Minimizing Harm to Vulnerable Patients Participating in Research - Term Paper Example

Researchers must be particularly aware of vulnerability of some participants.’(Parahoo200 6:117 Critically analyse the ways in which researchers can minimise harm to vulnerable patients participating in research within the NHS. Introduction: Ethical research practice requires a consideration of duties and ethical responsibilities to research participants, professional and academic colleagues, research sponsors and the wider public. There is existence of ethical guidelines for most disciplines. It is acknowledged that qualitative health research often generates ethical dilemmas, and these are not easily solved by application of codes of practice (Cormack, 2000, 23-46). Any research study involves a number of different stakeholders, potentially including the research team and the institution for which they work, the professional organizations they may represent, the participants, the sponsors, policy-makers who may use results, various groups affected by those results, and the wider public. Meeting the diverse needs of these stakeholders generates a number of questions and sometimes conflicts about responsibilities and values, where the most important philosophical need would be to carry out research in a way sensitive to the needs of participants in the field (Chadwick and Tadd, 1992, 7-63). Gaining Access Some basic issues in research ethics centre on special levels of protection and aid for vulnerable and disadvantaged parties, when a research is contemplated involving their participation. These issues cut across clinical ethics, public health ethics and research ethics (Nursing and Midwifery Council, 2002a). When individuals lack the ability to select the approach that would be most consistent with their values and preferences, it is inappropriate to give them control over their consent to a research (Royal College Of Nursing Research Society, 2004). Vulnerable persons usually need the protection of a trustworthy individual to make decisions on their behalf. The capacity evaluation is essential to determine whether autonomy or protection is the appropriate governing principle in particular cases (Broome, 1999, 96-103). Ethical and Legal Principles in Research To make autonomous choices, people must have certain abilities, and there is agreement on the basic features of decisional capacity. It has been mentioned that four abilities are central, the ability to communicate a choice; the ability to understand relevant information; the ability to appreciate how this information applies to one’s current and future situation; and the ability to give comprehensible reasons for a decision (Noble-Adams, 1999, 888-892). Simple mental status assessments may furnish preliminary guidance; they are insufficient to determine whether someone is able to make autonomous decisions about participating in research. This is more so if the person is being treated for some mental reasons, and research involving these persons are very common (Polit, Becks, & Hungler, 2001, 143-160). Therefore, it is necessary to evaluate decisional capacity in the context of the specific research situation at hand. Decision-making capacity should be assessed through a discussion of the facts relevant to the particular choice facing a patient. At the least, patients should demonstrate the ability to understand the goals, potential benefits and risks of a proposed research, and should be able to express a reasonably stable choice as well (Manning, 2006, 35-47). Consent and Informed Consent Often, in research, it is insufficient to obtain the cooperation of prospective study participants alone. If the sample includes children, mentally incompetent people, or senile individuals, it would be necessary to secure the permission of parents or guardians. From that point of view, a research problem may not be feasible because the investigation of the problem would pose unfair or unethical demands on participants. The ethical responsibilities of researchers should not be taken lightly (Noble-Adams, 1999, 956-960). Some researchers support a sliding-scale approach to evaluate a person’s capacity to decide about treatment. According to this approach, capacity standards may be lower when patients are in low risk situations, where any choice offers reasonable benefit and minimal risk. Conversely, a higher level of decisional ability should be required for decisions with more serious consequences, such as decisions about life-sustaining treatment. Others oppose the sliding-scale approach; however, contending that genuine respect for autonomy requires adopting the same capacity standards for all decisions, no matter how significant the consequences are (Paniagua, 2002, 22-25). Assessing a person’s decision-making capacity should go hand-in-hand with assessing that person’s understanding about the matter. To make an informed choice, a patient must be cognitively capable of understanding the basic facts about the relevant research. In mental health research, this problem becomes more acute, and autonomous consent may become invalid and unethical, since the subjects understanding about the research may be totally erroneous given the mental challenge that the person might have been facing. Caretaker consent may be equally unethical since like the researcher, the caretaker might have been unable to make the prospective participants understanding clear (Davis, 1989b, 448-457). The fundamental ethical and legal issue raised by research involves a balancing exercise between the interests of the researcher on one hand and on the other, the welfare of those human subjects who are included in medical research for the purpose of the study. People with mental handicap are in greater danger of being victims of the good intentions of others than most other marginalized groups. It is precisely because of their intellectual limitations that others make decisions for them. These decisions can be fundamental—beginning with the right to life itself. Self-determination and self-advocacy are central to the goal of independence of adults with a mental handicap. Although it is a truism to state that the degree to which adults can achieve independence will vary greatly from person to person, it is equally true to say that their abilities are frequently underestimated, even by those who know them well (Dimond, 1995, 13-35). Humans should be treated as autonomous agents, capable of controlling their own activities. The principle of self-determination means that prospective participants have the right to decide voluntarily whether to participate in a study, without risking any penalty or prejudicial treatment. It also means that people have the right to ask questions, to refuse to give information, to ask for clarification, or to terminate their participation. A person’s right to self-determination includes freedom from coercion of any type. Coercion involves explicit or implicit threats of penalty from failing to participate in a study or excessive rewards from agreeing to participate. The obligation to protect people from