Quorum Review presents a special webinar with J. Claire Carbary, JD, CIP to discuss IRB expectations when research involves minors or adults with limited capacity to consent. The presenter will outline guidance in recruiting these populations and clarify who might serve as the appropriate legal representatives based on federal regulations and state law.
This document discusses addressing future research and biobanking in the protocol and consent form for research studies. It notes that IRB review of future research using stored samples may not always be legally required in the US, depending on whether the samples are identifiable. However, IRB review is generally required in Canada regardless of identifiability. When reviewing biobanks, IRBs should consider how samples are entered and stored, as well as issues around access, disclosure, confidentiality and data security. Consent forms for future research should specify what types of future research may be conducted with samples and data.
Presentation focusing on the additional requirements imposed by states on clinical research, with an emphasis on those required by California and Texas on such issues as the Legally Authorized Representative (LAR), Assent by children, IRBs, etc.
Presentation focusing on the additional requirements imposed by states on clinical research, with an emphasis on those required by California and Texas on such issues as the Legally Authorized Representative (LAR), Assent by children, IRBs, etc.
Our medical treatment and the courts seminar in partnership with 39 Essex Chambers covered the following topics:
- medical treatment & the courts – autonomy v paternalism
- end of life decisions
- the role of family in decision making
- deprivation of liberty in hospital.
For further information and resources visit our website - https://www.brownejacobson.com/health
Revitalizing the Code: Delinquency & Competencybartoncenter
This document summarizes key provisions of Article 6 and 7 of Georgia's juvenile code related to delinquency and competency. The summary includes:
1) Article 6 outlines the purpose, parties, roles of prosecutors/defense attorneys, case timelines, intake process, detention procedures, petition requirements, adjudication process, and disposition options for delinquency cases, including regular and designated felony offenses.
2) Article 7 defines incompetency to proceed and outlines competency evaluation and hearing procedures. If a child is found incompetent, the court may dismiss the case without prejudice or order competency remediation services.
3) Key changes include expanded victims' rights, notice requirements for designated felony releases, and
This document provides an overview of the FDA and its regulatory processes. It discusses that the FDA regulates over 20% of US consumer spending and has both enforcement and public health roles. The document outlines the FDA's structure, including its centers and offices. It also summarizes the FDA's authorities which stem from the Constitution, statutes like the FDCA, regulations, and guidance documents. The document then explains key FDA statutes and pathways for drug and device approvals. It closes by discussing the FDA's jurisdiction regarding adulteration and misbranding.
The document discusses effective strategies for advertising clinical trials, including:
1) Using graphics and visual design elements like color, spacing, and layout to draw attention and guide the eye through the advertisement.
2) Providing concise, fact-based information in an easy-to-read format like bullet points.
3) Including appropriate images of potential participants to increase identification and interest in the trial.
Recruitment & Retention Plan: A Sample Strategy PresentationMarwah Zagzoug, PhD
The document outlines a trial enrollment strategy and patient recruitment plan for a clinical trial comparing ZOCOR and Lipitor in patients with high cholesterol. The trial is currently under-enrolled, with only 2 patients enrolled out of a goal of 10. Various recruitment methods like advertising and outreach are proposed to boost enrollment. Barriers to recruitment and retention like patient burden and lack of communication are identified, along with strategies to improve participation like transportation assistance and regular contact with patients.
This document discusses addressing future research and biobanking in the protocol and consent form for research studies. It notes that IRB review of future research using stored samples may not always be legally required in the US, depending on whether the samples are identifiable. However, IRB review is generally required in Canada regardless of identifiability. When reviewing biobanks, IRBs should consider how samples are entered and stored, as well as issues around access, disclosure, confidentiality and data security. Consent forms for future research should specify what types of future research may be conducted with samples and data.
Presentation focusing on the additional requirements imposed by states on clinical research, with an emphasis on those required by California and Texas on such issues as the Legally Authorized Representative (LAR), Assent by children, IRBs, etc.
Presentation focusing on the additional requirements imposed by states on clinical research, with an emphasis on those required by California and Texas on such issues as the Legally Authorized Representative (LAR), Assent by children, IRBs, etc.
Our medical treatment and the courts seminar in partnership with 39 Essex Chambers covered the following topics:
- medical treatment & the courts – autonomy v paternalism
- end of life decisions
- the role of family in decision making
- deprivation of liberty in hospital.
For further information and resources visit our website - https://www.brownejacobson.com/health
Revitalizing the Code: Delinquency & Competencybartoncenter
This document summarizes key provisions of Article 6 and 7 of Georgia's juvenile code related to delinquency and competency. The summary includes:
1) Article 6 outlines the purpose, parties, roles of prosecutors/defense attorneys, case timelines, intake process, detention procedures, petition requirements, adjudication process, and disposition options for delinquency cases, including regular and designated felony offenses.
2) Article 7 defines incompetency to proceed and outlines competency evaluation and hearing procedures. If a child is found incompetent, the court may dismiss the case without prejudice or order competency remediation services.
3) Key changes include expanded victims' rights, notice requirements for designated felony releases, and
This document provides an overview of the FDA and its regulatory processes. It discusses that the FDA regulates over 20% of US consumer spending and has both enforcement and public health roles. The document outlines the FDA's structure, including its centers and offices. It also summarizes the FDA's authorities which stem from the Constitution, statutes like the FDCA, regulations, and guidance documents. The document then explains key FDA statutes and pathways for drug and device approvals. It closes by discussing the FDA's jurisdiction regarding adulteration and misbranding.
The document discusses effective strategies for advertising clinical trials, including:
1) Using graphics and visual design elements like color, spacing, and layout to draw attention and guide the eye through the advertisement.
2) Providing concise, fact-based information in an easy-to-read format like bullet points.
3) Including appropriate images of potential participants to increase identification and interest in the trial.
Recruitment & Retention Plan: A Sample Strategy PresentationMarwah Zagzoug, PhD
The document outlines a trial enrollment strategy and patient recruitment plan for a clinical trial comparing ZOCOR and Lipitor in patients with high cholesterol. The trial is currently under-enrolled, with only 2 patients enrolled out of a goal of 10. Various recruitment methods like advertising and outreach are proposed to boost enrollment. Barriers to recruitment and retention like patient burden and lack of communication are identified, along with strategies to improve participation like transportation assistance and regular contact with patients.
This summarizes the key parts of 21 CFR Part 50 which protects human subjects in clinical investigations. It discusses the general provisions in Subpart A including what this part applies to. Subpart B covers informed consent requirements for human subjects. Key elements that must be included in obtaining consent are listed. Subpart D provides additional safeguards for children in clinical investigations, outlining different risk levels and criteria the IRB must consider before approving investigations involving children.
The CEO's letter discusses a recent controversy surrounding a study on care for premature infants that raised issues for IRBs. 23 IRBs had approved similar consent forms for the study, but the OHRP later issued a letter critical of the consent forms. The letter sparks debate around how much risk/benefit information should be included in consent forms. Two enclosed articles provide more information on consent for legally incapacitated adults and FDA changes regarding placebo-controlled pediatric trials.
