Role of IRB and IEC in Safeguarding the Subjects in Clinical Trials
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In clinical research, the protection of human subjects is of utmost importance to ensure ethical conduct and adherence to regulatory standards. Two key entities responsible for safeguarding the rights, safety, and well-being of subjects in clinical trials are Institutional Review Boards (IRBs) and Independent Ethics Committees (IECs). They play essential roles in the oversight and ethical review of clinical research protocols. Here's a breakdown of their roles in safeguarding clinical trial subjects: Institutional Review Boards (IRBs): Ethical Review: IRBs are responsible for conducting an ethical review of research protocols to ensure that the study is designed and conducted in an ethical and morally sound manner. They assess the study's potential risks, benefits, and the protection of subjects' rights. Informed Consent: IRBs review and approve the informed consent process to ensure that subjects are provided with comprehensive and understandable information about the study, including its purpose, procedures, risks, and benefits. They assess the adequacy of the informed consent document. Risk-Benefit Assessment: IRBs assess the risks and potential benefits of the research to determine whether they are balanced and reasonable. They weigh the scientific and societal value of the research against the risks posed to subjects. Subject Recruitment and Selection: IRBs review the methods and materials used for subject recruitment and selection to ensure that they are non-coercive, fair, and do not discriminate against vulnerable populations. Continual Oversight: IRBs provide ongoing oversight of approved studies. They monitor the progress of research, ensuring that it adheres to the approved protocol and that any deviations or adverse events are appropriately reported and addressed. Conflict of Interest: IRBs evaluate potential conflicts of interest among researchers, ensuring that financial or non-financial interests do not compromise the rights or safety of research subjects. Privacy and Confidentiality: IRBs assess how subjects' privacy and confidentiality will be protected, particularly in studies involving sensitive information or data. Emergency Use of Investigational Products: In cases of emergency use of investigational products, IRBs may provide authorization, ensuring that the use is in the best interest of the subject.
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2a. The Institutional Review Boards (IRB) are entrusted to protect t.pdf
2a. The Institutional Review Boards (IRB) are entrusted to protect the rights and safety of
participants undergoing clinical research studies. The regulations formulated for reviewing,
approving and conductiong research on humans generally refer to such independant boards like
IRB. IRB has been recognised as one component of Human Research Protection Program
(HRPP) of the Asssociation for the Accreditation of Human Research Protection Program
(AAHRPP) formed in 2001.
The IRB shoulkd have atleast FIVE members from diverse scientific and non-scientific
backgrounds; professional domains, and cultural interests including gender, race and attitude
toward community issues. Atleast one memebr should be from scientific area (having primary
concern in scientific area such as physician, Ph D level physical or biological scientists) and
atleast one from non-scientific area (FDA regulation: 21 CFR 56.107 (C)). Also atleast one
member should not be affiliated with the institution directly or be a community member.
Primary source of information: Jacobs M R (2014) Institutional Review Boards and Independant
Ethics Committees, White paper. Technical report.
b. Most IRB\'s consist of more than five members to encompass additional expertise while
convening the meetings. As per the regulations of International Conference on Harmonisation
(ICH), department of Health and Human sciences (DHHS) and the Food and Drug
Administration (FAD), the memebers of IRB should have adequate expertise in assessing the
quality of science, medical aspects of proposed research and the ethics of conducting
studies.This implies the need to have atleast one member as physician. IRB can also approve an
alternate member in the absence of the primary member. Even outside consultants can be invited
to have opinion on scientific and ethical issues beyond the expertise of the convened committee,
however, they do not have the right to vote for approving the research.
When the research involve vulnerable populations such as children, prisoners, pregnant women,
handicapped and mentally impaired, the individuals having expertise and understanding on the
issue should be included. So also, the participants or subjects in the research study who can
become potential vulnerable groups should also be considered.
c. The IRB reviews the clinical trial protocols and ensure that the participants have minimal risks
in relation to the benefits from the research. Such reviews are done before and during the trials.
