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.
Quorum Review's Institution Bulletin includes Letter from CEO, Cami Gearhart, JD, addressing OHRP's determination letter referring to consent forms and the SUPPORT trail, as well as Quorum's insights on two important topics: The first addresses consent for legally incapacitated adults and subjects physically unable to sign; the second reviews the recent FDA Subpart D changes on implications for placebo-controlled pediatric trials.
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.
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.
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.
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.
Quorum Review's Institution Bulletin includes Letter from CEO, Cami Gearhart, JD, addressing OHRP's determination letter referring to consent forms and the SUPPORT trail, as well as Quorum's insights on two important topics: The first addresses consent for legally incapacitated adults and subjects physically unable to sign; the second reviews the recent FDA Subpart D changes on implications for placebo-controlled pediatric trials.
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.
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.
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.
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.
From the event "Specimen Science: Ethics and Policy Implications," held at Harvard Law School on November 16, 2015.
This event is 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 is 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
DQ 2 Responses1.With the advances science and technology, it i.docxelinoraudley582231
DQ 2 Responses
1.
With the advances science and technology, it is important to keep up with the current trends and clinical data being used today. The research process also continues to change as more practices and techniques are being developed for implementation. Usually the goal in research is to apply these practices for the benefits of patients, curing disease, providing treatments, diagnosing, etc. Some research requires testing on human subjects or patients. Clinical guidelines are placed to protect research, especially subjects and human rights. Thus the Institutional Review Board (IRB) and approves all research these research, (American Public University System, 2016). In 1974, the National Research Act of the United States regions was put into action to respect the right of research participants by explaining to them the purposes of the study and the procedures and foreseeable risks or discomfort. (Kennedy, 2015). The importance of the IRB to the research process is to review all research contents are morally and ethically sound in the protection of patient rights.
References:
American Public University System. (2016). Institutional Review Board. Retrieved from http://www.apus.edu/academic-community/research/institutional-review-board/index
Kennedy, S. (2015). The National Research Act of 1974. Retrieved from http://www.imarcresearch.com/blog/the-national-research-act-1974
U.S. Food and Drug Administration. (2017). Institutional Review Board. Retrieved from https://www.fda.gov/RegulatoryInformation/Guidances/ucm126420.htm#IRBOrg
2.
Institutional Review Boards (IRB) are a board of researchers and non-researchers where they review research procedures at a proposal or preliminary stage, making certain that ethical principles are upheld (Neuman, 2017). The IRB is located at any facility that holds human research studies. The IRB reviews all research studies with human participants to make sure that they are ethically being treated and that no harm is being done to them. Review of the IRB prevents any liability issues when researchers run human studies. The research study has to meet the criteria for the IRB to approve which includes the risks to human research subjects are minimized by using procedures that do not unnecessarily expose the research participants to risk, the risks to human research subjects are reasonable in relation to the anticipated benefits to the individual, the selection of human subjects for research participation is equitable, human research subjects are adequately informed of the risk and benefits of research participation, informed consent of human research subjects is obtained in advance of research participation, the research plan makes adequate provisions for monitoring the data collected to ensure the safety of human research subjects, there are adequate provisions to protect the privacy of human research subjects, appropriate additional safeguards have been included for vulnerable human subjects (Human Re.
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.
CHAPTER 4 ETHICS AND THE INSTITUTIONAL REVIEW BOARD (IRB) PROCESSWilheminaRossi174
CHAPTER 4 ETHICS AND THE INSTITUTIONAL REVIEW BOARD (IRB) PROCESS
Chapter highlights
The need for ethical review: IRBs; purpose and history of ethical oversight
Nuts and bolts of IRBs: Revised Common Rule including definitions; IRB duties, membership, and types of reviews
Deception and its role in IRB review
Components of IRB proposal (especially, informed consent)
Research with children
The ethics of participant pool use and alternatives to participation
Incentives in research
IRB training modules: CITI and alternatives
OVERVIEW
When thinking about research, one question that arises fairly early is whether there are rules or regulations that govern what you can and cannot study and how you can study it. The answer is “yes.” Regulations, starting at the federal level, have been developed to protect people who participate in research (and animals used in research), the researchers themselves, and the institutions they represent. There are also specific definitions of what constitutes research and what a human subject is. Research is essentially a systematic investigation designed to contribute to generalizable knowledge. A human subject is a living individual from whom the researcher gathers information or biospecimens through interaction or intervention or about whom the researcher has access to identifiable private information or identifiable biospecimens. A biospecimen from humans is material such as blood, tissue, urine, cells, or protein. These definitions of research and human subjects come from the federal regulations known as the revised Common Rule (45 CFR Subpart A 46.102[l] and [e][1], respectively), which is discussed in more detail later in the chapter. Not every study rises to the level of research (e.g., a study on food preferences in a single residence hall might not be designed to contribute to generalizable knowledge), but the ethical treatment of people who participate in studies is an important aspect, whether or not the study is technically “research.”