The FDA is seeking input on modernizing its regulations and practices for clinical trials to address increased complexity and globalization of trials. It is asking how it can encourage innovative methods to build quality into trials and eliminate challenges posed by its regulations. A public hearing was held in April where several industry speakers presented, including the CEO recommending regulatory harmonization and relief from IND safety letters. Comments can be submitted to the FDA until May 31. The newsletter then discusses two research topics - a FDA guidance on IRB continuing review criteria, emphasizing the sponsor's role in providing study-wide information, and state laws regarding consent for research with pregnant minors.
This document discusses the reproductive health needs of court-involved youth and the legal authority to provide them care. It notes that pregnancy rates are much higher for youth in foster care than others, and early parenting exacerbates challenges. The law authorizes medical consent for these youth and supports providing education, exams, and contraception. Collaboration between legal and child welfare systems can help address motivations for early pregnancy and improve long-term outcomes.
This document discusses human subjects research regulations and considerations for teaching and scholarship. It covers the federal regulations stemming from the Belmont Principles, activities that require Institutional Review Board (IRB) approval including research involving systematic investigations designed to develop generalizable knowledge and human subjects. It also discusses quality improvement activities, determining if an activity is considered human subjects research, levels of IRB review including exempt, expedited and full review, criteria for IRB approval, and requirements for approved research such as continuing review and reporting requirements.
This document discusses considerations for human subjects research for teaching and scholarship. It provides an overview of federal regulations and policies governing human subjects research, including activities that require Institutional Review Board (IRB) approval. It discusses the differences between quality improvement projects and human subjects research, and provides examples to help determine if an activity would be considered human subjects research. It also outlines the different levels of IRB review, including exempt, expedited, and full board review. Key areas like assessing risks, obtaining consent, and criteria for IRB approval are summarized.
This document discusses ethical considerations in pediatric research. It notes that children are considered a vulnerable population due to their developing decision-making capacity and dependence on others. Key ethical principles for research with children include beneficence, non-maleficence, justice, respect for consent/assent, and privacy. Research risks to children must be justified by potential benefits and should not disadvantage children. Assent from children and consent from parents are also required, with standards varying based on the study's risk level.
This document summarizes common regulatory myths and misconceptions about clinical research regulations. It addresses 20 statements and indicates whether they are true or false, providing the relevant regulatory citation to support each response. The document aims to clarify areas of misunderstanding around regulations from the FDA, HHS, and other agencies governing clinical research practices.
(2014) To Be or Not to Be? Is parental consent necessary for informed consent...Dr. Chiachen Cheng
While parental consent is typically required for minors to participate in research, the NorthBEAT study examining youth mental health in Northern Ontario faced unique challenges making parental consent impractical. Due to the vast, sparsely populated geography and privacy concerns, obtaining parental consent could seriously lower recruitment and minimize youth privacy over their health issues. After reviewing literature on consent capacity, the researchers developed a two-step process to assess youth capacity directly. Youth deemed capable by their clinicians of understanding the study would have their capacity to consent formally assessed during the verbal consent process. This allowed capable youth to provide their own consent without parental involvement given the context of the Northern Ontario study area.
Human Subject Protection in Clinical ResearchClinosolIndia
Human subject protection in clinical research is an essential aspect of ensuring that research is conducted in an ethical and responsible manner. It involves the implementation of policies and procedures to protect the rights, safety, and welfare of human subjects who participate in clinical research studies. Here are some key aspects of human subject protection in clinical research:
Informed Consent: Informed consent is the cornerstone of human subject protection in clinical research. It involves providing potential participants with clear and understandable information about the study's purpose, procedures, risks, and benefits, and obtaining their voluntary agreement to participate.
Ethics Review: Clinical research studies involving human subjects must be reviewed by an independent ethics committee or institutional review board (IRB) to ensure that the study design and procedures are ethical, and the potential risks and benefits of the study are carefully evaluated.
Safety Monitoring: The safety and well-being of human subjects must be monitored throughout the study to ensure that any adverse events or unexpected outcomes are promptly identified, reported, and addressed.
Confidentiality and Privacy: Participants' personal information must be kept confidential and protected from unauthorized disclosure. Researchers must take appropriate measures to ensure that the data is secure and used only for the purposes outlined in the research protocol.
Risk Minimization: Researchers have an ethical responsibility to minimize the risks of harm to human subjects by designing studies that are safe and feasible, using appropriate study procedures and interventions, and providing appropriate medical care and follow-up.
Vulnerable Populations: Special considerations must be given to vulnerable populations, such as children, pregnant women, prisoners, and individuals with cognitive impairments or mental illness. Additional safeguards must be in place to protect their rights and welfare.
Regulatory Compliance: Researchers must comply with relevant laws and regulations governing clinical research, including obtaining regulatory approvals, conducting studies according to Good Clinical Practice (GCP) guidelines, and reporting adverse events or unexpected outcomes.
1) Malpractice in pediatric settings requires proving four elements: a duty owed by the nurse, a breach of that duty, that the breach caused harm, and actual damage. The "5 R's" help avoid breaching duty.
2) Statutory law defines nursing scope and penalties. Reporting statutes mandate reporting child abuse, elder abuse, and diseases.
3) Informed consent requires discussing a treatment's risks, benefits, alternatives, and nature unless in emergencies or suspected abuse cases. Minors can sometimes consent depending on the treatment and state laws.
This document discusses guidelines for obtaining assent from children participating in research. It provides an overview of the history of regulations protecting human subjects, including the Belmont Report and Common Rule. For research with children, federal regulations require assessing their capacity to provide assent or waiving assent. The document recommends a flexible approach to assent that respects children's autonomy, involves them in decisions to an appropriate degree, and integrates their perspective into family decision making about research participation.
This document provides guidance on developing comprehensive and legally compliant consent documents for research. It reviews the key elements that must be included in a consent form according to federal regulations, such as risks, benefits, confidentiality, voluntary participation, and contact information. The document also discusses additional consent requirements for clinical trials and situations where waivers of documentation or consent may be permitted. Researchers are advised to write consent forms at a 6th-8th grade reading level using clear and simple language.
From the event "Specimen Science: Ethics and Policy Implications," held at Harvard Law School on November 16, 2015.
This event was a collaboration between The Center for Child Health and Policy at Case Western Reserve University and University Hospitals Rainbow Babies & Children’s Hospital; the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School; the Multi-Regional Clinical Trials Center of Harvard and Brigham and Women's Hospital; and Harvard Catalyst | The Harvard Clinical and Translational Science Center. It was supported by funding from the National Human Genome Research Institute and the Oswald DeN. Cammann Fund at Harvard University.
For more information, visit our website at http://petrieflom.law.harvard.edu/events/details/specimen-science-ethics-and-policy
This document discusses the categorization and review of quality improvement (QI) projects by Institutional Review Boards (IRBs). It defines key terms like research and QI. It describes how QI projects fall on a continuum between clinical practice and clinical research. The document outlines the different levels of IRB review including exempt, expedited and full board review based on the level of risk. It discusses current controversies around the appropriate role and scope of IRB review for QI projects. A case study of a QI project that was initially deemed exempt but later required further IRB review is also summarized.
HIPAA provides privacy and security provisions for safeguarding medical information. It was updated by the Affordable Care Act to include new expanded requirements. Protected health information (PHI) includes individually identifiable health information. PHI can be in any form, including written, electronic, and verbal. Key dates in HIPAA history include the signing into law in 1996 and various effective dates for rules. New HIPAA requirements for clinical studies include obtaining authorization or waiver from an IRB or Privacy Board to use or disclose PHI for research. Covered entities have faced fines for various HIPAA violations involving unencrypted devices and disclosing ePHI.