The IRB perform periodic reviews or continuing reviews through out the entire duration of the
trial. Such reviews happen atleast once a year and cover the entire trials and not just changes.
The IRB also seek additional information about the payments and compenations to study
participants and informed consent process.
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2) The guidelines establish responsibilities for investigators, sponsors, and ethics committees to follow principles where subject welfare prevails over science and trials must be scientifically sound.
3) The ICH facilitates harmonization across countries/regions to streamline drug development and avoid duplicative trials through consensus guidelines.
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A well-established hospital is frequently approached by pharmaceutical industry to conduct research on human subjects, for their products and / or for new drug and new formulation.
Even doctors in the hospitals have a keen desire to investigate some of their new ideas by experimenting on the patients.
For all such research involving human subjects in hospital should be routed through an important committee called , 'research and ethics committee' or simply 'independent ethics committee (IEC).
All research involving human subject should be conducted in accordance with ethical principle contained in the current revision of 'declaration of helsinki'.
The declaration is based on three basic considerations namely, justice, respect for persons and to maximize benefits and to minimize harms.
Role of Drug Regulatory agencies in Clinical Research.
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Approval and Oversight of Clinical Trials: Regulatory agencies review and approve clinical trial protocols, ensuring that they adhere to ethical and scientific standards. They assess the design, methodology, and objectives of trials to ensure patient safety and the reliability of data generated.
Regulatory Guidance and Standards: These agencies provide guidance and establish regulations governing the conduct of clinical trials, including Good Clinical Practice (GCP) guidelines, which outline standards for trial design, conduct, monitoring, and reporting.
Review and Evaluation of Data: Regulatory agencies review the data collected from clinical trials to assess the safety and efficacy of investigational drugs. They evaluate study results, adverse events, and other relevant information to make informed decisions about drug approval.
Drug Approval and Labeling: Based on the evaluation of clinical trial data, regulatory agencies decide whether to approve a drug for marketing and use. They also determine the appropriate labeling, including indications, dosages, contraindications, and warnings, to ensure safe and effective use by healthcare professionals and patients.
Post-Marketing Surveillance: Regulatory agencies continue to monitor the safety and effectiveness of approved drugs through post-marketing surveillance programs. They collect and analyze real-world data on adverse events and drug utilization to identify potential risks and take appropriate regulatory actions if safety concerns arise.
Enforcement of Regulations: Regulatory agencies enforce compliance with regulatory requirements and take enforcement actions against sponsors, investigators, or manufacturers who fail to adhere to ethical or regulatory standards in clinical research.
International Collaboration: Many regulatory agencies collaborate with counterparts in other countries to harmonize regulatory standards, exchange information, and streamline the drug approval process, facilitating global drug development and access to new therapies.
Data Privacy and consent management .. .
Data privacy and consent management are critical aspects of ensuring that individuals' personal information is handled responsibly and ethically, particularly in healthcare settings where sensitive medical data is involved. Data privacy refers to the protection of personal information from unauthorized access, use, or disclosure, while consent management involves obtaining and managing individuals' permissions for the collection, storage, and processing of their data.
In healthcare, patients entrust providers with their sensitive medical information, expecting that it will be kept confidential and used only for legitimate purposes related to their care. Robust data privacy measures include encryption, access controls, and anonymization techniques to safeguard patient data from unauthorized access or breaches. Additionally, healthcare organizations must adhere to regulatory standards such as HIPAA in the United States or GDPR in the European Union, which outline specific requirements for the protection of patient information and impose penalties for non-compliance.
Consent management plays a crucial role in ensuring that individuals have control over how their data is used. Patients should be informed about the purposes for which their data will be collected and processed, as well as any potential risks or benefits associated with its use. Obtaining informed consent involves providing individuals with clear and transparent information about their privacy rights and giving them the opportunity to consent to or decline the use of their data for specific purposes. Consent management systems help healthcare organizations track and manage patients' consent preferences, ensuring that data is used in accordance with their wishes and legal requirements.