After a lengthy review process that generated over 2,000 public comments in response to the proposed rule changes, the Common Rule has been substantially revised. The essential components of Subpart A of the revised Common Rule (also called the 2018 Requirements and the 2018 Rule), which went into effect on January 21, 2019, are presented in this chapter. Additional subparts (B–D) dealing with subjects in the revised Common Rule include Subpart B: Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research; Subpart C: Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects; and Subpart D: Additional Protections for Children Involved as Subjects in Research. While this chapter focuses on the material in Subpart A, additional information regarding the protections for children involved in research will also be highlighted.
Research: With respect to the federal definition (45 CFR 46), research invol ...
THE BELMONT REPORT Office of the Secretary Ethical Princip.docxtodd541
THE BELMONT REPORT
Office of the Secretary
Ethical Principles and Guidelines for the Protection of Human
Subjects of Research
The National Commission for the Protection of Human Subjects of
Biomedical and Behavioral Research
April 18, 1979
AGENCY: Department of Health, Education, and Welfare.
ACTION: Notice of Report for Public Comment.
SUMMARY: On July 12, 1974, the National Research Act (Pub. L. 93-348) was signed into law, there-by creating the
National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. One of the
charges to the Commission was to identify the basic ethical principles that should underlie the conduct of biomedical
and behavioral research involving human subjects and to develop guidelines which should be followed to assure that
such research is conducted in accordance with those principles. In carrying out the above, the Commission was
directed to consider: (i) the boundaries between biomedical and behavioral research and the accepted and routine
practice of medicine, (ii) the role of assessment of risk-benefit criteria in the determination of the appropriateness of
research involving human subjects, (iii) appropriate guidelines for the selection of human subjects for participation in
such research and (iv) the nature and definition of informed consent in various research settings.
The Belmont Report attempts to summarize the basic ethical principles identified by the Commission in the course of
its deliberations. It is the outgrowth of an intensive four-day period of discussions that were held in February 1976 at
the Smithsonian Institution's Belmont Conference Center supplemented by the monthly deliberations of the
Commission that were held over a period of nearly four years. It is a statement of basic ethical principles and
guidelines that should assist in resolving the ethical problems that surround the conduct of research with human
subjects. By publishing the Report in the Federal Register, and providing reprints upon request, the Secretary intends
that it may be made readily available to scientists, members of Institutional Review Boards, and Federal employees.
The two-volume Appendix, containing the lengthy reports of experts and specialists who assisted the Commission in
fulfilling this part of its charge, is available as DHEW Publication No. (OS) 78-0013 and No. (OS) 78-0014, for sale by
the Superintendent of Documents, U.S. Government Printing Office, Washington, D.C. 20402.
Unlike most other reports of the Commission, the Belmont Report does not make specific recommendations for
administrative action by the Secretary of Health, Education, and Welfare. Rather, the Commission recommended that
the Belmont Report be adopted in its entirety, as a statement of the Department's policy. The Department requests
public comment on this recommendation.
National Commission for the Protection of Human Subjects of
Biomedical and Behavioral Resea.
In this webinar, we briefly discussed the regulatory considerations for biorepositories including the following: When HHS, FDA and HIPAA regulations apply, When informed consent is not required , Pros and cons of different informed consent approaches
2a. The Institutional Review Boards (IRB) are entrusted to protect t.pdfnipuns1983
2a. The Institutional Review Boards (IRB) are entrusted to protect the rights and safety of
participants undergoing clinical research studies. The regulations formulated for reviewing,
approving and conductiong research on humans generally refer to such independant boards like
IRB. IRB has been recognised as one component of Human Research Protection Program
(HRPP) of the Asssociation for the Accreditation of Human Research Protection Program
(AAHRPP) formed in 2001.
The IRB shoulkd have atleast FIVE members from diverse scientific and non-scientific
backgrounds; professional domains, and cultural interests including gender, race and attitude
toward community issues. Atleast one memebr should be from scientific area (having primary
concern in scientific area such as physician, Ph D level physical or biological scientists) and
atleast one from non-scientific area (FDA regulation: 21 CFR 56.107 (C)). Also atleast one
member should not be affiliated with the institution directly or be a community member.
Primary source of information: Jacobs M R (2014) Institutional Review Boards and Independant
Ethics Committees, White paper. Technical report.
b. Most IRB\'s consist of more than five members to encompass additional expertise while
convening the meetings. As per the regulations of International Conference on Harmonisation
(ICH), department of Health and Human sciences (DHHS) and the Food and Drug
Administration (FAD), the memebers of IRB should have adequate expertise in assessing the
quality of science, medical aspects of proposed research and the ethics of conducting
studies.This implies the need to have atleast one member as physician. IRB can also approve an
alternate member in the absence of the primary member. Even outside consultants can be invited
to have opinion on scientific and ethical issues beyond the expertise of the convened committee,
however, they do not have the right to vote for approving the research.