coercion requires careful thought when the researcher is in a position of authority, control, or influence over potential participants. The principle of respect for human dignity encompasses people’s right to make informed, voluntary decisions about study participation, which requires full disclosure. Full disclosure means that the researcher has fully described the nature of the study, the person’s right to refuse participation, the researcher’s responsibilities, and likely risks and benefits . (Tingle & Cribb, 2000, 5-24). The issues of autonomy and dependency are seen clearly when the older person is considered to lack the capacity to make important decisions. The nurse in this situation must not overlook the possibility that older people are sometimes denied their wishes, not because of any form of incompetence on their part, but rather because they are dependent upon inadequate social support. In vulnerable populations, a persons decision making capacity is called into question. When it comes to consent to research, where we might have anticipated that things would be more rigorous, there is evidence of older people being involved in research projects although they do not pass the tests of capacity. Current law in England and Wales suggests that to have capacity, the person must be able to understand, recall, weigh up the material information and communicate his or her decision. All of this is rather cognitive, whereas some have argued that emotional and volitional aspects also come into the assessment of capacity. It is certainly the case that decisions about capacity can be problematic (MacHale, Tingle & Peynsner, 1998, 11-34). For studies involving more than minimal risk, researchers need to make special efforts to ensure that prospective participants understand what participation will involve. In some cases, this might involve testing participants for their comprehension of the informed consent material before deeming them eligible for participation. Adherence to ethical standards is often straightforward. However, the rights of special vulnerable groups may need to be protected through additional procedures and heightened sensitivity. Vulnerable population, such as, mentally challenged people may be incapable of giving fully informed consent or may be at high risk of unintended side effects because of their circumstances. These are high-risk groups, and researchers interested in studying high-risk groups should become acquainted with guidelines governing informed consent, risk/benefit assessments, and acceptable research procedures for such groups. In general, research with vulnerable subjects should be undertaken only when the risk/benefit ratio is low or when there is no alternative (Thompson, Melia, & Boyd, 2000, 12-37). For example, legally and ethically, children do not have the competence to give informed consent. Usually, the informed consent of children’s parents or legal guardians should be obtained. Individuals whose disability makes it impossible for them to weigh the risks and benefits of participation and make an informed decision, such as, people affected by mental retardation, senility, mental illness, or unconsciousness also cannot legally or ethically provide informed consent. In such cases, researchers should obtain the written consent of a legal guardian. Researchers should, however, be aware of the fact that a legal guardian may not necessarily have the person’s best interests in mind. In such cases, informed consent should also be obtained from someone whose primary interest is the person’s welfare. As in this authors practice, where work involved institutionalized people, particular care may be required in recruiting such people because they often depend on health care personnel and may feel pressured into participating or may feel that their treatment would be jeopardized by their failure to cooperate. It should go without saying that researchers need to proceed with extreme caution in conducting research with people who might fall into two or more vulnerable categories (Parker, 1999, 57-82). Confidentiality and Privacy Virtually all research with humans involves intruding into personal lives. Researchers should ensure that their research is not more intrusive than it needs to be and that participants’ privacy is maintained throughout the study. Participants have the right to expect that any data they provide will be kept in strictest confidence. This can occur either through anonymity or through other confidentiality procedures. Anonymity occurs when even the researcher cannot link participants to their data. When anonymity is impossible, appropriate confidentiality procedures need to be implemented. A promise of confidentiality is a pledge that any information participants provide will not be publicly reported in a manner that identifies them and will not be made accessible to others. This means that research information should not be shared with strangers nor with people known to the participants (Damrosch, 1986, 61-63). Data Protection Researchers can take a number of steps to ensure that breaches of confidentiality do not occur. They may obtain identifying information, such as, name, address from participants only when essential. Researchers may assign an identification (ID) number to each participant and attach the ID number rather than other identifiers to the actual data. The identifying information should be kept in a locked file, where only a small number of people can access the information on a need to know basis (Parliament Act, 1998). The computer files should have no identifying information, and identifying information should be destroyed as quickly as possible once the need is fulfilled. All research personnel must sign confidentiality pledges if they have access to data or identifying information. Reporting of the research information should be done in aggregate. Where information about a specific person is reported, adequate measures must be taken to conceal the persons identity (Nursing and Midwifery Council, 2002). Qualitative researchers may need to take extra steps to safeguard the privacy of their participants. Anonymity is almost never possible in qualitative studies because researchers typically become closely involved with participants. Moreover, because of the in-depth nature of qualitative studies, there may be a greater invasion of privacy than is true in quantitative research (Holloway & Wheeler, 2002, 23-56). A final issue is adequately disguising participants in research reports. Because the number of respondents is small, qualitative researchers may need to take considerable precautions to safeguard identities. This may mean more than simply using a fictitious name—it may also mean not sharing detailed information about informants’ characteristics, such as their occupation and diagnosis (Parahoo, 2006, 15-57). Non-maleficence The principle of non-maleficence implies no harm to the vulnerable population subjected to research. Safety issues and risk to the participants have largely been silenced within the social science research domain. This is probably because researchers