Welcome to The Office of Research and Innovation! Research Discovery - PowerPoint PPT Presentation

Welcome to The Office of Research and Innovation! Research Discovery (RD) Graduate Appointees Orientation August 26, 2020 Julia Mays Associate Director, Research Compliance Office of Research and Innovation

Research Compliance Oversee the conduct of research to promote integrity and maintain compliance with regulations  Institutional Review Board (IRB)  Institutional Animal Care and Use Committee Julia Mays Associate Director (IACUC)  Institution Biosafety Committee (IBC)  Provides required training in responsible conduct of research, human subjects research, animal research  Export control review and compliance

RESEARCH COMPLIANCE All research done under the aegis of Western Michigan University must adhere to federal, state, and local regulations, along w ith University policies. Much of the research (human subject, animal, biohazards, genetic materials, or nuclear materials/radiation, and international) you may be engaged in during your graduate student career or as a graduate assistant requires oversight/approval from the appropriate University board/committee/official. Approval must be obtained prior to implementing the research project. There are no exceptions to this requirement. In addition, some research requires a training component that must be completed before the project can be approved.

Institutional Review Board (IRB) Charged with protecting the rights and welfare of humans participating in research as the subject of that project. All faculty, students, and staff engaged in research with human subjects must comply with the oversight and guidelines of the University’s Institutional Review Board (WMU IRB) and the policies of the University, which are based on the federal regulations governing human subject research.

Are you planning to do any of the follow ing? Now that the consent Thanks for explaining document has been the risks and benefits • Conduct a survey signed…we can begin of your research the interview for my • Interview individuals study. research study. I agree to participate. • Observe behaviors of individuals • Implement an intervention involving people • Analyze data about individuals Engaging in any of the mentioned or similar activities Visit our w ebsite at http://w w w.w mich.edu/research/compliance/hsirb or contact WMU’s Associate Director Research Compliance or the Compliance Assistant ovpr-hsirb@ w mich.edu Office of the Vice President for Research

The Institutional Animal Care and Use Committee (IACUC) A local review board, charged with the ethical care and use of animals in teaching and research. All faculty, students, and staff engaged in teaching or research with any vertebrate animals must comply with the oversight and guidelines of the University’s Institutional Animal and Use Committee (WMU IACUC) and the policies of the University, which are based on federal regulations.

Institutional Biosafety Committee (IBC) Reviews all constructing and handling: (i) recombinant nucleic acid molecules, (ii) synthetic nucleic acid molecules, including those that are chemically or otherwise modified but can base pair with naturally occurring nucleic acid molecules, and (iii) cells, organisms, and viruses containing such molecules. No activity involving the construction or handling of recombinant or synthetic DNA molecules or organisms and viruses containing recombinant or synthetic DNA molecules shall be initiated without prior notification, and if necessary review and approval of the WMU Institutional Biosafety Committee unless specifically exempt as described in the regulations.

Radiation and Biosafety: Federal and State of Michigan rules and regulations require WMU to assure that exposure to radiation is as low as reasonably achievable. Jim Center The radiation safety officer must approve research involving Radiation Safety Biosafety Officer use of radiation and/or radioactive materials. All projects are and Export Control Officer reviewed to ensure that all teaching, research, and clinical activities involving the use of potentially hazardous microbial agents and/or their products are conducted in a safe and secure environment.

Using Microbial Agents and their Products OR Engaging in Research Involving Recombinant and Synthetic DNA? • Difference between Microbial Agents and Recombinant or Synthetic DNA/RNA: Recombinant DNA is genetically-engineered molecules formed by splicing fragments of DNA/RNA o into a recipient (host) cell that can then replicate. Microbial agents are any potentially pathogenic microorganisms and/or their products. o • Biosafety and Security services provided:  Training  Placement of ALL microbial agent orders  Assist in the transportation of microbial agents  Liaison with regulatory agencies  Emergency response • Recombinant and Synthetic DNA services provided:  Review and Approval of ALL projects  Institutional Biosafety Committee (IBC) oversight of projects  Liaison with regulatory agencies  Emergency response Visit our w ebsites http://w w w.w mich.edu/research/compliance/biosafety/dna Or http://w w w.w mich.edu/research/compliance/biosafetymicrobes Office of Research or contact WMU’s Associate Director of Research Compliance 269-387-8293 and Innovation

Is the Use of Radioactive Material (RAM) or Radiation Producing Machines in your Future? • Common uses include electron microscopy, x-ray diffraction, accelerator research, DNA and protein labeling, DNA hybridization, and enzyme assays. • People using RAM and/or radiation producing machines are exposed to low doses of radiation. ALARA As Low As Reasonably Achievable the principle of minimizing occupational exposure to radiation • Radiation Services provided: •Minimize exposure time •Maximize distance from the source of radiation  Training •Maximize the shielding between the source and people  Exposure monitoring and surveys  Placement of ALL material orders  Transportation of ALL materials  Liaison with regulatory agencies  Emergency response Visit our w ebsite at http://w w w.w mich.edu/research/compliance/radiation Office of Research and Innovation or contact WMU’s Radiation Safety Officer 269-387-5933

Export Control Federal laws that prohibit the unlicensed export of certain commodities or information for reasons of national security or protections of trade. Export controls usually arise for one or more of the following reasons: • The nature of the export has actual or potential military applications or economic protection issues. • Government concerns about the destination country, organization, or individual. • Government concerns about the declared or suspected end use or the end user of the export.

Are you planning to do any of the The LAST piece! follow ing? This is Must remember the piece. it and send • Giving a tour through research labs that have controlled items the info! • Having a sidebar conversation with a foreign person during a conference • Going on international travel in relation to duties/activities with your WMU employment • Conducting research that will have restrictions on publication • Hosting an international visitor • Shipping/transporting/carrying an item into a foreign country • Sending an email to a foreign colleague or person • Providing informal review comments or inputs of an unpublished paper/article for a foreign colleague • Carrying non-commercial encryption software on your computer outside of the U.S. • Working on a project that could have commercial and military uses • Paying or providing an honorarium, a stipend, or per diem to a foreign person from a sanctioned country Engaging in any of the mentioned or similar activities Visit our w ebsite at http://w w w.w mich.edu/research/compliance/exportcontrol or contact WMU’s Research Export Control Officer ovpr-export-control@ w mich.edu Office of Research and Innovation

Research Compliance – Training Provides required training in responsible conduct of research, human subjects research, animal research All individuals working on an IRB or IACUC protocol must complete the appropriate courses required through the Collaborative Institutional Training Initiative (CITI) program.

Responsible Conduct of Research (RCR) Training Who should complete the RCR training? Individuals working on an NSF funded project must complete a course in the Responsible Conduct of Research. NIH requires RCR training in some of its funded programs, along with an 8 hour face-to-face training.

General Objectives for RCR Impart information Policies & regulations Codes of ethics Best practices Know regulations governing research Develop critical reasoning skills Principle-based reasoning Ways to recognize and resolve ethical dilemmas Awareness/Change behavior/enhance integrity Recognize and change unprofessional behavior Avoid practices that could lead to misconduct Career Development Foster Integrity/Prevent Misconduct Encourage researchers to adopt higher standards Stop researchers from engaging in falsification, fabrication, and plagiarism (FFP)

Research Compliance Webpages Institutional Review Board for the Protection of Human Subjects in Research Institutional Animal Care and Use Committee Institutional Biosafety Committee Biosafety Responsible Conduct of Research Export Controls Radiation Safety