When the research involve vulnerable populations such as children, prisoners, pregnant women,
handicapped and mentally impaired, the individuals having expertise and understanding on the
issue should be included. So also, the participants or subjects in the research study who can
become potential vulnerable groups should also be considered.
c. The IRB reviews the clinical trial protocols and ensure that the participants have minimal risks
in relation to the benefits from the research. Such reviews are done before and during the trials.
The IRB perform periodic reviews or continuing reviews through out the entire duration of the
trial. Such reviews happen atleast once a year and cover the entire trials and not just changes.
The IRB also seek additional information about the payments and compenations to study
participants and informed consent process.
Solution
2a. The Institutional Review Boards (IRB) are entrusted to protect the rights and safety of
participants undergoing clinical research studies. The regulations formulated for.
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.
More Related Content
Similar to Institution Newsletter Volume 2, Issue 1
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.
From the event "Specimen Science: Ethics and Policy Implications," held at Harvard Law School on November 16, 2015.
This event is 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 is 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
DQ 2 Responses1.With the advances science and technology, it i.docxelinoraudley582231
DQ 2 Responses
1.
With the advances science and technology, it is important to keep up with the current trends and clinical data being used today. The research process also continues to change as more practices and techniques are being developed for implementation. Usually the goal in research is to apply these practices for the benefits of patients, curing disease, providing treatments, diagnosing, etc. Some research requires testing on human subjects or patients. Clinical guidelines are placed to protect research, especially subjects and human rights. Thus the Institutional Review Board (IRB) and approves all research these research, (American Public University System, 2016). In 1974, the National Research Act of the United States regions was put into action to respect the right of research participants by explaining to them the purposes of the study and the procedures and foreseeable risks or discomfort. (Kennedy, 2015). The importance of the IRB to the research process is to review all research contents are morally and ethically sound in the protection of patient rights.
References:
American Public University System. (2016). Institutional Review Board. Retrieved from http://www.apus.edu/academic-community/research/institutional-review-board/index
Kennedy, S. (2015). The National Research Act of 1974. Retrieved from http://www.imarcresearch.com/blog/the-national-research-act-1974
U.S. Food and Drug Administration. (2017). Institutional Review Board. Retrieved from https://www.fda.gov/RegulatoryInformation/Guidances/ucm126420.htm#IRBOrg
2.
Institutional Review Boards (IRB) are a board of researchers and non-researchers where they review research procedures at a proposal or preliminary stage, making certain that ethical principles are upheld (Neuman, 2017). The IRB is located at any facility that holds human research studies. The IRB reviews all research studies with human participants to make sure that they are ethically being treated and that no harm is being done to them. Review of the IRB prevents any liability issues when researchers run human studies. The research study has to meet the criteria for the IRB to approve which includes the risks to human research subjects are minimized by using procedures that do not unnecessarily expose the research participants to risk, the risks to human research subjects are reasonable in relation to the anticipated benefits to the individual, the selection of human subjects for research participation is equitable, human research subjects are adequately informed of the risk and benefits of research participation, informed consent of human research subjects is obtained in advance of research participation, the research plan makes adequate provisions for monitoring the data collected to ensure the safety of human research subjects, there are adequate provisions to protect the privacy of human research subjects, appropriate additional safeguards have been included for vulnerable human subjects (Human Re.
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.
CHAPTER 4 ETHICS AND THE INSTITUTIONAL REVIEW BOARD (IRB) PROCESSWilheminaRossi174
CHAPTER 4 ETHICS AND THE INSTITUTIONAL REVIEW BOARD (IRB) PROCESS
Chapter highlights
The need for ethical review: IRBs; purpose and history of ethical oversight
Nuts and bolts of IRBs: Revised Common Rule including definitions; IRB duties, membership, and types of reviews
Deception and its role in IRB review
Components of IRB proposal (especially, informed consent)
Research with children
The ethics of participant pool use and alternatives to participation
Incentives in research
IRB training modules: CITI and alternatives
OVERVIEW
When thinking about research, one question that arises fairly early is whether there are rules or regulations that govern what you can and cannot study and how you can study it. The answer is “yes.” Regulations, starting at the federal level, have been developed to protect people who participate in research (and animals used in research), the researchers themselves, and the institutions they represent. There are also specific definitions of what constitutes research and what a human subject is. Research is essentially a systematic investigation designed to contribute to generalizable knowledge. A human subject is a living individual from whom the researcher gathers information or biospecimens through interaction or intervention or about whom the researcher has access to identifiable private information or identifiable biospecimens. A biospecimen from humans is material such as blood, tissue, urine, cells, or protein. These definitions of research and human subjects come from the federal regulations known as the revised Common Rule (45 CFR Subpart A 46.102[l] and [e][1], respectively), which is discussed in more detail later in the chapter. Not every study rises to the level of research (e.g., a study on food preferences in a single residence hall might not be designed to contribute to generalizable knowledge), but the ethical treatment of people who participate in studies is an important aspect, whether or not the study is technically “research.”
