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
1
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
2
Overview
Research compliance is:
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
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
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”
Various codes for the proper and responsible conduct of human research have been incorporated into researchers interact with people and how universities conduct business.
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
Department of Health and Human Services
46) Protection of Human Subjects
(
Defines research and who is a human participant
45 CFR
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)
All above further defines research and human participant status while also describing responsibilities of investigators
Rules and regulations
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
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
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
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
Understand what research is:
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:
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
• Emotional or psychological harm
• Social harm
• Physical harm
• Financial harm
• Legal harm
• Moral harm
Risks
• 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
IRB Support
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
IRB Researcher’s Guide http://www.umbc.edu/irb/IRBResearchersGuide_09_13_11.pdf
Human Use Protocol Submission Guidelines http://www.umbc.edu/research/ORPC/IRBprotdevelop.html
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
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
Information Systems
Interactive Systems Research Center
Empirical and Applied Software Engineering Lab
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
Exempt
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.
Expedited
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
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
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 irbsubmissions@umbc.edu
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”
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
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
Guide for the Care and Use of Laboratory Animals
Promotes the humane care of animals
Provides information that will enhance animal wellbeing
Rules and regulations
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.
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
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
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
The animal care program is directed by the
Institutional Animal Care and Use Committee (IACUC) whose members include:
Animal researchers, veterinarians, individuals who do not use animals
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
Reporting and following up on the reporting of all animal care and use concerns
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
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:
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
Laboratory research – performed in animal facilities
Examples – cancer research, behavior studies, environmental impacts on animals
Teaching - done in the classroom
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
Examples - Tracking migratory birds, avian and fish behavior
IACUC Support
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 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
IACUC Policy & Procedure Guidebook http://www.umbc.edu/iacuc/IACUC_manual_dec09.pdf
Animal Use Protocol Submission Guidelines http://www.umbc.edu/research/ORPC/IACUCprotdevelop.html
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
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
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
New
Modifications (minor and significant)
Annual reporting
Renewals
Closures
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 iacucsubmissions@umbc.edu
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
Questions??
Office for Research Protections and Compliance compliance@umbc.edu http://www.umbc.edu/research/ORPC
410-455-2737
