The document discusses informed consent regulations for research using leftover human biospecimens. It argues that moving to a broad consent standard could undermine public trust by prioritizing medical discovery over patient rights and privacy. Broad consent forms may confuse patients and fail to prevent unforeseen future uses of their genetic data. The regulations do not sufficiently prevent re-identification of specimens. Amendments are needed to clarify allowed re-identification circumstances and require prior written authorization. Separating informed consent for treatment from broad consent for unspecified future research allows patients to proceed with procedures without implied consent to downstream uses of their specimens.
The document provides an overview of 10 topics for a biomedical sciences portfolio, including:
1. The Human Tissue Act which regulates the use and storage of human tissue and requires consent.
2. HCPC standards of proficiency for biomedical scientists which outline requirements for registration including practicing safely, ethically and maintaining confidentiality.
3. Pre-analytical variables in emergency departments which can cause errors like misidentification and hemolysis affecting test accuracy.
4. Advantages and disadvantages of point of care testing including faster results but risks of improper sample collection and lack of records.
5. The SHOT report which analyzes transfusion risks and recommendations to improve safety based on reported adverse events and
Evaluation of sex specific data in medical device clinical studiesSalutaria
This document provides guidance from the FDA to encourage the evaluation of sex-specific data in medical device clinical studies. It aims to improve the quality of data on how devices perform in both sexes by recommending appropriate enrollment of women and men in studies. The guidance outlines recommendations for study design, conduct, analysis and reporting of data to better understand potential differences in device safety or effectiveness between sexes. This includes considering sex during study planning, pre-specifying sex-specific statistical analysis, and reporting enrollment demographics and outcomes by sex. The goal is to provide more useful information to patients, doctors and researchers on device performance in both female and male populations.
This document discusses alternative approaches to 100% source data verification (SDV) in clinical trials, specifically risk-based SDV. It evaluates the pros and cons of different SDV approaches, including the FDA-supported risk-based approach. The document proposes modifying the SDV process using a risk-based approach to focus monitoring on critical data elements rather than all data, which could reduce costs without undermining data integrity. Literature on SDV approaches and extent of monitoring is reviewed, and factors to consider in a risk-based approach are discussed.
The FDA oversees clinical trials through inspections and monitoring. The FDA can inspect sponsor and investigator records and reports relating to clinical trials. Sponsors are responsible for monitoring trials and selecting qualified monitors. The FDA's Bioresearch Monitoring Program conducts inspections using compliance program manuals to inspect clinical investigators, sponsors, IRBs, and nonclinical laboratories. Inspections verify compliance and ensure accurate and reliable trial data.
FDA's David L. Daly July 2002 Response and Denial to include CNS shunts in ne...Stephen Dolle
The letter responds to a request to add CNS shunts to a postmarket surveillance list under Section 522 of the FDA. It apologizes for the delayed response. While CNS shunts meet the criteria of being a Class II implantable device, the FDA believes postmarket surveillance is not needed as issues are related to understanding the disease and improving device materials, not significant postmarket safety questions. The letter states postmarket surveillance would not provide benefit and manufacturers will not be required to conduct it for CNS shunts.
Patient Advocate Stephen Dolle's FDA Stamp Conference RecommendationsStephen Dolle
This is a paper of FDA STAMP Conference recommendations FDA patient advocate and CNS shunt user Stephen Dolle, which he wrote for this 1999 Conference in Bethesda, MD, a conference he was responsible for, yet was not invited to speak on panel, nor was his new solution oriented DiaCeph Test included in the conference. STAMP was held in part due to Dolle's 1996 FDA petition on anti siphon shunts, of which he was an affected user, and FDA upheld, but oddly withheld their Sept. 1998 ruling from the Federal Register. Dolle did everything he could possibly do to bring progress in CNS shunts, yet wasn't allowed.
You can read from his recommendations back in 1999 that he had a vision to bring progress in this area. Since 1999, CNS shunts have been plagued by widespread device failures, more notably programmable shunts.
CNS shunts users today face new risks from years of over use of CT scanning, which DiaCeph would have reduced. Some patients have had as many as 100 and 200.
I can be reached at contact[at]dollecommunications[dot]com and via my blog.
The document discusses determining quality indicators for health information. Interviews with clinicians identified 21 quality criteria they use to evaluate health information. The criteria fall into objective and subjective categories. A prototype was developed to detect the criteria within a health record standard and model the results as quality indicators that could be presented to clinicians. The goal is to help clinicians safely rely on health information by highlighting important quality criteria.
This document provides a summary of the work experience and qualifications of Venkatakrishna Shyamala, Ph.D. It outlines her extensive experience in molecular diagnostics and blood testing spanning over 30 years, including roles leading research and development teams at multiple biotech companies. Her areas of expertise include assay development, scientific affairs, and evaluating nucleic acid testing technologies.
The document provides an overview of 10 topics for a biomedical sciences portfolio, including:
1. The Human Tissue Act which regulates the use and storage of human tissue and requires consent.
2. HCPC standards of proficiency for biomedical scientists which outline requirements for registration including practicing safely, ethically and maintaining confidentiality.
3. Pre-analytical variables in emergency departments which can cause errors like misidentification and hemolysis affecting test accuracy.
4. Advantages and disadvantages of point of care testing including faster results but risks of improper sample collection and lack of records.
5. The SHOT report which analyzes transfusion risks and recommendations to improve safety based on reported adverse events and
Evaluation of sex specific data in medical device clinical studiesSalutaria
This document provides guidance from the FDA to encourage the evaluation of sex-specific data in medical device clinical studies. It aims to improve the quality of data on how devices perform in both sexes by recommending appropriate enrollment of women and men in studies. The guidance outlines recommendations for study design, conduct, analysis and reporting of data to better understand potential differences in device safety or effectiveness between sexes. This includes considering sex during study planning, pre-specifying sex-specific statistical analysis, and reporting enrollment demographics and outcomes by sex. The goal is to provide more useful information to patients, doctors and researchers on device performance in both female and male populations.
This document discusses alternative approaches to 100% source data verification (SDV) in clinical trials, specifically risk-based SDV. It evaluates the pros and cons of different SDV approaches, including the FDA-supported risk-based approach. The document proposes modifying the SDV process using a risk-based approach to focus monitoring on critical data elements rather than all data, which could reduce costs without undermining data integrity. Literature on SDV approaches and extent of monitoring is reviewed, and factors to consider in a risk-based approach are discussed.