Effective data privacy and consent management practices not only protect individuals' privacy rights but also foster trust and transparency in healthcare relationships. By implementing robust security measures, respecting patients' autonomy, and promoting informed decision-making, healthcare organizations can uphold the principles of data privacy and consent while leveraging data responsibly to improve patient care and outcomes.
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2a. The Institutional Review Boards (IRB) are entrusted to protect the rights and safety of
participants undergoing clinical research studies. The regulations formulated for reviewing,
approving and conductiong research on humans generally refer to such independant boards like
IRB. IRB has been recognised as one component of Human Research Protection Program
(HRPP) of the Asssociation for the Accreditation of Human Research Protection Program
(AAHRPP) formed in 2001.
The IRB shoulkd have atleast FIVE members from diverse scientific and non-scientific
backgrounds; professional domains, and cultural interests including gender, race and attitude
toward community issues. Atleast one memebr should be from scientific area (having primary
concern in scientific area such as physician, Ph D level physical or biological scientists) and
atleast one from non-scientific area (FDA regulation: 21 CFR 56.107 (C)). Also atleast one
member should not be affiliated with the institution directly or be a community member.
Primary source of information: Jacobs M R (2014) Institutional Review Boards and Independant
Ethics Committees, White paper. Technical report.
b. Most IRB\'s consist of more than five members to encompass additional expertise while
convening the meetings. As per the regulations of International Conference on Harmonisation
(ICH), department of Health and Human sciences (DHHS) and the Food and Drug
Administration (FAD), the memebers of IRB should have adequate expertise in assessing the
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studies.This implies the need to have atleast one member as physician. IRB can also approve an
alternate member in the absence of the primary member. Even outside consultants can be invited
to have opinion on scientific and ethical issues beyond the expertise of the convened committee,
however, they do not have the right to vote for approving the research.
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handicapped and mentally impaired, the individuals having expertise and understanding on the
issue should be included. So also, the participants or subjects in the research study who can
become potential vulnerable groups should also be considered.
c. The IRB reviews the clinical trial protocols and ensure that the participants have minimal risks
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The IRB perform periodic reviews or continuing reviews through out the entire duration of the
trial. Such reviews happen atleast once a year and cover the entire trials and not just changes.
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INDIAN GCP GUIDELINE. for Regulatory affair 1st sem CRR
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2a. The Institutional Review Boards (IRB) are entrusted to protect t.pdf
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Role of Drug Regulatory agencies in Clinical Research.
Drug regulatory agencies play a pivotal role in overseeing and regulating clinical research to ensure the safety, efficacy, and quality of pharmaceutical products. Their primary responsibility is to protect public health by evaluating the data generated from clinical trials and determining whether a drug can be approved for marketing and use in patients. Here are some key roles of drug regulatory agencies in clinical research:
Approval and Oversight of Clinical Trials: Regulatory agencies review and approve clinical trial protocols, ensuring that they adhere to ethical and scientific standards. They assess the design, methodology, and objectives of trials to ensure patient safety and the reliability of data generated.
Regulatory Guidance and Standards: These agencies provide guidance and establish regulations governing the conduct of clinical trials, including Good Clinical Practice (GCP) guidelines, which outline standards for trial design, conduct, monitoring, and reporting.
Review and Evaluation of Data: Regulatory agencies review the data collected from clinical trials to assess the safety and efficacy of investigational drugs. They evaluate study results, adverse events, and other relevant information to make informed decisions about drug approval.
Drug Approval and Labeling: Based on the evaluation of clinical trial data, regulatory agencies decide whether to approve a drug for marketing and use. They also determine the appropriate labeling, including indications, dosages, contraindications, and warnings, to ensure safe and effective use by healthcare professionals and patients.
Post-Marketing Surveillance: Regulatory agencies continue to monitor the safety and effectiveness of approved drugs through post-marketing surveillance programs. They collect and analyze real-world data on adverse events and drug utilization to identify potential risks and take appropriate regulatory actions if safety concerns arise.