After a lengthy review process that generated over 2,000 public comments in response to the proposed rule changes, the Common Rule has been substantially revised. The essential components of Subpart A of the revised Common Rule (also called the 2018 Requirements and the 2018 Rule), which went into effect on January 21, 2019, are presented in this chapter. Additional subparts (B–D) dealing with subjects in the revised Common Rule include Subpart B: Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research; Subpart C: Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects; and Subpart D: Additional Protections for Children Involved as Subjects in Research. While this chapter focuses on the material in Subpart A, additional information regarding the protections for children involved in research will also be highlighted.
Research: With respect to the federal definition (45 CFR 46), research invol ...
THE BELMONT REPORT Office of the Secretary Ethical Princip.docxtodd541
THE BELMONT REPORT
Office of the Secretary
Ethical Principles and Guidelines for the Protection of Human
Subjects of Research
The National Commission for the Protection of Human Subjects of
Biomedical and Behavioral Research
April 18, 1979
AGENCY: Department of Health, Education, and Welfare.
ACTION: Notice of Report for Public Comment.
SUMMARY: On July 12, 1974, the National Research Act (Pub. L. 93-348) was signed into law, there-by creating the
National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. One of the
charges to the Commission was to identify the basic ethical principles that should underlie the conduct of biomedical
and behavioral research involving human subjects and to develop guidelines which should be followed to assure that
such research is conducted in accordance with those principles. In carrying out the above, the Commission was
directed to consider: (i) the boundaries between biomedical and behavioral research and the accepted and routine
practice of medicine, (ii) the role of assessment of risk-benefit criteria in the determination of the appropriateness of
research involving human subjects, (iii) appropriate guidelines for the selection of human subjects for participation in
such research and (iv) the nature and definition of informed consent in various research settings.
The Belmont Report attempts to summarize the basic ethical principles identified by the Commission in the course of
its deliberations. It is the outgrowth of an intensive four-day period of discussions that were held in February 1976 at
the Smithsonian Institution's Belmont Conference Center supplemented by the monthly deliberations of the
Commission that were held over a period of nearly four years. It is a statement of basic ethical principles and
guidelines that should assist in resolving the ethical problems that surround the conduct of research with human
subjects. By publishing the Report in the Federal Register, and providing reprints upon request, the Secretary intends
that it may be made readily available to scientists, members of Institutional Review Boards, and Federal employees.
The two-volume Appendix, containing the lengthy reports of experts and specialists who assisted the Commission in
fulfilling this part of its charge, is available as DHEW Publication No. (OS) 78-0013 and No. (OS) 78-0014, for sale by
the Superintendent of Documents, U.S. Government Printing Office, Washington, D.C. 20402.
Unlike most other reports of the Commission, the Belmont Report does not make specific recommendations for
administrative action by the Secretary of Health, Education, and Welfare. Rather, the Commission recommended that
the Belmont Report be adopted in its entirety, as a statement of the Department's policy. The Department requests
public comment on this recommendation.
National Commission for the Protection of Human Subjects of
Biomedical and Behavioral Resea.
In this webinar, we briefly discussed the regulatory considerations for biorepositories including the following: When HHS, FDA and HIPAA regulations apply, When informed consent is not required , Pros and cons of different informed consent approaches
2a. The Institutional Review Boards (IRB) are entrusted to protect t.pdfnipuns1983
2a. The Institutional Review Boards (IRB) are entrusted to protect the rights and safety of
participants undergoing clinical research studies. The regulations formulated for reviewing,
approving and conductiong research on humans generally refer to such independant boards like
IRB. IRB has been recognised as one component of Human Research Protection Program
(HRPP) of the Asssociation for the Accreditation of Human Research Protection Program
(AAHRPP) formed in 2001.
The IRB shoulkd have atleast FIVE members from diverse scientific and non-scientific
backgrounds; professional domains, and cultural interests including gender, race and attitude
toward community issues. Atleast one memebr should be from scientific area (having primary
concern in scientific area such as physician, Ph D level physical or biological scientists) and
atleast one from non-scientific area (FDA regulation: 21 CFR 56.107 (C)). Also atleast one
member should not be affiliated with the institution directly or be a community member.
