RESEARCH ETHICS BOARD AND PROTECTION OF HUMAN RESEARCH SUBJECTS Potential Model for setting up Office of Research Compliance and an Institutional Review Board (IRB) RESEARCH ETHICS BOARD AND PROTECTION OF HUMAN RESEARCH SUBJECTS

CONSIDERATIONS OF STEPS INVOLVED IN THE PROCESS OF ESTABLISHING A RESEARCH ETHICS BOARD: INSTITUTIONAL REVIEW BOARD This presentation will provide a model based on the Office of Research Compliance of Northern Illinois University, USA Minimal Steps in the process of establishing IRB: Establishing a structure of the Office of Research Compliance and Institutional Review Board with clear demarcation of ethical, legal, monitoring, and reporting responsibilities Defining terms of qualifications of those who will direct and serve as members of the board Training of those who will direct and serve as members of the board Development of policies (based on laws governing human subject research), educational materials—including ethics training/human research subject training materials, and official forms by the IRB and Office of Research Compliance—while materials are refined and developed the IRB must perform it’s task of evaluating prospective research on its ethical merits

Establishing a structure of the Office of Research Compliance and Institutional Review Board with clear demarcation of ethical, legal, monitoring, and reporting responsibilities OFFICE OF RESEARCH COMPLIANCE: Responsible for enforcing and reporting on violations of Federal guidelines and laws on Human subject research Animal research Research with hazardous biological material

RESPONSIBILITIES AND DUTIES OF ORC assists the NIU research community in maintaining high ethical standards and adhering to regulatory requirements by: Identifying research-related compliance risks and alerting our research community about those risks Working with our research community to manage and minimize research risks Providing education about regulatory requirements and best practices used to comply with them Providing education and training that promotes an ethical research environment and the Responsible Conduct of Research Handling instances of non-compliance or misconduct in accord with University policy and federal guidelines

In pursuit of these objectives and fulfillment of our mission, ORCIS shares the core values of the Division of Research and Innovation Partnerships: Excellence Ethical and accountable conduct Academic integrity and regulatory compliance A diverse and inclusive community of people, ideas and research initiatives

The Office of Research Compliance, Integrity, and Safety houses the mandated federal review boards for research.  These include the Institutional Review Board (IRB) which handles protections and approvals for research involving human subjects the Institutional Animal Care and Use Committee (IACUC) which is responsible for protections and approvals regarding research with animals the Institutional Biosafety Committee (IBC) which is  the authority for protections and approvals with research involving biohazards. 

THE WAY YOUR INSTITUTION MIGHT STRUCTURE AN OFFICE OF RESEARCH COMPLIANCE DEPENDS ON EXISTING BOARDS AND EXISTING THAI LAWS PERTAINING TO ANIMAL RESEARCH, HAZARDOUS BIOLOGICAL MATERIALS, AND HUMAN SUBJECT RESEARCH

CURRENT STRUCTURE of IRB at NORTHERN ILLINOIS UNIVERSITY IRB: INSTITUTIONAL REVIEW BOARD: handles protections and approvals for research involving human subjects CURRENT STRUCTURE of IRB at NORTHERN ILLINOIS UNIVERSITY (comparable to all other higher education institutions in USA) Departmental reviewer: chair / trained qualified faculty member Full IRB BOARD: Institutional Review Board 1 and IRB 2 difference between IRB 1 and IRB 2 is different schedules to accommodate the vast number of research submissions for review given that each board ONLY MEETS ONCE A MONTH.

Both IRB 1 and IRB 2 select at their monthly meeting a monthly reviewer from its board members who examine submissions and determines if the submissions show minimal risk or more substantial risk. In case of minimal risk the person is authorized to approve. In case of the monthly reviewer not able to determine with completely certainty that the project is minimal risk, and when a project proposes substantial risk the submission goes to the whole Institutional Review Board’s monthly meeting and consideration. Most projects end up in the IRB monthly meeting for consideration of the level of risk posed to human subjects and to reconcile with existing ethical laws

HARM IS DEFINED IN TERMS OF: RISK IS DEFINED IN TERMS OF HARM TO PARTICIPATING HUMAN RESEARCH SUBJECTS HARM IS DEFINED IN TERMS OF: threat to cultural integrity; physical harm; psychological harm; economic or social status harm; and so on. Therefore, harm is not just physical harm!!!!

IRB (both IRB 1 and 2) constituted of : Members with substantial research and publication experience Members who have been thoroughly trained (see later ‘qualifications’) Members must represent ALL academic disciplines dealing with human subject research -- humanities, social sciences, natural sciences (biology), medicine, nursing, nutrition, kinesiology, law For example, those representing social sciences must be familiar with the ethics and methods of all social science disciplines not just their own discipline within social science

University Legal Counsel (lawyer) must be one of the members An external member from the non-university community must be included: usually a professional who deals with human subjects in their own work (eg. Medical doctor, nurse, psychologist, etc.)

