This document discusses the role and procedures of an Institutional Review Board (IRB). The main points are:
- The IRB is a campus committee that reviews and provides oversight of research involving human subjects to ensure ethical standards are met.
- A typical IRB is composed of a diverse cross-section of faculty, staff, and community members.
- The IRB classifies research into exempt, expedited or full review categories depending on the risk and nature of the research. It reviews the research design, consent process and use of vulnerable populations.
- Informed consent from participants is typically required by the IRB and must outline the study purpose, risks, benefits, confidentiality and voluntary participation.
Patient safety has always been the industry’s focus during clinical trials. However, a recent spate of well-publicized patient safety issues have increased public scrutiny and the biotechnology, pharmaceutical and CRO industries' desire to improve study quality, resulting in larger, longer, more expensive trials. In this Q&A, James T. Gourzis, M.D., Ph.D., discusses issues affecting patient safety, including factors that have launched safety to the forefront; what to look for in evaluating CRO excellence; unique oncology considerations and the ramifications of the rare toxicity; optimizing the Data Monitoring Committee; budget decisions that affect patient safety and the evolution/future of FDA requirements.
The PV audit ensures that a company’s drug safety and pharmacovigilance operations comply with applicable laws, regulations and guidances worldwide, and compare to best practices for organizations of similar size.
Patient safety has always been the industry’s focus during clinical trials. However, a recent spate of well-publicized patient safety issues have increased public scrutiny and the biotechnology, pharmaceutical and CRO industries' desire to improve study quality, resulting in larger, longer, more expensive trials. In this Q&A, James T. Gourzis, M.D., Ph.D., discusses issues affecting patient safety, including factors that have launched safety to the forefront; what to look for in evaluating CRO excellence; unique oncology considerations and the ramifications of the rare toxicity; optimizing the Data Monitoring Committee; budget decisions that affect patient safety and the evolution/future of FDA requirements.
The PV audit ensures that a company’s drug safety and pharmacovigilance operations comply with applicable laws, regulations and guidances worldwide, and compare to best practices for organizations of similar size.
This presentation gives effective solutions to outliers issue in bioequivalence trials. It described what would be acceptable to Regulatory agencies as well as some new approaches.
Introduction to organisational research and case studiesHazel Hall
Presentation on organisational research and case studies delivered to research students at the ESRC Scottish Doctoral Training Centre Information Science Pathway Training day, Glasgow, on 25th June 2014. ** An updated version of this presentation from 2016 is available at http://www.slideshare.net/HazelHall/introduction-to-organisational-research-and-case-studies-60657001 **
When a new drug/device/surgical procedure/treatment or other potential medical innovation is developed it must be thoroughly tested to ensure that it is safe and does what it is supposed to be.
This presentation will provide a basic overview of clinical research process.
A standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity, and confidentiality of trial subjects are protected.
This presentation gives effective solutions to outliers issue in bioequivalence trials. It described what would be acceptable to Regulatory agencies as well as some new approaches.
Introduction to organisational research and case studiesHazel Hall
Presentation on organisational research and case studies delivered to research students at the ESRC Scottish Doctoral Training Centre Information Science Pathway Training day, Glasgow, on 25th June 2014. ** An updated version of this presentation from 2016 is available at http://www.slideshare.net/HazelHall/introduction-to-organisational-research-and-case-studies-60657001 **
When a new drug/device/surgical procedure/treatment or other potential medical innovation is developed it must be thoroughly tested to ensure that it is safe and does what it is supposed to be.
This presentation will provide a basic overview of clinical research process.
A standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity, and confidentiality of trial subjects are protected.