Primary source of information: Jacobs M R (2014) Institutional Review Boards and Independant
Ethics Committees, White paper. Technical report.
b. Most IRB\'s consist of more than five members to encompass additional expertise while
convening the meetings. As per the regulations of International Conference on Harmonisation
(ICH), department of Health and Human sciences (DHHS) and the Food and Drug
Administration (FAD), the memebers of IRB should have adequate expertise in assessing the
quality of science, medical aspects of proposed research and the ethics of conducting
studies.This implies the need to have atleast one member as physician. IRB can also approve an
alternate member in the absence of the primary member. Even outside consultants can be invited
to have opinion on scientific and ethical issues beyond the expertise of the convened committee,
however, they do not have the right to vote for approving the research.
When the research involve vulnerable populations such as children, prisoners, pregnant women,
handicapped and mentally impaired, the individuals having expertise and understanding on the
issue should be included. So also, the participants or subjects in the research study who can
become potential vulnerable groups should also be considered.
c. The IRB reviews the clinical trial protocols and ensure that the participants have minimal risks
in relation to the benefits from the research. Such reviews are done before and during the trials.
The IRB perform periodic reviews or continuing reviews through out the entire duration of the
trial. Such reviews happen atleast once a year and cover the entire trials and not just changes.
The IRB also seek additional information about the payments and compenations to study
participants and informed consent process.
Solution
2a. The Institutional Review Boards (IRB) are entrusted to protect the rights and safety of
participants undergoing clinical research studies. The regulations formulated for.
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.
Quorum Review presents a special webinar with J. Claire Carbary, JD, CIP to discuss IRB expectations surrounding Biobanking and Future Research. This presentation covers U.S. and Canadian regulatory/legal requirements regarding collection and use of samples and data. We also discuss how to address these issues in a study protocol and consent, as well as implications of returning results to study participants.
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.
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.
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.
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The IoT and OT threat landscape report has been prepared by the Threat Research Team at Sectrio using data from Sectrio, cyber threat intelligence farming facilities spread across over 85 cities around the world. In addition, Sectrio also runs AI-based advanced threat and payload engagement facilities that serve as sinks to attract and engage sophisticated threat actors, and newer malware including new variants and latent threats that are at an earlier stage of development.
The latest edition of the OT/ICS and IoT security Threat Landscape Report 2024 also covers:
State of global ICS asset and network exposure
Sectoral targets and attacks as well as the cost of ransom
Global APT activity, AI usage, actor and tactic profiles, and implications
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Major cyber events in 2024
Malware and malicious payload trends
Cyberattack types and targets
Vulnerability exploit attempts on CVEs
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In-depth analysis of the cyber threat landscape across North America, South America, Europe, APAC, and the Middle East
Why are attacks on smart factories rising?
Cyber risk predictions
Axis of attacks – Europe
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Download the full report from here:
https://sectrio.com/resources/ot-threat-landscape-reports/sectrio-releases-ot-ics-and-iot-security-threat-landscape-report-2024/
Why You Should Replace Windows 11 with Nitrux Linux 3.5.0 for enhanced perfor...SOFTTECHHUB
The choice of an operating system plays a pivotal role in shaping our computing experience. For decades, Microsoft's Windows has dominated the market, offering a familiar and widely adopted platform for personal and professional use. However, as technological advancements continue to push the boundaries of innovation, alternative operating systems have emerged, challenging the status quo and offering users a fresh perspective on computing.
One such alternative that has garnered significant attention and acclaim is Nitrux Linux 3.5.0, a sleek, powerful, and user-friendly Linux distribution that promises to redefine the way we interact with our devices. With its focus on performance, security, and customization, Nitrux Linux presents a compelling case for those seeking to break free from the constraints of proprietary software and embrace the freedom and flexibility of open-source computing.
Threats to mobile devices are more prevalent and increasing in scope and complexity. Users of mobile devices desire to take full advantage of the features
available on those devices, but many of the features provide convenience and capability but sacrifice security. This best practices guide outlines steps the users can take to better protect personal devices and information.
Alt. GDG Cloud Southlake #33: Boule & Rebala: Effective AppSec in SDLC using ...James Anderson
Effective Application Security in Software Delivery lifecycle using Deployment Firewall and DBOM
The modern software delivery process (or the CI/CD process) includes many tools, distributed teams, open-source code, and cloud platforms. Constant focus on speed to release software to market, along with the traditional slow and manual security checks has caused gaps in continuous security as an important piece in the software supply chain. Today organizations feel more susceptible to external and internal cyber threats due to the vast attack surface in their applications supply chain and the lack of end-to-end governance and risk management.
The software team must secure its software delivery process to avoid vulnerability and security breaches. This needs to be achieved with existing tool chains and without extensive rework of the delivery processes. This talk will present strategies and techniques for providing visibility into the true risk of the existing vulnerabilities, preventing the introduction of security issues in the software, resolving vulnerabilities in production environments quickly, and capturing the deployment bill of materials (DBOM).