have conformed to issues of informed consent and promises of anonymity and confidentiality of the participants, and this is seen as sufficient to protect them from harm. However, sensitive researchers have responsibility to ensure the physical, emotional, and social well-being of research participants, and they must ensure that they will not be adversely affected by participating in any research. Indeed, ethically, researchers have a duty to ensure that no harm comes to their subjects, whatever their ages, as a result of their agreement to participate in research. It may happen that the researchers cannot guarantee that such participation may improve their lives, but they must ensure, at least, that the research scrutiny does not leave them worse off. It has been suggested that safety issues need to be more visible in discussions of qualitative research methodology due to the extent and depth of involvement of the participants, not just as individuals taking part in the research, who can be harmed by our research findings (Cowles, 1988, 163-169). For example, if any research points to negative images of homeless people and drug users, the whole community of homeless people and drug users will be stigmatised, and it may have great influence on health and welfare services provided for these groups of vulnerable people. Conducting research with vulnerable populations may lead to unintentional danger to the participants. Therefore, special attention needs to be paid to risks to the participants throughout the research processes. Psychological and emotional distress is also common, where the participants may be vulnerable to their own emotions being stirred by taking part in the research. Researchers need to consider some strategies to protect the research participants from harm arising out of their participation in the research, and the researchers have their ethical responsibility to find ways to minimise this emotional experience. Some authors have recommended a debrief session after the interview in order to assist the participants to have an opportunity to talk about the situations or feelings that trigger their emotions. It has also been contended that debriefing may not suffice to protect vulnerable participants. They need to have access to other types of support services, including counselling, once debriefing is done (Rees, 2003, 11-36). Dual Role of Nurses Nurses are to primarily care for their patients, and as scholars they must undertake research to facilitate knowledge that will help care for these patients. Dual responsibilities occur in a wide range of settings. All health professionals sometimes find themselves owing a simultaneous moral, legal or contractual duty to several parties whose aims do not coincide. Nevertheless, duties to people other than the patient are likely to weigh persistently and considerably more in some branches of health care, such as prison medicine, than they usually do for doctors in normal therapeutic settings. Involvement with a third party may raise the issues of dual responsibility in case of nurses. Although in many circumstances, the interests of their patient and the third party will coincide, this is not always the case. Where dual loyalties are most acute, however, and where there is the greatest potential for conflict, is where nurses are contracted to an organization or institution to provide care for patients who may be in a particularly vulnerable position or for patients whose freedom is restricted in some way by their circumstances. Examples include prison nurses, forensic mental health nurses and those working in similar facilities. It should be said, however, that in many instances where a duality of obligation comes into play, there is no ethical dilemma (de Casterte and Meulenbergs, 2002, 612-622). This is because it would be abundantly clear to any detached observer whose interests should take precedence and which moral principle carries more weight in the particular context. Listening to individuals and demonstrating an appropriate respect for autonomy is an ethical requirement in all settings, even though individuals’ own wishes may not be determinative or even acknowledged as important by others in authority. Convicted prisoners, for example, may have little choice about who examines them or the range of treatment on offer, but their consent to examination and treatment should still be sought. Their informed refusal of medical interventions can only be overridden in cases comparable to where valid refusal would be superseded in the community, such as when the patient’s condition represents a serious threat to others. Likewise, all health information about identifiable individuals which the nurses learn in a professional capacity is subject to the professional duty of confidentiality. In all situations, however, confidentiality can be breached if individuals consent to that happening or if there are strong arguments for subordinating the individual’s wish to the needs of others. Where information might avert a miscarriage of justice or foreseeable serious harm to others, disclosure is likely to be justified (Fry & Johnston, 2002, 32-67). Respecting the autonomy of others by seeking their voluntary consent and co-operation is as important as it is in other areas of medical practice. Also the ethical duty of confidentiality remains, even though contractual terms may inhibit how much freedom patients have to exercise it. Nevertheless, information should normally not be disclosed without the patient’s knowledge and consent. Nurses with clearly articulated dual responsibilities – like all other health professionals – must ensure that they remain objective and impartial even though the situations in which they work can make this difficult to achieve. Above all, it is essential that they are open and transparent about their dual loyalties and that their patients are aware of how the nurse–patient relationship differs from the usual therapeutic encounter and the practical implications of this in terms of consent and confidentiality (Butler, 2003, 21-22). Conclusion In theory and practice, informed consent is considered a requirement of ethical clinical research. It has been a recognized ethical goal that people not only decide freely whether to participate in clinical research, but decide with an understanding of the relevant facts. This requirement helps to protect the autonomy of research participants and avert serious research abuses. This simple doctrine – that consent should be not just voluntary but informed – has proved difficult to realize in practice. Ethically sound research must also ensure confidentiality and privacy of the participants that may extend to protection of data, which is given very high weightage. Moreover, at any cost the research professional must protect the vulnerable participants from biological, physical, social, and psychological harm. In doing so there may be conflict between the caring relationship between the nurse and the patient and responsibilities of a nurse scholar as a researcher. 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