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Using Consent to Utilize Healthcare Information for Research - Essay Example

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This paper "Using Consent to Utilize Healthcare Information for Research" investigates how a literature review may be conducted to assist in the process of research on any particular subject. The subject of healthcare is mainly examined in the current paper…
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Using Consent to Utilize Healthcare Information for Research
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Literature Review - The Process - Using 'Consent' to utilise Healthcare Information for Research Introduction: This particular paper investigates how a literature review may be conducted to assist in the process of research on any particular subject. The particular subject chosen in an exemplary sense is 'Consent to use Healthcare Information for Research Purposes'. Since the review process itself is synonymous with the overall research strategy it is good to remember that, as such, it is necessary to conduct it efficaciously so that it can act both as a stand-alone as well as a complementary process of the entire research process. In this sense it is meant that the review should be constructed in such a manner that the researcher/researchers can either use it as a stand-alone published material that can assist other researchers with similar topical considerations in their own research or the researcher/researchers can use the review exclusively as an assisting part of their own research on the topic. This brings out the importance of literature review that is possibly more important a part of the initial research strategy than any other part of such initial research. The paper shall now proceed onto the next part that shall outline in brief the initial research strategy that a researcher/group of researchers may use to begin their research endeavor. Research Strategy - A Brief Outline: The initial research strategy any researcher may use to initiate his/her research is chalked out in the following steps. Choice of Topic - The first consideration that a researcher or group of researchers must take into account is the choice of topic. For this, they may first scrutinize the subject they are studying and thresh out a topical part that has scope for research the researchers themselves feel they are competent enough to carry out. It is notable that this is the very initial step to beginning an earnest literature review (Reed, Undated). The choice of a suitable topic may constitute the following steps - Brainstorming - This is process with which the researcher scans the subject he/she is studying currently to pinpoint a topic within that subject he/she may want to research upon. Within this process the subject is broken down into its topical components and basic keywords are derived from these. For example, as in this case, where the subject is taken to be 'information within the healthcare system', some of the topical interests that may get unearthed are as follows: Acquisition of such information; Storage of such information; Retrieval of such information; Ethics regarding retrieval; etc. Next, books, journal articles and other resources that have been recommended for these topics within the main study subject are next scrutinized and studied to ensure which of these topics may be the most suitable for research. Some of the criteria with which this is judged may be as follows: if there is any scope for further research within any of these topics; and whether such research can be easily carried out with the resources and facilities that are presently available with the researchers. In this manner a topic is settled upon on which the researchers decide they want to do research. The topic has scope for further research and the research type is suitable for being conducted by the researchers, who consider themselves capable of it. The topic settled upon in this case is 'Ethical issues regarding retrieval of healthcare information available from storage'. Consultation with the Instructor/Professor - Another adjacent step to brainstorming to settle upon the research topic is consultation with the instructor ort professor in charge of the discipline the researchers are incumbent upon. Often, these able persons are capable of making valuable suggestions that allow the research to proceed smoothly and efficiently. Researching Background Information - After a topic suitable for conducting research upon has been selected, the next logical step is to find background information on it from resources like encyclopedias, books, journals, etc. This is the core of literature review (Reed, Undated). This literature review has certain well-aimed purposes as follows: I) it gives the readers access to background information on the field of research; II) it demonstrates the researcher's familiarity with the subject; and III) it demonstrates how the present research adds to the knowledge base already existent in that particular field of research. (Reed, Undated) In this particular case, all information broadly available on the chosen topic - 'Ethical issues regarding retrieval of healthcare information available from storage' is retrieved from various sources and scrutinized. Narrowing Down the Topic - The overview on the topic prepared in the previous step is utilized in this step to narrow down the topic into a componential area where some scope for research has already been pinpointed in the first step when the topic itself was chosen. This is the principal area of research and a focal point where the researchers will concentrate on in future. In this step a high degree of specificity is allotted to the topic and some related questions are generated (Reed, Undated). For