Speakers:
Bob Boule
Robert Boule is a technology enthusiast with PASSION for technology and making things work along with a knack for helping others understand how things work. He comes with around 20 years of solution engineering experience in application security, software continuous delivery, and SaaS platforms. He is known for his dynamic presentations in CI/CD and application security integrated in software delivery lifecycle.
Gopinath Rebala
Gopinath Rebala is the CTO of OpsMx, where he has overall responsibility for the machine learning and data processing architectures for Secure Software Delivery. Gopi also has a strong connection with our customers, leading design and architecture for strategic implementations. Gopi is a frequent speaker and well-known leader in continuous delivery and integrating security into software delivery.
A tale of scale & speed: How the US Navy is enabling software delivery from l...sonjaschweigert1
Rapid and secure feature delivery is a goal across every application team and every branch of the DoD. The Navy’s DevSecOps platform, Party Barge, has achieved:
- Reduction in onboarding time from 5 weeks to 1 day
- Improved developer experience and productivity through actionable findings and reduction of false positives
- Maintenance of superior security standards and inherent policy enforcement with Authorization to Operate (ATO)
Development teams can ship efficiently and ensure applications are cyber ready for Navy Authorizing Officials (AOs). In this webinar, Sigma Defense and Anchore will give attendees a look behind the scenes and demo secure pipeline automation and security artifacts that speed up application ATO and time to production.
We will cover:
- How to remove silos in DevSecOps
- How to build efficient development pipeline roles and component templates
- How to deliver security artifacts that matter for ATO’s (SBOMs, vulnerability reports, and policy evidence)
- How to streamline operations with automated policy checks on container images
GDG Cloud Southlake #33: Boule & Rebala: Effective AppSec in SDLC using Deplo...James Anderson
Effective Application Security in Software Delivery lifecycle using Deployment Firewall and DBOM
The modern software delivery process (or the CI/CD process) includes many tools, distributed teams, open-source code, and cloud platforms. Constant focus on speed to release software to market, along with the traditional slow and manual security checks has caused gaps in continuous security as an important piece in the software supply chain. Today organizations feel more susceptible to external and internal cyber threats due to the vast attack surface in their applications supply chain and the lack of end-to-end governance and risk management.
The software team must secure its software delivery process to avoid vulnerability and security breaches. This needs to be achieved with existing tool chains and without extensive rework of the delivery processes. This talk will present strategies and techniques for providing visibility into the true risk of the existing vulnerabilities, preventing the introduction of security issues in the software, resolving vulnerabilities in production environments quickly, and capturing the deployment bill of materials (DBOM).
Speakers:
Bob Boule
Robert Boule is a technology enthusiast with PASSION for technology and making things work along with a knack for helping others understand how things work. He comes with around 20 years of solution engineering experience in application security, software continuous delivery, and SaaS platforms. He is known for his dynamic presentations in CI/CD and application security integrated in software delivery lifecycle.
Gopinath Rebala
Gopinath Rebala is the CTO of OpsMx, where he has overall responsibility for the machine learning and data processing architectures for Secure Software Delivery. Gopi also has a strong connection with our customers, leading design and architecture for strategic implementations. Gopi is a frequent speaker and well-known leader in continuous delivery and integrating security into software delivery.
In his public lecture, Christian Timmerer provides insights into the fascinating history of video streaming, starting from its humble beginnings before YouTube to the groundbreaking technologies that now dominate platforms like Netflix and ORF ON. Timmerer also presents provocative contributions of his own that have significantly influenced the industry. He concludes by looking at future challenges and invites the audience to join in a discussion.
Encryption in Microsoft 365 - ExpertsLive Netherlands 2024Albert Hoitingh
In this session I delve into the encryption technology used in Microsoft 365 and Microsoft Purview. Including the concepts of Customer Key and Double Key Encryption.
GraphSummit Singapore | The Future of Agility: Supercharging Digital Transfor...Neo4j
Leonard Jayamohan, Partner & Generative AI Lead, Deloitte
This keynote will reveal how Deloitte leverages Neo4j’s graph power for groundbreaking digital twin solutions, achieving a staggering 100x performance boost. Discover the essential role knowledge graphs play in successful generative AI implementations. Plus, get an exclusive look at an innovative Neo4j + Generative AI solution Deloitte is developing in-house.
The Art of the Pitch: WordPress Relationships and SalesLaura Byrne
Clients don’t know what they don’t know. What web solutions are right for them? How does WordPress come into the picture? How do you make sure you understand scope and timeline? What do you do if sometime changes?
