Transcript Research Compliance I

Departmental Research Administrators
Training Track
Research Protections & Compliance
Part I of II
Responsible Conduct of Research:
Human Subjects Protection
Use of Animals in Research
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Learning Outcomes
Understand the importance of research
compliance
 Get a better understanding and appreciation of
how essential your role is in University research
compliance
 Learn of resources available on campus to be
successful in this role
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Overview
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Research compliance is:
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Being aware of rules and regulations
Understanding what compliance means and sharing this with others in
your department
Showing and telling others how to “Do the right thing”
How do you fit in
 Be aware of the concepts and components of Responsible
Conduct of Research
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May need to help researchers complete sections of grant application
forms related to human and animal research
May be involved in the participant payment or animal procurement
process
“Doing the right thing”
“Do the right thing. It will gratify some people and astonish the
rest.” – Mark Twain
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For individuals, there are many ethical and legal aspects related to human
research
Animal research raises questions about its purpose and opens a wide
spectrum of ethical and moral views on use of animals in research, teaching
and testing
Nine (9) Areas of RCR
Circle of Compliance
Administration
Compliance
Units
Research
Compliance
Researchers
Compliance
Committees
Ensures the ethical review of research
Human Research
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“Doing the right thing”
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Various codes for the proper and responsible conduct of
human research have been incorporated into researchers
interact with people and how universities conduct business.
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Respect for persons – freedom to make a choice and voluntarily
participate
Beneficience – freedom from harm with maximizing benefits and
minimizing risks
Justice – fair distribution of benefits/risk of participating in
research (impose risks unnecessarily/advantage of benefits who
can afford them)
Foundations of ethics in human research
Protection from risks and safeguard from harm
Led to creation of 45CFR46 - Protection of Human Subjects
History teaches us that knowing about the past will help important decisions today
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Federal Laws, Guidelines and Ethical Principles
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Department of Health and Human Services (45 CFR
46) Protection of Human Subjects
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Defines research and who is a human participant
Designates IRB oversight
University of Maryland System Policy on Human
Subject Research
U.S. Department of Education (34 CFR 97) Protection
of Human Subjects
Protection of Pupil Rights Amendment (PPRA) (34 CFR
98)
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All above further defines research and human participant
status while also describing responsibilities of investigators
Rules and regulations
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The University of Maryland, Baltimore County has an Federalwide Assurance
(FWA00000069, approved through 09/13/2016) from the Office for Human
Research Protections.
 This assurance spells out the roles and responsibilities of UMBC, in
particular the Institutional Official (the Vice President for Research),
Institutional Review Board (IRB – the committee that approves human
research) and the human use investigators (faculty in your department).
All human use researchers follow The University of Maryland,
Baltimore County Researcher’s Guide
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This guide discusses the human use research protocol review and
approval process, when and how participants can be enrolled in
research studies, the importance of being appropriate trained in working
with people in research and the investigator’s responsibilities in being
compliant with all IRB policies, decisions, conditions, and requirements
BIOSAFETY
UMBC Human Research Use
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UMBC has an human research use program to
ensure
 Ethical
review of research
 Ensure participants rights are protected and that
they are safeguarded from risk and harm
 Compliance with federal guidelines and principles
IRB
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The human research use program is directed by the Institutional
Review Board (IRB) whose members include:
 Scientists and non scientists from various disciplines on
campus as well as graduate and undergraduate student
members (Psychology, Africana Studies, Information Systems, Modern Languages and
Linguistics, Sociology/Anthropology, Public Policy)
Individuals not affiliated with the Campus who represent the
concerns of the Community
 Use subject matter experts to advise on research that falls
outside of fields of expertise
Provides assurance to the federal government that UMBC will comply
with the rules and regulations and provides oversight for the
university's human research use program
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Understand what research is:
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Systematic investigation that contributes to generalizable
knowledge
"Research" is defined in the Code of Federal Regulations as "a
systematic investigation that contributes to generalizable
knowledge“.
 In other words, for the most part, an investigator will:
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be "engaged in research”
proposed an intention to explore a particular topic
interact with a living person and
have a plan to “generalize “ the information by either publishing (e.g., in a
journal) or presenting at a conference.
