text: Who can be the PI of a study?
  The PI must have a faculty appointment at RFUMS with the title of Professor, Associate Professor, Assistant Professor, or Instructor (regardless of suffix or prefix). Those with only a title of Lecturer may not be a PI. PRINCIPAL INVESTIGATOR Does the PI and research staff need to complete yearly human participant research training?
  Yes, PIs, CO-Is, and all research staff need to complete yearly human participant research training PRIOR TO engaging in any research protocol activity. MANDATORY TRAINING
  If research is going to be conducted at another site, but the PI is a RFUMS faculty member do they still need to go through RFUMS IRB?
  Yes, the PI would need to obtain RFUMS IRB and the other site's approval before initiation of the study.
  The PI would need to provide the other site's recent (within past year) approval letter to our RFUMS IRB or an explanation as to why approval letter is not feasible. The other site's recent (within past year) IRB approved consent form also needs to be provided.
  If a PI is planning on recruiting RFUMS students and/or employees do they need to get each Dean's/Vice President's approval to do so?
  If a general advertisement is going to be used (e.g., an advertisement hung in a common area at RFUMS where all students and/or employees have the chance of being recruited for a study), then Dean/VP approvals do not need to be obtained. If a specific classroom or group of employees are going to be targeted and recruited face-to-face by the research staff for a study, then the PI would need to obtain the necessary Dean/VP approval. VULNERABLE POPULATIONS AS HUMAN PARTICIPANTS
  Can a PI ever personally recruit their own students/employees or be present during individual recruitment of their own students/employees? Can they consent their own students/employees or be present for the informed consent process of their own/students employees? No, the PI may not personally engage in the individual solicitation of students/employees who are supervised by the PI. Nor may the PI be present during that individual solicitation. VULNERABLE POPULATIONS AS HUMAN PARTICIPANTS
  What materials should be submitted to the IRB in submissions?
  This is not an all inclusive list: The IRB needs appropriate IRB applications, waiver of informed consent request or consent form, assent form for children if appropriate, all advertisements that will be used in the study, all surveys and measures that will be used in the study, a protocol summary written by PI, and a complete study protocol.
  What needs to be included in a study protocol?
  The following sections must be included in a study protocol: Purpose, introduction/hypotheses,
  design/procedures/materials/methods, data analysis/statistical treatment, potential risks to participants and precautions taken to minimize risks, potential benefits to participants and/or society, methods used to ensure confidentiality of data, financial considerations, and references/bibliography.
  For protocols that are up for renewal, does an adverse event summary and information on interim findings need to be provided?
  Yes, adverse event summaries and interim findings need to be provided with all protocols that are up for renewal. RENEWAL OF APPROVAL OR TERMINATION OF PROJECT
  What is the deadline for submitting IRB materials to go to the subsequent month's IRB meeting?
  IRB meetings are held the second Tuesday of each month. The deadline for submitting materials for a particular month's meeting is Tuesday, by noon, two weeks prior to the IRB meeting.
  What is the timeline for Expedited, Exempt, and Not Engaged submissions?
  Expedited, Exempt, and Not Engaged submissions are reviewed by the IRB Chair (they are not reviewed by the full IRB at the monthly meetings) and are usually looked at within four to six weeks after all paperwork is received.
  Do Expedited, Exempt, and Not Engaged protocols need to be reviewed on a yearly basis?
  Yes, whether a study is Expedited or has Exempt status, it needs to be reviewed on a yearly basis. If it has Not Engaged status, it does not need to be reviewed yearly. However, any changes to the protocol need to be submitted to the IRB Office prior to being implemented. MODIFICATION APPLICATION Does a PI have to apply to the IRB in order to terminate a study?
  Yes, if a study is completed, the PI must turn in a termination application in order for the study to be officially terminated. If a study is Expedited, Exempt, or Not Engaged then the Chair can look at the application in order to approve the study termination. If the study was originally a full board protocol, then the IRB itself needs to review the termination application and approve the study's termination. RENEWAL OF APPROVAL OR TERMINATION OF PROJECT
  How many copies of all paperwork are needed for IRB submissions?
  If a study needs to go to the full board, 1 original and 13 copies (14 total) of all the paperwork are needed. If a study is able to be Expedited or given Exempt or Not Engaged status, then only 1 original and 2 copies (3 total) of all paperwork is needed.
  Do case studies/case reports typically need to be submitted for IRB review?
  No, typically, case studies/case reports do not need to be submitted to the IRB. If a research case study has a hypothesis and contains findings which may be able to be generalized to a population, then the study would have to be submitted to the IRB.
  If a study is commercially sponsored research, what language needs to be used to describe compensation for a research-related injury in the consent form?
  It is RFUMS policy that if a study is commercially sponsored research, it must be specified in the consent form that the sponsor will pay for research-related injury. The following language should be used in the consent form: "The sponsor will pay for costs of medical treatment and care that are reasonable and necessary to diagnose, treat, and help you recover from any injury, illness, or condition you may suffer as a direct result of your participation in this research project. The coverage for such injury or illness will be paid by the study sponsor if:
  RFUMS Principal Investigator (PI) has determined that the injury or illness is directly related to the study drug and/or procedures
  If the injury or illness was not deliberately caused
  You have followed the directions of the study doctor
  In the event of injury or illness as a result of study medications, devices, or procedures, you should promptly contact the RFUMS PI and seek medical attention [Insert Phone Number]."
  If a study has been conditionally approved, is it okay to go ahead with the study?
  No, before commencing any research activity involving human participants, the PI must already have received written approval from the IRB.
  DETERMINATIONS AFTER IRB FULL BOARD OR EXPEDITED REVIEW
  What should the PI do if they check "yes" to having a "significant personal interest" in section X of the IRB application?
  The PI needs to fill out a Conflict of Interest (COI) disclosure form if they check "yes" to having a "significant personal interest" in section X of the IRB application. The Office of Compliance can be reached at (847) 578-3445.