All these questions and more will be explored as we talk about matching clients’ needs with what your agency offers without pulling teeth or pulling your hair out. Practical tips, and strategies for successful relationship building that leads to closing the deal.
Observability Concepts EVERY Developer Should Know -- DeveloperWeek Europe.pdfPaige Cruz
Monitoring and observability aren’t traditionally found in software curriculums and many of us cobble this knowledge together from whatever vendor or ecosystem we were first introduced to and whatever is a part of your current company’s observability stack.
While the dev and ops silo continues to crumble….many organizations still relegate monitoring & observability as the purview of ops, infra and SRE teams. This is a mistake - achieving a highly observable system requires collaboration up and down the stack.
I, a former op, would like to extend an invitation to all application developers to join the observability party will share these foundational concepts to build on:
Elevating Tactical DDD Patterns Through Object CalisthenicsDorra BARTAGUIZ
After immersing yourself in the blue book and its red counterpart, attending DDD-focused conferences, and applying tactical patterns, you're left with a crucial question: How do I ensure my design is effective? Tactical patterns within Domain-Driven Design (DDD) serve as guiding principles for creating clear and manageable domain models. However, achieving success with these patterns requires additional guidance. Interestingly, we've observed that a set of constraints initially designed for training purposes remarkably aligns with effective pattern implementation, offering a more ‘mechanical’ approach. Let's explore together how Object Calisthenics can elevate the design of your tactical DDD patterns, offering concrete help for those venturing into DDD for the first time!
Elevating Tactical DDD Patterns Through Object Calisthenics
Institution Newsletter Volume 2, Issue 1
1. The Quorum Review: Institutional Edition
Letter from the CEO
How can we help each research site initiate clinical trials as effectively as
possible? A recent article by researchers at Duke University1 concludes that
U.S. researchers face impediments from many sources, including:
Aging regulations
Broad risk management by trial sponsors
Layers of oversight by institutions
Health system incentives that do not favor research
The researchers describe the current clinical trials process as “unsustainably
burdensome, threatening to deprive patients and health-care providers of
new therapies and new evidence to guide the use of existing treatments.”
As this article makes clear, there is no easy fix to streamline the clinical
trials process. Even so, here at Quorum Review we will continue to do our
small part – to provide ethics review carefully, promptly, accurately and
courteously.
To help you with your mission, we’ve enclosed several articles regarding the
ethics review of proposed clinical research. Please contact us if we can be of additional assistance.
Sincerely,
Cami Gearhart, CEO
Quorum Review IRB
1
Kramer, Smith & Califf, Impediments to Clinical Research in the United States, Clinical Pharmacology & Therapeutics (February 2012), http://www.nature.com/clpt/journal/v91/n3/full/clpt2011341a.html
2. February 24, 2012 | Volume 2, Issue 1
New Draft Guidance on “Exculpatory Language” from FDA and OHRP
On August 19, 2011, OHRP and FDA issued a joint Draft Guidance document: “Guidance on Exculpatory Language in
Informed Consent.” When finalized, the Guidance will replace guidance on this topic from both OHRP2 and FDA3.
The Draft Guidance provides an updated interpretation of the regulatory restriction on “exculpatory language” in informed
consent documents.4 The Draft Guidance specifically addresses the issue of a subject’s rights with respect to a biospecimen
provided for research purposes, stating: “a subject’s waiver of any rights…with respect to a biospecimen…would not be
exculpatory.” This conclusion is based on two factors: (1) the practice of not compensating research subjects who provide
biospecimens for research purposes, and (2) the absence of federal or state laws or policies that recognize a legal right to
compensation if a subject has voluntarily signed an informed consent form stating they would not be paid for biospecimens.
The position is a departure from previous guidance documents, which will be replaced when this Draft Guidance is
finalized. The 1998 Frequently Asked Questions Guidance from FDA advised that it was acceptable “for [a] consent to say
that specimens are to be used for research purposes” but not to say that they were donated because “the word ‘donation’
implies abandonment of rights to the property [and] 21 CFR 50.20 prohibits requiring subjects to waive or appear to waive
any rights as a condition for participation in the study.”5 The 1996 Guidance from OHRP took the same position with
respect to sample ownership, providing the following examples of “exculpatory” language:
By agreeing to this use, you should understand that you will give up all claim to personal benefit from commercial or other use of these substances.
I voluntarily and freely donate any and all blood, urine, and tissue samples to the U.S. Government and hereby relinquish all right, title, and
interest to said items.
By consent to participate in this research, I give up any property rights I may have in bodily fluids or tissue samples obtained in the course of the
research.6
In contrast with the position taken in the previous guidance documents, the Draft Guidance provides several examples of
“acceptable language” as follows:
By agreeing to this use, you are giving up all claims to any money obtained by the researchers from commercial or other use of these specimens.
