This document provides definitions and explanations of key concepts in clinical research. It defines human subject research according to the Department of Health and Human Services as involving systematic investigation designed to develop generalizable knowledge and obtaining data from living individuals through intervention or identifiable private information. The document outlines the history of regulations protecting human subjects from the Nuremberg Code to the Belmont Report. It also describes types of study designs including observational studies like cohorts and case-controls and experimental designs involving interventions. Resources for conducting research like the IRB and Human Immunology Research Office are presented.
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.
Ethical considerations in molecular & biotechnology researchDr Ghaiath Hussein
A lecture presented by Dr. Ghaiath Hussein in University of Khartoum for the students of the MSc programme in Genetics/Molecular Biology.
Session 1 (Introduction): Definition of ethics, bioethics and medical ethics.
What is an ethical issue?
International approaches to medical ethics
Islamic approaches to medical ethics
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.
Ethical considerations in molecular & biotechnology researchDr Ghaiath Hussein
A lecture presented by Dr. Ghaiath Hussein in University of Khartoum for the students of the MSc programme in Genetics/Molecular Biology.
Session 1 (Introduction): Definition of ethics, bioethics and medical ethics.
What is an ethical issue?
International approaches to medical ethics
Islamic approaches to medical ethics
The term “research” refers to a class of activity designed to develop or contribute to generalizable knowledge. Generalizable knowledge consists of theories, principles, or relationships, or the accumulation of information on which they are based, that can be corroborated by accepted scientific methods of observation and inference. In the present context, “research” includes both medical and behavioral studies pertaining to human health. Usually “research” is modified by the adjective “biomedical” to indicate its relation to health.
This is one of the lectures for the POGS Research Forum in Bacolod, mostly based on the chapter on Clinical Practice Guidelines for Ethics Review from the POGS Research Handbook: The Essentials. I hope this can be a guide for residents who are preparing their research proposal for ethical review.
This week, reflect on what you learned from the NIH materials abouTakishaPeck109
This week, reflect on what you learned from the NIH materials about protecting the rights of human research participants.
·
·
·
· Describe the circumstances that influenced the need for a policy to protect human research subjects. Give examples of specific ways human research subjects can be harmed by researchers.
· Identify three vulnerable populations and the special restrictions associated with human research among these groups. Evaluate the requirements and restrictions. Do you think they are adequate? Why or why not?
· The Belmont Report summarizes the ethical principles and guidelines for research involving human subjects. Three core principles are identified: respect for persons, beneficence, and justice. Even though these principles are considered equal, prioritize them in order of importance to you. Explain your decisions.
· Although you are not implementing a change project at this time, and you may not be directly involved in research as part of your professional responsibilities, explain the reasons why it is important for you to know about these rights and protections.
3 pages only
2 scholarly articles
Protecting Human Research Participants
NIH Of fic e of E xt ramural R e se a rc h
Introduction
Research with human subjects can occasionally result in a dilemma for investigators. When the
goals of the research are designed to make major contributions to a field, such as improving the
understanding of a disease process or determining the efficacy of an intervention, investigators
may perceive the outcomes of their studies to be more important than providing protections
for individual participants in the research.
Although it is understandable to focus on goals, our society values the rights and welfare of
individuals. It is not considered ethical behavior to use individuals solely as means to an end.
The importance of demonstrating respect for research participants is reflected in the principles
used to define ethical research and the regulations, policies, and guidance that describe the
implementation of those principles.
Who?
This course is intended for use by individuals involved in the design and/or conduct of National
Institutes of Health (NIH) funded human subjects research.
What?
This course is designed to prepare investigators involved in the design and/or conduct of
research involving human subjects to understand their obligations to protect the rights and
welfare of subjects in research. The course material presents basic concepts, principles, and
issues related to the protection of research participants.
Why?
As a part of NIH's commitment to the protection of human subjects and its response to Federal
mandates for increased emphasis on protection for human subjects in research, the NIH Office
of Extramural Research released a policy on Required Education in the Protection of Human
Research Participants in June 2000. This course is specifically designed for extramural
investigat ...