Living persons are those about whom an investigator conducting research
obtains data through intervention or interaction with the individual or
identifiable private information
Harms and Risks
Harms
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Emotional or psychological
harm
Social harm
Physical harm
Financial harm
Legal harm
Moral harm
Risks
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social stigma,
loss of employment
legal prosecution
embarrassment
damaged family relationships
emotional risks (relive or reveal
violence ), which may lead to
physical danger
The greatest risk is often a breach of confidentiality
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What Studies are Covered
Questionnaires
 Interviews (audio or video recorded)
 Focus groups
 Participant observation
 Non-invasive physical measurements (blood
pressure, EKG, eye movement)
 Review of records and other data
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IRB Support
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Provided by the Office for Research Protections and
Compliance
 Assistance with protocol submissions
 Guidance on interpretation of regulations
 Shepherd protocols through the review and approval
process
 Provides information and help
to departments about the entire
human research process
 Work with OSP to deal with funding
agency paperwork (Just in Time)
 Education and training
 Post approval monitoring
Where do you fit into this?
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What researchers need to know
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IRB Researcher’s Guide
http://www.umbc.edu/irb/IRBResearchersGuide_09_13_11.pdf
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Human Use Protocol Submission Guidelines
http://www.umbc.edu/research/ORPC/IRBprotdevelop.html
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Human Use Training
http://www.umbc.edu/research/ORPC/human_subjects_use_training.html
Who is eligible to submit a protocol application as a
principal investigator?
• Faculty, staff and students (graduate and
undergraduate)
•Training must be completed before research begins
Human Research Facilities
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Human research is performed in various labs on campus –
Examples:
 Psychology
Pediatric Psychology Lab
 Culture, child and adolescent development lab
 HABITS lab (addictive and health behaviors,
including alcohol and drugs, diet, exercise)
 Social Development Lab
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Information Systems
Interactive Systems Research Center
 Empirical and Applied Software Engineering Lab
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Administrators working in these departments may assist
investigators in the purchase of supplies for the labs and
processing of payments to participants in studies
Types of review
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Exempt
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Expedited
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Minimal risk or less involving curriculum research, anonymous
surveys/interviews, surveys/interviews collecting non-sensitive data (data which
is not damaging to the subject’s financial status, employability, or reputation).
Exempt determination is made by the IRB chair.
Minimal risk or less research on individual or group characteristics or behavior,
or research employing surveys, interviews, focus groups, etc. where identifiers
would or might be collected. Review is performed by at least two members of the
committee. Expedited review does not necessarily mean a quick review!
Full Board
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Full board review is performed by the whole committee and reviews studies that
are more than minimal risk, involve vulnerable populations, or involve special
circumstances. Sensitive topics include: sex, drugs, alcohol use, suicide.
Submission of forms/grant applications
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New
Renewals
Modifications
Reports of problems (adverse events)
Closures
Submitting human research protocols
 IRB forms available at
http://www.umbc.edu/research/ORPC/irb_forms.html
 Exempt and expedited protocols may be submitted at any time. Full
Board reviews are to be submitted 1 month before a scheduled IRB
meeting
 Submit to [email protected]
UMBC Form Samples
Funding Agency Form Samples
Just in Time
(NIH) - IRB
review and
approval is not
required at
proposal time.
Funding Agency Form Samples
While IRB approval is not
needed at NIH proposal
submission time there are
Human Subjects issues that
must be addressed in the
Human Subjects Research
Section of the Research
Design and Methods
section of the proposal.
Funding Agency Form Samples
Animal Care and Use in Research
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“Doing the right thing”
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Consideration of the three “Rs” of alternatives (Refinements to
research, Reduction of animal numbers, and Replacement with
non-animal models)
These views have shaped the development and enforcement
animal use regulations (PHS and USDA) and affirmed by
organizations such as AAALAC, AALAS and the AVMA.
These regulations encourage ethical behavior
These regulations do lead most researchers to do the right
thing (humanely care for animals, perform approved research,
follow what the IACUC says)
Important to stay informed about the types of research
conducted and ask questions about things your not sure about.
Association for Assessment and Accreditation of Laboratory Animal Care, American Association for Laboratory Animal Science, American Veterinary Medical Association
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Federal Laws, Guidelines and Ethical Principles
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Public Health Service (PHS) policy on Humane
Care and Use of Laboratory Animals
Establish guidelines for the proper care and treatment
of animals used in research
 Designates IACUC oversight
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Guide for the Care and Use of Laboratory Animals
Promotes the humane care of animals
 Provides information that will enhance animal wellbeing
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Rules and regulations
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The University of Maryland, Baltimore County has an Animal
Welfare Assurance (A3784-01, approved through 09/30/2013)
from the Office of Laboratory Animal Welfare.
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This assurance spells out the roles and responsibilities of UMBC, in
particular the Institutional Official (the Vice President for Research),
Institutional Animal Care and Use Committee (IACUC – the committee
that approves animal research) and the animal investigators (faculty in
your department).
