Please create a high-level masters level PowerPoint (13 slides) with speaker notes on each slide for the following 2 questions Topic: Research Participation Please comment on the following “2”...

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Please create a high-level masters level PowerPoint (13 slides) with speaker notes on each slide for the following 2 questions



Topic: Research Participation



Please comment on the following “2” questions:


1. Reflecting on recruitment, screening, enrollment, and consenting, what do you think partnership, relationship, and engagement with patients mean in the context of clinical research?


2. How do these factors influence societal and cultural perceptions of clinical research at large, and individual decisions to participate in clinical research activity?



**Please utilize the following YouTube videos as well as the Attached PDFs**



https://www.youtube.com/watch?v=KHE-WsnI_TA



https://www.youtube.com/watch?v=JZQwSbcNzOQ



https://www.youtube.com/watch?v=FcGKgH-Tn6M



https://www.youtube.com/watch?v=M7wzpF2JSFI&t=2s




Informed Consent and the Regulations Informed Consent and the Regulations In this Chapter n What is informed consent? n Ethical codes regarding informed consent n Regulatory requirements for informed consent n Consent from vulnerable subjects n The informed consent process For complete details of regulatory requirements and guidelines regarding informed consent, refer to the Code of Federal Regulations, FDA Guidance Documents, and ICH E6 Guidelines. 4 “No man is good enough to govern another man without that other’s consent.” Abraham Lincoln (1809–1865), 16th President of the United States of America A Clinical Trials Manual From The Duke Clinical Research Institute: Lessons From A Horse Named Jim, 2nd edition. By Margaret B. Liu and Kate Davis. Published 2010 by Blackwell Publishing 9781405195157_4_C04.qxd 11/16/09 15:20 Page 73 A Clinical Trials Manual from the Duke Clinical Research Institute: Lessons From A Horse Named Jim, Second Edition Margaret B. Liu and Kate Davis © 2010 by Duke Clinical Research Institute. ISBN: 978-1-405-19515-7 Informed Consent: A process by which a subject voluntarily confirms his or her willingness to participate in a particular trial, after having been informed of all aspects of the trial that are relevant to the subject’s decision to participate. Informed consent is documented by means of a written, signed, and dated informed consent form.4 The very nature of clinical research requires a comparatively small number of individuals to shoulder the risks of participating in inves- tigations of unproven medical products. Researchers have the responsibility to inform subjects of these risks and to protect the rights and welfare of subjects who choose to participate in clinical trials. The informed consent process is one of the methods used to fulfill this responsibility. What Is Informed Consent? Informed consent is the process of giving potential research parti- cipants appropriate information and allowing them to make an informed and voluntary decision about study participation. After being informed of all relevant aspects of a trial, the prospective subject is given the choice of whether or not to participate in the study. Informed consent should begin before study participation and continue throughout the duration of the study (in other words, a research subject can also choose to stop participating in a study at any time, for any reason). Rather than “informed consent,” a more appropriate term might be “informed decision-making,” since this reflects the choices a subject can make – to give “consent” when choosing to participate or to “dissent” when choosing not to 74 1897 Yellow Fever Studies Increase Awareness of Informed Consent History provides many instances of investigations done without informed consent. One such example took place in the late 1800s when yellow fever was one of the most feared diseases, estimated to have killed hundreds of thousands of people in periodic epidemic outbreaks. Symptoms of yellow fever ranged from self-limiting bouts of fever to severe hepatitis (the disease’s name derives from the jaundice seen in some patients) and hemorrhagic fever. While working in South America, the Italian scientist Giuseppe Sanarelli claimed to have discovered that a bacterium (Bacillus icteroides) was the cause of yellow fever. Sanarelli injected patients with cultures of the bacillus without their permission or consent; three of the five subjects died. Responding to reports of Sanarelli’s investigation, physicians and scientists were outraged. Canadian physician Dr. William Osler, considered to be the father of scientific medical practice, stated that “To deliberately inject a poison of known high degree of virulency into a human being, unless you obtain that man’s sanction, is not ridiculous, it is criminal.”1 Major Walter Reed, a U.S. physician and surgeon, was influenced by Osler’s statement. As Reed conducted investigations into the cause of yellow fever, he obtained written consent from all of his subjects, soldiers and civilians in Cuba at the end of the Spanish-American War.2 Reed, building on pioneering work by the Cuban physician Carlos Juan Finlay, confirmed that yellow fever was in fact not caused by the bacillus, but was spread by the bites of mosquitoes infected with a virus that caused the disease.3 9781405195157_4_C04.qxd 11/16/09 15:20 Page 74 75 4. In fo rm ed C o n se n t an d t h e R eg u la ti o n s participate. It must be made clear to potential subjects that they can choose to decline study participation without fear of repercussions, guilt, or ill will on the part of the investigator. Ethical Codes Regarding Informed Consent A number of codes of medical ethics emphasize the personal respon- sibility of physician-investigators to provide subjects with adequate and appropriate information. The Belmont Report, the Declaration of Helsinki, and the Nuremberg Code all impart principles of ethical conduct for experiments in humans. Ethical issues revolve around the safety of the participating individual rather than the community at large. Although the