Alat koji sam otkrio zove se binarne opcije. Znam da zvuci kao nešto jako komplicirano, no u stvari jevrlo jednostavno. Sve što Vi trebate napraviti je odabrati nešto cime možete trgovati (dionicu,naprimjer) i pogoditi hoce li joj cijena rasti ili padati. Ne trebate znati u kojoj ce mjeri ici gore ili dolje. Vi samo trebate znati hoce li DA, rasti ili NE, pasti. Visit http://www.zaraditinovacnainternetu.com/
an Institutional Review Board plays a crucial role in safeguarding the ethical conduct of research involving human participants. Its primary focus is to protect the rights, safety, and well-being of individuals who volunteer to participate in research studies while simultaneously promoting the advancement of knowledge.
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.
Adjusting primitives for graph : SHORT REPORT / NOTESSubhajit Sahu
Graph algorithms, like PageRank Compressed Sparse Row (CSR) is an adjacency-list based graph representation that is
Multiply with different modes (map)
1. Performance of sequential execution based vs OpenMP based vector multiply.
2. Comparing various launch configs for CUDA based vector multiply.
Sum with different storage types (reduce)
1. Performance of vector element sum using float vs bfloat16 as the storage type.
Sum with different modes (reduce)
1. Performance of sequential execution based vs OpenMP based vector element sum.
2. Performance of memcpy vs in-place based CUDA based vector element sum.
3. Comparing various launch configs for CUDA based vector element sum (memcpy).
4. Comparing various launch configs for CUDA based vector element sum (in-place).
Sum with in-place strategies of CUDA mode (reduce)
1. Comparing various launch configs for CUDA based vector element sum (in-place).
Show drafts
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Empowering the Data Analytics Ecosystem: A Laser Focus on Value
The data analytics ecosystem thrives when every component functions at its peak, unlocking the true potential of data. Here's a laser focus on key areas for an empowered ecosystem:
1. Democratize Access, Not Data:
Granular Access Controls: Provide users with self-service tools tailored to their specific needs, preventing data overload and misuse.
Data Catalogs: Implement robust data catalogs for easy discovery and understanding of available data sources.
2. Foster Collaboration with Clear Roles:
Data Mesh Architecture: Break down data silos by creating a distributed data ownership model with clear ownership and responsibilities.
Collaborative Workspaces: Utilize interactive platforms where data scientists, analysts, and domain experts can work seamlessly together.
3. Leverage Advanced Analytics Strategically:
AI-powered Automation: Automate repetitive tasks like data cleaning and feature engineering, freeing up data talent for higher-level analysis.
Right-Tool Selection: Strategically choose the most effective advanced analytics techniques (e.g., AI, ML) based on specific business problems.
4. Prioritize Data Quality with Automation:
Automated Data Validation: Implement automated data quality checks to identify and rectify errors at the source, minimizing downstream issues.
Data Lineage Tracking: Track the flow of data throughout the ecosystem, ensuring transparency and facilitating root cause analysis for errors.
5. Cultivate a Data-Driven Mindset:
Metrics-Driven Performance Management: Align KPIs and performance metrics with data-driven insights to ensure actionable decision making.
Data Storytelling Workshops: Equip stakeholders with the skills to translate complex data findings into compelling narratives that drive action.
Benefits of a Precise Ecosystem:
Sharpened Focus: Precise access and clear roles ensure everyone works with the most relevant data, maximizing efficiency.
Actionable Insights: Strategic analytics and automated quality checks lead to more reliable and actionable data insights.
Continuous Improvement: Data-driven performance management fosters a culture of learning and continuous improvement.
Sustainable Growth: Empowered by data, organizations can make informed decisions to drive sustainable growth and innovation.
By focusing on these precise actions, organizations can create an empowered data analytics ecosystem that delivers real value by driving data-driven decisions and maximizing the return on their data investment.
3. The Institutional Review Board
• The Institutional Review Board (IRB) is a campus
review panel for the use of human participants in
research projects.
4. The Institutional Review Board
• The Institutional Review Board (IRB) is a campus
review panel for the use of human participants in
research projects.
– The typical IRB is composed of a cross-section of
individuals.
5. The Institutional Review Board
• The Institutional Review Board (IRB) is a campus
review panel for the use of human participants in
research projects.
– The typical IRB is composed of a cross-section of
individuals.