ODF III - 3.15.16 - Day Two Morning SessionsMichael Kerr
Slide presentations delivered during morning sessions of Day Two of the California Statewide Health and Human Services Open DataFest - March 14 - 15, 2016, Sacramento, CA
This document provides an overview of Georgia's CHINS (Children in Need of Services) process and statute. It defines a CHIN as a child adjudicated to need services due to issues like truancy, disobedience, or criminal offenses. The purpose is to acknowledge family issues, encourage participation, provide treatment programs, and ensure agency cooperation. The process involves complaints, petitions, hearings to determine custody and services, and dispositional orders up to 2 years. Key powers for courts include convening agencies, ordering services, referrals, and ongoing monitoring. Developing best practices requires understanding this population, using statutory authority, and adapting current models.
Social media is a powerful and widespread source of information and connectivity. Many in research are wondering whether and how to use social media to improve awareness and retention for their clinical trials. Quorum Review's Regulatory Attorney, Dominic Chiarelli, presents about the power of social media and practical tips for how to best harness social media in research.
Quorum Review IRB presented a live webinar in September 2014 covering the details of IRB review for medical device studies and their special considerations.
More Related Content
Similar to Webinar: Research Involving Subjects with Limited Capacity: IRB Expectations for Recruitment and Consent
This summarizes the key parts of 21 CFR Part 50 which protects human subjects in clinical investigations. It discusses the general provisions in Subpart A including what this part applies to. Subpart B covers informed consent requirements for human subjects. Key elements that must be included in obtaining consent are listed. Subpart D provides additional safeguards for children in clinical investigations, outlining different risk levels and criteria the IRB must consider before approving investigations involving children.
The CEO's letter discusses a recent controversy surrounding a study on care for premature infants that raised issues for IRBs. 23 IRBs had approved similar consent forms for the study, but the OHRP later issued a letter critical of the consent forms. The letter sparks debate around how much risk/benefit information should be included in consent forms. Two enclosed articles provide more information on consent for legally incapacitated adults and FDA changes regarding placebo-controlled pediatric trials.
The FDA is seeking input on modernizing its regulations and practices for clinical trials to address increased complexity and globalization of trials. It is asking how it can encourage innovative methods to build quality into trials and eliminate challenges posed by its regulations. A public hearing was held in April where several industry speakers presented, including the CEO recommending regulatory harmonization and relief from IND safety letters. Comments can be submitted to the FDA until May 31. The newsletter then discusses two research topics - a FDA guidance on IRB continuing review criteria, emphasizing the sponsor's role in providing study-wide information, and state laws regarding consent for research with pregnant minors.
This document discusses the reproductive health needs of court-involved youth and the legal authority to provide them care. It notes that pregnancy rates are much higher for youth in foster care than others, and early parenting exacerbates challenges. The law authorizes medical consent for these youth and supports providing education, exams, and contraception. Collaboration between legal and child welfare systems can help address motivations for early pregnancy and improve long-term outcomes.
This document discusses human subjects research regulations and considerations for teaching and scholarship. It covers the federal regulations stemming from the Belmont Principles, activities that require Institutional Review Board (IRB) approval including research involving systematic investigations designed to develop generalizable knowledge and human subjects. It also discusses quality improvement activities, determining if an activity is considered human subjects research, levels of IRB review including exempt, expedited and full review, criteria for IRB approval, and requirements for approved research such as continuing review and reporting requirements.
This document discusses considerations for human subjects research for teaching and scholarship. It provides an overview of federal regulations and policies governing human subjects research, including activities that require Institutional Review Board (IRB) approval. It discusses the differences between quality improvement projects and human subjects research, and provides examples to help determine if an activity would be considered human subjects research. It also outlines the different levels of IRB review, including exempt, expedited, and full board review. Key areas like assessing risks, obtaining consent, and criteria for IRB approval are summarized.
This document discusses ethical considerations in pediatric research. It notes that children are considered a vulnerable population due to their developing decision-making capacity and dependence on others. Key ethical principles for research with children include beneficence, non-maleficence, justice, respect for consent/assent, and privacy. Research risks to children must be justified by potential benefits and should not disadvantage children. Assent from children and consent from parents are also required, with standards varying based on the study's risk level.
This document summarizes common regulatory myths and misconceptions about clinical research regulations. It addresses 20 statements and indicates whether they are true or false, providing the relevant regulatory citation to support each response. The document aims to clarify areas of misunderstanding around regulations from the FDA, HHS, and other agencies governing clinical research practices.
(2014) To Be or Not to Be? Is parental consent necessary for informed consent...Dr. Chiachen Cheng
While parental consent is typically required for minors to participate in research, the NorthBEAT study examining youth mental health in Northern Ontario faced unique challenges making parental consent impractical. Due to the vast, sparsely populated geography and privacy concerns, obtaining parental consent could seriously lower recruitment and minimize youth privacy over their health issues. After reviewing literature on consent capacity, the researchers developed a two-step process to assess youth capacity directly. Youth deemed capable by their clinicians of understanding the study would have their capacity to consent formally assessed during the verbal consent process. This allowed capable youth to provide their own consent without parental involvement given the context of the Northern Ontario study area.
Human Subject Protection in Clinical ResearchClinosolIndia
Human subject protection in clinical research is an essential aspect of ensuring that research is conducted in an ethical and responsible manner. It involves the implementation of policies and procedures to protect the rights, safety, and welfare of human subjects who participate in clinical research studies. Here are some key aspects of human subject protection in clinical research:
Informed Consent: Informed consent is the cornerstone of human subject protection in clinical research. It involves providing potential participants with clear and understandable information about the study's purpose, procedures, risks, and benefits, and obtaining their voluntary agreement to participate.
Ethics Review: Clinical research studies involving human subjects must be reviewed by an independent ethics committee or institutional review board (IRB) to ensure that the study design and procedures are ethical, and the potential risks and benefits of the study are carefully evaluated.
Safety Monitoring: The safety and well-being of human subjects must be monitored throughout the study to ensure that any adverse events or unexpected outcomes are promptly identified, reported, and addressed.
Confidentiality and Privacy: Participants' personal information must be kept confidential and protected from unauthorized disclosure. Researchers must take appropriate measures to ensure that the data is secure and used only for the purposes outlined in the research protocol.
Risk Minimization: Researchers have an ethical responsibility to minimize the risks of harm to human subjects by designing studies that are safe and feasible, using appropriate study procedures and interventions, and providing appropriate medical care and follow-up.
Vulnerable Populations: Special considerations must be given to vulnerable populations, such as children, pregnant women, prisoners, and individuals with cognitive impairments or mental illness. Additional safeguards must be in place to protect their rights and welfare.
Regulatory Compliance: Researchers must comply with relevant laws and regulations governing clinical research, including obtaining regulatory approvals, conducting studies according to Good Clinical Practice (GCP) guidelines, and reporting adverse events or unexpected outcomes.
1) Malpractice in pediatric settings requires proving four elements: a duty owed by the nurse, a breach of that duty, that the breach caused harm, and actual damage. The "5 R's" help avoid breaching duty.
2) Statutory law defines nursing scope and penalties. Reporting statutes mandate reporting child abuse, elder abuse, and diseases.