The FDA oversees clinical trials through inspections and monitoring. The FDA can inspect sponsor and investigator records and reports relating to clinical trials. Sponsors are responsible for monitoring trials and selecting qualified monitors. The FDA's Bioresearch Monitoring Program conducts inspections using compliance program manuals to inspect clinical investigators, sponsors, IRBs, and nonclinical laboratories. Inspections verify compliance and ensure accurate and reliable trial data.
FDA's David L. Daly July 2002 Response and Denial to include CNS shunts in ne...Stephen Dolle
The letter responds to a request to add CNS shunts to a postmarket surveillance list under Section 522 of the FDA. It apologizes for the delayed response. While CNS shunts meet the criteria of being a Class II implantable device, the FDA believes postmarket surveillance is not needed as issues are related to understanding the disease and improving device materials, not significant postmarket safety questions. The letter states postmarket surveillance would not provide benefit and manufacturers will not be required to conduct it for CNS shunts.
Patient Advocate Stephen Dolle's FDA Stamp Conference RecommendationsStephen Dolle
This is a paper of FDA STAMP Conference recommendations FDA patient advocate and CNS shunt user Stephen Dolle, which he wrote for this 1999 Conference in Bethesda, MD, a conference he was responsible for, yet was not invited to speak on panel, nor was his new solution oriented DiaCeph Test included in the conference. STAMP was held in part due to Dolle's 1996 FDA petition on anti siphon shunts, of which he was an affected user, and FDA upheld, but oddly withheld their Sept. 1998 ruling from the Federal Register. Dolle did everything he could possibly do to bring progress in CNS shunts, yet wasn't allowed.
You can read from his recommendations back in 1999 that he had a vision to bring progress in this area. Since 1999, CNS shunts have been plagued by widespread device failures, more notably programmable shunts.
CNS shunts users today face new risks from years of over use of CT scanning, which DiaCeph would have reduced. Some patients have had as many as 100 and 200.
I can be reached at contact[at]dollecommunications[dot]com and via my blog.
The document discusses determining quality indicators for health information. Interviews with clinicians identified 21 quality criteria they use to evaluate health information. The criteria fall into objective and subjective categories. A prototype was developed to detect the criteria within a health record standard and model the results as quality indicators that could be presented to clinicians. The goal is to help clinicians safely rely on health information by highlighting important quality criteria.
This document provides a summary of the work experience and qualifications of Venkatakrishna Shyamala, Ph.D. It outlines her extensive experience in molecular diagnostics and blood testing spanning over 30 years, including roles leading research and development teams at multiple biotech companies. Her areas of expertise include assay development, scientific affairs, and evaluating nucleic acid testing technologies.
Michael Cea ISSCR 2015 Stem Cell Research Guideline Review Commentsms emporda
Michael Cea, an analyst/advocate, submitted comments on the ISSCR 2015 Draft Guidelines for Stem Cell Science and Clinical Translation. Some of his general comments included: (1) suggesting consolidating the informed consent sections for research and therapeutic use; (2) balancing language between deriving knowledge and prudent research; (3) providing an interactive online/offline version of the final draft. Cea also provided over 30 specific comments and recommendations, primarily addressing informed consent processes, definitions, clinical trial guidelines, and communication standards.
The document summarizes an audit of the Dallas County Crime Lab (SWIFS) conducted over 4 days in February 2008 by the American Society of Crime Lab Directors Laboratory Accreditation Board (ASCLD-LAB). The audit assessed over 2000 pages of manuals and procedures across 5 units for accuracy and compliance with standards. Inspectors also reviewed the building layout, safety, security, and interviewed about 50 analysts. The audit occurs every 5 years for the lab to maintain accreditation.
The document is a draft of guidelines for stem cell research and clinical translation being revised by an ISSCR task force. It invites readers to provide feedback by September 10th to help finalize the guidelines, which aim to advance stem cell science safely and ethically. The guidelines are based on principles of integrity in research, respect for human participants, and social justice.
FDA STAMP Conference on CNS Shunts Agenda January 1999Stephen Dolle
Conference agenda for the 1999 STAMP Conference on CNS Shunts and anti siphon devices in Bethesda, MD, brought about by patient advocate Stephen Dolle and his efforts with a 1996 petition to FDA on anti siphon shunts. Dolle oddly was not invited to speak or be a panelist, or to have his new mHealth DiaCeph Test included in the conference. In the years since, CNS shunts have suffered significant medical device and design failures, most of which have not been reported to FDA, which Dolle attributes to the cover ups dating back to this conference. As of 2015, Dolle has undergone 12 shunt operations, with the majority of these caused by failing CNS shunts that were never reported to FDA. The more your know!
This document analyzes the ethical considerations of conducting randomized controlled trials of the RRV-TV rotavirus vaccine in developing countries. It discusses four key ethical requirements: scientific validity, social value, favorable risk-benefit ratio, and collaborative partnership. Scientific validity requires the trials have a valid design and use reliable data. Social value means the trials must demonstrate important health benefits for developing countries. Risk-benefit ratio means the trials must ensure participants' safety and welfare. Collaborative partnership between researchers and host communities is needed to minimize exploitation and respect local contexts. The dilemma is enabling subjects to benefit from research while protecting their wellbeing and safety.
Genomic investigations often produce more information than is initially expected. Several documents have addressed this issue. While the approaches to the management of incidental findings (IFs) vary, it is usually recommended that the information be disclosed if there is clinical utility and the possibility of prevention or treatment. This leaves unsolved fundamental issues such as the different ways of interpreting clinical utility and countless sources of uncertainty. Guidelines can offer indications but should not be allowed to relieve healthcare professionals of their responsibilities.
This randomized controlled trial investigated whether early administration of a single high dose of 540,000 IU of vitamin D3 would reduce 90-day mortality in critically ill patients with vitamin D deficiency. 1360 patients screened vitamin D deficient and underwent randomization to receive either vitamin D3 or placebo within 12 hours of ICU admission. 1078 patients had baseline vitamin D deficiency (<20 ng/mL) confirmed by liquid chromatography-tandem mass spectrometry and comprised the primary analysis population. The trial found no significant difference in 90-day mortality between those receiving vitamin D3 (23.5%) versus placebo (20.6%), and no differences in other clinical or safety outcomes.
The document discusses informed consent, including its purpose, history, principles, elements, documentation, and common audit findings. Informed consent is a process of communicating with research participants to ensure they understand the study and can choose to participate voluntarily. It involves providing information on the study's risks and benefits and obtaining signed documentation of consent. Revisions are needed if the study procedures change, and special considerations apply for populations like children, non-English speakers, and the illiterate.
