Ethical Challenges in Consent to Research Participation

Ethical Challenges in Consent to Research Participation Belmont Report (basic principles underlying the ethical challenges): Autonomy respect for persons beneficence justice [AS1]What should participants understand to understand they are participants in research? (Wendler et al. 2008). In order for a participant to give valid consent, the PIL at minimum should include 20 elements as detailed out in section 4.8.10 of ICH GCP guidelines so that comprehensive information is provided to them. The CIOMS guideline lists 26 essential elements to informed consent. Hence, this question encompasses one of the major ethical challenges faced during the consenting process. According to participants perspective, is all the information included in the PIL relevant to their decision-making? It is often noticed in practice that participants feel overwhelmed by the information provided to them, and as a consequence they skim over information which they feel is not applicable or relevant to them. But then the next question arises, what about the elements that are considered non-relevant by the patient? Does it contain important information which the patients would otherwise be missing out on? As result it is unclear as to what should be the adequate content of the PILs to satisfy the needs of the patient and delivering the minimum sufficient (encompassing all perspectives) information at the same time. Failure to find a balance in this respect might undermine the validity of potential participants consent is it as informed consent or not? Fortun et al. 2008 noted that participant recall and understanding of clinical trial information was poor despite a comprehensive 13 page PIL. A systematic review also highlighted that providing patients with more information results in lower participation rates (Edwards et al. 1998) To determine what information potential participants need to understand in order to give valid informed consent, it is useful to identify the purpose or justification for requiring consent in the first place. Once we answer this question, we can then determine what information individuals need to realize this purpose or goal (Wendler et al. 2008). Informed consent serves at least two purposes. First, the requirement for informed consent allows competent individuals to understand whether participation in research is consistent with their interests. Second, informed consent allows individuals to decide for themselves whether they will enrol in the study in question. For this purpose, potential participants should be provided with the information they want to decide whether to enrol in the study, which goes back to our earlier challenge of the content of consent. Not[AS2] just the content of PIL, but the quality of its content should also come under ethical scrutiny. Both the content and its quality together will help the patient to make a reasoned choice. In order to truly understand something, one must exercise two capacities (which together constitute the meaning of decisional capacity in healthcare) the capacity to understand the meaning of the information provided, and the capacity to appreciate the relevance of this information to ones own situation and come to a decision [Iltis, 2006, 181]. In terms of the actual words used in PIL, the complexity of the technical language in which consent forms are written remains a problem, though this can easily be remedied. (Macklin). But its not just that. Its even the simple terms like describing research using other terms, for example, explaining that the project involves a study or a clinical trial, seems unlikely to help those who do not already understand research. For example, a potential participant understands the studys risks, potential benefits, procedures, and alternatives. What else should the patient understand to understand that the project in which they are being invited to participate involves research? And what additional information should investigators disclose to help them understand this fact? Another facet to this linguistic challenge is when considering translation to local (or regional language). For example, some languages do not include a word for research. Does it follow, as some commentators speculate, that these individuals cannot understand that a study involves research, hence, may not be able to provide valid informed consent? At the other extreme, explaining every aspect of clinical research seems impractical, if not impossible. Understanding the history of clinical research and its abuses alone might require a lifetime of study. Between the insufficiently minimalist and impossibly maximalist extremes lie many questions, and the need for guidance. Must investigators disclose and must potential participants understand the scientific design of the study? Do they need to understand that the study is phase I, and how that differs from phase II and phase III studies? Too much information can be as bad as too little; both tend to interfere with the ability of research participants to grasp what is relevant Macklin et al. After the information has been provided, the next question is, has the information been received? As Nijhawan et al. states, it