3) Informed consent requires discussing a treatment's risks, benefits, alternatives, and nature unless in emergencies or suspected abuse cases. Minors can sometimes consent depending on the treatment and state laws.
This document discusses guidelines for obtaining assent from children participating in research. It provides an overview of the history of regulations protecting human subjects, including the Belmont Report and Common Rule. For research with children, federal regulations require assessing their capacity to provide assent or waiving assent. The document recommends a flexible approach to assent that respects children's autonomy, involves them in decisions to an appropriate degree, and integrates their perspective into family decision making about research participation.
This document provides guidance on developing comprehensive and legally compliant consent documents for research. It reviews the key elements that must be included in a consent form according to federal regulations, such as risks, benefits, confidentiality, voluntary participation, and contact information. The document also discusses additional consent requirements for clinical trials and situations where waivers of documentation or consent may be permitted. Researchers are advised to write consent forms at a 6th-8th grade reading level using clear and simple language.
From the event "Specimen Science: Ethics and Policy Implications," held at Harvard Law School on November 16, 2015.
This event was a collaboration between The Center for Child Health and Policy at Case Western Reserve University and University Hospitals Rainbow Babies & Children’s Hospital; the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School; the Multi-Regional Clinical Trials Center of Harvard and Brigham and Women's Hospital; and Harvard Catalyst | The Harvard Clinical and Translational Science Center. It was supported by funding from the National Human Genome Research Institute and the Oswald DeN. Cammann Fund at Harvard University.
For more information, visit our website at http://petrieflom.law.harvard.edu/events/details/specimen-science-ethics-and-policy
This document discusses the categorization and review of quality improvement (QI) projects by Institutional Review Boards (IRBs). It defines key terms like research and QI. It describes how QI projects fall on a continuum between clinical practice and clinical research. The document outlines the different levels of IRB review including exempt, expedited and full board review based on the level of risk. It discusses current controversies around the appropriate role and scope of IRB review for QI projects. A case study of a QI project that was initially deemed exempt but later required further IRB review is also summarized.
HIPAA provides privacy and security provisions for safeguarding medical information. It was updated by the Affordable Care Act to include new expanded requirements. Protected health information (PHI) includes individually identifiable health information. PHI can be in any form, including written, electronic, and verbal. Key dates in HIPAA history include the signing into law in 1996 and various effective dates for rules. New HIPAA requirements for clinical studies include obtaining authorization or waiver from an IRB or Privacy Board to use or disclose PHI for research. Covered entities have faced fines for various HIPAA violations involving unencrypted devices and disclosing ePHI.
ODF III - 3.15.16 - Day Two Morning SessionsMichael Kerr
Slide presentations delivered during morning sessions of Day Two of the California Statewide Health and Human Services Open DataFest - March 14 - 15, 2016, Sacramento, CA
This document provides an overview of Georgia's CHINS (Children in Need of Services) process and statute. It defines a CHIN as a child adjudicated to need services due to issues like truancy, disobedience, or criminal offenses. The purpose is to acknowledge family issues, encourage participation, provide treatment programs, and ensure agency cooperation. The process involves complaints, petitions, hearings to determine custody and services, and dispositional orders up to 2 years. Key powers for courts include convening agencies, ordering services, referrals, and ongoing monitoring. Developing best practices requires understanding this population, using statutory authority, and adapting current models.
Similar to Webinar: Research Involving Subjects with Limited Capacity: IRB Expectations for Recruitment and Consent (20)
Social media is a powerful and widespread source of information and connectivity. Many in research are wondering whether and how to use social media to improve awareness and retention for their clinical trials. Quorum Review's Regulatory Attorney, Dominic Chiarelli, presents about the power of social media and practical tips for how to best harness social media in research.
Quorum Review IRB presented a live webinar in September 2014 covering the details of IRB review for medical device studies and their special considerations.
Reporting to the IRB can mean navigating a maze of regulatory requirements. Staying current on what’s required – and what isn’t – is challenging. In this webinar, Quorum Review’s regulatory expert, Mitchell Parrish, JD, RAC, CIP, helps you concretely understand IRB reporting obligations.
Quorum Review's April 2014 Institution Bulletin includes a letter from CEO, Cami Gearhart, JD, discussing the need to reform the regulations around biobanking and repositories, HIPAA templates and procedures, and the lessons IRBs can learn from 2013 FDA Warning Letters.
This document provides an overview of considerations for implementing and obtaining IRB review of electronic consent (eConsent) systems. It discusses key topics such as documentation of consent, privacy and data security, IRB review and documentation requirements, and ensuring an adequate consent process. The main points covered are the regulatory requirements around electronic signatures, evaluating the technical and procedural controls of an eConsent system, how an IRB can approve and document review of an electronic consent form, and factors to consider regarding the consent process and a subject's ability to ask questions.
The Sunshine Act requires pharmaceutical companies to report payments made to physicians, but does not require reporting payments made by independent IRBs to board members for three reasons: 1) IRB members review research proposals rather than practice medicine, which is the target of the Sunshine Act, 2) payments to IRBs for required oversight of research do not constitute direct payments to physicians, and 3) IRB members already face strict rules against conflicts of interest when reviewing research. While the Sunshine Act aims to increase transparency of industry payments to doctors, its requirements do not extend to fees paid to IRB board members for their review of research protocols.
Quorum Review's February 2014 Institution Bulletin includes a letter from CEO, Cami Gearhart, JD, discussing factors to consider when assessing the strength of your IRB, SACHRP guidelines on internet research, international ethics review, and how the 2014 Congressional Appropriations Bill impacts clinical research.
Quorum Review's October 2013 Institution Bulletin includes Letter from CEO, Cami Gearhart, JD, addressing the delicate balance of protecting privacy and future research, as well as Quorum's insights on recent FDA guidance regarding how IRB's evaluate clinical trials as well as determining whether or not an IND is needed for a particular drug study.
This document provides a decision tree to help determine if an activity constitutes human subjects research under 45 CFR 46. It involves asking a series of yes or no questions to evaluate if the activity is a systematic investigation designed to develop generalizable knowledge, involves obtaining private information about living individuals, and involves intervention or interaction with those individuals. If the answers indicate it is research involving human subjects, it may require IRB review unless an exemption applies under 45 CFR 46.101(b)(1)-(6).
Quorum Review's July 2013 Institution Bulletin includes Letter from CEO, Cami Gearhart, JD, addressing support for effective human research protection programs, as well as Quorum's insights on two important topics: The first addresses exculpatory language in consent forms; the second provides insight on considerations when planning eConsent implementation and questions to ask the IRB.
Presented by Quorum Review Regulatory Attorney J. Claire Carbary, JD, CIP, and Consent Solutions President and CEO Susan G. Brink, DrPH, this presentation discusses considerations in the review and approval of eConsent processes, meeting the requirements related to documentation of IRB review and approval, the decision to use an eConsent, how an eConsent system may impact IRB process, and questions regarding what the IRB should consider
when evaluating the use of eConsent for a given study.
With the adoption of EHRs and electronic data collection, researchers, trial sponsors and IRBs are looking toward possible adoption of electronic consent processes and systems. The use of an eConsent process has many advantages. However, early consideration, planning and close coordination at the IRB review stage is important before implementation.