The FDA revoked the EUA for chloroquine phosphate and hydroxychloroquine sulfate to treat COVID-19 based on new clinical trial data. New data showed the suggested dosages were unlikely to produce an antiviral effect and a large randomized controlled trial found no evidence of benefit for mortality or other outcomes. Based on this new information, the FDA determined the criteria for issuing the EUA were no longer met and revoked the authorization to protect public health and safety.
INFORMED CONSENT: Pledge, Promise, Contract or Platitude? Key Aspects of Inf...Michael Swit
A discussion of the various theories of how informed consent operates under the law, who is bound by it, who is liable for a breach, and key cases relating to access to drugs.
This document provides an informed consent form for a clinical trial studying the investigational drug KW-2478 in combination with Bortezomib for the treatment of relapsed or refractory multiple myeloma. The summary includes:
1) The study involves two phases to evaluate safety and effectiveness of the drug combination over 28 months total, with screening tests performed over 3 weeks prior to enrollment.
2) Participants will undergo 8 treatment cycles for Phase I and 6 cycles for Phase II, each involving scheduled visits for drug administration and monitoring over 2 months.
3) Potential risks of the study drugs include side effects like headache, nausea, and peripheral neuropathy, with unforeseen risks also possible given the investigational
Around 1 in 10 healthcare workers involved in tracheal intubation of patients with suspected or confirmed COVID-19 subsequently reported a COVID-19 outcome according to a prospective international study. The study found that 10.7% of 1718 healthcare workers from 503 hospitals in 17 countries reported a COVID-19 diagnosis or symptoms requiring self-isolation or hospitalization within a median follow-up of 32 days after performing or assisting with tracheal intubations. The risk varied by country and was higher in women, but not associated with other factors. This highlights the potential occupational hazard for healthcare workers conducting high-risk aerosol-generating procedures during the COVID-19 pandemic.
Clinical Trial Feasibility using Healthcare Datashc66columbia
Qiagram is business intelligence software that allows non-programmers to explore and analyze large, complex datasets through an intuitive diagramming interface. It communicates with multiple data sources to help clinical trial teams conduct in silico feasibility studies. These studies use real-world evidence like electronic health records to better estimate patient enrollment numbers and timelines. This helps address the high failure rate of trials due to poor enrollment and delays. Qiagram enables investigators to dynamically apply and adjust trial criteria to rapidly identify eligible patient profiles within datasets and optimize trial design.
This document provides an overview of oral diagnosis and laboratory investigation processes. It discusses obtaining a thorough medical history from patients, conducting comprehensive oral examinations, establishing differential diagnoses, and ordering appropriate laboratory tests and diagnostic imaging to reach final diagnoses. Key steps in the diagnostic process include gathering patient histories, examining patients, developing differential diagnoses, acquiring additional test results, and formulating treatment plans. The document also covers specific examination techniques, types of biopsy and imaging procedures, interpreting laboratory results, and documenting findings in SOAP notes.
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.
This document discusses digital pathology and its potential to address challenges facing anatomic pathology in Canada. It summarizes the current process which involves biopsy samples being prepared as slides that pathologists physically examine under microscopes. It notes pathology is essential for healthcare but faces issues like unequal rural access, inefficient manual processes, and increasing workload. Digital pathology could help by allowing virtual slide sharing to improve access, and using image analysis to increase efficiency and allow pathologists to handle higher caseloads. This represents a new frontier with the potential to enhance pathology services in Canada.
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.
Dokumen tersebut membahas tentang penggunaan teknologi informasi dalam pendidikan, khususnya biologi. Beberapa metode yang dijelaskan adalah pembelajaran berbasis komputer (CBT), berbasis web (WBT), e-learning, dan penggunaan blog. Metode-metode tersebut memanfaatkan komputer dan internet untuk menyampaikan materi pembelajaran secara interaktif dan fleksibel.
Global Examples of Renewable Energy and Their Futures in the United StatesKirk Williamson, MPH
This document summarizes global examples of renewable energy implementation with a focus on geothermal energy in Iceland and opportunities for the United States. Iceland has successfully harnessed geothermal energy, providing heat to 90% of homes and meeting 30% of electricity needs. Despite similar geological conditions, Hawaii has been less proactive in developing geothermal energy due to some cultural issues. The document argues Hawaii and other US regions could benefit economically and environmentally from increased geothermal energy development with proper research, support and engagement with indigenous communities.
La ingeniería biomédica se dedica al diseño y construcción de equipos médicos, prótesis, dispositivos médicos y de diagnóstico y terapia aplicando principios de ingeniería a la medicina. Combina la experiencia de la ingeniería con las necesidades médicas para mejorar la atención médica. También gestiona los recursos técnicos hospitalarios y se considera de naturaleza multidisciplinaria al integrar conocimientos de diversas áreas.
Michael Cea ISSCR 2015 Stem Cell Research Guideline Review Commentsms emporda
Michael Cea, an analyst/advocate, submitted comments on the ISSCR 2015 Draft Guidelines for Stem Cell Science and Clinical Translation. Some of his general comments included: (1) suggesting consolidating the informed consent sections for research and therapeutic use; (2) balancing language between deriving knowledge and prudent research; (3) providing an interactive online/offline version of the final draft. Cea also provided over 30 specific comments and recommendations, primarily addressing informed consent processes, definitions, clinical trial guidelines, and communication standards.
The document summarizes an audit of the Dallas County Crime Lab (SWIFS) conducted over 4 days in February 2008 by the American Society of Crime Lab Directors Laboratory Accreditation Board (ASCLD-LAB). The audit assessed over 2000 pages of manuals and procedures across 5 units for accuracy and compliance with standards. Inspectors also reviewed the building layout, safety, security, and interviewed about 50 analysts. The audit occurs every 5 years for the lab to maintain accreditation.
The document is a draft of guidelines for stem cell research and clinical translation being revised by an ISSCR task force. It invites readers to provide feedback by September 10th to help finalize the guidelines, which aim to advance stem cell science safely and ethically. The guidelines are based on principles of integrity in research, respect for human participants, and social justice.
FDA STAMP Conference on CNS Shunts Agenda January 1999Stephen Dolle
Conference agenda for the 1999 STAMP Conference on CNS Shunts and anti siphon devices in Bethesda, MD, brought about by patient advocate Stephen Dolle and his efforts with a 1996 petition to FDA on anti siphon shunts. Dolle oddly was not invited to speak or be a panelist, or to have his new mHealth DiaCeph Test included in the conference. In the years since, CNS shunts have suffered significant medical device and design failures, most of which have not been reported to FDA, which Dolle attributes to the cover ups dating back to this conference. As of 2015, Dolle has undergone 12 shunt operations, with the majority of these caused by failing CNS shunts that were never reported to FDA. The more your know!