EMPHNET-PHE Course: Module seven ethical issues in public health research& in...Dr Ghaiath Hussein
This is a series of presentations I gave in the Eastern Mediterranean Public Health Network (EMPHNET)'s Public Health Ethics (PHE) that was held in Amman in June 2014.
This presentation outlines the ethical issues in research, especially the international research in low-middle income countries
At the end of this lecture , all participants will be able to know …
What is Ethics
Brief History of ethics
Ethical Principles
Types Of Ethics
Research Ethical Codes and Policies
Importance Of Ethical Norms in Research
The term “research” refers to a class of activity designed to develop or contribute to generalizable knowledge. Generalizable knowledge consists of theories, principles, or relationships, or the accumulation of information on which they are based, that can be corroborated by accepted scientific methods of observation and inference. In the present context, “research” includes both medical and behavioral studies pertaining to human health. Usually “research” is modified by the adjective “biomedical” to indicate its relation to health.
This is one of the lectures for the POGS Research Forum in Bacolod, mostly based on the chapter on Clinical Practice Guidelines for Ethics Review from the POGS Research Handbook: The Essentials. I hope this can be a guide for residents who are preparing their research proposal for ethical review.
This week, reflect on what you learned from the NIH materials abouTakishaPeck109
This week, reflect on what you learned from the NIH materials about protecting the rights of human research participants.
·
·
·
· Describe the circumstances that influenced the need for a policy to protect human research subjects. Give examples of specific ways human research subjects can be harmed by researchers.
· Identify three vulnerable populations and the special restrictions associated with human research among these groups. Evaluate the requirements and restrictions. Do you think they are adequate? Why or why not?
· The Belmont Report summarizes the ethical principles and guidelines for research involving human subjects. Three core principles are identified: respect for persons, beneficence, and justice. Even though these principles are considered equal, prioritize them in order of importance to you. Explain your decisions.
· Although you are not implementing a change project at this time, and you may not be directly involved in research as part of your professional responsibilities, explain the reasons why it is important for you to know about these rights and protections.
3 pages only
2 scholarly articles
Protecting Human Research Participants
NIH Of fic e of E xt ramural R e se a rc h
Introduction
Research with human subjects can occasionally result in a dilemma for investigators. When the
goals of the research are designed to make major contributions to a field, such as improving the
understanding of a disease process or determining the efficacy of an intervention, investigators
may perceive the outcomes of their studies to be more important than providing protections
for individual participants in the research.
Although it is understandable to focus on goals, our society values the rights and welfare of
individuals. It is not considered ethical behavior to use individuals solely as means to an end.
The importance of demonstrating respect for research participants is reflected in the principles
used to define ethical research and the regulations, policies, and guidance that describe the
implementation of those principles.
Who?
This course is intended for use by individuals involved in the design and/or conduct of National
Institutes of Health (NIH) funded human subjects research.
What?
This course is designed to prepare investigators involved in the design and/or conduct of
research involving human subjects to understand their obligations to protect the rights and
welfare of subjects in research. The course material presents basic concepts, principles, and
issues related to the protection of research participants.
Why?
As a part of NIH's commitment to the protection of human subjects and its response to Federal
mandates for increased emphasis on protection for human subjects in research, the NIH Office
of Extramural Research released a policy on Required Education in the Protection of Human
Research Participants in June 2000. This course is specifically designed for extramural
investigat ...
EMPHNET-PHE Course: Module seven ethical issues in public health research& in...Dr Ghaiath Hussein
This is a series of presentations I gave in the Eastern Mediterranean Public Health Network (EMPHNET)'s Public Health Ethics (PHE) that was held in Amman in June 2014.
This presentation outlines the ethical issues in research, especially the international research in low-middle income countries
At the end of this lecture , all participants will be able to know …
What is Ethics
Brief History of ethics
Ethical Principles
Types Of Ethics
Research Ethical Codes and Policies
Importance Of Ethical Norms in Research
Similar to Basics%20of%20Clinical%20Research%20(1).pptx (20)
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The House of Representatives will not countenance the use of federal funds to indoctrinate students into hateful, antisemitic, anti-American supporters of terrorism. Investigations into campus antisemitism by the Committee on Education and the Workforce and the Committee on Ways and Means have been expanded into a Congress-wide probe across all relevant jurisdictions to address this national crisis. The undersigned Committees will conduct oversight into the use of federal funds at MIT and its learning environment under authorities granted to each Committee.
