Dr. R. Kirk JonasMs. Carolyn Strong, CIM,CRA Chair, Institutional Review Board Research Compliance Coordinator University of Richmond James Madison University October 12,

 Clearly establishing areas of responsibility.  Getting the academic community to know that the IRB exists and has an important role.  Ensuring that the research community understands what human subjects research is  Educating the community on subject protection.  Developing a service-oriented board.  Launching a website as de facto SOP.  Developing an FWA (with the Common Rule).  Records Management.  Champions and advocates. 2

 Establish who will do what. ◦ Who is going to do the work? (receive and distribute proposals; schedule meetings; prepare notices of action; prepare/maintain website and SOP, maintain files, etc.) ◦ Who is going to make decisions? (on expedited reviews, exemptions, training, policies, etc.) ◦ Who is the ultimate authority? The higher the better, e.g. the University President as the IRB Signatory Authority for an FWA. 3

University of Richmond James Madison University  The President is the Signatory authority  The Chair and the IRB Administrator are the same person (Jonas, one 30 hour person; used to have an assistant)  PI’s rarely attend meetings; the Chair clarifies issues on behalf of the PI; invite PI’s where necessary  Subcommittees used to review some conditions of approval  The Interim Provost and Vice-President for Academic Affairs is the Signatory Authority  For administration: one full-time person (Carolyn), two part-time persons, and one student  Chair is a faculty member doing service  Every PI is invited and strongly encouraged to attend 4

University of Richmond James Madison University  Chair makes the exempt determination and handles the administration on it as well.  Workflow varies a great deal  There is no backup  Use of downtime  Staff processes exemptions and sends to Chair  Workflow varies a great deal  Administrator has a backup  Use of downtime 5

 Ensure that academic leaders understand the role of an IRB  Tell faculty and student groups about IRB; discuss one on one with key persons  Lay out benefits of an IRB: protection of subjects, best practice, education, etc.  Lay out the risks of human subject research: subject harm, harm to researchers, inappropriate distribution of information, institutional damage, etc.  Ensure that university community understands the authority of the IRB; that the IRB has the “final say” 6

 Human subject research is generally research involving living human beings, including collection of information about people.  Two major categories of human subject research are biomedical research and behavioral/social science research.  Most human subject research at smaller colleges and universities falls under the category of behavioral/ social science research, often from the collection of information from and about individuals through the use of surveys and interviews.  Students do research and can publish “globally.” 7

 Since 2009,UR has had 2,400 users  Since 2012, JMU has had over 4,500 users 8

 Enroll in CITI or develop shortcuts to free educational programs for researchers.CITI ◦ (CITI is about $2,500 per year and provides training in many areas, such as RCR, Conflict of Interest, etc.)  National Institutes of Health (NIH) offers a free training module  Develop in-house training for faculty groups, research classes, and others. 9

 While the IRB necessarily exercises compliance and regulatory functions, it can also serve the university community and its researchers.  Develop protocols and templates to help guide researchers through the process.  Invite researchers to board meetings for complex proposals.  Build capital for when the board needs to firmly enforce regulations and procedures. 10

The IRB has the authority to: Approve Require modifications prior to approval Table Disapprove all research activities including proposed changes in previously approved human subject research The IRB’s decision is FINAL. 11

 Establishing an IRB is an iterative activity.  A website can serve as a “test site” for procedures while an SOP is being developed.website  A website can provide temporary documentation of institution-specific IRB policies.  FAQs can be used later as part of an SOP.  Use OHRP and other links, but try to provide plain language to explain their relevance.OHRP  The final policy guide must be OHRP compliant.final policy guide 12

og/irb/irbmission.html 13

University of Richmond James Madison University  IRB Overview  Submitting Proposals  Research Training Requirements  Policies and Resources  Contact  FAQ’s  Submit a Proposal  IRB News  IRB Mission Statement  Protocol Submission Procedure  Training  Policy  FAQ’s  Forms  IRB Committee & Meeting Schedule  IRB Feedback 14

 Developing an Federalwide Assurance agreement is a good way to provide an IRB with needed legitimacy and authority. (Registering an IRB and obtaining an FWA are related but separate processes.)Federalwide Assurance Registering an IRB obtaining an FWA  The FWA Signatory Official should be a very high ranking person. At UR it is the University President. The IRB Chair reports directly to the Provost.  At some point an institution will likely want to apply the Common Rule to all research involving human subjects. Common Rule  The UR IRB Chair and IRB administrator are the same person. 15

 As a recipient of federal funds for research, JMU is required to have an IRB that meets federal requirements to review research protocols involving human subjects and to evaluate both risk and protection against risk for those subjects.  JMU is required to register with the Federal Office of Human Research Protections (OHRP) through a process called Federal Wide Assurance.  In this Assurance, JMU is given the option to designate whether the University and the IRB will follow federal regulations for only federally funded research or for all research. 16

 IRB activity generates records that must be maintained for at least three years after the completion of the research, IAW § IRB records.§ IRB records  Records may be maintained in electronic form. 17

 Developing a system for maintaining records is key. ◦ Keep it simple: PI Name, Research Title, Date of Submission, Date of Action  Keep in mind records that may have other retention requirements (i.e. grant funded research)  Weed records that you are no longer required to maintain. 18

 IRBs must make decisions.  Decisions can result in unhappy people.  Develop champions and advocates of the IRB. ◦ IRB members (establish regular meetings; provide lunch if possible) ◦ Research-active faculty members ◦ Administrators who will support the function.  Meet regularly with champions and advocates. 19

 Researchers don’t want their research activities to harm subjects.  The university doesn’t want research by members of the university community to harm subjects.  A determination by the IRB does not free a researcher of responsibility. The researchers – whether faculty, staff members, or students – must know that they retain primary responsibility for the protection of subjects. 20