Continuing Review Application 3/31/06 by HC120623002311

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									                                                              CONTINUING REVIEW APPLICATION
                                                                  Johns Hopkins Medicine-IRB
                                                                 Submit to: Office of Human Subjects Research
                                                                 1620 McElderry Street, Reed Hall, Suite B-130
                                                         Phone: (410) 955-3008 Fax: (410) 955-4367 or (443) 287-5353
 Website http://irb.jhmi.edu                                               E-mail: jhmirb@jhmi.edu

 Do not submit proposed changes on this application. If you are submitting changes, submit the “Changes
 in Research Application” with this application.
                                                                                          Date Protocol expires:
            Application Number:                                                            Approval Granted by JHM-IRB #:
            Principal Investigator:                                                       Department/Division:
                                      PI Title:
                                      Email Address:
                                      Phone Number:
                 Co-Investigators:
                Title of Research:
A. RESEARCH STATUS: Check the applicable category below:
       1.          Enrollment/Recruitment has not started
       2.          Active Enrollment
       3.          Enrollment closed and participants are receiving study intervention         Date Closed:
                        Participants receiving drugs/devices (including eye drops, Lidocaine, etc)
                        Participants receiving other research-related procedures (including protocol-specified testing, radiation, etc.)
                        Participants were consented since last continuing review before enrollment closed
       4.          Enrollment Closed. Research open for collection of follow-up (including Date Closed:
                   survival, if applicable) data and data analysis only
                        Participants were consented since last continuing review before enrollment closed

B.   PARTICIPANT ACCRUAL:
       1.    Number of participants approved for this research in original application:
     22.     Number of participants added through IRB approved changes:
     .
     33.                        Total number of participants approved by IRB:
     .
       4.    Study population approved by IRB:
             a. Age Range:
             b. Number of participants signed a Hopkins consent form, gave oral                  Since Last              Since Original
                  consent, or were studied under a waiver of consent                             Approval                Approval
                                                                           Male Adults
                                                                         Female Adults
                                                                         Male Children
                                                                       Female Children
                                                                           Total Enrolled




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                                                 Johns Hopkins Medicine-IRB

           c.     Number of Hopkins enrollees who failed screening (insert “0” if the           Since Last              Since Original
                  study has no screening procedures)                                            Approval                Approval
                                                                             Male Adults
                                                                           Female Adults
                                                                           Male Children
                                                                        Female Children
                                                                 Total Screen Failures
                                                           Total Hopkins Participants
                                                (Total Enrolled minus Total Screen Failures)
           d.     For Multi-Center Studies Only                                                 Since Last              Since Original
                                                                                                Approval                Approval
                  Number of participants for total study from all sites (including “Total
                  Hopkins Participants above)
                                                                                      Adults
                                                                                     Children
                                                                        Total for all Sites
      5.   Are you recruiting directly from any of the following categories?
                  JHH/JHBMC Emergency department patients
                  Employees/staff of the Johns Hopkins Hospital (including fellows, residents and interns)
                  JHU School of Medicine students
                  JHH Obstetric patients
                  Hopkins Inpatients
                  Hopkins Outpatients

      6.   Are you allowing any of the following populations to be enrolled?
                  Adults lacking capacity to consent
                  Non-English speakers
                  Pregnant women, fetuses or neonates
                  Prisoners
                  Children who are in foster care or wards of the state.

C.    FUNDING STATUS:
     1.         Yes     No          Is there monetary support for this research?
                                    If yes, complete the following:
           a.                        Sponsor or Grantor name(s):
           b.                     Grant/sponsor protocol number:
           c.                                              Status:           Awarded            Pending         Did not apply for funding
           d.         Yes    No     If this research has commercial funding, is the funding in excess of $10,000?
                      NA            If yes, you may be billed for continuing review. (See Notices/Updates: April 2006
                                    http://irb.jhmi.edu/Notices/DeskoftheViceDean/ChangesinWIRBReview.html )
     2.         Yes     No          Is there material or equipment support for this research?
                                    (such as drug products, botanical or biological substances, or devices)
                                    If yes, complete the following:

           a.     Source of funding or sponsor name(s):
           b.     Type of material or equipment:




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                                                Johns Hopkins Medicine-IRB

D.    RENEWAL SUMMARY:
     1.   Research Summary:
          Provide a brief summary of the research, including the purpose of the research, the research design, inclusion criteria,
          exclusion criteria, study population, outline of methods and significant interventions, risk and benefits, and outline of safety
          monitoring plan: (You do not need to complete this section if you are submitting Form A; type “See Form A”).