is very difficult to evaluate a participants viewpoint about trial since there is no established method to measure the level of understanding that a participant has about the information given. There are various factors involved in this. A participants level of understanding would be affected by a degree of misunderstanding that can occur because of incorrect or inadequate language translations as well as their level of education. (Ferguson, 2002) The national and international guidelines state that the comprehension of PIL should be accessible to a 12 year old. However, only 50% of patients feel that the provided information is clear and concise, with many patients having to read the document numerous times to gain a grasp of the medical terms contained within the PIL. There is also considerable debate about patients perception of the goal of research, which is termed as Therapeutic Misconception in an article by Appelbaum et al. It states that a further difficulty arises from the failure to distinguish between experimental research and therapeutic medicine in the context of clinical research. Surveys have shown that many patients who are enrolled as subjects develop the misconception that the goal of the research is a therapeutic one, and they agree to be enrolled in the often unrealistic hope that they will benefit directly from participation in the study which yet again undermines the validity of informed consent. Another [AS3]related difficulty involves the widespread variation in subjects comprehension and appreciation of the nature of risk. The Belmont Report reminds investigators that they have responsibility for ensuring that the subject has comprehended the information provided to them, and that the obligation to ascertain that the subject has adequately understood the nature of the risk entailed by the research increases in proportion to the seriousness of the risk (Section C). Studies have shown that most adults have a limited ability to think in terms of probabilities and to appreciate risk, even when steps are taken to enhance their understanding [Iltis, 2006, 181, 185]. It is generally agreed that the amount of information provided should be based on the typical reasonable adults understanding of risk, although there is much disagreement about how to define this, given that interpretations of both linguistic and numerical ways of expressing the possibility of risk vary considerably, as does the amount of risk different people are willing to assume. Moreover, what might be risky for one person, it necessarily wont be the same for another. While the investigator can provide the prospective participant with scientific data relating to types and probability of risk in order to assist her in making a decision, it is the value they attach to risk which will ultimately determine whether or not they chooses to participate. Thus great care has to be taken to ens ure that research risks and potential adverse events are presented to prospective participants as unambiguously as possible. Then [AS4]again there are problems relating to research involving vulnerable populations, some of whom may have diminished or impaired mental capacity and may not be capable of providing consent at all. (Macklin) A balance needs to be established between the obligation to protect more vulnerable or less autonomous research participants, on one hand, and, on the other, the need to conduct research involving minors and persons with reduced mental capacity in order to provide these populations with access to results or interventions which may benefit them clinically. Persons with diminished mental capacity and children who have not yet reached decisional maturity should not be automatically denied the benefits of medical research, but neither should they be excluded without justification from decisions made about whether or not they become involved in research. What is crucial is that additional safeguards be put in place to ensure that these groups are protected from exploitation, in particular while explaining the nature of the research when obtaining their consent. Where this is not possible, and it is felt that the research has sufficient clinical value to proceed, stringent requirements f or obtaining proxy or surrogate consent should be put in place. Consent forms should reflect this need for additional protection. [task article] Given the current socio-legal research environment, it is difficult to know whether, in practice, researchers and research review bodies err in overestimating or underestimating the decisional capacities of persons with mental illness. Either type of systematic error can be costly. Allowing persons with mental illness to participate on the basis of defective consent would violate the most basic ethical tenets governing human research and can amount to exploitation. Yet, by erring too much in the other direction-that is, by overemphasizing the vulnerabilities of persons with mental illness-researchers and review bodies could unfairly exclude competent individuals with mental illness from opportunities to participate in research. The ethical costs of excluding willing individuals with mental illness from participating in research are not sufficiently