All animal researchers follow The University of Maryland,
Baltimore County IACUC Procedure Guidebook
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This guide discusses the animal research protocol review and approval
process, the importance of training in the care and use of animals and
special topics related to animal research, including occupational health
and safety, concerns regarding the care, treatment and use of animals
and the investigator’s responsibilities in being compliant with all IACUC
policies, decisions, conditions, and requirements
BIOSAFETY
UMBC Animal Care & Use
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UMBC has an Animal Care and Use Program to
ensure
 Ethical,
appropriate and humane care and use of
animals in teaching and research
 Compliance with federal and state animal-welfare
laws
 Overall purpose is to oversee all research and
instruction that involves vertebrate animals, in
order to ensure that the highest ethical and animal
welfare standards are met
IACUC
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The animal care program is directed by the
Institutional Animal Care and Use Committee (IACUC)
whose members include:
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Animal researchers, veterinarians, individuals who do not
use animals
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Individuals not affiliated with the Campus who represent the
concerns of the Community
Provides assurance to the federal government that
UMBC will comply with the rules and regulations
and provides oversight for the university's
animal care and use program
Other issues or concerns
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Reporting and following up on the reporting of all animal care and use
concerns
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The IACUC has procedures in place to investigate all concerns regarding the
care, treatment and use of animals for research or teaching on campus or off
campus. Concerns should first be discussed with the investigator, instructor or
facility manager to eliminate the possibility of any erroneous perceptions. Many
instances of noncompliance may be corrected within the laboratory.
Occupational Safety and Health
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The occupational health and safety program is supported by University Health
Services (UHS) and Office of Environmental Safety and Health (OESH). Most
common risks present while working in the UMBC animal facilities include:
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Animal bites and scratches
Animal allergens from saliva, urine, blood, dander or fur
Zoonotic diseases, i.e. Salmonellosis, Yersinia enterocolitica
All work-related injuries must be reported to the OESH
What Studies are Covered
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Laboratory research – performed in animal facilities
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Teaching - done in the classroom
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Examples – cancer research, behavior studies,
environmental impacts on animals
Examples – instructions to students about cardiovascular
systems and cellular biology using animal models
Field studies – travel around the country and the
world to observe and interact with animals
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Examples - Tracking migratory birds, avian and fish behavior
IACUC Support
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Provided by the Office for Research Protections and
Compliance
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Assistance with protocol submissions
Guidance on interpretation of regulations
Shepherd protocols through the review and approval process
Provides information and help
to departments about the entire
animal research process
Education and training
Assist with reports (anonymous or not) of
concerns regarding animal care
Direct where to go to file report of work
related injuries
Where do you fit into this?
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What researchers need to know
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IACUC Policy & Procedure Guidebook
http://www.umbc.edu/iacuc/IACUC_manual_dec09.pdf
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Animal Use Protocol Submission Guidelines
http://www.umbc.edu/research/ORPC/IACUCprotdevelop.html
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Animal Care and Use Training
http://www.umbc.edu/research/ORPC/Animal_care_use_training.html
Who is eligible to submit a protocol application as a
principal investigator?
• Faculty and staff
• Students may not submit an application of their own
but may be listed as an co-investigator
•Training must be completed before research begins
Lab Animal Facilities
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Animal research is performed in IACUC
approved facilities and are supported by
departmental staff and a campus veterinarian
 Interaction
with animal technicians,
student assistants, PIs
Animal Purchase
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Animals used at UMBC are purchased from preapproved commercial suppliers and dealers
The Director of the animal care facility handles all
arrangements for the acquisition, transportation and
receipt of animals
ORPC has a list of pre-approved vendors
Animals from other sources, such as other
universities, may be brought to UMBC – the IACUC
Chair and campus veterinarian must approve
Submission of forms/grant applications
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New
Modifications (minor and significant)
Annual reporting
Renewals
Closures
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IACUC forms available at
http://www.umbc.edu/research/ORPC/iacuc_forms.html
Protocols must be submitted 1 ½ month before scheduled
meeting as the IACUC meets quarterly
Submit to [email protected]
UMBC Form Samples
Funding Agency Samples
Just in Time
(NIH) - IACUC
review and
approval is not
required at
proposal time.
Points To Remember
Be aware of rules and regulations
 Understand what compliance means while
helping others to do the right thing
 Your role is in University research compliance is
important
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Questions??
Office for Research Protections and Compliance
[email protected]
http://www.umbc.edu/research/ORPC
410-455-2737