This document analyzes the ethical considerations of conducting randomized controlled trials of the RRV-TV rotavirus vaccine in developing countries. It discusses four key ethical requirements: scientific validity, social value, favorable risk-benefit ratio, and collaborative partnership. Scientific validity requires the trials have a valid design and use reliable data. Social value means the trials must demonstrate important health benefits for developing countries. Risk-benefit ratio means the trials must ensure participants' safety and welfare. Collaborative partnership between researchers and host communities is needed to minimize exploitation and respect local contexts. The dilemma is enabling subjects to benefit from research while protecting their wellbeing and safety.
Genomic investigations often produce more information than is initially expected. Several documents have addressed this issue. While the approaches to the management of incidental findings (IFs) vary, it is usually recommended that the information be disclosed if there is clinical utility and the possibility of prevention or treatment. This leaves unsolved fundamental issues such as the different ways of interpreting clinical utility and countless sources of uncertainty. Guidelines can offer indications but should not be allowed to relieve healthcare professionals of their responsibilities.
This randomized controlled trial investigated whether early administration of a single high dose of 540,000 IU of vitamin D3 would reduce 90-day mortality in critically ill patients with vitamin D deficiency. 1360 patients screened vitamin D deficient and underwent randomization to receive either vitamin D3 or placebo within 12 hours of ICU admission. 1078 patients had baseline vitamin D deficiency (<20 ng/mL) confirmed by liquid chromatography-tandem mass spectrometry and comprised the primary analysis population. The trial found no significant difference in 90-day mortality between those receiving vitamin D3 (23.5%) versus placebo (20.6%), and no differences in other clinical or safety outcomes.
The document discusses informed consent, including its purpose, history, principles, elements, documentation, and common audit findings. Informed consent is a process of communicating with research participants to ensure they understand the study and can choose to participate voluntarily. It involves providing information on the study's risks and benefits and obtaining signed documentation of consent. Revisions are needed if the study procedures change, and special considerations apply for populations like children, non-English speakers, and the illiterate.
The FDA revoked the EUA for chloroquine phosphate and hydroxychloroquine sulfate to treat COVID-19 based on new clinical trial data. New data showed the suggested dosages were unlikely to produce an antiviral effect and a large randomized controlled trial found no evidence of benefit for mortality or other outcomes. Based on this new information, the FDA determined the criteria for issuing the EUA were no longer met and revoked the authorization to protect public health and safety.
INFORMED CONSENT: Pledge, Promise, Contract or Platitude? Key Aspects of Inf...Michael Swit
A discussion of the various theories of how informed consent operates under the law, who is bound by it, who is liable for a breach, and key cases relating to access to drugs.
This document provides an informed consent form for a clinical trial studying the investigational drug KW-2478 in combination with Bortezomib for the treatment of relapsed or refractory multiple myeloma. The summary includes:
1) The study involves two phases to evaluate safety and effectiveness of the drug combination over 28 months total, with screening tests performed over 3 weeks prior to enrollment.
2) Participants will undergo 8 treatment cycles for Phase I and 6 cycles for Phase II, each involving scheduled visits for drug administration and monitoring over 2 months.
3) Potential risks of the study drugs include side effects like headache, nausea, and peripheral neuropathy, with unforeseen risks also possible given the investigational
Around 1 in 10 healthcare workers involved in tracheal intubation of patients with suspected or confirmed COVID-19 subsequently reported a COVID-19 outcome according to a prospective international study. The study found that 10.7% of 1718 healthcare workers from 503 hospitals in 17 countries reported a COVID-19 diagnosis or symptoms requiring self-isolation or hospitalization within a median follow-up of 32 days after performing or assisting with tracheal intubations. The risk varied by country and was higher in women, but not associated with other factors. This highlights the potential occupational hazard for healthcare workers conducting high-risk aerosol-generating procedures during the COVID-19 pandemic.
Clinical Trial Feasibility using Healthcare Datashc66columbia
Qiagram is business intelligence software that allows non-programmers to explore and analyze large, complex datasets through an intuitive diagramming interface. It communicates with multiple data sources to help clinical trial teams conduct in silico feasibility studies. These studies use real-world evidence like electronic health records to better estimate patient enrollment numbers and timelines. This helps address the high failure rate of trials due to poor enrollment and delays. Qiagram enables investigators to dynamically apply and adjust trial criteria to rapidly identify eligible patient profiles within datasets and optimize trial design.
This document provides an overview of oral diagnosis and laboratory investigation processes. It discusses obtaining a thorough medical history from patients, conducting comprehensive oral examinations, establishing differential diagnoses, and ordering appropriate laboratory tests and diagnostic imaging to reach final diagnoses. Key steps in the diagnostic process include gathering patient histories, examining patients, developing differential diagnoses, acquiring additional test results, and formulating treatment plans. The document also covers specific examination techniques, types of biopsy and imaging procedures, interpreting laboratory results, and documenting findings in SOAP notes.
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.
This document discusses digital pathology and its potential to address challenges facing anatomic pathology in Canada. It summarizes the current process which involves biopsy samples being prepared as slides that pathologists physically examine under microscopes. It notes pathology is essential for healthcare but faces issues like unequal rural access, inefficient manual processes, and increasing workload. Digital pathology could help by allowing virtual slide sharing to improve access, and using image analysis to increase efficiency and allow pathologists to handle higher caseloads. This represents a new frontier with the potential to enhance pathology services in Canada.
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.
Dokumen tersebut membahas tentang penggunaan teknologi informasi dalam pendidikan, khususnya biologi. Beberapa metode yang dijelaskan adalah pembelajaran berbasis komputer (CBT), berbasis web (WBT), e-learning, dan penggunaan blog. Metode-metode tersebut memanfaatkan komputer dan internet untuk menyampaikan materi pembelajaran secara interaktif dan fleksibel.
Global Examples of Renewable Energy and Their Futures in the United StatesKirk Williamson, MPH
This document summarizes global examples of renewable energy implementation with a focus on geothermal energy in Iceland and opportunities for the United States. Iceland has successfully harnessed geothermal energy, providing heat to 90% of homes and meeting 30% of electricity needs. Despite similar geological conditions, Hawaii has been less proactive in developing geothermal energy due to some cultural issues. The document argues Hawaii and other US regions could benefit economically and environmentally from increased geothermal energy development with proper research, support and engagement with indigenous communities.
La ingeniería biomédica se dedica al diseño y construcción de equipos médicos, prótesis, dispositivos médicos y de diagnóstico y terapia aplicando principios de ingeniería a la medicina. Combina la experiencia de la ingeniería con las necesidades médicas para mejorar la atención médica. También gestiona los recursos técnicos hospitalarios y se considera de naturaleza multidisciplinaria al integrar conocimientos de diversas áreas.