• IRB’s might contain faculty members from history, biology,
education, psychology, and economics, as well as one or two
members from the community who are not associated with the
institution.
6. The Institutional Review Board
• The Institutional Review Board (IRB) is a campus
review panel for the use of human participants in
research projects.
– The typical IRB is composed of a cross-section of
individuals.
7. The Institutional Review Board
• The Institutional Review Board (IRB) is a campus
review panel for the use of human participants in
research projects.
– The typical IRB is composed of a cross-section of
individuals.
– The IRB serves to ensure that the experimenter treats
research participants according to the established ethical
guidelines.
9. IRB Chair:
Dr. Ken Rossi, Financial Economics and Information Systems, College of Business
Administration
email: irbchair@hpu.edu
IRB Committee Members:
Dr. Trish Ellerson, Assistant Dean, College of Humanities and Social Sciences
Dr. Valentina Abordanado, School of Education, College of Humanities and Social
Sciences
Dr. Patricia Burrell, Chair, Graduate and Post Baccalaureate Programs, College of
Nursing and Health Sciences
Dr. Susan Watson, Department of Psychology, College of Humanities and Social
Sciences
Tammy Chung, Community Member
Vacant, Community Member
Vacant, Community Member
Teddy Snodgrass, Student Member, College of Nursing and Health Sciences
The HPU IRB
10. The HPU IRB
• Categories of Review:
–Exempt Review
–Expedited Review
–Full Review
11. The HPU IRB
• Exempt Review:
– Exempt review determines whether or not the
proposed research meets the requirements for
Exempt status or whether the project should be
submitted for review under another category.
Exempt category does not apply to any research
with children or other vulnerable subjects.
– However, research involving children under 18 years
or pregnant women or other vulnerable subjects is
not eligible for Exempt review.
12. The HPU IRB
• Exempt Review:
– Research involving educational practices and outcomes
– Data gathering as part of a classroom exercise which is intended to
familiarize students with existing instruments and procedures or to explicate
concepts presented in the classroom is not considered research.
– Research involving the use of educational tests (cognitive, diagnostic,
aptitude, attitudinal, achievement), surveys, interviews or observation of
public behavior
– Research involving the study or analysis of existing data, documents,
records, or specimens, if these are publicly available or if the information
has been recorded in such a manner that subjects cannot be identified.
– Research that has been approved by another IRB
– Occasionally, you will fit here – if your study does NOT involve human
subjects, e.g. content analysis, use of existing records or data bases, etc.
13. The HPU IRB
• Expedited Review:
– Expedited review procedures may be used for certain types of research
involving no more than minimal risk.
– The review may be carried out by the IRB Co-chair or by one or more IRB
members designated by the Co-chair. In reviewing the research, the
reviewers may exercise all of the authorities of the IRB except that the
reviewers may not disapprove the research.
– A research activity may be disapproved only after review in accordance
with the Full review procedure set forth below.
– Reviewers may also refer the proposal to a Full review by the IRB if they
believe that a full discussion is warranted.
– Expedited review can also be used for minor changes in previously
approved research during the period for which approval has been
authorized
14. The HPU IRB
• Expedited Review:
– Data collection methods that do not involve invasive procedures, deception,
or more than minimal stress.
– Research involves only noninvasive, painless, and non-disfiguring collection
of physical samples, such as hair, sweat, and excreta.
– There is no use of vulnerable subjects.
– Data are recorded using noninvasive, painless, and non-disfiguring sensors
or equipment, such as EKG, weighing scales, or voice/video recording.
– Research involving physical exertion requires only moderate levels of
exercise in healthy volunteers.
– The research does not involve ingestion of drugs or use of hazardous
devices.
– If existing data, documents, records, or specimens with identifiers are used,
procedures are in place to ensure confidentiality
– Most of your studies fit here
15. The HPU IRB
• Full Review:
– Any research not covered under the Exempt or Expedited
review categories is referred to the IRB for Full review.