Enforcement of Regulations: Regulatory agencies enforce compliance with regulatory requirements and take enforcement actions against sponsors, investigators, or manufacturers who fail to adhere to ethical or regulatory standards in clinical research.
International Collaboration: Many regulatory agencies collaborate with counterparts in other countries to harmonize regulatory standards, exchange information, and streamline the drug approval process, facilitating global drug development and access to new therapies.
Data Privacy and consent management .. .
Data privacy and consent management are critical aspects of ensuring that individuals' personal information is handled responsibly and ethically, particularly in healthcare settings where sensitive medical data is involved. Data privacy refers to the protection of personal information from unauthorized access, use, or disclosure, while consent management involves obtaining and managing individuals' permissions for the collection, storage, and processing of their data.
In healthcare, patients entrust providers with their sensitive medical information, expecting that it will be kept confidential and used only for legitimate purposes related to their care. Robust data privacy measures include encryption, access controls, and anonymization techniques to safeguard patient data from unauthorized access or breaches. Additionally, healthcare organizations must adhere to regulatory standards such as HIPAA in the United States or GDPR in the European Union, which outline specific requirements for the protection of patient information and impose penalties for non-compliance.
Consent management plays a crucial role in ensuring that individuals have control over how their data is used. Patients should be informed about the purposes for which their data will be collected and processed, as well as any potential risks or benefits associated with its use. Obtaining informed consent involves providing individuals with clear and transparent information about their privacy rights and giving them the opportunity to consent to or decline the use of their data for specific purposes. Consent management systems help healthcare organizations track and manage patients' consent preferences, ensuring that data is used in accordance with their wishes and legal requirements.
Effective data privacy and consent management practices not only protect individuals' privacy rights but also foster trust and transparency in healthcare relationships. By implementing robust security measures, respecting patients' autonomy, and promoting informed decision-making, healthcare organizations can uphold the principles of data privacy and consent while leveraging data responsibly to improve patient care and outcomes.
Clinical data security and Integrity in Clinical Research
Clinical data security and integrity are paramount in maintaining patient confidentiality, protecting sensitive medical information, and ensuring the reliability of healthcare data. Security measures encompass various strategies and technologies aimed at safeguarding clinical data from unauthorized access, breaches, or manipulation.
Encryption techniques, access controls, and secure authentication mechanisms are commonly employed to restrict access to patient records and prevent unauthorized individuals from viewing or altering sensitive data. Additionally, robust network security protocols, such as firewalls and intrusion detection systems, help safeguard against external threats and cyberattacks targeting healthcare systems.
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Pharmacovigilance in pediatrics and geriatrics is of paramount importance due to the unique physiological and pharmacokinetic characteristics of these populations. In pediatrics, factors such as rapid growth, organ maturation, and differences in drug metabolism can influence the safety and efficacy of medications. Therefore, monitoring for adverse drug reactions (ADRs), including both known and unexpected effects, is crucial in ensuring the safe use of drugs in children. Additionally, since pediatric patients often receive off-label or unlicensed medications due to limited clinical trials in this population, pharmacovigilance efforts play a critical role in gathering real-world data to inform pediatric drug use.
Presenting- Signal mining in Pharmacovigilance
Signal mining in pharmacovigilance involves the systematic analysis of large datasets to identify potential safety signals associated with medications. It encompasses a variety of computational and statistical methods aimed at detecting patterns or trends that may indicate previously unrecognized adverse drug reactions (ADRs). Signal mining relies on data from sources such as spontaneous reporting systems, electronic health records, clinical trials, and medical literature. Advanced algorithms and data mining techniques, including disproportionality analysis, Bayesian data mining, and machine learning, are employed to sift through vast amounts of data to uncover potential signals of concern. These signals are then subjected to further evaluation to determine their clinical relevance and potential impact on patient safety. By leveraging the power of big data and analytics, signal mining plays a crucial role in enhancing pharmacovigilance efforts, enabling proactive identification and mitigation of medication-related risks, and ultimately contributing to improved patient care and drug safety.
Patient centered Pharmacovigilance .. .