An Institutional Review Board (IRB) is a committee that protects research participants by thoroughly reviewing study designs, monitoring safety, and ensuring consent is obtained equitably. The IRB must have at least five members from different professions and genders. It convenes regular meetings where a majority must vote to approve research based on minimizing risks compared to potential benefits. Federal regulations require the IRB to include at least one scientific and non-scientific member, as well as a member not affiliated with the institution.
This document provides a flowchart to determine if an activity qualifies as human subjects research according to 45 CFR 46. It asks a series of yes or no questions to determine if the activity is a systematic investigation designed to develop generalizable knowledge, involves obtaining information about living individuals, and whether that information is individually identifiable or private. If the activity meets all these criteria, it qualifies as human subjects research under 45 CFR 46 and requires IRB review.
Presented by J. Claire Carbary, JD, CIP, this webinar addresses some of the common issues confronted during ethics review of advertisements, consent forms and study tools from the perspective of the IRB.
Development of effective recruitment tools and consent documents is essential to meeting enrollment goals and keeping a clinical trial moving forward.
Advertising is the beginning of the informed consent and subject selection process and sets the stage for the consent process. Understanding the regulatory and ethical obligations that form IRB evaluation of advertisements and consent forms is critical during the development of the recruitment and consent plans and tools.
Quorum Review's Institution Bulletin includes Letter from CEO, Cami Gearhart, JD, on Tuskegee Syphilis Experiment as a leading key component of today's subject protection requirements, as well as Quorum's insights on two recent FDA draft guidances: The first addresses specific IRB responsibilities and explains how an IRB may efficiently fulfill them and the second explains that researchers must obtain informed consent before initiating clinical screening for eligibility.
When designing pediatric research, one size does not fit all. Simply adapting the adult clinical study protocol into its child-sized version will not be enough to gain IRB approval.
Research involving minors must prioritize the rights, safety, and welfare of its young participants, and the FDA has issued substantial regulations to ensure pediatric research is conducted safely and ethically.
The document discusses training requirements for principal investigators and study staff conducting human subjects research. It notes that while the HHS regulations do not explicitly require training, they recommend institutions ensure investigators understand ethical principles, regulations, and policies for protecting human subjects. Most granting agencies specify required training programs. The NIH requires key personnel to describe completed human subjects protection education. The FDA Form 1572 signed by investigators also addresses responsibilities regarding clinical trial conduct and knowledge. The document recommends investigators complete institutional educational training before conducting human subjects research.
8 Surprising Reasons To Meditate 40 Minutes A Day That Can Change Your Life.pptxHolistified Wellness
We’re talking about Vedic Meditation, a form of meditation that has been around for at least 5,000 years. Back then, the people who lived in the Indus Valley, now known as India and Pakistan, practised meditation as a fundamental part of daily life. This knowledge that has given us yoga and Ayurveda, was known as Veda, hence the name Vedic. And though there are some written records, the practice has been passed down verbally from generation to generation.
Local Advanced Lung Cancer: Artificial Intelligence, Synergetics, Complex Sys...Oleg Kshivets
Overall life span (LS) was 1671.7±1721.6 days and cumulative 5YS reached 62.4%, 10 years – 50.4%, 20 years – 44.6%. 94 LCP lived more than 5 years without cancer (LS=2958.6±1723.6 days), 22 – more than 10 years (LS=5571±1841.8 days). 67 LCP died because of LC (LS=471.9±344 days). AT significantly improved 5YS (68% vs. 53.7%) (P=0.028 by log-rank test). Cox modeling displayed that 5YS of LCP significantly depended on: N0-N12, T3-4, blood cell circuit, cell ratio factors (ratio between cancer cells-CC and blood cells subpopulations), LC cell dynamics, recalcification time, heparin tolerance, prothrombin index, protein, AT, procedure type (P=0.000-0.031). Neural networks, genetic algorithm selection and bootstrap simulation revealed relationships between 5YS and N0-12 (rank=1), thrombocytes/CC (rank=2), segmented neutrophils/CC (3), eosinophils/CC (4), erythrocytes/CC (5), healthy cells/CC (6), lymphocytes/CC (7), stick neutrophils/CC (8), leucocytes/CC (9), monocytes/CC (10). Correct prediction of 5YS was 100% by neural networks computing (error=0.000; area under ROC curve=1.0).
- Video recording of this lecture in English language: https://youtu.be/kqbnxVAZs-0
- Video recording of this lecture in Arabic language: https://youtu.be/SINlygW1Mpc
- Link to download the book free: https://nephrotube.blogspot.com/p/nephrotube-nephrology-books.html
- Link to NephroTube website: www.NephroTube.com
- Link to NephroTube social media accounts: https://nephrotube.blogspot.com/p/join-nephrotube-on-social-media.html
Here is the updated list of Top Best Ayurvedic medicine for Gas and Indigestion and those are Gas-O-Go Syp for Dyspepsia | Lavizyme Syrup for Acidity | Yumzyme Hepatoprotective Capsules etc
These lecture slides, by Dr Sidra Arshad, offer a quick overview of the physiological basis of a normal electrocardiogram.
Learning objectives:
1. Define an electrocardiogram (ECG) and electrocardiography
2. Describe how dipoles generated by the heart produce the waveforms of the ECG
3. Describe the components of a normal electrocardiogram of a typical bipolar lead (limb II)
4. Differentiate between intervals and segments
5. Enlist some common indications for obtaining an ECG
6. Describe the flow of current around the heart during the cardiac cycle
7. Discuss the placement and polarity of the leads of electrocardiograph
8. Describe the normal electrocardiograms recorded from the limb leads and explain the physiological basis of the different records that are obtained
9. Define mean electrical vector (axis) of the heart and give the normal range
10. Define the mean QRS vector
11. Describe the axes of leads (hexagonal reference system)
12. Comprehend the vectorial analysis of the normal ECG
13. Determine the mean electrical axis of the ventricular QRS and appreciate the mean axis deviation
14. Explain the concepts of current of injury, J point, and their significance
Study Resources:
1. Chapter 11, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 9, Human Physiology - From Cells to Systems, Lauralee Sherwood, 9th edition
3. Chapter 29, Ganong’s Review of Medical Physiology, 26th edition
4. Electrocardiogram, StatPearls - https://www.ncbi.nlm.nih.gov/books/NBK549803/
5. ECG in Medical Practice by ABM Abdullah, 4th edition
6. Chapter 3, Cardiology Explained, https://www.ncbi.nlm.nih.gov/books/NBK2214/
7. ECG Basics, http://www.nataliescasebook.com/tag/e-c-g-basics
Muktapishti is a traditional Ayurvedic preparation made from Shoditha Mukta (Purified Pearl), is believed to help regulate thyroid function and reduce symptoms of hyperthyroidism due to its cooling and balancing properties. Clinical evidence on its efficacy remains limited, necessitating further research to validate its therapeutic benefits.
NVBDCP.pptx Nation vector borne disease control programSapna Thakur
NVBDCP was launched in 2003-2004 . Vector-Borne Disease: Disease that results from an infection transmitted to humans and other animals by blood-feeding arthropods, such as mosquitoes, ticks, and fleas. Examples of vector-borne diseases include Dengue fever, West Nile Virus, Lyme disease, and malaria.