     2.   Progress Report:
          Briefly describe the progress of the research during the last approval period:


     3.   Interim Findings:
          Briefly describe any significant preliminary observations/interim findings during the last approval period:


     4.   Literature:
          Summarize recent (within the last year) relevant literature from peer reviewed publications (if any exist) and their relevance
          to your research. Note: Do not merely provide a list of publications without analysis as to significance to the research:


     5.   Data Safety Monitoring:
          Check the type of Data Safety Monitoring Plan (DSMP):
                                   a.    The principal investigator has sole responsibility for monitoring, or
                                   b.    A group of designated JH faculty/staff has responsibility for monitoring, or
                                   c.    An independent individual or group of non-JH individuals will have responsibility for monitoring
                                         ( e.g., coordinating center) and oversight of problem/events for this research, or
                                   d.    A designated medical monitor, or group of monitors, for commercially funded or for not-for-
                                         profit sponsored studies has responsibility for monitoring, or
                                   e.    A formal Data and Safety Monitoring Board (DSMB) will have responsibility for monitoring, or
                                   f.    The SKCCC Clinical Research Office performs data and safety monitoring for the research.
                                         For a-e, describe data safety monitoring plan. If the research involves more than minimal
                                         risk, include procedures for analysis and interpretation of data, actions to be taken
                                         concerning specific events or end points, time points for review and reporting procedures.
                                         For e, include a description of the criteria for membership on the DSMB.

             Yes     No     Are there any reports or interim findings generated by the DSMP?
                            If yes, submit any reports or interim findings generated by the DSMP.
                            If no, explain why.
     6.   Multi-Center Studies:
             Yes     No     Is this a multi-center study?
                            If yes, does the coordinating center distribute multi-center trial reports?   Yes    No
                            If yes, submit a copy of the most recent report.
     7.   Projected date of study completion:
     8.   Approved Protocol Changes:
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                                                 Johns Hopkins Medicine-IRB
                 Yes     No    Have there been any changes approved by the JHM IRB during the last approval period?

                               If yes, briefly describe the changes below:

            Date of            Description of Change:
            Approval
            1.
            2.

       9.        Consent/Assent:
                                  Check the type(s) of consent:
                                      Written        Oral         Waiver/Alteration     None
                                  Number of consent forms:
                   Yes    No      Will you be using the same consent form(s) without any changes?
                                  If yes, do not resubmit the consent form(s).
                                  If no, submit a Changes in Research application with the revised consent form(s) on the currently posted
                                  consent template (http://irb.jhmi.edu/Forms), with tracked changes.
      10.        Drugs/Substance
                   Yes    No      Are marketed drugs or diagnostic reagents administered to human subjects?
                                  If yes, list the drug/substance names:


                   Yes    No      Are investigational drugs to be administered?
                                  If yes, list the drug/substance names:


                   Yes    No      Is there an Investigational New Drug (IND) number?
                                  If yes, list the IND number(s):
                                  Who holds the IND?                         Sponsor           *Investigator
                                                                        *Attach the IND application annual report submitted to the FDA?
                                                                        If not submitted to the FDA enter
                                                                        projected date to be submitted
                                  Name IND holder:
                   Yes    No      Did you submit the annual IND application report to FDA as the sponsor?
                                  If yes, attach a copy of the report or indicate the projected date to be submitted. _____________
                                  (Submit a copy to the IRB when available)
                   Yes    No      Are non-FDA approved substances (botanicals, dietary substance, etc.) administered?
                                  If yes, list the substance (botanicals, dietary substance, etc.) names:


                   Yes    No      Is there IND #?
                                  If yes, list the IND number(s):
                   Yes    No      Is there an FDA letter of exemption?
                                  If yes, provide a copy of the FDA letter of exemption.

