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1 Tuesday, May 15, 2012 Please be sure to sign in and take copies of each handout. 1

2 Michelle Dolske, ORA 2

3 Laura Orem, IRB

4 Must be in list of Categories (see IRBNet Forms and Templates) No more than minimal risk Minor changes to previously approved research IRB Review by Chair or experienced IRB member reviewers designated by the Chair Full IRB to be notified at next IRB meeting

5 Minutes to include: Research presents no more than minimal risk to subjects Identification of subjects or their responses will not reasonably place them at risk Research is not classified The category or categories of research which permitted expedited review

6 All documents are available to assigned IRB reviewers IRB records will document which IRB member(s) reviewed the study Typically, researchers are not made aware of which IRB member(s) reviewed their study Researcher must abide by same rules as for studies that go through full IRB review

7 IRB approval required prior to initiation of research study ORA WRITTEN CLEARANCE MUST BE RECEIVED PRIOR TO BEGINNING RESEARCH STUDY Approval period one year

8 PI notified in writing of required changes; Revisions reviewed by the IRB reviewer; If questions are of a substantive nature, the protocol may be referred to the convened IRB; If revisions are not approved by the IRB reviewer, the reviewer may refer the study to convened meeting; Approval period is one year from approval date noted on initial letter of approval.

9 IRB Chair or convened IRB may suspend study if determination is made that the study requires further review/evaluation; Determination may result from: Adverse event Noncompliance Other issues regarding welfare of subject Chair may suspend, full IRB may terminate

10 Reviewers may exercise all the authorities of the IRB except disapprove research minor changes to previously approved research may be disapproved through expedited review

11 IRB sends written notification of actions taken to PI; No regulatory requirement that IRB action documents be signed; Florida Hospital IRB does not require signatures on such documents; Action documents are generated electronically by a password-protected IRB information system with access limited to authorized IRB personnel.

12 Summaries of actions taken provided to the Institutional Official (O) and/or the VP for Research through minutes. If revisions to new or continuing human subjects applications are required, the PI is notified in writing. Office of Research Administration has access to IRB action letters through IRBNet.

13 Must fit one of the exemption categories (see IRBNet Forms and Templates); IRB is not required to exempt studies that is an IRB decision; Changes to exempted studies that might change the exempt status must be brought back to the IRB; FHIRB DOES require renewal of the study on a yearly basis to determine if the study is still ongoing.

14 Do not apply to prisoners; Do not apply to FDA regulated research with the exception of Category 6; IRB Minutes will include the name of the IRB reviewer for the Exempt study

15 IRB review and approval required before investigators can start using modified research studies, except to eliminate apparent immediate hazards to subjects; Any proposed change must be submitted as an amendment and may be reviewed by expedited or full board review, depending on the Chair s or designated IRB member s assessment of associated risks.

16 Minor changes may be approved by expedited review. Minor changes are those that do not involve procedures that increase risk more than minimally or add procedures that would make the protocol ineligible for initial review using the expedited procedure. Major modifications should be reviewed by the convened IRB.

17 Modifications involving new findings: The IRB will determine whether the new findings may be related to participants willingness to continue participation and if the findings should be shared with the subjects. If that determination is made, a change request form shall accompany a copy of the notification (letter) to be sent to the subjects.

18 If the change must be made immediately to protect human subjects, the changes should be made as appropriate. Within five (5) business days, the investigator should describe the change using the change request form, which will be reviewed by the IRB Chair or his designee to determine if a change in risk has occurred in the research and if further changes are warranted. A deviation from the approved research should be submitted, as well. If the deviation was approved by the sponsor but not sent to the IRB prior to the change which caused the deviation, a copy of the sponsor s approval is to be sent to the IRB, as well.

19 IRB shall (must) conduct continuing review (renewal) of research at intervals appropriate to the degree of risk, but not less than once per year. IRB may determine to review a study more often than once per year. Study expires on midnight on the expiration date. IRBNet automates these calculations and accounts for leap years.

20 IRB responsibilities include: Reviewing reports of unanticipated problems that involve risk to subjects or others. This information may be gathered through: Investigator or sponsor reports Third party observations IRB inquiring. Renewal may stop only when the research is permanently closed to enrollment, all participants have completed research related interventions or activities, and collection and active analysis of private identifiable information has been completed. Sponsored studies renewal continues until after the sponsor s close out visit, unless sponsor requires termination prior to close out visit.

21 Nature, probability and magnitude of anticipated risks to subjects; Medical/psychological condition of proposed subjects; Qualifications of the PI and other members of the research team; Specific experience of the PI and other members of the research team in conducting similar research; Nature and frequency of adverse events observed in similar research at this and other facilities; Vulnerability of the population being studied.