community may benefit from an individual’s par- ticipation in clinical research, an individual should not be subjected to unreasonable harm or risk for the sake of the community. The Belmont Report: Application of Respect for Persons The Belmont Report, issued in 1979, is a statement of three basic ethical principles for the protection of human research subjects. The first is Respect for Persons, and application of this principle occurs as part of the informed consent process. Respect for persons requires investigators to acknowledge subjects as autonomous persons, cap- able of understanding and making judgments for self-determination. This principle also requires investigators to recognize that some individuals are not or cannot be autonomous, and therefore need additional protection. Diminished autonomy may occur at different times, such as during childhood when immaturity prevents the child from making informed decisions, or during an illness when an indi- vidual may be temporarily unable to understand and make informed choices. Diminished autonomy may also be a permanent or persistent condition, as in individuals with cognitive impairment from birth or because of injury. In order to allow subjects to make an informed decision about participating in clinical research, the informed consent process must be based upon three components: 1) information, 2) comprehension, and 3) voluntariness.5 First, subjects should be given sufficient information regarding the investigational therapy, the purpose of the study, potential risks and benefits of the therapy, alternative Informed consent is based upon three components: 1 giving information about the proposed research study; 2 ensuring comprehension of that information; and 3 requesting voluntary participation. 9781405195157_4_C04.qxd 11/16/09 15:20 Page 75 therapies or drugs, and any other information necessary to make an informed decision. Second, information must be presented in ways that the subject can readily comprehend. This requires the investigator to present information in an organized, unhurried manner, allowing enough time for the potential subject to consider the information and ask questions. The information must also be presented at an appropriate level of complexity and in a language that can easily be understood by the individual. Last, consent is only valid when it is given voluntarily. The component of voluntariness prohibits the use of undue influence (i.e., excessive or inappropriate reward to obtain compliance) or coercion (i.e., intentional threat of harm to obtain compliance). In situations where the investigator is the subject’s physician and the subject depends upon the physician to make all decisions regarding health care, it can be difficult to obtain truly informed and voluntary consent. In such a situation, it is advisable to have someone other than the physician-investigator lead the discussion about the study. Investigators must be extremely careful to avoid exerting undue influence in the informed consent process. The Declaration of Helsinki Originally written in 1964 at a meeting of the World Medical Association (WMA), the Declaration of Helsinki is a statement of ethical principles to guide physicians in clinical research. The declara- tion is prefaced with a binding statement for physicians: “The health of my patient will be my first consideration.” The Declaration of Helsinki includes several principles related to informed consent, including: 1 Subjects must be volunteers and informed participants. 2 Subjects must be adequately informed, which includes being told of the right to choose not to participate or to withdraw consent at any time without reprisal. 3 Physicians should be particularly cautious when approaching patients who are dependent upon the physician for decision making regarding health care; it is advised that an independent physician approach the patient for consent. 4 When subjects are not autonomous or capable of giving informed consent, consent must be obtained from a legally authorized representative. 5 Assent should be obtained from children in addition to consent from the legally authorized representative. 76 9781405195157_4_C04.qxd 11/16/09 15:20 Page 76 77 4. In fo rm ed C o n se n t an d t h e R eg u la ti o n s During the trial of Nazi physicians held at Nuremberg in 1946, fundamental ethical standards for the conduct of human research were documented in the Nuremberg Code, which set forth ten conditions that must be met to justify research involving human subjects. One of the most important conditions was the need for voluntary informed consent from subjects. In 1972 it came to the public’s attention that, since 1932, approximately 400 African-American men who had syphilis had been studied, without their knowledge, to observe the natural course of the disease. In this study, performed in Tuskegee, Alabama, subjects were denied treatment with penicillin, which was known to cure syphilis, to allow researchers to follow the progression of the untreated disease. The Nuremberg Code The Nuremberg Code, developed as a method for judging Nazi physicians who conducted abusive biomedical experiments during World War II, contains 10 standards or conditions, which became the prototype for ethical codes governing the conduct of experiments on humans. The first standard makes a strong statement regarding the requirement for voluntary consent, holding the investigator directly responsible: The voluntary consent of the human subject is absolutely essential. This means that the person involved should have legal capacity to give consent; should be so situated as to be able to exercise free power of choice, without the intervention of any element of force, fraud, deceit, duress, over-reaching, or other ulterior form of constraint or coercion; and should have sufficient knowledge and comprehension of the elements of the subject matter involved, as to enable him to make an understanding and enlightened decision. This latter element 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 experiment. The duty and responsibility for ascertaining the quality of the consent rests
Answered 1 days AfterJul 26, 2022