The document provides information about Valeport's products and services for underwater instrumentation. It discusses their manufacturing and testing processes, design capabilities, and products including sound velocity sensors and profilers, tide gauges, current meters, wave recorders, and more. Valeport prides itself on high quality instrumentation developed through rigorous research and manufacturing standards.
R2Sonic was founded in 2006 by three engineers to develop leading edge underwater acoustic products focused on customer needs. They have launched innovative wideband multibeam sonar systems that have redefined the industry with unparalleled performance. The company is located in Austin, Texas and has facilities equipped for product development, modeling, and testing.
This document summarizes inertial navigation systems and motion sensing products from SBG Systems, including their Apogee and Ekinox series. It provides specifications for accuracy, interfaces, environmental tolerances, and positioning capabilities for their MEMS-based inertial measurement units, attitude and heading reference systems, motion reference units, and inertial navigation systems. Their products are designed for applications in aerospace, ground, marine, and tactical domains.
This document summarizes the products and services offered by EIVA to optimize offshore and shallow water operations while promoting sustainability. EIVA provides integrated hardware and software solutions, equipment rental, training and 24/7 support for industries like oil & gas, offshore wind, construction, oceanography, and hydrography. Their portfolio includes underwater vehicles, sensors, navigation and positioning software, and remote monitoring systems to digitally capture underwater environments.
CARIS Onboard processes sonar and other sensor data in near real-time, applying the same algorithms as CARIS HIPS and SIPS to automatically generate products like DEMs, mosaics, and HIPS projects. It monitors data collection, automatically imports new data, and updates products continuously so processed data is available for quality control while the survey is still underway. The software has three main components - Process Designer to design workflows, Onboard Service to monitor and process data automatically, and Control Centre to manage and monitor processing.
This document summarizes research on various social factors that influence student academic success. It reports on a survey of 106 college students that found cultural stereotypes may negatively impact minority student performance, with Caucasian students more likely to have a GPA over 3.5. It also found that students with loans reported their financial status as more influential on grades and had slightly lower GPAs. Further, students with more involved parents or alloparents in their education tended to have higher GPAs. The document concludes that social factors likely influence academic success but the study results were inconclusive due to limitations.
Cloud computing allows users to access data and programs over the internet rather than on a local hard drive. Amazon Web Services (AWS) is a major provider of cloud computing infrastructure and services. A case study describes how Netflix uses AWS to host its video streaming platform, taking advantage of AWS's scalable and cost-effective resources. The document discusses concepts of cloud computing and outlines some of AWS's core services like EC2, S3, and advantages they provide to users.
The document provides an overview of 10 topics for a biomedical sciences portfolio, including:
1. The Human Tissue Act which regulates the use and storage of human tissue and requires proper consent.
2. HCPC standards of proficiency that biomedical scientists must meet to practice, including demonstrating skills and knowledge in their field.
3. Common pre-analytical errors in emergency department testing like improper sample collection that can impact results.
4. Both advantages and disadvantages of point-of-care testing compared to standard laboratory methods.
5. The SHOT report which analyzes transfusion errors and recommendations to improve patient safety.
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.
Clinical Trial Regulations in The USA.pdfProRelixInfo
Historical events such as the sulfanilamide elixir tragedy that resulted in the mass poisoning and the deaths of hundreds of patients in the 1930s and the thalidomide scandal which caused birth defects and mortality of babies prompted the United States Congress to enact legislation pertaining to the regulation of drugs, medical devices, biologicals, and food articles that involved an extensive safety evaluation of products prior to marketing authorization. The Federal Food, Drug, and Cosmetic Act of 1938 was enacted with the primary purpose of consumer protection in mind and to ensure the safety and well-being of all people consuming or utilizing the products mentioned in the Act. Several years later, the United States remains as having the strictest regulations and laws relating to clinical research in human subjects, and rightly so as patient health, well-being, and integrity are of paramount importance in all aspects of Good Clinical Practice (GCP) guidelines.
The document summarizes key aspects of the new HIPAA regulations regarding privacy of medical records. It discusses how the regulations set federal standards for privacy but allow more protective state laws. It outlines new requirements for privacy notices, patient authorization for disclosure of records, and patient rights to access and amend their medical records. While intended to inform patients and strengthen privacy, the regulations are also very complex and aim to ensure businesses and agencies can still access records.
Using real-time-data-to-drive-better-decisions-fasterPrateek Rathi
This document discusses the opportunities and risks associated with using real-time data access during clinical trials. It examines how real-time data can enhance patient safety, strengthen quality, and accelerate timelines by allowing drug developers to review data shortly after collection and make faster decisions. However, it also notes risks like unintentionally unblinding trials or introducing bias if not properly controlled. The document provides guidelines for granting access based on roles and recommends only giving access to pre-treatment data rather than on-treatment data to most roles. It emphasizes the need for protocols outlining how real-time data will be used and establishing firewalls to mitigate risks while enabling the benefits of real-time data reviews.
The United States has always been and remains to be the leading place
for the conduct of clinical trials. According to Clinicaltrials.gov, the largest
clinical trials registry, 32% of registered clinical trials were conducted in
the U.S. as of May 2022 (1). Factors such as the availability of qualified
healthcare professionals, high-quality infrastructure and facilities,
cutting-edge research, an efficient regulatory system, and a high
standard of ethics and participant protection make the U.S. the leading
country for clinical trials.
Clinical trials follow extensive preclinical research to test the safety and
efficacy of a new drug, medical device, or biological in humans. They are
usually divided into three phases: phases I, II, and III which are designed
to ascertain safety, pharmacokinetics, efficacy, dosage, and adverse
events. Figure 1 shows the typical route from discovery and preclinical
studies to the post-marketing phase (phase IV).Clinical trials represent the longest and most expensive step in bringing
drugs to the market and have the highest attrition rate, only 10% of drugs
that enter phase I trials are granted marketing approval. Therefore,
clinical trials should be conducted by experts that are
well-versed with all the regulations and guidelines in a particular region to
boost the chances of drug approval.
The United States Food and Drug Administration (US FDA) is the
regulatory body that approves and oversees the conduct of clinical trials
for drugs, medical devices, and biologicals that are intended to be
marketed in the U.S and is touted to have the most stringent standards
for drug approval. The primary role of the FDA is to protect public health
by ensuring that medicinal products and devices are safe and efficacious.