TEST BANK For Community Health Nursing A Canadian Perspective, 5th Edition by...Donc Test
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Rasamanikya is a excellent preparation in the field of Rasashastra, it is used in various Kushtha Roga, Shwasa, Vicharchika, Bhagandara, Vatarakta, and Phiranga Roga. In this article Preparation& Comparative analytical profile for both Formulationon i.e Rasamanikya prepared by Kushmanda swarasa & Churnodhaka Shodita Haratala. The study aims to provide insights into the comparative efficacy and analytical aspects of these formulations for enhanced therapeutic outcomes.
4. • Questions & Answers
• Feel free to submit questions at
any point during the webinar
using the chat box on your
webinar dashboard
4
WEBINAR HOUSEKEEPING
• We will address a select number of questions
at the end of the presentation today.
Responses will be sent by the presenters
following the presentation for the remainder.
5. • Recording & Slide Deck
• The webinar recording and slide
deck will be posted on our
website within 5 business days
• We will email you a link to view the recording
as soon as it is available
• Feel free to share the link with your staff
and/or colleagues
5
WEBINAR HOUSEKEEPING
6. 6
ABOUT QUORUM REVIEW IRB
Accredited
Fully accredited by AAHRPP through 2014
Fully compliant with FDA and OHRP requirements
Regulatory
Leadership
6 in-house licensed attorneys providing guidance and
thought-leadership
International
Boards available for the review of U.S. and Canadian
studies
Strong
Framework
One of the largest IRBs in the U.S. with ~180 employees
Certified IRB
Professionals
(CIP)
60% of Affiliated IRB members, 40% of Regulatory staff
and 20% of study management & study support positions
7. • 14 Board meetings each week
• 24-hour site turnaround, 36-hour amendment review,
and same day site changes
• One time CV and audit documentation submission
• Support available 8am-8pm ET
• Dedicated Study Manager
7
THE QUORUM ADVANTAGE
8. • Secure portal with SmartForms, status
reports, and approval documents
• Customized Phase I and Post-Marketing
processes
• Flexible, customized process for AMCs
• 100% Quality Control on all documents
8
THE QUORUM ADVANTAGE
9. Quorum Review Regulatory Attorney
J. Claire Carbary, JD, CIP
IRB Experience
Joined Quorum Review IRB in September 2009
WIRB prior to Quorum
CIP certification since 2010
Member of the Northwest Association for
Biomedical Research (NWABR) and Public
Responsibility in Medicine and Research (PRIM&R)
Legal Background
Juris Doctor from Seattle University
Member of the Washington State Bar Association (WSBA)
Member of the Health and Corporate Law Sections of the WSBA
9
ABOUT THE PRESENTER
10. Research Involving Subjects with Limited Capacity:
IRB Expectations for Recruitment and Consent
Research Involving Children 11
Allowable Research with Children 12
Defining “Child” 16
Recruitment for Research Involving Children 20
Assent 21
Permission 27
Wards 32
Neonates 35
Research Involving Adults Requiring a Legally
Authorized Representative (LAR) 37
Allowable Research with Adults Requiring an LAR 38
Determining whether an LAR is Needed 40
Identifying an Appropriate LAR 43
Recruitment for Research with Adults Requiring an LAR 46
Assent 47
10
WEBINAR OVERVIEW
11. 11
Research
Involving
Children
“The inclusion of children in research
advances the commitment to justice in
research by improving our knowledge of,
and ability to respond to, the unique needs
of children throughout their development”
- Canadian Tri-Council Policy Statement
(TCPS 2), Ethical Conduct for Research
Involving Humans
12. Category 1:
Research not involving greater than “minimal risk”
• “Minimal Risk” means that the probability and magnitude of
harm or discomfort anticipated in the research are not greater in
and of themselves than those ordinarily encountered in daily life
or during the performance of routine physical examinations or
tests.
• Must have adequate provision for soliciting assent of children
and permission of parent/guardian
Citation: 21 CFR 50.51, 50.53; 45 CFR 46.404, 46.102(i)
Allowable Research with Children
12
13. Category 2:
Research involving greater than minimal risk but
presenting the prospect of direct benefit to the
individual subjects
• Risks must be justified by anticipated benefits
• Risk-benefit ratio must be at least as favorable as
that presented by alternative approaches
• Must have adequate provision for soliciting assent of
children and permission of parent/guardian
Citation: 21 CFR 50.52; 45 CFR 46.405
Allowable Research with Children
13
14. Category 3:
Research involving greater than minimal risk and no
prospect of direct benefit to individual subjects, but likely to
yield generalizable knowledge about the subject’s disorder
or condition
• Risk must represent a “minor” increase over minimal risk
• The intervention or procedures must present experiences
on par with those inherent in their actual or expected
“situations”
• Must have adequate provision for soliciting assent of
children and permission of both parents/guardian
Citation: 21 CFR 50.53; 45 CFR 46.406
Allowable Research with Children
14
15. Allowable Research with Children
Category 4:
Research not otherwise approvable which presents an opportunity to
understand, prevent, or alleviate a serious problem affecting the health
or welfare of children
• Must be disapproved by the IRB and sent to the Commissioner of Food and Drugs or
Secretary of HHS
• IRB must find that research presents a reasonable opportunity to further understanding,
prevention, or alleviation of a serious problem affecting the
health or welfare of children
• The Commissioner or Secretary (as applicable) must determine the
research actually meets one of the previous categories OR must agree
with IRB determination about the research and find:
o that the research will be conducted in an ethically sound manner, and
o Must have adequate provision for soliciting assent of children and
permission of parent/guardian
Citation: 21 CFR 50.54; 45 CFR 46.407
15
16. 16
“Quote involving children in research…”
Defining
“Child”
“A person’s a person,
no matter how small.”
- Dr. Suess, Horton Hears A Who!
17. Defining “Child”
Children means persons who have not attained the legal age for consent to
treatments or procedures involved in clinical investigations, under the
applicable law of the jurisdiction in which the clinical investigation will be
conducted.
Citation: 21 CFR 50.3; 45 CFR 46.402
17
18. • Most states set the age of majority at 18 or over, with some exceptions:
o Alabama- Age 19 (Ala. Code § 26-1-1)
o Nebraska- Age 19 (Nebraska Revised Statues 43-2101)
o Puerto Rico- Age 21 (21 P.R. Laws Ann. Tit. 31 § 971)
State Law & Age of Majority
Nebraska
Alabama
Puerto Rico
18
If the protocol inclusion
criterion regarding age
indicates “18 and older”, and
the research will be in these
jurisdictions, then, the research
involves “children.”
19. • Generally- minors aged 14-15 can consent to medical “treatment”
• There may be notification requirements:
o Connecticut: Minors 14 and older may consent to mental health
treatment, provided that the parents are notified within five days.
See Connecticut Gen. Stat. §21a-110.
Citation: Boonstra, Heather and Elizabeth Nash; Minors and the Right to Consent to Health Care, Guttmacher Institute,
Guttmacher Report on Public Policy, August 2000, Volume 3, Number 4
Available at: http://www.guttmacher.org/pubs/tgr/03/4/gr030404.html, accessed 08.26.2013.
State Law &
Consent to Medical Care vs. Research
19
If the research involves
procedures or
interventions that are not
treatment, it is likely
parental permission is
needed.
Connecticut
20. • Payments
o Who is paid?
o Type of payment?
• Advertisements
o Where are you advertising?
o Directed to children or parents?