22 IRB may define the period of approval time with either a time interval or a research milestone, e.g. number of subjects enrolled. Minutes will clearly reflect any determination requiring a review more frequently than annually. Written reminders automatically generated by IRBNet and sent to the project owner at approximately 90, 60, 30 days before the expiration date and on the expiration date.

23 Progress report or Termination report located in IRBNet in Forms and Templates. Once the renewal application is received, it is checked by an IRB staff member and, if everything is in order, it is sent on to 1 or 2 reviewers. Submissions for renewal will include the progress report with the Narrative thoughtfully completed, along with the most current informed consent.

24 If study initially approved by expedited review, generally available for expedited renewal; If study initially approved by full board, generally receives full board review for renewal unless it fits into Category 8 or 9 in SOP 13.0; IRB will determine if subjects need any modifications; IRB will determine if protocol requires verification from sources other than the investigator that no material changes have occurred since previous IRB review. PIs are notified in writing of the decision of the IRB and any required changes. Final approval is not granted until all required changes have been made and submitted for IRB review and approval.

25 IRB approval expires automatically at end of day on expiration date; All research activities involving human subjects must stop (including new enrollment); IRB may approve temporarily continuing participation of already enrolled subjects; During time period between when lapse occurs and the determination is approved by the IRB, subjects may continue intervention, as necessary, for their help and welfare.

26 If the IRB determines that the investigation should continue with the PI completing the appropriate paperwork, IRB will notify the PI regarding that. If the IRB decides that already enrolled subjects should continue to receive interventions under unapproved research protocol and data collection, the IRB will also determine how follow-up will be reviewed.

27 IRB should document why the lapse occurred and identify steps to be taken to prevent any future lapses. Once the study is back on track the IRB approval will be one year from when the renewal should take place.

28 Failure to meet continuing review obligations may be grounds for suspension or termination; May affect future research you wish to conduct at FH; May prompt a requirement for continuing education; If the study is suspended or terminated, appropriate federal agencies must be notified.

29 Michelle Dolske, PhD Michelle Kilponen 29

30 Laura Orem, IRB 30

31 Office of Research Administration Julie Pepe, PhD

32

33

34 * IRBNet Forms should be completed at this stage. ORA package with the RRA needs to be submitted.

35

36

37 Principal investigator or Mentor (along with sub- investigators) should be present at the initial meeting to discuss the project and answer questions. After initial meeting, several versions of the protocol may be necessary. Contact at the protocol stage will eliminate most problems at the analysis stage.

38

39 Julie Pepe, ORA Michelle McKinney, IRB Maria Rizzo, Volunteer Services 39

40 FH Research Volunteer Process

41 Definition: Volunteer Individuals that provide services without any expectation of compensation, and without any coercion or intimidation. Federal Fair Labor Standards Act (FLSA)

42 Steps: Department completes a job description and request form

43 Department Request Form

44 Contact: Volunteer Services Maria Rizzo Manager Volunteer Services Orlando 407/ office 407/ fax If you have an intern or a specific volunteer already, then you can provide that information to Volunteer Services. Volunteer Services will provide a general orientation (sessions monthly), background check, badge and any additional checks (credit, drug, or criminal) necessary. On the first day, a Training/Competency form will need to be completed and faxed to Volunteer Services.

45 Research Specifics Volunteers may only participate on a study through an established FH Research Department. Must complete CITI training. FH Volunteer must be IRB credentialed and register in the IRB electronic submission software system. Volunteers can be assigned tasks for which they have appropriate background, experience, training and/or education. If the Volunteer needs access to the EMR, this must be indicated on their job description.

46 Research Volunteers may not: Take the place of an employee, (i.e., their absence should not adversely affect the daily operations of a department). Be solely responsible for a specific project or meeting a deadline. Sign legal documents Obtain informed consent* Be Principal Investigator or a Sub-Investigator* for a FH research project.

47 *A new classification for volunteers will be developed that will allow a volunteer (in this classification) to: Obtain informed consent- for minimal risk studies Be a Sub-investigator for minimal risk studies

48 Details Consider whether or not the volunteer needs access to EMR, or Department H drive. Access needs to be arranged with your IS manager. Upon departure: Retrieve FH identification badge. Ensure FH system access is terminated. Instruct Volunteer to schedule exit interview with Volunteer Services.

49 Comments or Questions ORA has gone through the process to acquire a biostatistics intern. Maria Rizzo, Manager Volunteer Services, is here to answer questions. Michelle Tall, intern, can comment on the process from the volunteer perspective.

50 Michelle McKinney, IRB and Michelle Kilponen, ORA 50

51 Laura Orem, IRB Thank you for coming! Please be sure you ve signed in to reflect your training of the new SOPs! 51

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