Therefore, it is necessary for sponsors/investigators or contract research
organizations (CRO) that are conducting clinical trials to be familiar with
regulations and guidances that govern the conduct of clinical trials.Conducting a clinical trial in the United States requires a deep understanding of the
regulations and guidelines set by the FDA. It is important to know what is needed for a
successful clinical trial, from selecting an appropriate study site to obtaining informed
consent from participants. Additionally, it is essential to understand the requirements for data
collection and analysis, as well as how to develop an effective protocol. Clinical trial services
in USA can provide guidance on all of these aspects and more, helping you ensure that your
clinical trial meets all necessary standards
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.
Here are the key points about protecting patient confidentiality:
- Patient confidentiality has always been an important ethical principle in healthcare, but modern technologies like electronic health records present new challenges to protecting privacy.
- While laws and regulations around confidentiality may still be evolving, physicians should make reasonable efforts to protect patient information and only disclose it with proper consent or in situations required by law.
- Maintaining patient trust is critical, so any accidental or improper disclosure of private health information could damage the patient-physician relationship and potentially lead to legal issues.
- Educating patients about privacy limitations and obtaining signed releases for sensitive records helps ensure confidentiality protections while allowing important treatment to continue.
Here are the key points about protecting patient confidentiality:
- Patient confidentiality has always been an important ethical principle in healthcare, but modern technologies like electronic health records present new challenges to protecting privacy.
- While laws and regulations around confidentiality may still be evolving, physicians should make reasonable efforts to protect patient information and only disclose it with proper consent or in situations required by law.
- Maintaining patient trust is critical, so any accidental or improper disclosure of private health information could damage the patient-physician relationship and potentially lead to legal issues.
- Educating patients about privacy limitations and obtaining signed releases for sensitive records helps ensure confidentiality protections while allowing important sharing of information for care coordination.
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 discusses the risks to patient privacy posed by electronic health records and health information exchanges given existing legislation and regulations. While laws like HIPAA provide some protections, they were created before widespread use of EHRs and do little to protect electronically stored data. Additionally, patients have little control over their health information under current policies. Attempts to balance privacy with the goals of improving population health through data sharing and EHR use have been challenging, with no clear resolution. Compromise is needed to define what information can be shared while maintaining patient anonymity.
China Annual Drug Information Association MeetingMichael Ibara
The document discusses how digitization of healthcare data enables new business models for drug safety based on this data rather than traditional paper-based practices. It describes the ASTER study, which used electronic health records to automatically generate adverse event reports in real-time. The study found this approach improved reporting rates and efficiency compared to traditional methods. The implications are that drug safety monitoring will merge with broader public health monitoring using digital data sources. China is discussed as an example of building a new public health and drug safety system based on these opportunities rather than replicating older Western models.
Evaluation Summary for Quantitative Lit. RQLT Task 4Final Score.docxgitagrimston
Evaluation Summary for Quantitative Lit.: RQLT Task 4
Final Score:
Does not Meet
Overall comments:
A two-column was provided in the submission and reflected generally appropriate mathematical logic. Some revisions are needed to ensure that the steps in the proof adequately lead to the statement being proven.
Detailed Results (Rubric used: RQLT Task 4)
Articulation of Response (clarity, organization, mechanics)
(0) Unsatisfactory
(1) Needs Revision
(2) Satisfactory
The candidate provides unsatisfactory articulation of response.
The candidate provides weak articulation of response.
The candidate provides adequate articulation of response.
Criterion Score: 2.00
A. Proof
(0) Unsatisfactory
(1) Needs Revision
(2) Satisfactory
The candidate does not accurately complete the appropriate proof using a 2-column proof format with statements on the left and reasons on the right.
The candidate accurately completes all but 1 to 2 steps of the appropriate proof using a 2-column proof format with statements on the left and reasons on the right.
The candidate accurately completes the appropriate proof using a 2-column proof format with statements on the left and reasons on the right.
Criterion Score: 1.00
Comments on this criterion: The submission included a two-column proof that was on the right track to show that triangle DGF is isosceles. The use of ASA was appropriate. Revisions are needed, though, to determine if some of the steps were necessary (e.g., steps 3 through 6) as well as to make sure that the supporting reasons are adequate (e.g., steps 2, 7, 9, and 10).
B. Sources
(0) Unsatisfactory
(1) Needs Revision
(2) Satisfactory
When the candidate uses sources, the candidate does not provide in-text citations and/or references for each source used.
When the candidate uses sources, the candidate provides appropriate in-text citations and/or references with major deviations from APA style.
When the candidate uses sources, the candidate provides appropriate in-text citations and/or references accurately or with only minor deviations from APA style, OR the candidate does not use sources.
Criterion Score: 2.00
Comments on this criterion: No sources were cited.
Last Name 8
Name
Instructor
Course
20 May 2013
Rebecca Skloot’s Obtained Consent in Medical Research and ‘Free Choice’ Consent
Each year in the United States, around 2.3 million patients sign consent forms in order to participate in government and industry-sponsored clinical trials, with many more participating in research at academic health centers and hospitals (Cohn & Larson 273). The Federal Policy for the Protection of Human Subjects, also known as the Common Rule, requires informed consent for all human-subject research. But, in reality, this does not happen because a huge number of tissue research are not federally funded, and the research is also never considered research on humans since researchers never get to meet donors firsthand (Skloot 231). Henrietta Lacks gifted ...
The document discusses trends in medical device manufacturing and regulation. It provides an overview of Georgia's Centers of Innovation which support industry collaborations. It also summarizes challenges with the FDA approval process, including lengthy times and high costs of clinical trials that have stalled innovation. Stakeholders are advocating for reforms that balance appropriate oversight with supporting new technologies to benefit patients.
The difference between practice and research 111607Lanka Praneeth
The document discusses the key differences between clinical practice and clinical research. Clinical research must be conducted according to an approved protocol and involves more oversight, documentation and risk to subjects. It outlines sponsor and investigator responsibilities, good clinical practice standards, and FDA expectations for clinical trial design, conduct and oversight. Clinical trials aim to generate generalizable knowledge, while practice focuses on individual patient treatment.
The 21st Century Cures Act a focus on Title III Subtitle F – Medical Device I...David Loeser
The 21st Century Cures Act aims to improve and expedite medical device development and regulation. Specifically, Title III Subtitle F focuses on medical device innovations through 10 sections that rewrite rules around devices. This document analyzes 5 key sections: breakthrough devices designation and expedited review (§3051), recognition of standards training for FDA reviewers (§3053), reclassifying some devices (§3054), requiring validated cleaning instructions (§3059), and clarifying software regulation (§3060). The analysis argues these sections will reduce device approval times, improve FDA efficiency, and help safe, effective devices reach patients faster.
