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- Operations Manual - Education and Training
Operations Manual - Part 13
The University of Michigan (U-M) and its faculty, staff, and trainees are committed to complying with the laws and regulations that govern the review and conduct of human research and to upholding the highest ethical standards. To help achieve this and ensure protection of research participants, the University requires a basic level of human subjects protection education and provides a variety of educational activities designed to enhance the understanding of human subjects protection at all levels including leadership, Institutional Review Board (IRB) members and staff, investigators, research staff, and study participants and their communities.
U-M has developed an online Program for Education and Evaluation in Responsible Research and Scholarship (PEERRS) required for designated University faculty and staff, students, and collaborators involved in human research. PEERRS offers two courses that fulfill regulatory requirements for training in the protection of human subjects in research. Completion of at least one of these courses is a requirement for IRB approval and is monitored through the IRB application. The two courses are:
Human Subjects Protection – Biomedical & Health
Human Subjects Protection – Social & Behavioral
These courses are modeled on the Collaborative Institutional Training Initiative (CITI) human subjects protection modules and provide training required per university, state, and federal regulations.
PEERRS certification is obtained by passing a short quiz for each required topic area. Certification in a module is granted for three years from the last date the user passes a certification test. Certification status is visible in the eResearch IRB application. The IRBs will not release initial study approval until all required individuals have completed the required training.
In addition to PEERRS, individuals may be required to complete additional training depending on the scope and nature of the specific research. For example, the NIH has established the expectation that investigators involved in the conduct, oversight, or managmeent of NIH-funded clinical trials be trained in GCP (NOT-OD-16-148).
To complement the required PEERRS training, the IRBs and other components of the HRPP offer a wide range of additional educational activities to continuously improve the quality of human subjects protections at U-M.
University officials responsible for regulatory compliance are made aware of new legal and policy developments through a variety of sources. These include: membership in professional associations; participation in and assumption of leadership roles with professional organizations; participation in relevant electronic listservs; access to electronic regulatory, legislative, and analytical resources; and attendance at regional and national educational conferences. Government Relations representatives keep regulatory compliance staff apprised of relevant pending legislation and regulatory activities, and the Office of the Vice President and General Counsel assists in providing analysis of these developments.
University officials in turn notify the research community of relevant developments through multiple mechanisms including: policy revisions; changes to application forms and guidelines; newsletters; educational sessions; web postings; and other communications, as necessary to promote ongoing compliance.
All of the individuals with a defined leadership role in the HRPP are linked to multiple nodes in the system. For example, the Deputy Institutional Official (DIO) has roles on the Conflict of Interest Review Committees, the General Safety Committee, and the Institutional Biosafety Committee. IRB chairs and directors serve on the IRB Council. IRB staff representatives serve on these and other committees and provide direction to the eResearch initiative. This integrative approach facilitates communication of new legal and policy developments throughout the HRPP organization.
IRB chairs, members, and staff are trained through a detailed orientation procedure to provide them with the knowledge and skills to effectively discharge their duties and uphold the federal and local laws, University policies, and ethical standards on human subjects research. Continuing education for new and existing IRB staff and members is also required and is provided in the form of workshops, presentations, national webinars, and printed and electronic materials that are shared on an on-going basis. IRB members and staff are also kept informed of opportunities for continuing education and encouraged to attend.
Details of the initial orientation procedure, continuing education requirements, and evaluations of IRB Chairs, members, and staff are described in the IRB SOPs.
The U-M IRBs are committed to providing educational activities that supplement required training and are tailored to meet the on-going educational needs of the research community. A variety of activities are offered online and in-person including:
- Seminar series;
- On-demand presentations;
- One-on-one consultations;
- On-line materials and recorded presentations; and
- A multimedia library called U-MIC that offers voice-over slideshows covering a wide range of human subjects protection topics.
The activities are designed to improve the understanding of regulatory requirements, IRB application completion, and special topics related to human subjects research.
Websites of the U-M IRBs provide detailed descriptions of the educational offerings as well as access to online materials.
Michigan Institute for Clinical and Health Research (MICHR) supports clinical research at the University through education and study management services. MICHR offers an extensive selection of courses, workshops, and seminars to the U-M research community, designed to meet the needs of students, faculty, and staff. The educational offerings include: pre-doctoral, post doctoral, and study coordinator programs; mentoring; and general education. Examples of on-going activities include:
- MICHR Symposium;
- Responsible Conduct of Research for K Awardees;
- Responsibilities of Investigational New Drug Application (IND)/Investigational Device Exemption (IDE) Sponsor-Investigators; and
- Research Basics for Study Coordinators.
The MICHR website has a full description of the offerings and a calendar of events.
In addition to required training, IRB and MICHR educational offerings, various on-going educational activities and events are available through colleges, schools, departments and institutes throughout the University. Such activities promote compliance within the colleges, schools and units and continually enhance the human subjects protections knowledge of the U-M reserach community. Examples include, but are not limited to:
- The Medical School Office of Regulatory Affairs, in collaboration with other HRPP units, occasionally organize symposiums on U.S. Food and Drug Administration (FDA)-regulated research, and continually offer individual orientation sessions to Sponsor-Investigators who hold INDs and IDEs;
- The School of Public Health offers a Responsible Conduct of Research and Scholarship Seminar for incoming graduate students. The seminar covers a number of topics to raise student awareness and help them apply ethical principles in their research activities;
- The Cardiovascular Center Clinical Research Group (C3RG) is a group of research professionals that was formed in 2009 with the aim to develop and provide educational resources to support research staff and faculty who conduct clinical research trials within the center; and
- The Office of Research Compliance Review (ORCR) is a post-IRB approval monitoring unit. ORCR applies an educational approach to all of their activities which are integrated with the HRPP programs. Human subjects protections education is a major part of ORCR Routine Reviews. In addition, the office staff members collaborate with other HRPP units and participate in educational activities to advance ethical conduct of research at the University.