Recruitment for
Research Involving Children
20
• Understandability
o Is advertisement or recruitment
aimed at children written at an
appropriate grade
level?
• Therapeutic misconception
ENROLL
YOUR CHILD
TODAY!
22. Assent means a child's affirmative
agreement to participate in a clinical
investigation. Mere failure to object
should not, absent affirmative
agreement, be construed as assent.
Citation: 21 CFR 50.3; 45 CFR 46.402
22
What is Assent?
23. The IRB must determine whether “adequate
provisions are made for soliciting the assent
of children WHEN…the children are capable
of providing assent”
If the IRB determines the capability of some
or all of the children is so limited that they
cannot reasonably be consulted or that the
intervention or procedure involved in the
research holds out the 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, the assent of
the children is not a necessary condition for
proceeding with the research.
Citation: (21 CFR 50.55(a); 45 CFR 46.408(a)
23
When is Assent of Children Required?
24. 24
State Laws
Regarding Assent for Research
• Illinois: Minors must consent when considered “capable.”
(405 ILCS 5/2-110 774 Ad. Code 260.1900 (2010)).
• Maine: Subjects between the age of
12-18 must provide consent unless they
are unable to do so in addition to
parent/guardian consent.
(CMR 14-472001 (XI)(H)(3)(c)(2010)).
• Massachusetts: Informed consent cannot be
given on behalf of a minor who has refused consent.
(105 CMR 700.009(E)(4)).
• California: If subject is older than 7 years or older - must provide consent themselves.
(California Health and Saf. Code § 111530 (2012).
California
Illinois
Maine
Massachusetts
25. The IRB should take into account:
• Ages of the participants
• Maturity level
• Psychological state
Citation: 21 CFR 50.55(a); 45 CFR 46.408(a)
25
Factors to Consider when determining
whether Assent is required
26. • Written assent forms for ages that
would typically be reading
• Reading level should match age-
range of participants (might need
multiple assent forms)
• Consider including images to explain
concepts
• Consider an electronic-based
approach to assent
• Signature or not?
Obtaining Assent
28. • The IRB must determine that the
permission of each child’s parents
or guardian is granted
• For categories 1 and 2 of research
involving children - the IRB may
determine that the permission of
one parent is sufficient, otherwise
permission of both parents is
required
• The signature of the second parent
is not required if that parent
is deceased, unknown,
incompetent, or not reasonably
available
Citation: 21 CFR 50.55 (e); 45 CFR 46.408(b)
Parental Permission
29. Permission means the agreement of
parent(s) or guardian to the participation of
their child or ward in a clinical investigation.
Parent means a child's biological or adoptive
parent.
Guardian means an individual who is
authorized under applicable State or local law
to consent on behalf of a child to general
medical care.
Citation: 21 CFR 50.3; 45 CFR 46.402
29
Permission for Children to
Participate in Research
30. • Legally effective consent
of children is required if
the research is ongoing
(including data collection)
• Remote consent may be
needed
• If this is anticipated,
develop a consent form to
be signed by adolescents
that will reach the age of
majority during the
research
30
When Children Become Adults
31. 31
Minor Parents
• Minor parents are still parents
• May not be able to consent for themselves
but can consent for their children.
o Delaware: a minor parent may
consent for medical treatment for
his/her child
(13 Del. C. §707 (2010).
o Maryland: minors who are parents
may consent to healthcare treatment.
Md. Health Code 20-102-20-104 (2010).
o Minnesota: Minor parents may
consent to health care.
(Minn. R 952S.3050.)
• This can complicate consent for some
studies (example: pregnancy exposure
registry that would follow mother and child)
Minnesota
Maryland
Delaware
32. 32
Research Involving “Wards”
Ward means a child who is placed in the legal custody of the State or other
agency, institution, or entity, consistent with applicable Federal, State, or local law.
Citation: Citation: 21 CFR 50.3; 45 CFR 46.402
33. 33
Additional Federal Requirements
for Research Involving “Wards”
Research that would not provide direct benefit (Categories 3 and 4) is not
allowable unless the research meets one of the following requirements:
1. Relates to their status as wards; or
2. Is conducted in schools, camps, hospitals, institutions, or similar settings in which the
majority of children involved as subjects are not wards.
Citation: 21 CFR 50.56(a); 45 CFR 46.409(a).
34. 34
Research Involving Wards
and State Law
State laws may provide additional protections for children-further restricting
research involving wards of the state.
• Alabama: Juveniles in residential facilities are not permitted to be subjects in medical
or pharmaceutical experiments (Alabama- Ala Admin. Code r. 950-1-6-.03 (6)(d))
• New Hampshire: Guardian of a minor cannot consent to experimental treatment of any
kind unless approved by order of a court
(New Hampshire Revised Statutes Annotated 463:12).
.
New Hampshire
Alabama
35. 35
Research Involving Neonates
• Research involving viable neonates- is subject to the requirements for the standard Subpart D
requirements for research involving children
• Research involving neonates of uncertain viability and nonviable neonates is subject to a
number of additional requirements:
o Where scientifically appropriate, preclinical and clinical studies have been conducted and provide data
for assessing potential risks to neonates.
o Individuals providing consent must be fully informed regarding the reasonably foreseeable impact of the
research on the neonate.
o Individuals engaged in the research can have no part in determining the viability of a neonate.
Neonates of uncertain viability.
Research must potentially enhance the
probability of survival of the neonate to
the point of viability, and any risk is the
least possible for achieving that
objective, OR
The purpose of the research is the
development of important biomedical
knowledge which cannot be obtained by
other means and there will be no added
risk to the neonate resulting from the
research; and
Consent of one parent
Nonviable neonates.
Vital functions of the neonate will not be
artificially maintained for research;
Research will not terminate the
heartbeat or respiration of the neonate;
There will be no added risk to the
neonate resulting from the research;
The purpose of the research is the
development of important biomedical
knowledge that cannot be obtained by
other means; and
Consent of both parents (unless one is
not available) - consent by LAR is not
acceptable
36. Ramifications of storing tissue/specimens
– Data privacy concerns due to limited ability to “de-identify” data
– Genetic markers discovered in the future could identify risk for developing
diseases or conditions
– Growing concerns may lead to laws impacting genetic testing-
• Example: Genetic testing on minors can only be performed with the consent of the
parent/legal guardian and written informed consent of the minor
(Arizona A.R.S. § 12-2803)
36
Specimens & Genetic Testing –
Research Involving Children
37. 37
Research
Involving
Incapacitated
“In keeping with the principle of Justice,
those who lack the capacity to consent on
their own behalf must neither be unfairly excluded
from the potential benefits of research participation,
nor may their lack of capacity to consent be used
to inappropriately include them in research.”
- Canadian Tri-Council Policy Statement (TCPS 2),
Ethical Conduct for Research Involving Humans
Adults
38. • Earliest version of the Nuremberg Code only allowed
subjects to consent for themselves
• No federal regulatory restrictions on the research in the
U.S. Proposed additional regulations in 1978 for
research involving the “institutionalized mentally infirm”
were never finalized
• The International Conference on Harmonisation of
Technical Requirements for Registration of
Pharmaceuticals for Human Use, Guideline for Good
Clinical Practice (ICH-GCP) (E6) provides guidance on
research involving incapacitated adults
38
Allowable Research Involving Adults
Requiring an LAR
Citation: National Bioethics Advisory Commission. Research involving persons with
mental disorders that may affect decision-making capacity: report and recommendations,
December 1998.