Members annually MUST refresh their training and read current materials on research ethics, issues that arose with research compliance, etc.—must keep up with laws and ethical issues in the literature ACADEMIC members are rotated out every three years, although term can be renewed IRB has a Chair and Vice Chair responsible for all ethical approval and reporting activities IRB has Research Compliance Coordinator (for questions related to the IRB approval process and to coordinate between IRB 1 and 2) These last three positions are continuously undergoing training and refresher courses along with coordinating with legal council and attending conferences on human research subject protections and ethics

The IRB will be made up of at least five individuals, one of whom must not be affiliated with the University in any way. The members must be of varied background, including consideration of the gender and racial and cultural backgrounds of members and sensitivity to such issues as community attitudes, to promote respect for its advice and counsel in safeguarding the rights and welfare of human subject. The IRB members must also possess sufficient expertise to provide complete and adequate review of the types of human subjects research commonly conducted at NIU. The IRB shall include at least one member whose primary concerns are in scientific areas, and at least one member whose primary concerns are in nonscientific areas. The IRB membership is appointed by the IO. All NIU IRBs will include at least one member from each of the following categories: Representative from the University Health Service, physician Faculty member, Psychological Expertise Faculty member, Educational Expertise Faculty member, Physiological Expertise Faculty member, Kinesiology Expertise Faculty member, Social Science Expertise, Non-Scientist (humanities) Community member (not affiliated with NIU)

Other IRB members may be recruited based on an assessment of need Other IRB members may be recruited based on an assessment of need. Individuals internal or external to NIU may be recruited to serve as a consultant to the IRB when the IRB Chair or IRB administrator determines that expertise or knowledge not available within the IRB membership is needed to fully consider a specific research protocol. Such consultants may not vote on the protocol(s) and are not appointed to the IRB. Recruitment of IRB members and consultants may be performed by the IRB Chair, IRB members and staff, and NIU administrators such as Deans and Department Chairs as appropriate. Members are appointed to three-year, renewable terms. When a member term is concluding, the IRB Chair and the IRB administrator, in consultation with the IO as needed, will evaluate whether or not reappointment should be offered. A reappointment offer is made based on the member’s attendance, meeting preparation, and contribution to the IRB’s work over the course of his/her membership as well as the anticipated needs of the IRB in the future.

The IO will appoint a Chair for each IRB The IO will appoint a Chair for each IRB. IRBs may also have one or more Vice Chairs who may serve as an alternate for the Chair when necessary. IRB Chairs are appointed for a three year term and are subject to the same reappointment considerations described above for IRB members. Currently NIU IRBs have members from the following departments: anthropology, political science, sociology, psychology, geography, history, foreign languages and literature, art history, kinesiology, nursing, nutrition, biology, education, law Nondepartmental members: university health services, university counselling services, university lawyer Non-university community members: doctor, nurse

TRAINING: PLEASE NOTE: every single person on the IRB, including departmental reviewers, department chairs, and the Chairs and Vice Chairs of IRB, the Research Compliance Coordinator must undergo extensive and continuous training on the protection of human subjects! Academic or administrative rank does NOT excuse anyone from training and a thorough knowledge of the laws, guidelines, ethical rules of various professional organizations that govern human subject research Please consult some of the handouts provided for this seminar—Belmont Report, US federal Laws, ethical rules and materials of at least one professional organization, the American Anthropological Association.

Qualifications for IRB members from different departments of the university Thoroughly trained in: Research ethics Research methods Federal laws and professional ethical rules on Human subject research Ethics rules of their professional organizations Training is ON-GOING: annually IRB members must take a refresher course and demonstrate that they kept up with the latest literature on ethics and protection of human research subject literature, including literature on adverse incidents, the ways these were resolved and so on. It is also desirable that the members be of high ethical and professional character; e.g. do not show favoritism, do not cut corners, do not bring their own political, cultural, and religious views to the table etc.

Development of policies, educational materials—including ethics training/human research subject training materials, and official forms Once the IRB has been constituted and trained the IRB can start development of policies Policies are based in the laws and professional ethical rules and guidelines on the protection of human research subjects The IRB also must develop training materials on the protection of human research subjects: Training materials for ALL faculty members engaging in research with human subjects Training materials for departmental IRB reviewers and departmental Chairs Training materials for members of the IRB—important since the members rotate out and are refreshed every 3 years.

The IRB must develop official forms and information documents concernig the forms Once the forms have been developed, the IRB must hold annual seminars open to researchers on how to use and to fill out the forms—there always are a lot of questions in spite of the training all researchers get on protection of human research subjects. PLEASE SEE THE HANDOUTS FOR SOME OF THE MODELS FOR THE DEVELOPMENT OF AFOREMENTIONED FORMS.