Answer To: Please create a high-level masters level PowerPoint (13 slides) with speaker notes on each slide for...

Dr Insiyah R. answered on Jul 27 2022
79 Votes
Title:Research Participation
Introduction
Health research participant recruitment is often difficult.
Finding efficient recruiting strategies facilitates the timely gathering of data and avoids interference with research schedules (Amin,2011).
The cost of hiring new employees is rising, and tried-and-true methods like media advertising are los
ing their effectiveness.
Additionally, it might take longer to attract people throughout the country from varied locations utilising conventional means (Benedict et al,2019).
The internet, which provides direct, immediate engagement with individuals from a vast geographic region, is a more modern recruiting technique.
Understanding recruiting is crucial for nurse researchers so they may obtain the right participants, increase their research's findings, and have a bigger impact on healthcare (Amin,2011). However, inexperienced researchers may not be aware of the possible difficulties in recruiting, and there is little published material on how to recruit from the community, health, and educational contexts (Amin,2011).
Reflecting on recruitment in the context of clinical research
The typical recruiting difficulties that may and should be addressed in the first phases of trial design and development are defined by the Clinical Trials Transformation Initiative's (CTTI) strategic recruitment planning guidelines (Bird et al,2020).
Furthermore, the three organisational aspects of the recommendation—protocol design, site selection, and communication—have the ability to work in concert with one another to improve recruitment planning as a whole (Bird et al,2020).
For instance, patients might explain the significance of the research question, and study locations can provide information on the numbers of people who could be qualified to respond to the question (Bird et al,2020). In turn, both parties may collaborate to develop the best plan for connecting with the patient and provider communities and maximising the impact of the communications. Examples of these techniques show how effective and useful the method is (Bird et al,2020).
Screening of clinical research
Screening activities tend to focus on general health-related and demographic inquiries, but a clinical trial's screening process often involves a more thorough investigation of a patient's medical background and present state of health.
A physical examination and any necessary lab tests or diagnostic exams like MRIs or x-rays are nearly usually part of this (Boden‐Albala et al,2021).
These screening techniques are essential for getting a good picture of the patient's health before the start of the trial to guarantee their safety.
Enrollment of clinical research
Advances in illness prevention, treatment, and rehabilitation, notably for cancer, have come through clinical trials (Amin, 2011).
Although the percentage of patients taking part in clinical trials is typically low, enrolment is considerably lower among communities of colour and rural areas.
Although programmes and research requirements for ensuring diversity in clinical trial participation have been supported by federal legislation and national and local educational activities, decreased involvement of racial or ethnic minorities and underprivileged patients in clinical trials continues to persist.
Ensure that clinical trials are diverse A lack of involvement by racial or ethnic minorities or underprivileged patients has a negative impact on the validity of study findings for these...
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