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Informed Consent and Ethical Considerations in Clinical Trials PowerPoint Presentation

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Description : Check out this medical PowerPoint presentation titled "Informed Consent and Ethical Considerations in Clinical Trials" by Christine Grady RN PhD.

This medical PowerPoint presentation tells us how informed consent is a fundamental ethical principle in clinical research that ensures that individuals have the information and understanding necessary to make a voluntary decision about whether to participate in a clinical trial. Informed consent is based on the concept of respect for persons, which recognizes that individuals have the right to make decisions about their own healthcare and that they should be treated with dignity and autonomy.

Ethical considerations in clinical trials go beyond informed consent and include a range of issues related to the design, conduct, and reporting of the trial. These considerations include the protection of human subjects, the balance of risks and benefits, the scientific validity of the study, and the transparency of the research process.

The informed consent process involves providing potential participants with information about the study, including the purpose of the research, the procedures involved, the potential risks and benefits, and their rights as participants. Participants must also be informed of their right to withdraw from the study at any time without penalty. Informed consent must be obtained voluntarily, without coercion, and with the understanding that participation is entirely voluntary.

Ethical considerations in clinical trials also involve protecting the safety and welfare of participants. Researchers must follow established protocols for recruiting participants, monitoring their health during the study, and providing appropriate medical care if adverse events occur. The study design should also balance the risks and benefits to participants, ensuring that potential risks are minimized and that the benefits of the study justify the risks.

Another ethical consideration in clinical trials is the scientific validity of the study. The trial must be designed in a way that allows for meaningful and accurate results, with appropriate controls, randomization, and blinding. The data collected during the study must also be rigorously analyzed and reported, with full transparency about any conflicts of interest or potential biases.

Finally, ethical considerations in clinical trials involve the responsible reporting of the study results. The findings of the study should be reported accurately, without exaggeration or distortion, and with full transparency about the methods and data used in the study. Any potential conflicts of interest or sources of funding should also be disclosed.

Overall, informed consent and ethical considerations in clinical trials are critical to ensuring that research is conducted in a responsible and respectful manner, protecting the rights and welfare of participants, and producing reliable and meaningful scientific results.

Tags : Clinical Trials, informed consent, Ethical considerations in clinical trials, pharmaceuticals, pharmaceuticals PowerPoint presentations