Patient-centered pharmacovigilance represents a pivotal shift in the landscape of healthcare, emphasizing the active involvement of patients in the monitoring and reporting of adverse drug reactions. Unlike traditional pharmacovigilance, which primarily relies on healthcare professionals to identify and document adverse events, this approach recognizes patients as critical stakeholders in ensuring medication safety. By empowering patients to share their experiences, concerns, and observations regarding medication effects, whether positive or negative, healthcare systems can gain a comprehensive understanding of drug safety and efficacy in real-world settings. Patient-centered pharmacovigilance fosters a collaborative partnership between patients, healthcare providers, and regulatory agencies, promoting transparency, accountability, and ultimately, better patient outcomes. Through increased patient engagement and the utilization of patient-reported data, this approach enables healthcare systems to identify potential safety issues earlier, tailor treatment strategies to individual needs, and enhance overall drug safety surveillance efforts.
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Patient-Centric Approaches in Precision Medicine Trials: Strategies for Success
Precision medicine, with its focus on tailoring medical treatment to the individual characteristics of each patient, has ushered in a new era in healthcare. Within this paradigm, clinical trials play a pivotal role in testing and validating targeted therapies. This article explores the importance of adopting patient-centric approaches in precision medicine trials and outlines strategies to enhance their success. By prioritizing patient engagement, leveraging digital technologies, and fostering collaborative partnerships, precision medicine trials can not only advance scientific understanding but also ensure that patient perspectives and experiences are integral to the research process.
Collaborative Initiatives: How Patient Advocacy Groups Contribute to the Succ...
Collaborative initiatives involving patient advocacy groups play a crucial role in advancing the success of precision medicine. Precision medicine, also known as personalized medicine, tailors medical treatment and interventions to the characteristics of each patient, considering factors such as genetic makeup, lifestyle, and environment. Patient advocacy groups contribute to the success of precision medicine in several ways:
Raising Awareness and Education:
Patient advocacy groups are instrumental in raising awareness about precision medicine among their communities.
They provide education and resources to patients, caregivers, and the general public, promoting a better understanding of the benefits and implications of precision medicine.
Patient Empowerment:
Advocacy groups empower patients by providing them with information about their conditions and treatment options.
They help patients understand the importance of participating in precision medicine initiatives, including clinical trials and genetic testing.
Supporting Research and Development:
Patient advocacy groups often collaborate with researchers and industry stakeholders to support the development of targeted therapies and diagnostics.
By actively participating in research initiatives, advocacy groups contribute to the identification of genetic markers, biomarkers, and other factors that influence treatment response.
Influencing Policy and Regulation:
Advocacy groups advocate for policies that support the advancement of precision medicine.
They work to ensure that regulations promote patient access to personalized treatments and protect patient rights, privacy, and data security.
Fostering Collaboration:
Patient advocacy groups facilitate collaboration among patients, researchers, healthcare providers, and industry partners.
They create platforms for sharing information, experiences, and best practices, fostering a collaborative environment that accelerates progress in precision medicine.
Clinical Trial Recruitment:
Advocacy groups play a crucial role in recruiting patients for clinical trials related to precision medicine.
Their engagement helps ensure diverse and representative participant populations, leading to more robust and applicable research outcomes.
Feedback and Patient-Centric Approaches:
Advocacy groups provide valuable feedback on the patient experience, preferences, and priorities.
This patient-centric approach helps researchers and healthcare professionals tailor precision medicine strategies to better meet the needs and expectations of the individuals they serve.
Championing Access to Treatments:
Patient advocacy groups work to improve patient access to precision medicine treatments.
They advocate for affordable and equitable access to innovative therapies, ensuring that the benefits of precision medicine are accessible to a broader population.