emphasized. Unjustified exclusion from research, however well intended, is a form of discrimination. Moreover, in the abse nce of adequate research on the most severe forms of mental illness, individuals with these illnesses are relegated to receiving treatments for which there is only inferential evidence of efficacy. For these reasons, a major ethical challenge for psychiatrists and other professionals engaged in mental illness research is to develop ethical principles and practices for selecting research participants that ensure proper respect and protection without reinforcing incorrect assumptions about individuals with mental disorders. Another major ethical challenge faced during obtaining consent is assessing the patients voluntariness. Macklin et al. paper questions, can the complete voluntariness of patients decisions to participate in research always be guaranteed, especially when the person conducting the research is the patients own physician? Objective of a researcher is to perform systematic investigations involving human beings to develop generalizable knowledge whereas as a practitioner their focus is on diagnosing and treating the illness in individual or group to meet their health needs. So an interesting, albeit ethical, dilemma arises. Should the physician fulfil their sole obligation of focusing on the well-being of the patient, yet in the context of trial conduct, the physician (now an investigator) has competing obligation to generate high quality data. The trial distracts from good personal care. Declaration of Helsinki 2000 Article 28 says: The physician may combine medical research with medical care, only to the extent that the research is justified by its potential prophylactic, diagnostic or therapeutic value. When medical research is combined with medical care, additional standards apply to protect the patients who are research subjects. [macklin] There are problems concerning the way research is presented to patients who are potential subjects when the investigator is faced with such a dual role. When researchers are also clinicians caring for their patients, they face a conflict of interest that is non-financial. The need to accrue a sufficient number of patients in a study could affect the way a researcher conducts the informed consent process. Patients tend to trust their doctors, even when the intervention is research rather than a treatment proven to be effective. Practically in such a situation, patients often rely on the responsible doctor for decisions about whether to take part in a research study, the treatment available and its associated risks, despite the information available in the PIL [Bjorn et. Al, 1999] Hence, a sense of patience and training as a researcher is required from the investigators end. Investigators should receive education in research ethics that addresses rules and norms governing research; sensitivity to ethical implications of decisions and actions; and skills in ethical problem solving, including ascertainment and disclosure of conflicts of interest. [task article] Conclusion: Informed Consent is not enough. There are multi-factorial challenges to this single concept. With subject populations that are mostly medically naive and for whom the whole concept of clinical research and the umpteen terms and concepts associated with it are alien; the true essence of an informed and autonomous decision is fundamentally lost. The consent process thus gets reduced to mainly a narration-followed-by-signature process. Over the last few years, this gap in principles and practices of ethics and consent has been acknowledged and innovative concepts and attempts are being fostered, to make the informed consent process more ethical. Pranati et al. [AS1]Information Overload [AS2]Language Barrier [AS3]Comprehension and perception [AS4]Vulnerable patients

Handling of Grievance Procedurin Organizations

Various organizations are aware about the diversification of the employees’ traits and characteristics. Instead of letting these individuals affects the culture of the organization, it is the corporate culture that tends to affect their behavior. Still, there are chances that within the organization, the collision and clash of ideas might turn into arguments. In order to bring back the harmony inside the organization, the management is engaged in handling the different faces of issues to maintain the life and the employees’ relationship. Background of the StudyThe issue of grievance within the organization is identified as the protest of the people against the application of the policies which is placed in an unjust or unfair manner (Hardeman, 2006). The organization sets rules or regulations which some of the employees’ finds faults or conflicts. In order to compensate their right to clarify the things, in which they believe that will affect them sooner, the emp loyees do what for them fits and right. The grievance is the kind of procedure that values the idea and participation of the employees’ but often taken as a negative factor within the organizations.However, the organizations are still looking for an effective way in handling the grievances in their organization. Scope of the Study The scope of the study intentionally