Published on : Jun 23, 2023 | Views : 982 | Downloads : 0

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Slide 1-

Informed Consent and Ethical Considerations in ClinicalTrials Christine Grady RN PhDChief, Department of BioethicsNIH Clinical Center
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The views presented are mine and do not necessarily represent those of the Clinical Center, National Institutes of Health, or the Department of Health and Human Services I have no conflicts of interest www.fda.gov
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Research Ethics Scientific Conduct and Integrity Ethics of Research with Animals Protection of Human Subjects Ethics of Clinical Research www.fda.gov
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Research Science Ethics
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Ethics of clinical research Goal- generating knowledge useful for understanding human health and preventing, diagnosing, and treating human disease Study human beings and ask a small number of people to bear risk and burden in service to the many Benefit to individual participants is not the goal (although there is sometimes benefit) People are thus the means to developing useful knowledge and at risk of exploitation
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Ethics of Clinical Research Ethical requirements in clinical research: Promote the responsible conduct of useful clinical research and progress in understanding and intervening in human health and illness Minimize the possibility of exploitation and harm Ensure that the rights and welfare of subjects are respected while they contribute to the generation of knowledge Help to maintain public trust
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Ethics of clinical research Benefits to society and future patients Protection of rights and welfare of research participants
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Ethics of Clinical Research International codes and guidelines U.S. Regulations Laws and regulations from other jurisdictions Institutional policies and guidelines
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Codes and Guidelines Nuremberg Code (1949) Declaration of Helsinki (1964- multiple revisions-2013) The Belmont Report (1979) CIOMS/WHO International Guidelines (1993, 2002, 2015) ICH/GCP-International Conference on Harmonization- Good Clinical Practice (1996, 2016)
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Ethics of Clinical Research National Research Act (1974) establishes the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research Ethical principles underlying the conduct of research: Respect for persons Beneficence Justice Boundaries between Practice and Research U.S. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, The Belmont Report 1979
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U.S. Regulations The Common Rule (US 45CFR.46) 45CFR.46 Subparts B, C, D FDA regulations (US 21CFR50, 56, 312, 812, and others)
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Confusion reigns… 45CFR46 OHRP FDA
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Ethical framework: 8 principles Collaborative partnership Valuable scientific question Valid scientific methodology Fair subject selection Favorable risk-benefit Independent review Informed consent Respect for enrolled subjects Emanuel E, Wendler D, Grady C. What makes clinical research ethical? J Am Med Assoc. 2000; 283(20):2701-11; Chpt 11 Oxford Textbook 2008 Emanuel E, Wendler D, Killen J, Grady C. J Infect. Diseases 2004; 189:930-7.
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Collaborative Partnership Ethical clinical research should be a collaborative partnership with the relevant partners, e.g. Collaboration in planning, conducting and overseeing research, and integrating research results into the health system Respect for contributions of partners Collaboration with existing systems of health care
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Collaborative Partnership Collaborative partnership can be facilitated by planning and working with: Policy makers and health systems Community advisory boards and communities Patient advocates on scientific advisory boards Advocates for research funding Collaborating investigators Practicing clinicians Etc.
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Valuable Scientific Question Ethical clinical research should answer a valuable question, i.e., one that will generate new knowledge or understanding about human health or illness, i.e. a socially, clinically, or scientifically useful question
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Social Value What is the research question? How is value judged? To whom is answering the question valuable? (who are the beneficiaries?) Participants Community in which participants live? People with similar condition? Society, future people etc?
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Value: case examples B. Freedman (IRB 1987) HIV vaccine (Science 2004) Me-too drugs Malarone testing in pregnant women (Lavery et al. 2007)
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Valid Scientific Methodology Ethical clinical research should be designed in a methodologically rigorous manner (design, methods, statistical power and methods, etc.) that will yield valid, reliable, generalizable, and interpretable data, and that is feasible
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Scientific validity Choice of endpoints e.g. ischemic or hemolytic stroke Choice of design Randomized double blinded control Noninferiority or superiority Choice of procedures Measures of outcome, length of follow- up Statistical methods Power, methods, level of significance Feasiblity
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Scientific Validity Examples of design controversies Feasibility
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Fair subject selection Scientific objectives should guide inclusion criteria, recruitment strategies, and selection (not privilege or easy availability or vulnerability) Minimize harms and fairly distribute harms and benefits No exclusion without justification JUSTICE AND BENEFICENCE
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Research as burden or benefit? Research as ‘burden’ Subjects need protection Research as ‘benefit’ Subjects need access
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Fair subject selection: the appropriate population? Is it preferable to test an early potentially risky therapy in healthy affected adults who can consent but have mild disease or in severely ill infants who are otherwise likely to die as infants? Protecting vulnerable participants
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Favorable risk-benefit Are risks to subjects necessary and minimized? Are risks justified by benefit to individual subjects and/or the importance of the knowledge to society? Are benefits enhanced? Non-maleficence and Beneficence
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Benefits and Risks in Research [I]nterests other than those of the subject may on some occasions be sufficient by themselves to justify the risks involved in the research, so long as the subjects’ rights have been protected. The Belmont Report
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Challenges Identifying risks- which ones count? Minimizing, limiting risks Direct vs. indirect benefits