I voluntarily and freely donate any and all blood, urine, and tissue samples to the [name of research institution] and hereby relinquish all property
rights, title, and interest I may have in those samples.
By consenting to participate in this research, I give up any property rights I may have in bodily fluids or tissue samples collected during this
research.7
Quorum Review’s practice, based on the existing guidance, has been to modify language that explicitly or implicitly
indicated subjects were “donating” samples or otherwise giving up ownership rights with respect to samples. Given the
updated interpretation of “exculpatory language”, Quorum Review anticipates making a change to our policies. Quorum
Review will not make a formal change until the Final Guidance is issued; however, please feel free to contact us with
questions about consent language addressing sample ownership in the interim. Questions can be addressed to your study
manager or sent to our Site Support Team at sitesupport@quorumreview.com.
2
Exculpatory Language in Informed Consent, OHRP (November 15, 1996).
3
Question 52, Institutional Review Boards Frequently Asked Questions—Information Sheet Guidance for Institutional Review Boards and Clinical Investigators, FDA (1998).
4
45 CFR 45.116 and 21 CFR 50.20 state: “No informed consent, whether oral or written, may include any exculpatory language through which the subject or the representative is made to waive or appear to
waive any of the subject’s legal rights, or releases or appears to release the investigator, the sponsor, the institution, or its agents from liability for negligence.”
5
Question 52, Institutional Review Boards Frequently Asked Questions—Information Sheet Guidance for Institutional Review Boards and Clinical Investigators, FDA (1998).
6
Exculpatory Language in Informed Consent, OHRP (November 15, 1996).
7
Draft Guidance, Guidance on Exculpatory Language in Informed Consent, DHHS (August 19, 2011).
3. February 24, 2012 | Volume 2, Issue 1
method for maintenance of confidentiality of data
The Importance of Addressing Local language(s) understood by prospective subjects
Research Context method for minimizing the possibility of coercion or undue
influence in seeking consent, and,
safeguards to protect the rights and welfare of vulnerable
An important consideration for the IRB is commonly subjects10
referred to as the “local research context.” Local research
The OHRP memorandum includes a number of methods
context may include community attitudes towards research,
by which an IRB may obtain necessary information,
the literacy rate, subject recruitment, or other community
including personal knowledge of the research context by
factors, such as: geographic, socioeconomic, gender,
one or more IRB members, consultants, and an exchange of
cultural, and moral backgrounds of the proposed human
information between the IRB and the research site.
subject population.
Quorum Review IRB recognizes the importance of the local
In January, 2010, the Office for Human Research
research context for institutions. We have incorporated a
Protections (OHRP) withdrew two policy documents
number of steps within our standard process to obtain
suggesting that OHRP favored local IRB review over review
knowledge about the research context in your community.
by a non-local IRB.8 OHRP has clarified that it no longer
Quorum solicits information about the local population,
holds this position.9 Although OHRP’s policy has shifted,
site privacy and confidentiality practices, and local laws and
the reviewing IRB, whether local or central, still must
requirements from investigators on our required
obtain appropriate knowledge of the local research context.
submission forms. In addition, Quorum maintains
information about unique local requirements related to
The OHRP policy memorandum “IRB Knowledge of Local research, such as state law, or institution-specific
Research Context” outlines the necessary information an requirements. Quorum’s IRB members come from a variety
IRB should obtain as follows: of backgrounds, professions, and geographic regions. If
needed, our specialty consultants are available to field
the anticipated scope of the institution's research activities questions for the IRB members regarding specific scientific
the types of subject populations likely to be involved and local context issues.
the size and complexity of the institution
institutional commitments and regulations For further information or to obtain a copy of Quorum’s
applicable law Institutional Start-Up Package, please contact Quorum’s
standards of professional conduct and practice Business Development Team at
method for equitable selection of subjects busdev@quorumreview.com.
method for protection of privacy of subjects
8
(Archived) OPRR Policy Memorandum, Local Institutional Review Board (IRB) of Multicenter Clinical
Trials Sponsored by the Division of Aids (DAIDS) Nat’l Institute of Allergy and Infectious Diseases
(NIAID), Sept.13,’93,, http://www.hhs.gov/ohrp/archive/humansubjects/guidance/hsdcsep93.htm
(Archived) OPRR Policy Memorandum, Local IRB Review of Multicenter Clinical Trials, Nov.9, ‘92,
93-01, http://www.hhs.gov/ohrp/humansubjects/guidance/hsdc93-01.htm.
9 10
OHRP April 30, 2010 Response, Use of a Central Institutional Review Board, OPRR Policy Memorandum, IRB Knowledge of Local Research Context, August 27, 1998 (updated
http://www.hhs.gov/ohrp/policy/Correspondence/mcdeavitt20100430letter.html 2000), http://www.hhs.gov/ohrp/policy/local.html