This document discusses guidance from the CDC and DHHS on applying the HIPAA Privacy Rule to public health activities. It provides an overview of the Privacy Rule and its requirements for covered entities. It explains that the Privacy Rule permits disclosures without individual authorization for public health purposes, such as disease prevention and control. Public health authorities are able to obtain protected health information to carry out mandated public health activities while respecting confidentiality. The purpose is to help public health agencies understand their responsibilities under the Privacy Rule in balancing individual privacy with the need to protect the public's health.
Similar to Guidance on Informed Consent FDA_Williamson (20)
1. 2016
Office of Information & Regulatory
Affairs, OMB: Guidance on
Informed Consent for In Vitro
Diagnostic Device Studies Using
Leftover Human Specimens
ATTN: FDA DESK OFFICER
WILLIAMSON, KIRK BASCOM
2. 1
Control No. 0910-0582
Docket No. FDA-2012-N-0560
Author of “The Immortal Life of Henrietta Lacks,” Rebecca Skloot, in a recent New York
Times article, recounted the story of a Des Moines University Medical School Professor who
recently instructed his medical students to unlock their cellphones and pass their unlocked
phones to the student sitting behind them. The students fired back a litany of questions, such as,
“Why? What will they look at? How will they use that information?1
” This social experiment
illustrates that people want to be informed, and they want to give their consent. It would come as
a surprise if one found out their cells, which contain all of the genetic sequencing that makes
them entirely unique, are being passed around by researchers without one’s consent.
U.S. informed consent law takes its roots in the Nuremburg Code2
, explicitly spelling out
the need to proactively secure voluntary consent of any human research subject, but one of the
law’s grounding foundations is the case of Moore v. Regents of University of California Los
Angeles. Over the course of several years, Moore’s doctor removed blood and other bodily fluids
which eventually became a “cell line” that was patented and sold for commercial use, without
Moore’s knowledge of the physician’s research interest. Although rejecting the theory of
conversion allegation, The Court noted, “that the breach of fiduciary duty and the lack of
informed consent theory were better suited to protect the rights of patients3
.” I argue that the
devolution of informed consent into a nationalized “broad consent” standard would be a
detriment to public trust in the study of human subjects because deference given towards
researchers prioritizes the advancement of medical discovery over the protection of patients’
rights. The authorization requirements set forth by the regulations should bolster public trust by
protecting an individual’s right to privacy, not make it easier to perform research involving the
use of de-identified biospecimens4
.
In a Level One document entitled “Guidance on Informed Consent for In Vitro
Diagnostic Device Studies Using Leftover Human Specimens That Are Not Individually
Identifiable5
,” the Food and Drug Administration (FDA) outlines its intended use of enforcement
discretion as to the informed consent regulations for clinical investigators, sponsors, and IRBs.
Current FDA regulations regarding investigational device (IVD) studies that are exempt from
most provisions of part 812, “Investigational Device Exemptions” (21 CFR 812.2(c)(3)), do not
contain exceptions from the requirements of informed consent “on the grounds that the
specimens are not identifiable or that they are remnants of human specimens… that would
1
Skloot, R. (2015, December 30). Your Cells. Their Research. Your Permission? The New York Times. Retrieved
from http://www.nytimes.com/2015/12/30/opinion/your-cells-their-research-your-permission.html?_r=0
2
Teitelbaum, J. B., & Wilensky, S. E. (2013). Individual Rights and the Health Care System. Essentials of Health
Policy and Law (pp. 111–112). Burlington, MA: Jones & Bartlett Learning.
3
Rosenbaum, S. (2001). Part Three. Health Care Quality and Law: Defining Standards and Structuring Enforcement
and Accountability. Law and the American Health System (pp. 98–101).
4
Hudson, K., & Collins, F. (2015). Bringing the Common Rule into the 21st Century. The New England Journal of
Medicine, 373(24), 2293–2296. Retrieved from http://www.nejm.org/doi/pdf/10.1056/NEJMp1512205
5
Guidance for Sponsors, Institutional Review Boards, Clinical Investigators and FDA Staff; Guidance on Informed
Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually
Identifiable. (2006). Retrieved from
www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm078384.htm
3. 2
Control No. 0910-0582
Docket No. FDA-2012-N-0560
otherwise have been discarded. Nor do FDA regulations allow IRBs to decide whether or not to
waive informed consent for research involving leftover or unidentifiable specimens6
.”
The revisions to the Federal Policy for Protection of Human Subjects, colloquially known
as the Common Rule, would require scientists to obtain consent on all biospecimens; however,
nothing prohibits the re-identification of anonymous samples using DNA and publicly available
data. Furthermore, the revised rule doesn’t require informed consent on research utilizing the
genetic information inside the biospecimen7
. If one of the National Proposed Rule Making’s
(NPRM) primary rationales for these regulations is to address governmental concern that data
can no longer be “unidentifiable,” it would seem self-defeating that the language used to describe
the broad consent form perpetuates the idea of “nonidentifiable data8
.”
To further illustrate the deleterious effects of the NPRM’s broad consent form, in order to
avoid the burdens of IRB review, investigators must plan to not return research results to
individual donors, even if the results are medically actionable9
. It is then plausible to believe
such perverse incentives to withhold medically actionable results will only fuel the already
vehement debate concerning what to return, how, and when such action should take place.
Certainly, the difficulty of obtaining informed consent by the donor of a de-identified
specimen is no easy feat; however, it should be emphasized that informed consent is a process,
not a form. A researcher’s intentions regarding biological samples a decade from now are simply
not foreseeable, and adding one more piece of paper on top of a stack of already confusing
informed consent documents is bad governance and poor regulation10
. Retroactively seeking
“broad consent” from patients who already have specimens that are being investigated poses an
implied breach of confidentiality that may cause the patient to question the multifarious ways in
which the medical community has been using his or her genetic information over the past years,
even decades.
In fact, creation of a broad consent form is legally restricted pursuant to 45 CFR
§164.508(b)(3)(i) “Compound Authorizations” where “any compound authorization created
under this paragraph must clearly differentiate between the conditioned and unconditioned
components and provide the individual with an opportunity to opt in to the research activities
described in the unconditioned authorization.” Clearly, delineating between the “conditioned”
and “unconditioned” components of an authorization would be confusing to the patient and has
the potential to be misconstrued if the physician fails to distinguish between the two components.