39. Non-therapeutic trials may be conducted in subjects with consent of a legally
acceptable representative provided the following conditions are fulfilled:
(a) The objectives of the trial cannot be met by means of a trial in subjects who can give informed consent
personally.
(b) The foreseeable risks to the subjects are low.
(c) The negative impact on the subject’s well-being is minimized and low.
(d) The trial is not prohibited by law.
(e) The approval/favorable opinion of the IRB/IEC is expressly sought on the inclusion of such subjects,
and the written approval/ favorable opinion covers this aspect.
Such trials unless an exception is justified, should be conducted in subjects having a
disease or condition for which the investigational product is intended. Participants in
these trials should be particularly closely monitored and should be withdrawn if they
appear to be unduly distressed.
Citation: ICH GCP E6
39
Allowable Research Involving Adults
Requiring an LAR
40. “It is generally agreed that a prospective
subject’s capacity to decide whether to
participate in a particular research project
cannot be determined through a general mental
status assessment. Instead, investigators must
develop and present the specific material
relevant to that project and evaluate the
prospective subject’s understanding and
appreciation of that information.”
40
Standards for Assessing Capacity
Citation: National Citation: National Bioethics Advisory Commission. Research involving persons
with mental disorders that may affect decision-making capacity: report and recommendations,
December 1998.
41. • Protocol may dictate the tools or process that should be used to
assess capacity- for example specific scores on the MMSE
• Should be conducted by the person obtaining consent
• Depending on risk/benefit ratio and other factors- an independent
capacity assessment might be warranted
• Evaluate for:
– Ability to evidence a choice (express their preference)
– Ability to understand relevant information
– Ability to appreciate the situation and its likely consequences
– Ability to manipulate information rationally
Citation: Bankert, Elizabeth A. and Robert J. Amdur, Institutional Review Board Management and Function, 2nd Edition,
Research Involving Adults with Decisional Impairments, 2006. Leo, Raphael J., Competency and the Capacity to Make
Treatment Decisions: A Primer for Primary Care Physicians, Prim Care Companion J Clin Psychiatry. 1999 October; 1(5):
131-141.
41
Capacity Assessment
42. • Idaho: “Any person with sufficient intelligence and awareness to
understand the necessity of, nature of, and significant risks involved in
any medical treatment is competent to consent to the treatment.”
(Idaho Code § 39-4502 (2010).
42
State Law Definitions of Capacity
Idaho
43. 43
Identifying an appropriate LAR
Legally authorized representative
means an individual or judicial or other
body authorized under applicable law
to consent on behalf of a prospective
subject to the subject's participation in
the procedure(s) involved in the
research.
Family member means any one of the
following legally competent persons:
Spouse; parents; children (including
adopted children); brothers, sisters,
and spouses of brothers and sisters;
and any individual related by blood or
affinity whose close association with
the subject is the equivalent of a
family relationship.
Citation: 21 CFR 50.3; 45 CFR 46.102
44. 44
State Law and LARs
for Incapacitated Adults
• General order of authority for consent
o Agent/guardian with authority to make health care decision on person’s
behalf
o Spouse /Domestic Partner
o Adult children
o Custodial parent
o Adult sibling
o Adult grandchild
o Available adult relative with closest degree of kinship
• If there are multiple people at the same level- they generally
must all agree (for example- siblings or children) unless one
is the designated agent under an advance health care
directive
• U.S. jurisdictions with civil unions or same-sex marriage:
o Civil Unions: Colorado, Hawaii, Illinois, and New Jersey
o Same-sex marriage: California, Connecticut, Delaware, Iowa, Maine,
Maryland, Massachusetts, Minnesota, New Hampshire, New York,
Rhode Island, Vermont, Washington and the District of Columbia
o Domestic Partnerships: Nevada, Wisconsin, Oregon, and the District
of Columbia (for both same-sex and opposite-sex couples)
Same-Sex Marriage
Civil Unions
Domestic Partnerships
45. Colorado: If a patient is not competent to provide consent the
physician must make efforts to locate as many interested persons
(spouse, parent, adult child, sibling, grandchild or close friend) as
possible and inform them of the patient’s lack of decision-making
authority so the interested persons may select a proxy. (Colorado-
C.R.S. 15-18.5-103(3)).
Colorado: Experimental research involving developmentally disabled
individuals is prohibited without consent and a non-affiliated
interdisciplinary team is consulted
(Colorado—C.R.S. § 27-10.5-114 (7)).
Delaware: Restrictions on research involving residents in a state-
operated mental health institution include: objective psychiatrist to
monitor capacity to provide consent, witness of consent process and
documentation with signature on the consent form—special state-run
IRB review. (16 Del. C. §5171-5175).
Minnesota: The guardian of a patient at a mental health institution
cannot provide consent to research participation unless a court initially
grants approval. (Minn. R §952S.3060).
New Jersey: A public guardian for an elderly individual cannot consent
to medical experimentation without the permission of the court. (N.J.St.
52:27G-26).
45
State Law and Permission for
Incapacitated Adults
Minnesota
Colorado
New Jersey
Delaware
46. • Advertising
– Care providers or LARs
– Support groups
• Consider Logistics
– Payment or services
– Ease of access to
sites/parking, etc.
• Therapeutic Misconception
46
Recruitment for Research Involving
Incapacitated Adults
47. “When a trial (therapeutic or non-
therapeutic) includes subjects who can
only be enrolled in the trial with the
consent of the subject’s legally
acceptable representative (e.g. minors
or patients with severe dementia), the
subject should be informed about the
trial to the extent compatible with the
subject’s understanding and, if capable,
the subject should sign and personally
date the written informed consent.”
Citation: ICH GCP E6, Section 4.8.12
47
Assent for Adults Requiring an LAR
48. • Missouri: Consent cannot be provided if the
incompetent adult expressly declines to participate
in the research. (R.S.Mo. § 431.064).
• Indiana: Mental Health patients must be informed
of the investigator’s credentials, the risks and
benefits of participating in the clinical study, and
their ability to revoke consent. (Burns Ind. Code
Ann. § 16-36-1.5-10).
• New Mexico: Involuntary commitment to a mental
institution does not necessarily mean the patient is
incapable of providing consent to research. (New
Mexico-N.M. Stat. Ann. §43-1-15).
48
State Law & Assent from Adults
Requiring an LAR
New Mexico
Missouri
Indiana
49. • There are several additional
considerations when utilizing proxy
consent for research involving children and
incapacitated adults in research.
• It is important to be aware of the legal
requirements and ethical guidelines when:
– Designing research
– Developing recruitment, and
– Approaching the consent process
SUMMARY
49
50. • You may submit questions during our webinar
survey, or…
• You may email your questions to:
clientrelations@quorumreview.com
• We will do our best to follow-up individually or
answer your questions in the Q&A we post on
our website
50
ADDITIONAL QUESTIONS
51. • The webinar Recording, Slide Deck,
and Q&A will be posted on our
website
• We will email you a link to view
these items as they become
available
• We value your opinion – please take
our SURVEY and provide us with
feedback
51
WEBINAR FOLLOW-UP
54. fully accredited since 2006
September 10 & 12, 2013
Research Involving
Subjects with Limited Capacity:
IRB Expectations for Recruitment and Consent