example, these may be as follows. Who can be considered as fully competent to give consent Who can be considered as fully competent to receive such consent From these two specificities, the research questions generated by the review, it is disclosed that one of the most sensitive issues surrounding retrieval of such information in the present day is the retrieval of such information for research. The principal ethics concerning retrieval for research purposes is acquiring consent of a competent authority in particular context to who can actually retrieve it - whether it is the patient him/herself or any other that is deemed competent The research may now consider him/herself sufficiently supplied with motive to begin the research procedure. The next two parts of the research endeavor are succinctly put for the principal purpose of this paper is to expound on the literature review process. 1) Solve or develop solutions to the research questions. 2) Document the results of the developed solutions. (Reed, Undated) The Literature Review: A number of premier research papers and documents have been procured by searching the Internet. All of these pertain to 'consent to utilize healthcare information for research purposes'. It is expected that this particular review of literature pertaining to this chosen topic shall adequately serve the three afore-mentioned purposes of such literature review. The first piece of document under review is a 'National Cancer Institute' (NCI), US, webpage document that strives to put in a nutshell the whole concept of 'informed consent' as it is perceived commonly across global parameters. While a succinct definition of 'informed consent' may not be practically available the document does shortly describe what the phrase may signify. Informed Consent: In the present context, ideally, informed consent is a process. It begins with the participant - the patient or other whose healthcare information is being sought for research purposes - being presented with the consent form that introduces the details of the clinical trial, its purpose, treatment procedures and schedules, potential risks and benefits, alternatives to participation, etc. (NCI, 2008). The participant's rights are explained. This initial part of the process strives to educate the potential participant in such a manner that he/she becomes fully competent to take the decision to participate or not. There are also ongoing discussions with the research team and, eventually, if the potential participant does decide to sign the form he/she can keep it throughout the trails as an information resource (NCI, 2008). The signing of the form does not imply that the participant's consent is considered fully committed for the rest of the trials. Instead, it is required that the research team continue to update the participant with information as the trials progress so that he/she can continue deciding whether to remain in participation or not (NCI, 2008). This option to withdraw or remain committed available throughout the trials is considered the most desired part of the consent process. Background: After the 2nd World War the Nuremberg Trials of 1947 revealed highly unethical practices by Axis doctors where human subjects were used for highly unusual and unfair clinical trials. The responsible among human communities everywhere were rudely awakened to the possibility of unethical clinical practices during research with human subjects. The Nuremberg Code was subsequently adopted by the United Nations General Assembly in 1948 and it assured that: participants were allowed to consent; they were free from coercion; and they understood the risk and benefits. (NCI, 2008) The code also assured that participants were allowed to withdraw anytime within the trial period. Since then, the concept of informed consent has been progressing as it is being refined and developed. There is consensus among a number of persons that it is still not ideal. The Research Questions: Now that the concept of 'informed consent' has been introduced it is necessary to se it in the light of the two research questions developed in this paper. These are reiterated as follows. Who can be considered as fully competent to give consent Who can be considered as fully competent to receive such consent In context of the first question, from the introductory part of the concept it can be induced that if the potential participant is informed of and understands the full implications of the clinical trials he/she can be deemed fully competent to give consent. In a study (Lynoe et al, 1991) conducted on participants of a previous gynecological clinical trial where both participants and researchers were unaware of it in advance it was revealed that the participants had deficiencies in fully understanding the implications of the trial and that these deficiencies were generated by flaws in imparting information. In this case the participants cannot be deemed to be fully informed and, thus, consent may be considered flawed. In this particular situation the quality of information was inadequate and participant understanding was subsequently not fully to the desired levels. In other situations, as in emergency medical treatments where participants may not be at desired levels of consciousness to give informed consent yet clinical trials have to be conducted because existing therapeutic measures are considered inadequate (Foex, 2001), the participants undergo clinical trials without prior consent. In two specific instances - the Beta-blocker Heart Attack Trial (BHAT) (Howard and DeMets, 1981) and the Corticosteroid Randomisation After Significant Head injury (CRASH) trials (Foex, 2001) - participants are not considered at desired levels of consciousness to give informed consent and trial administrators have to closely follow the ethics