Responsible Conduct of Research: Human Subjects Protection Use of Animals in Research 1 Departmental Research Administrators Training Track Research Protections & Compliance Part I of II

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 Researchers Compliance Committees Compliance Units Research Compliance Compliance Ensures the ethical review of research

Human Research 7

“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 8

Federal Laws, Guidelines and Ethical Principles  Department of Health and Human Services ( 45 CFR 46) Protection of Human Subjects  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)  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 (FWA , approved through 09/13/2016) from the Office for Human Research Protections.Federalwide AssuranceOffice 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 GuideThe 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

14 The greatest risk is often a breach of confidentiality 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 Harms and Risks

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? 17

What researchers need to know  IRB Researcher’s Guide  Human Use Protocol Submission Guidelines  Human Use Training 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  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

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 27

“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 28

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 well- being

Rules and regulations  The University of Maryland, Baltimore County has an Animal Welfare Assurance (A , approved through 09/30/2013) from the Office of Laboratory Animal Welfare.Animal Welfare AssuranceOffice 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 GuidebookUniversity 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? 36

What researchers need to know  IACUC Policy & Procedure Guidebook  Animal Use Protocol Submission Guidelines  Animal Care and Use Training 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 pre- approved 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  Protocols must be submitted 1 ½ month before scheduled meeting as the IACUC meets quarterly  Submit to

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