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      11.   Devices
                 Yes     No     Are medical devices used in this study?
                                If yes, list the device(s) names:
                 Yes     No     If yes, is the device FDA-approved for this indication?
                                If an approved Humanitarian Use Device (HUD), provide HDE#:
                 Yes     No     Is there an Investigational Device Exemption (IDE) number?
                                If yes, provide IDE# and provide FDA documentation as
                                attachment.
                                If no, is an IDE # required?          Yes       If yes, list IDE#:
                                                                      No
                 Yes     No     Has the device had 510(k) clearance?
                 Yes     No     Do you believe this is a Non-Significant Risk Medical Device Research?
                                If yes, provide to the IRB with an explanation to support your determination.



      12.   Radiation:
                 Yes     No     Has the amount of radiation or radioactive materials changed?
                                If yes, submit a Changes in Research Application.
      13.   Human Biologicals:
                 Yes     No     Are fetal tissue samples collected in this research?
                 Yes     No     Are any infectious or biohazardous agents or specimens obtained in this research?(Any specimens
                                involving blood or body fluids)
                 Yes     No     Has biosafety registration been renewed, or is it under review for renewal?
                                Submit to IRB when available
      14.   Unanticipated Problems:
                 Yes     No     During the last approval period, have there been any unanticipated problems (events involving risks to
                                participants or others)?
                                If yes, attach a summary of the problems.
                 Yes     No     During the last approval period, has the profile of adverse events (in terms of frequency, severity, or
                                specificity) changed from previous experience or from protocol expectation?
                                If yes, attach a summary of the changes.
                 Yes     No     During the last approval period, have any participants or others complained about the research?
                                If yes, attach a summary describing the number and nature of the complaints, and explain whether the
                                complaint was resolved.
                 Yes     No     During the last approval period, have any participants withdrawn from the research?
                                If yes, attach a summary describing the numbers of withdrawals and their reasons.

                 Yes     No     During the last approval period, have there been any protocol deviations?
                                If yes, attach a summary describing the protocol deviations.
      15.   Information:
                 Yes     No     During the last approval period, has any new information affected the reasonableness of the risks
                                associated with the research in relation to the anticipated benefits, and/or affected the willingness of
                                participants to enroll, or to continue in the research?
                                If yes, attach a summary of the new information.
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  16.   Benefits/Risks:
               Yes     No       During the last approval period, have participants experienced any direct medical benefits as described in
                                the consent form (if any)?
                                If yes, attach a summary of participant benefits.
               Yes     No       During the last approval period, has there been any new risk information that would affect this research?
                                If yes, attach a summary of this information.
               Yes     No       In the opinion of the principal investigator, have the risks or potential benefits of this research changed?
                                If yes, attach a summary description of those changes and the rationale behind the PI’s opinion.
17.     Conflict of Interest:
               Yes     No       Do any of the participating faculty (or their immediate family, staff, or students) have a financial interest
                                (royalty, equity, or consulting) in the sponsor and/or products used in this research?
                                If yes, submit a written statement of disclosure and request for review of conflict of interest to the
                                designated official.
                                If yes, list a non-conflicted designee for inclusion in the consent forms.
                                Name of non-conflicted designee:
18.     Clinical Trials:
             Yes      No      Is this research a Clinical Trial? (If no skip the next set of questions)
             Yes      No      If yes, does the JHUSOM Clinical Trials Registry policy (See Guidance at:
                              http://irb.jhmi.edu/Policies/103_25.html?) require registration of this trial?
                              If no, describe why the trial does not need to be registered:


                                   Yes     No     Has this trial been registered?
                                                  If yes, List the site where the trial was registered and the registration number.
                                                  (Note: www.clinicaltrials.gov is the preferred site.)
                                                  Registration Site:
                                                  Registration Number:
                                                  If registered on a site other that www.clinicaltrials.gov, provide justification for using
                                                  this site:


                                                  If this trial requires registration but has not been registered, describe why it was not
                                                  registered?




__________________________________                        _______________________________
Signature of Principal Investigator                       Date




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