In summary, patient advocacy groups play a multifaceted role in advancing precision medicine by fostering awareness,
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The Ethical dilemmas in precision medicine arise from balancing the potential benefits of tailored treatments with concerns about privacy, consent, equity, and the implications of genetic information. These Dilemmas include issues around informed consent for data sharing, ensuring equitable access to precision medicine technologies, and safeguarding against discrimination based on Information. The potential for misuse or unintended consequences further complicate the ethical landscape of precision medicine. The Precision medicine widely used in Data Integration, Biomarkers, Targeted Therapies, predictive modeling, Clinical Decision Support. Precision Medicine improves the Patient outcomes, enhancing treatment efficacy, and reducing healthcare costs by minimizing trial and error in treatment selection. The precision medicine also raises Ethical legal and social complications related to data privacy, consent and equitable access and the potential for Discrimination based on information.
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Precision medicine, with its focus on tailoring medical treatments to individual characteristics, presents unique regulatory challenges in the drug development and approval process. This ppt delves into the regulatory considerations associated with precision medicine, exploring the key aspects that pharmaceutical and biotechnology companies need to navigate
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Precision medicine has witnessed significant advancements with the integration of emerging technologies and innovative tools. This abstract explores the current landscape of precision medicine research, focusing on the role of cutting-edge technologies and tools in revolutionizing healthcare approaches.
Precision Medicine in Action: Case Studies and Success Stories
Precision medicine, an innovative approach tailoring medical treatment to individual characteristics, holds great promise for improved patient outcomes. In this paradigm, pharmacovigilance plays a crucial role in monitoring and ensuring the safety of personalized treatments. The integration of big data and artificial intelligence (AI) into pharmacovigilance practices becomes paramount for handling the complexities of individualized therapies and identifying potential safety concerns. This article explores the synergies between big data, AI, and pharmacovigilance in the context of precision medicine.
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Clinical trials are complex endeavors that involve numerous stakeholders, vast datasets, and intricate processes. To streamline operations, enhance collaboration, and improve efficiency, the integration of clinical trial systems has emerged as a pivotal solution. This strategic approach involves connecting various components, such as electronic data capture (EDC) systems, clinical trial management systems (CTMS), and electronic health records (EHR), fostering a cohesive ecosystem that accelerates the pace of research and ensures data accuracy.
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Pharmacovigilance, a critical component of the healthcare and pharmaceutical industry, plays a pivotal role in monitoring and ensuring the safety of drugs. As personalized treatment approaches gain prominence, the responsibilities of PV companies become even more significant. This article explores the key functions of pharmacovigilance companies in the context of personalized medicine, focusing on their role in ensuring drug safety and mitigating potential risks associated with tailored therapeutic interventions.
Adoptive Design: Optimizing Clinical Trial Strategies for Precision Medicine
Clinical trials play a pivotal role in advancing medical research and ensuring the efficacy of new treatments. In the context of precision medicine, where therapies are tailored to individual characteristics, adaptive design emerges as a powerful strategy to optimize clinical trial outcomes. This approach deviates from traditional fixed trial designs, allowing for modifications based on accumulating data, thus enhancing efficiency, flexibility, and the likelihood of success in precision medicine endeavors.
Artificial Intelligence In Clinical Trial
Clinical trials are a cornerstone of medical research, paving the way for new treatments and advancements in healthcare. In recent years, Artificial Intelligence (AI) has emerged as a transformative force, reshaping the landscape of clinical trials. This article explores the various ways in which AI is revolutionizing the design, execution, and analysis of clinical trials.
Emerging Technologies Shaping the Future of Precision Medicine
Precision medicine, with its focus on tailoring healthcare interventions to individual characteristics, is undergoing a transformative evolution propelled by emerging technologies. From advanced genomic tools to artificial intelligence, these technologies are revolutionizing our ability to understand, diagnose, and treat diseases at an unprecedented level of specificity. This article explores the key emerging technologies shaping the future of precision medicine.
