งานนำเสนอเรื่อง: "Principles of ICH GCP & Ethical Consideration in Vulnerable subjects"— ใบสำเนางานนำเสนอ:
1Principles of ICH GCP & Ethical Consideration in Vulnerable subjects Assist. Prof. Chanchai Traivaree MD. Msc.(Clini Epi)Chief , Division of Hematology / OncologyPhramongkutklao Hospital &College of Medicines
2International Ethical Standards Nuremberg CodeDeclaration of Helsinki (WMA) 1964Belmont Report (USA)CIOMS (WHO)ICH (EU, Japan, USA)
3วัตถุประสงค์ของแนวปฏิบัติ ICH GCP เพื่อให้มีมาตรฐานเพียงหนึ่งเดียว สําหรับการศึกษาวิจัยทางคลินิกของประเทศในสหภาพยุโรปญี่ปุ่น และสหรัฐอเมริ กาซึ่ งจะเอื้อให้หน่วยงานควบคุมระเบียบกฎหมายยอมรับข้อมูลทางคลินิกของกันและกัน
4International Conference on Harmonization (ICH) E6 The Principles of ICH GCPGlossaryInstitutional Review Board (IRB/IEC)InvestigatorSponsorClinical Trial Protocol And Protocol Amendment(s)Investigator’s BrochureEssential Documents for Conducting a Clinical Trial
513 Principles of ICH-GCP1 Clinical trials should be conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki, and that are consistent with GCP and the applicable regulatory requirement(s).
613 Principles of ICH-GCP2 A trial should be initiated and continued only if the anticipated benefits justify the risks.
713 Principles of ICH-GCP3 The rights, safety, and well-being of the trial subjects are the most important considerations and should prevail over interests of science and society.
813 Principles of ICH-GCP4 The available nonclinical and clinical information on an investigational product should be adequate to support the proposed clinical trial.
913 Principles of ICH-GCP5 Clinical trials should be scientifically sound, and described in a clear, detailed protocol.
1013 Principles of ICH-GCP6 A trial should be conducted in compliance with the protocol that has received prior institutional review board (IRB)/independent ethics committee (IEC) approval/favorable opinion.
1113 Principles of ICH-GCP7 The medical care given to, and medical decisions made on behalf of, subjects should always be the responsibility of a qualified physician or, when appropriate, of a qualified dentist.
1213 Principles of ICH-GCP8 Each individual involved in conducting a trial should be qualified by education, training, and experience to perform his or her respective task(s).
1313 Principles of ICH-GCP9 Freely given informed consent should be obtained from every subject prior to clinical trial participation.
1413 Principles of ICH-GCP10 All clinical trial information should be recorded, handled, and stored in a way that allows its accurate reporting, interpretation, and verification.
1513 Principles of ICH-GCP11 The confidentiality of records that could identify subjects should be protected, respecting the privacy and confidentiality rules in accordance with the applicable regulatory requirement(s).
1613 Principles of ICH-GCP12 Investigational products should be manufactured, handled, and stored in accordance with applicable good manufacturing practice (GMP). They should be used in accordance with the approved protocol.
1713 Principles of ICH-GCP13 Systems with procedures that assure the quality of every aspect of the trial should be implemented.
18Ethical Consideration In Vulnerable subjects Assist. Prof. Chanchai Traivaree MD. Msc.(Clini Epi)Chief , Division of Hematology / OncologyPhramongkutklao Hospital &College of Medicines
19CONTENTS Definition of vulnerable groups Ethical issues related How to protection
20Subjects with diminished Vulnerable SubjectsSubjects with diminished( limited) autonomyHarm more than normal( need protection)
21Autonomy & vulnerability Informed consentLimited capacity or freedom to consent or to decline to participate in researchVulnerability
22Mental Capacity Voluntariness AUTONOMYMental CapacityTo understand and process informationEx: children, mentally disabledVoluntarinessFreedom from the control or influence of othersEx: emergency situation, social structure, incurable disease, educationally disadvantaged
23Vulnerability : Board considerations General guidelines 1. The research in intended to obtain knowledge that willlead to improved health problems characteristics of, or unique tothe vulnerable class.2. The research could not be carried out equally well withless vulnerable subjects.3. If the research involves greater than minimal risk, it shouldpresent a prospect of direct benefit to the person.
