IUPUI Institutional Biosafety Committee - DOC by qI8D3u

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									                                     INDIANA UNIVERSITY INSTITUTIONAL REVIEW BOARD (IRB)

                              CONTINUING REVIEW/CLOSEOUT FORM INSTRUCTIONS
When completing the continuing review/close out forms, please keep the following things in mind:

1.   The forms must be completed in MS Word or similar word processing software.
2.   Ensure that a response is provided for ALL items, even if you are closing the study – DO NOT LEAVE ITEMS BLANK. If items are left
     blank, the form may be returned to you for additional information, which could cause delays in processing your continuing review and result in
     your study expiring.
3.   Additional pages may be added as necessary (Please note at the appropriate location on the continuing review/closeout form when attachments
     have been provided).
4.   Do not include these instructions with your continuing review/closeout submission to the IRB.
5.   If you have questions about completing the forms, please contact the IU Human Subjects Office:
                         Bloomington: (812) 856-4242 or iub_hsc@indiana.edu
                         Indianapolis: (317) 274-8289 or resrisk@iupui.edu
6.   Submissions to the Indiana University IRBs (i.e. IUB, IRB-01, IRB-02, IRB-03, IRB-04, IRB-05) must be submitted via email to the
     appropriate IRB email. Please visit the IU Human Subjects Office website for more information.

Depending on the current status of the research project, you should complete the appropriate form:
    1. Ongoing – Open to Enrollment: studies are open for active enrollment of new subjects
    2. Ongoing – Closed to Enrollment
    3. Closeout Report

Section III: Subject Summary.
Please consider the following definitions when completing the subject summary table. Please note that the numbers provided in the Subject
Summary Table should add up correctly. If not, please provide more information in the space provided under the table.
     1. Consented: Provide the total number of subjects (at the local site) who signed an informed consent document since the last review. This
          number should include any subjects who signed a consent document and were either found to be ineligible for the study or withdrew from
          the study prior to completion. Be sure to also account for the number of screen failures and withdrawals in the appropriate table field.
          NOTE: If the IRB approved a waiver of consent for the study, the “consented” number should reflect the number of records,
          specimens, etc. that have been reviewed or collected.

     2.   Failed Screening: Provide the total number of subjects who signed an informed consent document and were then found to be ineligible
          for the study (during or after the screening process). NOTE: If the IRB approved a waiver of consent for the study, the “failed
          screening” number should reflect the number of records, specimens, etc. that were found to be ineligible.

     3.   Withdrawn: Provide the total number of subjects who signed an informed consent document (unless the IRB approved a waiver of
          consent) and subsequently discontinued participation prior to their completion of the study. This discontinuation can be initiated by the
          PI, sponsor or by the subject and may occur at any point during the study, but prior to study completion. Withdrawn also includes deaths
          if death is not an endpoint of the study, in which case the death should be reported as a completion.

     4.   Active: Provide the total number of subjects who signed an informed consent document (unless the IRB approved a waiver of consent)
          and are either awaiting treatment or study intervention/interaction or are actively receiving treatment or intervention/interaction or being
          followed.

     5.   Completed: Provide the total number of subjects who signed an informed consent document (unless the IRB approved a waiver of
          consent) and have completed the planned protocol. This does not include any subject who is considered “withdrawn” or has been lost to
          follow-up. Completed includes deaths if death is an endpoint of the study.

Section IV: Ethnic/Racial Reporting Required For Federally-Sponsored Studies. Pursuant to the Office of Management and Budget (OMB),
Federal Register Notice (October 30, 1997), all federally-sponsored studies must report data on race and ethnicity for all subjects enrolled in human
subjects research. This includes, but is not limited to, studies sponsored by the NIH or CDC and studies or sponsored by the VA or involving VA
subjects. Please provide that total number of subjects in each category.

Section V: Summary of Events:
     1. Events that require reporting (e.g. unanticipated problems and noncompliance that occurred since the last review) must be provided in
         summary form.
     2. Complaints: Please explain any complaint made by a subject as part of the research (e.g. could include complaints such as “the
         investigator was late to my appointment” or “the clinic was dirty”). This clarification, which was provided by the Office for Human
         Research Protections (OHRP), is because these and other complaints could be indications of larger problems.




                                                                          1                                                    IRB Form v09/01/2010
                                  INDIANA UNIVERSITY INSTITUTIONAL REVIEW BOARD (IRB)

                            CONTINUING REVIEW/CLOSEOUT FORM INSTRUCTIONS

                                Checklist of Required Revisions at the Time of Continuing Review

           Please read the instructions below to ensure that you submit complete paperwork with your continuing review/closeout
           report. Otherwise, you may experience delays in your study receiving approval.

If the study’s status is Ongoing – Open to Enrollment, you must include an up-to-date summary safeguard statement, i.e. version
05.01.09 or later.

If the study’s status is Ongoing – Open to Enrollment or Ongoing – Closed to Enrollment and participants are still receiving
research-related interventions or interactions, or participants have completed research-related intervention or interaction but long-term
follow-up continues, you must include the most current protocol with the renewal submission.

CITI Education: Beginning October 1, all investigators participating in human subjects research must complete the required CITI
modules. After this date, studies cannot be approved until all co-investigators have completed and passed the appropriate modules.
Please visit http://researchadmin.iu.edu/REEP/reep_citi.html for more information.

SPECIAL CIRCUMSTANCES: The below requirements only apply to research studies that remain open to enrollment or
closed to enrollment but planning to reconsent subjects.

     FINANCIAL INTEREST STATEMENT. If any investigator has a financial interest in this research, the informed consent
     document must include the financial interest statement. Please see the Informed Consent Template for more information.

     STUDIES INVOLVING GENETIC INFORMATION: if the study involves genetic testing or the tracking of a particular
     disease or disorder in an individual’s family, the informed consent document must include the statement regarding GINA. Please
     see the Informed Consent Template for more information.

     VA STUDIES. The following new requirements for VA studies must be met.

           If the study includes a HIPAA Authorization form, the VA-specific HIPAA Authorization must be used.

           Signature lines for the Legally Authorized Representative (LAR) must be removed from the Authorization and informed
           consent statement, unless the IRB has approved a process for representative consent.

           In the informed consent statement:

                  If sensitive VA data will be removed or stored outside of the VA facility or electronic firewall, the informed consent
                  statement must include information regarding where the information will be stored, how long it will be stored, and by
                  whom.

                  The research injury statement should reference compensation for injury from the VA only.

                  The costs section should indicate that neither the subject nor the subject’s insurance provider will be responsible for
                  costs related to the research.




                                                                   2                                               IRB Form v09/01/2010

								
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