addresses the handling of the grievances inside the organization. The administration of the grievance is important in all types of organization. The creation of the study is meant for properly handling the grievances with administration’s judgment and the person or people involved should be addressed their on role and address their issue of grievance. Research ObjectivesThe first objective of the study is to determine the effectiveness of the grievance procedures within the organization. The second objective is to identify the appropriate techniques in handling the grievance within the organizations. With these two objectives, the respected organization can identify the right formula in handling the conflict such as grievance in the workplace. Literature Review In order to adjust the employees’ concerns, there are recognized procedures that applied by the organization in detailing the every inch of the problems.The grievance procedures are part in the specified area of labor in which the main concept is to implement the system regarding the various concerns and complaints. People are important for the business leaders and managers, and to minimize the conflicts and other problem within the workplace, they have to handle the issue with fair treatment. Historically, the grievance procedures can formulate the positive outcomes and contribute to for the effectiveness of the management. This can be another tool for the management to maintain the relationships within the workplace.With the use of the system, the management can evaluate its own flexibility for the managers are capabl e in handling the arguments by providing therapeutic value. The grievance procedures provide the means of indentifying the appropriate practices, procedures, and administrative policies that can cause the employee’s complaints be considered (Bohlander, 1989). The creation of the grievance procedures began through the various conceptualizations of the people and their access in resolutions. The comparison of the female and male employees has difference means of grievance procedure.Mostly, women are anticipated in seeking justice but are lacked in the access in networks that are necessary towards the resolution. Meanwhile, the men are hesitant to embrace the formality of the grievance procedures for they were reluctant to damage their relationships with other people (Hoffman, 2005). There are recognized steps in handling the grievance which can be also applied in the process of the organizations. Firstly and maybe the most important, is to let the person or the people stand up and speak on what are the things they believed is wrong.Everybody has a right to be heard, and with the open communication, the problem can be easily resolved (Hardeman, 2004). The people who participated should be true to himself to let the organization what he truly desires regarding on the imposed regulations. Methodology The proposed method in the study is the use of the comparative case study which is related and concern regarding to the grievance procedures. With the aid of the past literatures and other related study, the current study can have the opportunity to compare and review the related study that emphasizes the handling of grievance and the procedures.In addition, the study can generate its own analysis and conclusion on what would be the best applied technique/s to handle and, therefore, resolve the recognized grievance within the organization. References: Bohlander, G. W. , 1989. Public Sector Independent Grievance Systems: Methods and Procedures, Public Personnel M anagement, Vol. 18, No. 3. Hardeman, T. , 2004. Complaint, Grievance, Whistle-Blowing Administrative Regulation [Online] Available at: http://www. faith. edu. ph/manila/uploads/file/policies/grievance-policy-web. df [Accessed 22 March 2010]. Hoffman, E. , 2005. Dispute Resolution in a Worker Cooperative: Formal Procedures and Procedural Justice, Law & Society Review, Vol. 39, No. 1. Read more: http://ivythesis. typepad. com/term_paper_topics/2010/03/handling-of-grievance-procedures-in-organizations. html#ixzz17KYToojb Introduction Maintaining quality of work life for its employees is an important concern for the any organisation. The grievance handling procedure of the organisation can affect the harmonious environment of the organisation.The grievances of the employees are related to the contract, work rule or regulation, policy or procedure, health and safety regulation, past practice, changing the cultural norms unilaterally, individual victimization, wage, bonus, etc. Here, the attitude on the part of management in their effort to understand the problems of employees and resolve the issues amicably have better probability to maintain a culture of high performance. Managers must be educated about the importance of the grievance process and their role in maintaining favorable relations with the union.Effective grievance handling is an essential part of cultivating good employee relations and running a fair, successful, and productive workplace. Positive labor relations are two-way street both sides must give a little and try to work together. Relationship building is key to successful labor relations. Precautions and Prescriptions The management should take care of following aspects to develop a culture of trust and confidence upon the employees. 