The National Bioethics Advisory Commission stated during the 2002 debate over new HIPAA
regulations, “Federal policy should be developed and mechanisms should be provided to enable
6
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment
Request; Guidance on Informed Consent for In Vitro Diagnostic Device Studies Usi. (2016).Federal
Register,81(70), 21558–21559. Retrieved from https://www.gpo.gov/fdsys/pkg/FR-2016-04-12/pdf/2016-08329.pdf
7
Skloot, R. (2015, December 30). Your Cells. Their Research. Your Permission?
8
Robertson, C., & Rogers, J. (2016). Federal Government’s Proposed Expansion of Regulation of Biospecimen
Research Should Be Reconsidered. BIOPRESERVATION AND BIOBANKING, 00(00), 1–3.
9
Robertson, C., & Rogers, J. (2016). Federal Government’s Proposed Expansion of Regulation of Biospecimen
Research Should Be Reconsidered.
10
Robertson, C., & Rogers, J. (2016). Federal Government’s Proposed Expansion of Regulation of Biospecimen
Research Should Be Reconsidered.
4. 3
Control No. 0910-0582
Docket No. FDA-2012-N-0560
investigators and institutions to reduce threats to privacy and breaches of confidentiality. The
feasibility of additional mechanisms should be examined to strengthen confidentiality protections
in research studies.11
”
The use of bio-banked specimens in research is particularly questionable where
advancement in genetic testing currently has the ability to re-identify these specimens12
; briefly,
there are no safeguards in the law to prevent such re-identification. The new regulation also fails
to ensure that this new ideology of “broad consent” prevents human subjects from once again
being objects of specimen procurement in the name of “medical science.”
A revision of the security provision regarding the re-identification of de-identified
specimens is then sin qua non for the “additional mechanism” of waiving the requirement for
informed consent on research regarding the genetic information inside a de-identified specimen.
For example, the current statutory text for the protection of de-identified private health
information reads, “The covered entity does not use [sic] or disclose the code or other means of
record identification for any other purpose, and does not disclose [sic] the mechanism for re-
identification,” (45 CFR 164.514(c)(2)- Security). The statute provides only a duty not to
disclose on behalf of the covered entity. This vague, one sentence “safeguard” should be
amended to include the circumstances under which a covered entity is allowed to re-identify a
specimen, and whether or not this requires prior authorization in written form in compliance with
45 CFR part 46.
Willfully and clearly separating “informed consent” and “broad consent to be used in
research,” allows the patient to proceed with a given procedure without an implied stipulation
that their specimen will be taken out of their body to be used in downstream research for any
given purpose. Today’s research is moving towards a more participatory model, where
volunteers increasingly expect to be partners in research13
, with the trend to include multiple
sites and large numbers of participants. This trend rides on the heels of the 2013 publication of
the HeLa cell line (named for Henrietta Lacks), which underscored the need for greater inclusion
and respect of study participants. The experience of the Lacks family helps direct the future of
research, arguing for heightened awareness and robust knowledge to be given to participants.
Thus, there is an ethical obligation to seek permission and inform participants of risks to their
privacy14
. Empowering the public to have a choice through the use of a well-structured,
prospective broad consent form that respects well established ethics for research conducted on
human subjects from the Belmont Report and the Nuremberg Code will accordingly lead to
increased participation in the medical research community.
11
Annas, J.D., M.P.H., G. J. (2002). Medical Privacy and Medical Research- Judging the New Federal
Regulations.
12
Skloot, R. (2015, December 30). Your Cells. Their Research. Your Permission?
13
Robertson, C., & Rogers, J. (2016). Federal Government’s Proposed Expansion of Regulation of Biospecimen
Research Should Be Reconsidered.
14
Robertson, C., & Rogers, J. (2016). Federal Government’s Proposed Expansion of Regulation of Biospecimen
Research Should Be Reconsidered.
5. 4
Control No. 0910-0582
Docket No. FDA-2012-N-0560
References:
Agency Information Collection Activities; Submission for Office of Management and Budget
Review; Comment Request; Guidance on Informed Consent for In-Vitro Diagnostic
Device Studies Usi. (2016). Federal Register,81(70), 21558–21559. Retrieved from
https://www.gpo.gov/fdsys/pkg/FR-2016-04-12/pdf/2016-08329.pdf
Agency Information Collection Activities; Submission for Office of Management and Budget
Review; Comment Request; Guidance on Informed Consent for In-Vitro Diagnostic
Device Studies Usi. (2015). Federal Register,80(205), 64422–64423. Retrieved from
https://www.gpo.gov/fdsys/pkg/FR-2015-10-23/pdf/2015-26985.pdf
Annas, J.D., M.P.H., G. J. (2002). Medical Privacy and Medical Research- Judging the New
Federal Regulations. The New England Journal of Medicine,346(3), 216–220.
Beskow, L. (2012). Informed Consent for Biobanking. Duke Institute for Genome Sciences &
Policy, 1–50. Retrieved from
https://www.niehs.nih.gov/news/assets/docs_f_o/informed_consent_for_biobanking_508.
pdf
Federal Policy for the Protection of Human Subjects (’Common Rule'). (2015). Retrieved from
http://www.hhs.gov/ohrp/humansubjects/commonrule/index.html
Guidance for Sponsors, Institutional Review Boards, Clinical Investigators and FDA Staff;
Guidance on Informed Consent for In-Vitro Diagnostic Device Studies Using Leftover
Human Specimens that are Not Individually Identifiable. (2006). Retrieved from
www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm
078384.htm
Hudson, K., & Collins, F. (2015). Bringing the Common Rule into the 21st Century. The New
England Journal of Medicine, 373(24), 2293–2296. Retrieved from
http://www.nejm.org/doi/pdf/10.1056/NEJMp1512205
Korenman, S. (n.d.). Respect for Persons. Teaching the Responsible Conduct of Research in
Humans. Office of Research Integrity. Retrieved from
https://ori.hhs.gov/education/products/ucla/chapter2/page02.htm
6. 5
Control No. 0910-0582
Docket No. FDA-2012-N-0560
NPRM 2015- Summary. (2015). Retrieved from
http://www.hhs.gov/ohrp/humansubjects/regulations/nprm2015summary.html
Rosenbaum, S. (2001). Part Three. Health Care Quality and Law: Defining Standards and
Structuring Enforcement and Accountability. Law and the American Health System (pp.
98–101).
Skloot, R. (2015, December 30). Your Cells. Their Research. Your Permission? The New York
Times. Retrieved from http://www.nytimes.com/2015/12/30/opinion/your-cells-their-
research-your-permission.html?_r=0
Teitelbaum, J. B., & Wilensky, S. E. (2013). Individual Rights and the Health Care
System. Essentials of Health Policy and Law (pp. 111–112). Burlington, MA: Jones &
Bartlett Learning.