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Case: Risks and Benefits Dr. Jones is planning a study of healthy adults and children compared to age, sex, race, and BMI matched adults and children with type 2 diabetes. Study involves 1 to 2 outpatient visits during which the following will be done: A physical exam Blood (approx. 1/3 cup) and urine tests Pregnancy test Psychological testing (Questionnaires and interviews about individual and family eating habits and exercise habits, emotional health, and quality of life. (1-2 hours) Oral glucose tolerance test (12 hours of fasting, glucose drink, regular blood draws over 2 hours through an IV) Full body MRI DEXA scan to determine % body fat (approximately 1 hour on a flat scanner table, small amount of radiation exposure) Fitness test (20-30 minutes on a treadmill or exercise bike- measuring O2 and CO2) Genetic testing/ DNA tests- stored indefinitely and used for future studies of diabetes and obesity Not a treatment study -no therapeutic benefits to the participants. Financial compensation is offered for time and procedures up to ~$300 per visit.
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Independent review To ensure ethical requirements have been fulfilled To check investigator biases and conflicts To assure the public that research is not exploiting individuals or groups
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Criteria for IRB Review (45CFR.46.111 and 21CFR56.111) Risks … are minimized. Risks are justified by anticipated benefits, if any, to the subjects or the importance of the knowledge to be gained Subjects will be selected and treated fairly Informed consent is adequate
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Challenges in Independent review Volume Conflicts Varied interpretations (inconsistency)
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Informed Consent Informed consent ensures that individuals have the opportunity to decide whether they want to participate in research or continue participation and whether it is compatible with their goals, values and interests RESPECT FOR PERSONS
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Informed consent in clinical research Informed consent is only one part of making research ethical A process of reasoned decision making (not a form or an episode)
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Informed consent in clinical research “Informed consent involves providing a potential subject with adequate information to allow for an informed decision about participation in the clinical investigation, facilitating the potential subject’s comprehension of the information, providing adequate opportunity for the potential subject to ask questions and to consider whether to participate, obtaining the potential subject’s voluntary agreement to participate, and continuing to provide information as the clinical investigation progresses or as the subject or situation requires.” US FDA Informed Consent Guidance Sheet, July 2014
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Informed consent Disclosure of information Understanding Voluntary decision making Authorization
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Research participant understanding Studies continue to show that research participants have variable and often limited understanding of study information Nature of research (27-100%: Krosin et al 2006, Joffe et al 2001, Pace et al 2005, Criscione et al 2003) Risks (37-100%: Leach et al 1999, Joffe et al 2001, Dougherty et al 2000) Research procedures (randomization) (23-42%, Harrison et al 1995, Hietanen et al 2000, Pace et al 2005)
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Thanh Tam et al Bull WHO 2015- systematic review and meta-analysis of three decades
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Research consent forms Reading level is high Consent forms and templates usually written at about the 11th grade level or higher LoVerde et al, 1989; Grossman et al 1994; Paasche-Orlow et al., 2003; Sharp 2004, etc. Consent forms are long Consent documents have increased in length over time Baker and Taub, 1983; LoVerde et al 1989; Tarnowski et al 1990; Beardsley et al 2007, Albala et al. 2010 Yet incomplete- Silverman et al 2001, Beardsley et al 2007, Abeysena et al 2012.
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Improving informed consent More is not always better Timing matters Technology can help Schenker Y and Meisel A, JAMA 2011
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Contemporary Challenges Stored data and biospecimens Pragmatic trials, learning health care systems Digital data What kind of consent is appropriate? What and how should information be disclosed? What level of understanding? Voluntary choice?
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Respect for enrolled subjects Ethical research requires continued respect for the rights and welfare of participants throughout research, including: Protecting confidentiality Monitoring welfare Recognizing right to withdraw Providing new information Informing participants of findings Planning for after the trial
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Framework- What makes clinical research ethical? Collaborative partnership Valuable scientific question Valid scientific methodology Fair subject selection Favorable risk-benefit Independent review Informed consent Respect for enrolled subjects Systematic and sequential Necessary Procedural requirements may be waived Universal Adapted and implemented according to context Requires balancing, specification
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Ethical framework: 8 principles In order to apply the principles, reconcile conflicts and make informed judgments about ethical research, need: Educated, informed, responsible investigators, research teams, partners Educated and informed IRBs with diverse members including investigators, statisticians, ethicists, and community members.
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The clinical investigator Henry Beecher (NEJM 1966) 22 examples, including: Withholding antibiotics from men with rheumatic fever, Injecting live cancer cells into nursing home patients (Jewish Chronic Disease Hospital), Transplanting melanoma from daughter to mother, who died about a year later.
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“The ethical approach to experimentation in man has several components: two are more important than the others, the first being informed consent…Secondly, there is the more reliable safeguard provided by the presence of an intelligent, informed, conscientious, compassionate, responsible investigator.”
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The role of the clinical investigator Inextricably involved in and responsible for the ethics of human research and respecting participants: Select/shape the research question Rigorous study design and methods Minimize risk and justification for methods Submit and defend proposal to IRB Recruit and enroll participants Write the consent document, obtain participant informed consent, and continue to engage the participant throughout Monitor participant welfare throughout the study, manage side effects and adverse events, attend to ancillary care needs, confidentiality Decide when to take someone out of a study, and how to responsibly transition participants at the study’s end.
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The role of the clinical investigator Responsible for collection, management, and analysis of data, reporting of adverse events, as well as interpreting, reporting, and disseminating findings
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Research team, collaborators, data collectors, DSMB, IRB, monitors, CROs, statisticians, caregivers etc. But Investigator ultimately responsible for all trial-related decisions. (ICH GCP E6. 4)
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Virtues of clinical investigators Integrity Intellectual honesty Trustworthiness Discernment Conscientiousness Compassion Grady, Fauci The role of the virtuous investigator in protecting human subjects. 2016
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Thank you