1. Always ensure that the managers involved in the grievance handling procedures have a quiet place to meet with the complainant. . Always ensure that managers have adequate time to be devoted to the complainant. 3. Explain manager's role, the policy and the procedures clearly in the grievance handling procedure. 4. Fully explaining the situation to the employee to eliminate any misunderstanding and promote better acceptance of the situation complained of. 5. Try to let employee present their issues without prejudging or commenting 6. Do use a positive, friendly ways to resolve the crisis than punitive steps, which disturb the system. 7.Do remain calm, cool, collected during the course of the meeting. 8. Always focus on the subject of the grievance than allied issues. 9. Don't make threats manage the grievances. 10. Never make use of allegations against personalities. 11. Be aware of the staff member's potential concerns to the possible repercussions of raising a grievance. 12. Don't become angry, belligerent, or hostile during grievance handling procedure. 13. Do listen for the main point of arguments and any possible avenue to resolve the grievance. 14.Listen and respond sensitively to any d istress exhibited by the employees. 15. Eliminating the source of the irritation or discomfort being complained of. 16. Reassure them that the managers will be acting impartially and that your hope is to resolve the matter if possible. 17. Don't â€Å"horse trade† or swap one grievance for another (where the union wins one, management wins one). Each case should be decided on its merits. 18. Avoid usage of verbosisms like   â€Å"it will be taken care of. † 19. Ensure effective, sensitive and confidential communication between all involved. 0. Take all possible steps to ensure that no victimization occurs as a result of the grievance being raised. 21. The investigator or decision maker acts impartially, which means they must exclude themselves if there is any bias or conflict of interest. 22. All parties are heard and those who have had complaints made against others are given an opportunity to respond. 23. Try to look upon the problem on different angles for appropr iate understanding. 24. Ensuring that there is proper investigation of the facts and figures related the problem under concern. 25.Consider all relevant information in the investigation process. 26. Ask the staff member their preferred resolution option, although it is important to make it clear that this may not be a possible outcome. 27. Be aware of the limits of authority of the person who involved in the grievance handling procedures. 28. If the manager feels that he/she is not the appropriate person (senior manager) to deal with the issue refer the complainant to the appropriate person as soon as possible. 29. Try to get a better idea of whether the alleged discrimination or harassment happened or didn't happen. 0. Tell them exactly what they are supposed to have done, to whom and explain, why this may be seen as discrimination/harassment or as inappropriate. 31. Grievances are preferably to be settled informally at the level of the employee's immediate supervisor. 32. Try the level best to involve team members to resolve the crisis at unit level itself. 33. Avoid as far as possible the union involvement in conflict resolution situation process. 34. Follow documentation the procedures, of all necessary steps taken to resolve the problem/complaint. ConclusionTo a great extend the aggravation of industrial problems depends on manager's approaches and attitude in effective handling of employees grievances. Care should be taken in the way managers approaches the problem and perceiving the pros and cons of the situation. The conflict management approaches include the win-win strategy that help in the healthy organisational practices and which reflects the strong organisational culture. The cooperation from both parties is the pre-requisite to handle the problem and effective settlement of the grievances.Conscious use of professional self can help managers in the conflict handling situations grievance redressal process. References 1. European Trade Union Instit ute (1989) Collective Bargaining in Western Europe 2. Ozaki (1987), ‘Labour Relations in the Public Service,' IL Review, July – Aug. 3. Schregle J (1991)'Workers Participation in Decisions Within Undertaking'   IL Review Jan – Feb. APSRACT A grievance is a sign of an employee's discontentment with his job or his relationship with his colleagues.Grievances generally arise out of the day-to-day working relations in an organization. An employee or a trade union protests against an act or policy of the management that they consider as violating employee's rights. One of the effective ways of minimizing and eliminating the source of an employee's grievance is by having an ‘open door policy'. An ‘open door policy'facilitates upward communication in the organization where employees can walk into a superiors'cabin at any time and express their grievances.The National Commission on Labor suggested a Model Grievance Procedure, which lays down the sequence of steps to be taken whenever a grievance is expressed. Conflict occurs when two or more people or parties perceive an incompatibility in their goals or expectations. There are seven methods for achieving reconciliation of conflict. These methods are win-lose, withdrawal and retreat from argument, smoothing and playing down the difference, arbitration, mediation, compromise and problem solving. Of all these methods

