therefore, it is important to know the medical or health status of all human participants before engaging them in clinical trials for responsibility and accountability purposes (Hoffmann 2010). There is also need for proper communication among researchers and all other participants involved in the study. Before clinical trails are carried out, the researchers need to disclose all the information in details to the participants so that the participants can make decisions from an informed point of view. Details concerning the design of the study, aims, procedures, justification, problem statement, benefits to the participants and more so the possible side effects to the participants need to be fully disclosed to the participants before the trials. All these details are important and the participants need to be fully aware as they make the decision whether to participate or not. This is to avoid regrets and claims/blames by the participants based on ignorance (Courtney 2010). For small children, all the details and the information concerning the study has to be disclosed to the immediate family members including parents since the child may not be able to make a decision for him or herself. Such information details will help the family members or the parents to make a decision to whether their child should be a participant in the study or not. In most studies, it is required that the target participants be of known health status, must not be linked to other hospitals and probably must not have participated in such a study or if possible any medical trial before. This is to avoid claiming of liability by the participant after the trial which may not be in any way linked to the study at hand. It may make the researchers to end up in court, or make compensations for what is not a result of their trial (Hoffmann 2010). When recruiting participants, it is advisable to apply an inclusion and exclusion criteria that reflects accurately on the intended target population. The use of narrow inclusion criteria is discouraged since it tends to impact negatively on the ability of the researchers to recruit and therefore affect the success or completion of the trial process. It also limits the ability of the study to generalize to a larger target population. In order to conduct a successful recruitment process, the number of invasive procedures needs to be minimized and there should be provision of enough or adequate resources to conduct the trial process since inadequate provision of resources for the recruitment process is likely to affect the acceptability of the study in a negative manner (Burls and Osborne 2005). Lastly, there is need for dedicated clinical trial research units to provide the expertise and at the same time give an assurance to the committee for ethics approval, regulatory authorities and the families for the participants that the clinical trials will be carried out in an efficient, effective and ethical manner. Such dedicated research units gives higher level of availability as well as flexibility of participants willing to participate in the clinical trials. The recruitment policies for the research units need to be consistent and reliable (Trinder 2000). Consent Consent together with assent form the two most vital considerations and practice guidelines for ethical recruitment of people into clinical trials. Consent and assent applies to both clinical trials involving adults and those involving young children. For the case of children, there is need to fully inform and agree with the parents or guardians of the child before any clinical trials are carried out. “Otherwise, this will be considered as taking children as guinea pigs” (Coates 2004, p153). In order for the committee for ethics and other regulatory committees to approve the study, the consent present must be fully informed and freely given by the participants or the family of the child. For adult participants, they have to agree and sign a consent form for accountability purposes. Once an adult, a participant has the right to decide from an informed point of view whether to participate in the study or not. The family and the close relatives have no obligation to indulge into the decision made by the adult participant to participate in the study because it is believed that adults have their right to enjoy making decisions for their own. However, advice and consultations are welcomed from close family members as well as friends. In some cases, children may be unwilling to take part in the trial process. In such a case, the ethics committee will only allow the study to go on if the child is not forced to participate in the study (Hoffmann 2010). The family of the child or other participants has no obligation to force the participant to participate for any benefits. On the other hand, the research company is prohibited from giving rewards that may sway the decision of the participants or the family of the child to be recruited. However, remuneration that caters for expenses incurred by the participants such as car parking while participating in the trial should be catered for by the research company. Lastly, incase the participants tends to benefit from the medicine that is still not yet available, it is unethical to withdraw the medicine at the conclusion of the study. The participants have the right to continue enjoying the medication after the trial (Grove and Goldenberg 2005). Other considerations The first one is notification of the eligible participants. Before the trials are carried out, the researchers need to timely and adequately notify the potential participants that actually the trials exist. For this to happen, the researchers have to be equipped with knowledge on all aspects of the study (Trinder 2000). Second, the participants need to be motivated by the recruiting agents. Participating in clinical trials has many side effects involved and many people may not be willing to act as trial agents. Patients appear to be highly motivated with hope that they may benefit from the trials as compared to volunteers. The only way to motivate participants is to assure them of health related complications and the efficiency and effectiveness of the study. The last one is dealing with the side effects or the outcomes that may follow after the clinical trials. Participants involved in clinical trials are subject to various complications and adverse effects that may result after the trial. It is the obligation of the research company to help in such cases. It is not supposed to let the participants suffer thereafter. In other words, the research company should take responsibility of the adverse effects (health, depression, social and financial implications) that may result after the trial (Hoffmann 2010). Conclusion Clinical trials are of great importance in the field of medical research and other research fields. However, in order to seek approval for the trials from the ethics committee, researchers have to strictly adhere to the above ethical practice guidelines for recruitment of human beings to participate in the clinical trials. Reference List Burls, A and Osborne, J 2005, ‘Debate: Sicily statement on evidence-based practice’, BMC Medical Education, Vol. 5, no.1, pp. 14-31. Available from: . (Accessed 25 May 2011). Bryan-Brown, C 2005, ‘The fallibility of certainty’, American Journal of Critical Care, vol. 1, no. 7, pp. 14-48. Coates, V 2004, ‘Randomized controlled trials – almost the best available evidence for practice’, Journal of Diabetes Nursing, Vol 6, no. 2, pp.141-162. Courtney, M 2010, Evidence for Nursing Practice, Elsevier, Sydney. Grove, C and Goldenberg, M 2005, ‘Evidence-based ethics? On evidence-based practice and the ‘empirical turn’ from normative bioethics’, BMC Medical Ethics, Vol. 6, no. 11, pp. 51-72. Available from: . (Accessed 25 May 2011). Hoffmann, T. et al. 2010, Evidence-Based practice: across the health Professions, Sydney: Elsevier. Trinder, L 2000, Evidence-Based Practice: A Critical Appraisal, Blackwell Science, Oxford. Read More