24Categories of Risk and Benefit in Vulnerable subjects Direct BenefitNo Direct BenefitMinimal Risk More thanMinimal Risk
25Vulnerability Considerations Are subjects vulnerable? Are additional safeguards put in place?Additional safeguardAppropriate recruitment (อิสระในการตัดสินใจ)Adequate informed consent process: witness available, capacity evaluated, LAR present, re-consenting considered (เข้าใจง่าย,อิสระในการตัดสินใจ)Acceptable stopping rules (เข้าใจง่าย)Optimal treatment available (เข้าใจง่าย)
26Vulnerable Populations Vulnerable populations include:ChildrenIndividuals whose capacity to give consent is questionableFetuses and pregnant womenTerminally ill subjectsStudentsMinorities
27Vulnerable Populations: Children A child is a person less than 18 years of age unless emancipated or married.Children cannot legally give consent.Any study involving children requires IRB review and approval.Parental consent must be obtained in all cases; a parent is the child’s legal parent or guardian.
28Vulnerable Populations: Children, Assent of Child The child’s signed assent is required.An assent form is a simplified, single page version of the consent form signed by the parent or guardian; the assent explains to the child what will happen should they agree to participate in the research.Federal guidelines recommend children 7-12 be given a separate assent form; children may be given the same consent form given to their parent or guardian.
30Waiver of child assentThe capability of some or all of the children is so limited that they cannot reasonably be consulted ( e.g. emergency)The intervention or procedure involved the research holds out a prospect of direct benefit that is important to the health or well-being of the children and is available only in the context of the research( e.g. oncology patients)
31Waiver of parental permission Emancipated or mature minorsMarriedPregnantLiving independentlyStudies involve investigation of adolescents’ beliefs and behavior regarding sexuality or use of recreational drugsResearch that involves only minimal risk, does not negatively affect the welfare of the subjects, and cannot be practically performed without the waiver ( e.g. survey)4. Research addresses domestic violence or child abuse
32Vulnerable Populations: Questionable Capacity to Consent Vulnerable populations may include persons with:Psychiatric disordersNeurological conditionsSubstance abuse
33Vulnerable Populations: Questionable Capacity to Consent Research involving persons whose capacity to consent is questionable requires careful consideration to ensure such persons are provided additional safeguards for their safety and welfare.In some cases, individuals who are not able to give informed consent may receive permission to participate from a legally authorized representative and then give their own assent.
34Vulnerable Populations: Questionable Capacity to Consent Special precautions:Additional use of witnesses for consentRenewing consent at specific stages of the researchLimiting time period for approval
35Vulnerable Populations: Pregnant Women Pregnant women may only be involved in bio-medical research if the study regards the health needs of the mother and the fetus will be placed at risk only to the minimal extent to meet the health needs of the mother or risk to the fetus is minimal.The father’s signature is required unless:The purpose of the study is to meet the mother’s health needs, orThe father is not reasonably available, orThe pregnancy was the result of sexual assault
36Vulnerable Populations: Terminally ill subjects ProtectionsConsent form states clearly the potential risks and benefits and characterizes the potential benefits appropriatelyImpartial third party perform IC and/or use patient advocate, consent monitorPotential subjects should not be approached: participation immediately after diagnosis or after they’ve learned a standard treatment has failed
37Vulnerable Populations: Students Various procedures may be used to reduce the possibility of unintentional coercion:Posting IRB approved advertisements throughout the campus to recruit from a broad base of studentsRecruitment procedures should not involve direct solicitation by superiorsInformed consent state clearly that participation is voluntary, without authority figures present, protections in place to prevent retaliationProviding alternative and equal methods for meeting course requirements other than participating as a research subject.
38Vulnerable Populations: Minorities ProtectionsKeep data strictly confidentialConsider whether study design could incorporate participants from all segments of societyConsult with community and include representatives of this group in study design and oversight to reduce potential for stereotyping and stigmatizationTranslated ICF, and translator present for IC process (not family member), & include provisions for continued communicationGroup- undervalued by society in which they live. Devalues their interests welfare or contributions- they are stereotyped and may be discriminated against.Also- for non-english speakers- may be vulnerable because their comprehension is compromised.Many times investigators don’t want to include these subjects because of the time/difficulty/money involved in translating the forms and having a translator involved. Important NOT to exclude this population- especially in treatment studies- just because it’s too hard.
39ConclusionEthical research is guided by the principles of justice, respect for persons, and beneficence.Vulnerable subjects should be included but also deserve special protections.Carefully about the populations and take steps to ensure their rights and welfare are protected.
40Principles of ICH GCP & Ethical Consideration in Vulnerable subjects Assist. Prof. Chanchai Traivaree MD. Msc.(Clini Epi)Chief , Division of Hematology / OncologyPhramongkutklao Hospital &College of Medicines