• The Committee on Education and the Workforce has been investigating your institution since December 7, 2023. The Committee has broad jurisdiction over postsecondary education, including its compliance with Title VI of the Civil Rights Act, campus safety concerns over disruptions to the learning environment, and the awarding of federal student aid under the Higher Education Act.
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2. What is Clinical Research/
Human Subject Research?
Department of Health and Human Services
(DHHS) Definitions (45 CFR 46.102):
1. Human Subject Research
In order for activities to be deemed “Human Subject
Research” by the DHHS, they must meet the definition
of “research” and involve one or more “human
subjects” as defined by DHHS regulations.
3. DHHS Definitions (con’t)
A. Research
“A systematic investigation, including research
development, testing and evaluation, designed to
develop or contribute to generalizable knowledge.”
Belmont Report Definition of Research
“Any activity designed to test a hypothesis, permit
conclusions to be drawn and thereby to develop or
contribute to generalizable knowledge (expressed, for
example, in theories, principles, and statements of
relationships).”
4. DHHS Definitions (con’t)
B. Human Subjects:
“A living individual about whom an investigator
conducting research obtains (1) data through
intervention or interaction with the individual; or (2)
identifiable private information.”
5. DHHS Definitions (con’t)
Intervention:
Includes both the physical procedures by which data
are gathered (eg. blood draw) and manipulations of the
subject or the subject’s environment that are performed
for research purposes
Interaction:
Includes communication or interpersonal contact (eg.
questionnaires, interviews) between the investigator and
subject
6. DHHS Definitions (con’t)
Private Information:
Includes information about behavior that occurs in a
context in which an individual can reasonably expect
that no observation or recording is taking place, and
information which has been provided for specific
purposes by an individual and which the individual can
reasonably expect will not be made public (eg. medical
record). Private information must be individually
identifiable (eg. the identity of the subject is or may
readily be ascertained by the investigator or associated
with the information).
7. Food and Drug Administration
(FDA) Definition of Human Subject
Research
FDA has different definitions of “research” and
“human subjects”
FDA guidelines must be followed when using a
drug or device in the study
8. History of Development of Human
Research Protections
1. Public Health Service Syphilis Study ’32-’71
Better known as the “Tuskeegee Syphilis Study”
Originally designed to make treatment available to
African-American men with syphilis, even though
there was no known effective treatment
Issues:
1. Men were recruited without their consent
2. Misinformation about procedures, ie spinal taps
3. After penicillin was proven an effective treatment ’40’s),
men were denied antibiotics and prevented treatment
from military and local physicians
9. History of Development of Human
Research Protections
2. US Food, Drug and Safety Act (1938)
107 people died after taking sulfanilamide, a cold
remedy that contained anti-freeze.
This act enforces manufacturers to demonstrate
drug safety.