– The investigator is welcome to attend the review in order to
answer any questions that may arise, and may bring others if
desired.
– The research is either approved, approved pending
modifications that must be verified by committee members,
or not approved.
– The IRB will be expeditious in its review and decision-making.
Investigators will be notified in writing about the IRB
decision.
16. The HPU IRB
• Full Review (Special Considerations):
– Children as Subjects in Research
– Research involving Fetuses, Pregnant Women, or Human In
Vitro Fertilization
– Research Involving Prisoners
– Research involving patients who have some incapacitation
– Fieldwork or Ethnographic Research
• This falls into the category of special populations that require
additional protection and oversight by the IRB.
• Fieldwork or ethnographic research commonly conducted in the field
of anthropology is a type of method in which the use of a consent
form may not be appropriate. The IRB should keep in mind the
possibility of granting a waiver of informed consent
17. The HPU IRB
• Informed Consent:
– Informed consent is a written agreement made between an
investigator and a freely participating subject, that describes
in easily understandable language:
• the subject’s role in the investigation,
• the potential risks and benefits associated with study participation,
• the confidential nature of all information obtained in the
investigation, and
• the provision for voluntary withdrawal without necessity for
explanation by the participant
• additionally, no informed consent, whether oral or written, may
include any 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.
18. The HPU IRB
• The basic elements of informed consent include:
– a description of the proposed study that includes the purpose, the
procedure, and the expected duration of the subject’s participation;
– a description of foreseeable risks (i.e., physical, psychological, social,
legal) that could be associated with study participation;
– a description of benefits that could be associated with study
participation;
– a disclosure of any appropriate alternative procedures that might be
advantageous for the subject;
– a statement describing the extent to which confidentiality of records
identifying the subject will be maintained;
– a related explanation for research involving more than minimal risk that
describes whether any compensation and/or medical treatment will be
available if injury occurs and, if necessary, a description of the
compensation and/or medical treatment and information about the
associated availability;
19. The HPU IRB
• Implied Consent:
– Implied consent is used when it is not appropriate or feasible
for use of an informed consent form:
• Your research involves a survey or other data collection instrument
that is mailed, emailed or made available in some other electronic
media (web-based) to the participant ,
• Follows the same rules as the informed consent except the
participant does not sign the form,
• It is placed in front of data collection instruments or read prior to
attempting to provide input to the data collection instrument;
• Reading beyond the form implies the participant’s consent to
participating in the study and your using their data for the study
• All the same rules apply as for informed consent.
• If the participants are from a protected category (children, prisoners,
elderly, confined, etc.) the informed consent must be used.
20. • All HPU faculty and staff involved in research (with or
without human subjects) are required to register for
and to take either the online course:
• “the CITI Course in The Protection of Human Research
Subjects” at
(https://www.citiprogram.org/Default.asp ), provided
by The Collaborative Institutional Training Initiative
(CITI) or,
• National Institutes of Health Office of Extramural
Research Training Course at
http://phrp.nihtraining.com/users/login.php
• All information about the IRB can be found at the IRB
tab in Pipeline
The HPU IRB
21. IRB Procedures
• The following IRB Project documents must be
submitted to the IRB by email (.doc or .docx format
only) in order:
– IRB Project Application Form (Appendix A)
– Informed Consent Form (example at Appendix B)
– Brief Summary of the research project and instruments
for collecting information (surveys, etc.)
– Debriefing Form
– Full Grant Proposal, if applicable
– NIH Certificate (.pdf, .doc or .docx format only)
– Amendment/Modification/Renewal Form, if applicable
(Appendix C)
– Submitted as a single document with your last name and
IRB Application as the document label
22. Annual Renewal Procedures
• Thirty days before the anniversary of the last
approval date, the following should be submitted
by email to the IRB Chair:
– Human Subjects Project Amendment/ Modification/
Renewal Form (Appendix C)
– If any changes have been made, submit instruments,
the consent form(s), and written explanation of study,
with all changes highlighted and noted to the IRB Chair
by email.