Individual schools and departments maintain a list of educational activities and events on their websites and/or in newsletters.
The U-M HRPP is committed to promoting public awareness and trust in research through outreach efforts designed to enhance the understanding of human subjects research by participants, prospective participants, and their communities. The HRPP website presents information to the public including: key considerations in human subjects protections; frequently asked questions; and list of resources and related links.
In addition, information about progress in research is regularly distributed through the U-M news service, including the University Record, Michigan Today, Michigan Radio, Michigan Television (UMTV), and UMHS News. In addition, continuous campus events showcase research for local, national, and international audiences.
When subject consent is not feasible in the context of research involving imminent life-threatening circumstances, the IRB may approve Emergency Research with Exception from Informed Consent (EFIC) under 21 CFR 50.24. Community Consultation Plans (including, where appropriate, consultation carried out by the IRB) are reviewed and approved in the course of the IRB review of EFIC, and may include consultation with representatives of the communities in which the clinical investigation will be conducted and subjects will be drawn.
Several initiatives have been established by MICHR to foster involvement of community members in human research activities at the U-M.
The Community Engagement (CE) Program was established with the specific goal of involving the community’s expertise and knowledge in improving the quality of U-M clinical health research and producing outcomes that measurably benefit the health of the local communities. Involving the community in the design and conduct of programs helps ensure that research participants understand intervention content and that research questions are reliable and valid. Researchers also often find that sharing research findings with members of the target population further illuminates those findings and also improves community partnerships.
The CE Program focuses on the following specific aims:
- Strengthen community-university partnerships emphasizing power-sharing processes to ensure research priorities directly reflect community and practitioner needs;
- Partner with community members, community-based organizations, and practice networks to stimulate and sustain a robust program of community-based participatory research and implementation/translation science;
- Develop programs and train researchers, practitioners, and community partners in community engagement, community-based participatory research methods, cultural sensitivity, and implementation science; and
- Develop mechanisms that accelerate dissemination and implementation of research results across health care systems practitioners, and communities.
Current educational offerings by the CE Program include:
- CURES Webinar: Community and academic investigators who want to learn more about the Community University Research Partnership (CURES) funding opportunity through MICHR’s Pilot grant Program (PGP), application components, and consultations services available through MICHR’s Community Engagement Program and Research Development Core.
- Ethics Protections in Community-Engaged Research: Training for Community Partners: MICHR has developed an interactive training to engage and prepare community partners engaged in research to both interact with IRBs and to perform ethical research practices in their community settings.
- MICHR’s Participant Recruitment Program: The MICHR Participant Recruitment Program provides expertise, tools, and resources to facilitate participant recruitment in clinical and health research studies. Study teams may also request a recruitment and retention consultation ideally at the time of the proposal development to discuss diverse recruitment and retention strategies.
MICHR has also established the U-M Health Research website to educate the community on research opportunities at the U-M and facilitate participant recruitment in clinical research. Interested study participants may use the tool to search for open research studies at the U-M using various parameters, express interest in studies, communicate securely with study teams, and receive personalized study recommendations. Study teams, in turn, may use the tool to search for eligible study participants.
The U-M Health Research website is also described in a brochure that is distributed in U-M health clinics, in various outreach events, and by community partners.
Additionally, colleges, schools, departments and other units throughout the University and the Health System have initiatives geared toward increasing and improving community involvement in human subjects research. Examples include:
- The University of Michigan Health System (UMHS) Comprehensive Cancer Center provides information on cancer clinical trials and research;
- The UMHS Comprehensive Cancer Center’s Community Outreach Program provides information to educate the community about cancer prevention, early diagnosis, and research opportunities at the U-M, through a variety of activities, including a Minority Outreach Initiative;
- The UMHS Office for Health Equity and Inclusion (OHEI) aims to advance health care and research that targets underserved populations;
- UMHS established the Community Benefit website to highlight UMHS contributions to the community in different areas, including research and education;
- The School of Public Health established Community-Based Public Health (CBPH) to promote community-based approaches through partnerships between community-based organizations, public health and human service agencies, and the School of Public Health;
- The Institute for Social Research (ISR) fosters community outreach through a number of its centers, and provides information to participants; and
- U-M Flint IRB developed a model of the Community Research Process with the Flint Office of Community Outreach, and holds a variety of events and community forums.
- The Office of the Provost established the University of Michigan Detroit Center to mutually enrich the University and Detroit communities through service, education, research and the exchange of culture. The facility accommodates U-M research projects and outreach initiatives in Detroit.
While each of the programs listed above have internal processes for evaluating their outreach activities, the IRB Council considers the institution's overall outreach generally at the first Council meeting of the year. The evaluation helps shape priority projects for the IRB Council and its working groups for the following year.