10. History of Development of Human
Research Protections
3. Nuremberg Code (1947)
Result of the trial of Nazi doctors and scientists
from WWII – no guidelines for human research
Guidelines:
1. Need for informed consent
2. Research should be based on prior animal work
3. Risks should be justified by anticipated benefits
4. Only qualified scientists must conduct research
5. Physical and mental suffering must be avoided
6. No research where death/severe injury is expected
11. History of Development of Human
Research Protections
3. Nuremberg Code (con’t)
Problems:
1. Little impact on research done in the US – thought to
condemn Nazis
2. No strength of the law behind it
3. Only applied to non-therapeutic human subject research
12. History of Development of Human
Research Protections
4. Declaration of Helsinki (1964)
Code of ethics developed by the World Medical
Association (now known and World Health Org)
Broader than Nuremberg Code
Geared towards therapeutic medical research
Recommended informed consent
Precursor to IRB requirement
Journals required all published research to follow
Declaration’s guidelines
13. History of Development of Human
Research Protections
5. The National Research Act (1974)
Culmination of hearings by US Congress
established the National Commission for the
Protection of Human Subjects of Biomedical and
Behavioral Research
Purpose of The National Commission:
1. Identify basic ethical principles underlying the
conduct of human subject research
2. Develop guidelines to ensure conduct of human
subject research in accordance with those principles
14. History of Development of Human
Research Protections
5. The National Research Act (con’t)
45 CFR 46 – “Regulations for the Protection of
Human Subjects of Biomedical and Behavioral
Research”; Issued by the Department of Health,
Education and Welfare (later renamed DHHS)
Revisions made in late 1970’s and early 1980’s
By 1991, 16 other federal agencies/departments
applied 45 CFR 46 to research they fund/conduct
Referred to as the “Common Rule”
15. History of Development of Human
Research Protections
6. The Belmont Report (1979)
Issued by the National Commission for the
Protection of Human Subjects of Biomedical and
Behavioral Research
Purpose: resolve ethical problems that surround
the conduct of human subject research
One principle does not outweigh another; each has
equal weight
16. History of Development of Human
Research Protections
6. The Belmont Report (con’t)
The three principles:
1. Respect for Persons – treat people as autonomous
creatures and not a means to an end; provide extra
protection for those with limited autonomy
Requires informed consent
Requires respect of privacy of research subjects
17. History of Development of Human
Research Protections
6. The Belmont Report (con’t)
The three principles:
2. Beneficence – minimize harm and maximize
benefit
Requires use of the best possible research design to
maximize benefit and minimize harm
Requires researchers to be able to perform the
procedures and manage the risks
Prohibits research without a favorable risk-benefit ratio
18. History of Development of Human
Research Protections
6. The Belmont Report (con’t)
The three principles:
3. Justice – treat all people fairly and ensure burdens
and benefits are shared equitably
Requires equitable selection of research subjects
Requires avoidance of exploitation of vulnerable
populations or populations of convenience (ie pregnant
women; children; incarcerated populations)
19. History of Development of Human
Research Protections
7. International Conference on Harmonisation -
ICH (1990)
Joint regulatory/industry project to improve
process of developing new products between
Japan, Europe and United States
Allows for international research studies to follow
same rules/regulations
Conference convenes to update regulations
Established “Good Clinical Practices”
20. Good Clinical Practices
Known as GCP’s
Misnomer – they are rules/regulations for the
conduct of research
Sometimes called “Good Research Practices”
Standard for the design, conduct, performance,
monitoring, analyses and reporting of research
Even though established for drug studies, they
dictate appropriate conduct for all research
21. Innovative Practice vs. Research
Innovative clinical practice is an intervention designed
solely to enhance the well-being of an individual patient
or client. The purpose is to provide diagnosis,
preventative treatment, or therapy to particular
individuals.
Considered “research” only if previous criteria is met.
At UPMC, the introduction of innovative procedures
or therapies into clinical practice (when research is not
involved), requires review by department chair and the
UPMC Technology Assessment Committee/Innovative
Practices Sub-Committee prior to implementation.
22. Quality Assurance vs. Research
Precise definitions to permit the distinction between
research studies and quality assurance projects are
difficult and have not been established. In general, a
quality assurance project is a project that is focused
primarily on improving patient care within a given
patient care environment and, as such, the outcome
may not be generalizable to other patient care
environments.
Both UPMC and CHP require the submission of all
quality assurance projects for review.
23. Questions to distinguish QA from Research
(any yes response indicates research)
1. Is there a commitment, in advance of data collection, to a
corrective plan given any one of a number of study outcomes?
Does the PI of the study have both clinical supervisory
responsibility and the authority to impose change?
2. Is the research being sponsored/funded by an external agency?
3. Does the proposed study involve the prospective assignment
of patients to different procedures or therapies based on a
predetermined plan?
4. Does the proposed study involve a “control group” in whom
the therapeutic or study intervention is intentionally withheld
to allow an assessment of its efficacy?
24. Questions to distinguish QA from Research
5. Will the study intervention be delivered in a blinded fashion
wherein neither the physician nor the patient knows to whom
the study intervention or comparative intervention (eg.
standard care, placebo) was given?
6. Is the assessment of outcome blinded to the study intervention
for purpose of establishing the efficacy of the intervention?