set down by designated regulatory authorities. The decision makers in these cases may well be others - family members or even the patient him/herself where prior consent or appraisal of the patient's wishes have been documented before - in consultation with a set of physicians (Informed Consent, ACOG, 2004). Solutions: In this particular situation the literature review has not really elicited any solutions to the research questions posited here. This is so because this is not a real research endeavor and only the review has been undertaken to demonstrate what value such a review may have to the research field under focus. The main reason why no definite solutions have been forthcoming from the review is because the research questions are current ones that are yet to be solved by researchers and there is, thus, no published literature to date that does posit complete solutions. The review has nevertheless revealed that there is ambiguity in consent when the information required to completely educate the consenter is inadequately imparted or acquired. In this case there may be deficiencies in both instructions from the imparters or in the understanding of the instructions by the consenters. The review has also revealed that the potential consenter may not be in a competent state to acquire the required information and consent. Thus, there is still a lot of research to be done on these two aspects to disclose interrelations among several factors that tend to affect these aspects and influence the decision-making process either directly on the part of the consenter or, in case the consenter is not deemed competent, indirectly on the part of the those deemed in charge. Conclusion: The paper has mostly, for the first parts, outlined the generalized version of a research process with emphasis on the componential literature review process. Within this outlining, the paper has pinpointed a topic and narrowed it down to two research questions that need solution. It has also pointed out the value of a literature review. In the last parts, the paper has conducted a literature review that has sought to answer the research questions. It is now to be seen if the review has maintained the values that the paper, in its initial parts, it must have. Firstly, the review has presented the reader with an overview and background of 'informed consent', the topic under review. Secondly, it has also demonstrated that the researcher is familiar with the topic, as the review has been fairly comprehensive yet focused. Thirdly, the review has also demonstrated that the research questions, though without solutions, are pivotal to the concept of 'informed consent' as they, once solved to some degree, can ensure that the consent, when of the participant him/herself, is truly informed and valuable. The research questions, also when solved to some degree, can ensure that, when the participant is unavailable for consent, the decision making process is truly ethical in the sense that all rights of the participant has been safe-guarded under the circumstances. References: 1. A Guide to Understanding Informed Consent, National Cancer Institute (NCI), 2008. Extracted on 11th January, 2008, from: http://www.cancer.gov/clinicaltrials/conducting/informed-consent-guide/allpages#7d89a6af-fb20-47a4-b1b7-ab238e53f244 2. Foex, BA., The problem of informed consent in emergency medicine research, Emerg Med J, 2001; 18; 198-204. 3. Howard, JM. and DeMets D., How informed is informed consent The BHAT experience. Control Clin Trials, 1981 Dec; 2(4); 287-303. 4. Informed Consent, American College of Obstetricians and Gynecologists (ACOG), 2004. Extracted on 12th January, 2008, from: http://www.acog.org/from_home/publications/ethics/ethics009.pdf 5. Lynoe, N., et al, Informed consent: study of quality of information given to participants in a clinical trial, BMJ, 1991 Sep 14; 303 (6803); 610-3. 6. Reed, Lois E., Performing a Literature Review, Report. Extracted on 11th January, 2008, from: http://fie.engrng.pitt.edu/fie98/papers/1298.pdf Bibliography: 1. Draper, Heather and Rogers, Wendy, Re-evaluating confidentiality: using patient information in teaching and publications, Advances in Psychiatric Treatment, 2005; 11; 115-124. 2. Dunn, Kate M., et al, Patterns of Consent in Epidemiologic Research: Evidence from over 25,000 Responders, Am J Epidemiol, 2004 159; 1087-1094. 3. Golden-Biddle, K., and Locke, K, pp. 26-36, Composing Qualitative Research, 1997, Sage Publications, Inc. 4. Huang, Nicole, et al, Record linkage research and informed consent: who consents BMC Health Services Research, 2007; 7:18. 5. Joffe, Steven, et al, Quality of Informed Consent: a New Measure of Understanding among Research Subjects, Journal of the National Cancer Institute, Vol 93, No. 2, 139-147; January 2001. 6. Kettis-Lindblad, Asa, et al, Genetic research and donation of tissue samples to biobanks. What do potential sample donors in the Swedish general public think The European Journal of Public Health, 2006, 16 (4); 433-440. 7. Moser, David J., et al, Capacity to Provide Informed Consent for Participation in Schizophrenia and HIV Research, Am J Psychiatry, 159; 1201-1207; July 2002. 8. Sterling, Rene, et al, Public Willingness to Participate in and Public Opinions about Genetic Variations Research: A Review of the Literature, American Journal of Public Health, November 2006, Vol 96, No. 11, 1971-1978. 9. Tate, A Rosemary, et al, Mother's consent to linkage of survey data with her child's birth records in a multi-ethnic national cohort study, International Journal of Epidemiology, 2006 35 (2); 294-298. 10. Woolf, Steven H., et al, Selection Bias from requiring Patients to give Consent to Examine Data for Health Services Research, Arch Fam Med, 2000; 9; 1111-1118. Read More
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