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Role of IRB and IEC in Safeguarding the Subjects in Clinical Trials
- 1. Welcome Role of IRB and IEC in Safeguarding the Subjects in Clinical Trials A. Hemanth B. Pharmacy Student Id- 202/092023 10/18/2022 www.clinosol.com | follow us on social media @clinosolresearch 1
- 2. Contents • What is IRB & IEC. • What are the responsibilities of IRB & IEC. • When did IRB & IEC monitor clinical Trails. • Other responsibilities of IRB & IRC. • Team composition of IRB & IRC. • Clinical trail decision by IRB & IRC. 10/18/2022 www.clinosol.com | follow us on social media @clinosolresearch 2
- 3. What is IRB or IEC • Institutional Review Board (IRB) or Independent Ethics Committee (IEC) • The International Council on Harmonisation (ICH) defines an institutional review board (IRB) as a group formally designated to protect the rights, safety and well-being of humans involved in a clinical trial by reviewing all aspects of the trial and approving its startup. IRBs can also be called independent ethics committees (IECs). • An unbiased frame created from medical, clinical, and non-medical members, whose obligation is to make certain the safety of the rights, protection and properly-being of human subjects concerned in an ordeal through, among different matters, reviewing, approving, and offering persevering with assessment of trial protocol and amendments and of the strategies and cloth to be used in acquiring and documenting informed consent of the trial subjects. 10/18/2022 www.clinosol.com | follow us on social media @clinosolresearch 3
- 4. Responsibilities of IRB or IEC • An IRB/IEC must safeguard the rights, protection and well-being of all trial topics. Unique attention have to be paid to trials that can encompass inclined subjects. • The IRB/IEC evaluations the following documents: trial protocol(s)/amendment(s), written informed consent form(s) and consent shape updates, subject recruitment strategies (e.g. advertisements), written records to be provided to subjects, investigator’s brochure, safety data, data approximately bills and reimbursement, investigator’s curriculum vitae, and some other essential documents. • The IRB/IEC need to assessment a proposed clinical trial within a affordable time and report its perspectives in writing, sincerely figuring out the trial, the files reviewed and the dates for its selection on approval 10/18/2022 www.clinosol.com | follow us on social media @clinosolresearch 4
- 5. • The IRB/IEC should conduct continuing review of each ongoing trial at intervals appropriate to the degree of risk to human subjects, but at least once a year. • The IRB/IEC may request more information to be given to subjects when, in the judgment of the IRB/IEC, the additional information would add meaningfully to the protection of the rights, safety and well-being of the subjects. 10/18/2022 www.clinosol.com | follow us on social media @clinosolresearch 5 When did IRB or IEC monitor clinical Trails.
- 6. Other responsibilities of IRB or IRC. • Where a non-therapeutic trial is to be carried out with the consent of the subject’s LAR, the IRB/IEC should determine that the proposed protocol and /or other documents adequately addresses relevant ethical concerns and meets applicable regulatory requirements for such trials. • The IRB/IEC should determine that the proposed protocol and/or other documents adequately addresses relevant ethical concerns and meets applicable regulatory requirements for such trials. 10/18/2022 www.clinosol.com | follow us on social media @clinosolresearch 6
- 7. Team composition of IRB or IRC. • The IRB/IEC should consist of a reasonable number of members who collectively have the qualifications and experience to review and evaluate the science, medical aspects, and ethics of the proposed trial. It is recommended that the IRB/IEC should include: 1. At least 5 members 2. At least one member whose primary area of interest is in a non-scientific area 3. At least one member who is independent of the institution/trial site. 10/18/2022 www.clinosol.com | follow us on social media @clinosolresearch 7
- 8. Clinical trail decision by IRB or IRC. • The IRB/IEC should make its decisions at announced meetings at which at least a quorum, as stipulated in its written SOP, is present. • Only members who participate in the review and discussion should vote/provide their opinion and/or advice • The investigator may provide information on any aspects of the trial, but should not participate in the deliberations or in the vote/opinion of the IRB/IEC. • An IRB/IEC may invite non-members with expertise in special areas for assistance. 10/18/2022 www.clinosol.com | follow us on social media @clinosolresearch 8
- 9. ThankYou! www.clinosol.com (India | Canada) 9121151622/623/624 info@clinosol.com 10/18/2022 www.clinosol.com | follow us on social media @clinosolresearch 9