7. Does the proposed study involve the prospective evaluation of
a drug, biologic or device that is not currently approved for
general use by the FDA?
8. Will patients involved in the proposed study be exposed to
additional risks or burdens beyond standard clinical practice in
order to make the results of the study generalizable?
26. Types of Observational Studies
Cohort Studies
A group of subjects followed over time
Purpose: defining the incidence and investigating
potential causes of a condition (incidence)
Can be prospective – investigator chooses a sample
group and measures characteristics in each subject
over a period of time that might predict outcomes
Can be retrospective – same as prospective, except
all data collection and follow-up has happened in the
past; only possible if adequate data is available
27. Types of Observational Studies
Cross-Sectional Studies
Similar to cohort studies except all the
measurements are made at one time point with no
follow-up
Purpose: describing variables and their distribution
patterns (prevalence)
Strength – fast and inexpensive since there is no
follow-up or waiting time for outcome
28. Types of Observational Studies
Case-Control Studies
Two groups of people examined for the same
outcome
Group 1 – “cases” or a population of people with a
certain disease
Group 2 – “controls” or a population of people without
that same disease
Purpose: compare prevalence of risk factor(s) in
subjects with the disease (cases) versus subjects
without the disease (controls)
29. Types of Study Designs
1. Observational Designs
1. Experimental Designs – interventional
studies
30. Experimental Studies
These studies evaluate the effects of an
intervention
Types of interventions:
Behavior modification (eg. a walking program to improve
weight loss)
Drug (eg. a new investigational drug or studying a drug
for off-label use – subject to FDA regulations)
Device (eg. a new investigational stent – subject to FDA
regulations)
Strength: Can demonstrate causality
31. Phases of Experimental Studies
Phase I:
Unblinded studies of a small number of healthy
volunteers to test safety of treatment (can sometimes
use people with the disease)
Phase II:
Randomized studies of relatively small number of
people with the disease to test dose ranges and/or
efficacy of treatment
32. Phases of Experimental Studies
Phase III:
Randomized studies of large number of people with
the disease to test efficacy of treatment on pre-
selected outcomes
Phase IV:
Large experimental studies or observational studies
conducted after treatment has been approved by the
FDA to assess performance of treatment (called
Post-Market Studies)
33. Do I really want to
conduct clinical
research?
34. What Help is Available?
University of Pittsburgh IRB/RCCO
IRB Coordinators – wealth of knowledge; will
perform an informal review prior to official review
www.irb.pitt.edu – IRB manual; required forms; link
to research training website; etc.
Sponsored educational activities – monthly “Ask the
IRB” sessions; conferences on current issues; etc.
Human Immunology Research Office
35. Human Immunology
Research Office
Assistance with investigational human studies
involving transplantation that are initiated by
STI research or involves substantial support
from STI research
Act as repository for all documents related to
above studies and all other studies requiring
STI research participation (eg. Processing of
blood samples on 15th floor BST
36. Human Immunology
Research Office
Services Available:
1. Consultation regarding clinical aspects/logistics of
new projects
2. IRB summary protocol and consent form
preparation assistance
3. Project coordination:
Assist with recruitment based on project
Ensure proper handling of samples/specimens from
patient to lab
37. Human Immunology
Research Office
Information to be stored in this office:
1. Copies of all current and future IRB submissions
2. Correspondence between IRB and investigators
including approval letters, audit reports, etc
3. Correspondence between sponsor and
investigators regarding protocol issues
4. RPF training certificates
5. Copies of current CV’s
6. Copies of current licenses
38. Human Immunology
Research Office
To request assistance:
1. Contact office to set up meeting to discuss project,
assistance requested, etc
2. Complete research outline (template will be
supplied by the office)
Contact information:
Location: E1540 BST
Phone: 412-624-6611
Email: elinoffbd@upmc.edu
39. Requirements Prior to IRB
Submission
Possible UPMC fiscal approval
STI PRC (protocol review committee) approval
Any protocol submitted to the IRB requires prior
scientific review; PRC review includes scientific
review.
submission is reviewed both by an investigator and a
research coordinator
Facilitator of committee is Agnes Zachoszcz (all
submissions are emailed to her)