Eating Disorders and Womens Self Image Essay - 1446 Words

Did you know that 90% of women dislike the way they look? And it’s all because of the media and their emphasis on the â€Å"ideal† figure of a woman. Supermodels like Kate Moss and other Barbie-doll-figure-inspired women grace the cover of magazines all over the world promoting a â€Å"perfect† shape. Girls of all ages think that this is what people want to see. They think that this is what they should look like and try to set impossible goals for themselves to look like covergirls. As a result, many women in North America suffer from psychological illnesses. Among the most common are eating disorders such as Anorexia and Bulimia Nervosa. Anorexia and Bulimia generally arise in young women, but may also occur in older females and occasionally in†¦show more content†¦Everyone has a chemical in their brain called Seratonin. This is what controls your appetite. In Bulimia patients, this chemical is deficient and so they keep eating and eating. At that point they feel guilty and have the urge to dispose of the consumed food either by vomiting or having a bowel movement promptly after eating. Subsequently, their Vasopressin level increases and eventually takes over, making the disposal of food the norm. The opposite occurs in Anorexia patients. The Norepinephrine chemical in their brain is deficient. Norepinephrine is the appetite stimulant. In their case, they have no desire to swallow anything for fear of becoming obese. Compulsive Overeating is another eating disorder although not as common as Anorexia or Bulimia Nervosa. Patients eat uncontrollably and gain a considerable amount of weight. And unlike Anorexia and Bulimia patients, Compulsive Overeaters are mostly male. Compulsive Overeaters eat mainly to cope with stress and anything that may be disturbing them. They, like Bulimics, understand that they have a problem. Most overeaters are people who were not taught how to deal with stressful situations. 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Returning Home From A Tour - 1360 Words

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While most wars are fought through conventional means, there were basically two wars that took place in Vietnam; the traditional war from 1964 – 1968 and the unconventional war from 1968 – 1972. â€Å"From the American G.I.’s point of view, the enemy was the North Vietnamese army whose members could be easily recognized and thus killed legally. The G.I.’s could related easily to Vietnamese villagers, talk to them, andRead MorePolitical And Social Upheavals Caused By War1533 Words   |  7 Pagesstyle warfare for the first time in Vietnam. The North Vietnamese Army used unconventional methods of fighting ranging from, ambushes and raids on the Americans. Vietnamese were able to carry out these tactics because they were able to build underground tunnels to shield their soldiers from the Americans and allow surprise attacks on U.S. soldiers in the Viet Cong jungles. â€Å"From the American G.I.’s point of view, the enemy was the North Vietnamese army whose members could be easily recognized andRead MoreThe Goa Honeymoon Tour : Why This Trip?763 Words   |  4 PagesAdoring Goa Honeymoon Tour Why this trip? In the Goa honeymoon package for 5 days, couples are treated exclusively to enjoy moments in stunningly excellent environment. Relish delectable Goan food, calming stay, and interesting sightseeing opportunities in North Goa and South Goa. Both the areas house ancient structures, sacred places, rich greenery, and delightful beaches. Invest some time in detachment, while wandering on these spots with your beloved. Itinerary Day 1 :Welcome to Goa ArrivalRead MoreDescription Of The Botanical Boat Trip1254 Words   |  6 Pages the Norfolk Botanical Gardens. There, people can walk through an enchanted forest just a short drive from their home. I arrived at the gatehouse to this wonderland ten minutes before I was due to embark. The road was surrounded on either side by a thick forest of trees that blocked out most of the noise from the airport and busy road outside, making me feel like I could be a thousand miles from civilization. The cool wind and overcast sky seemed to be warning me of some approaching rain, leadingRead MoreGo Tell It On The Mountain Analysis755 Words   |  4 Pageswants to embrace the earthly city to escape Gabriel’s circumscribed world, but he cannot free himself from seeing this city through Gabriel’s eyes† (4) and â€Å"Ironically, John cannot imagine a celestial city from the hellishness of his father’s house† (5). Scruggs’ observations highlight John’s inability to escape his invader. Psychological invasion is difficult to extricate from—how do people run from something inside of them? John cannot escape his father’s vision, which inhibits his ability to imagine