Medical/Behavioral Continuation Form by PUHLP0J7

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									             Directions for Full Board Protocol Amendment Submission
                                          (NOTE: Do not include directions with your submission)
     1.   IF YOUR STUDY IS ON HOLD FOR REASONS THAT MAY INCLUDE SAFETY, TOXICITY AND/OR EFFICACY—do not complete this
          form—complete the Unexpected Problem Form.
     2.   The following applies to ALL amendments:
                Any proposed modification to an IRB-approved research protocol or informed consent document must be approved by the IRB
                    prior to implementation of the proposed change (unless there is an urgent need to implement the change prior to IRB approval);
                    and
                Approval of an amendment by the IRB does not alter the original approval or expiration date assigned to the research protocol.
                If there are substantial changes from the original approved version, the IRB may require submission of a new protocol.

                                      Amendments that qualify for Full Board Review:
Full board review is required when an additional risk to participants has been identified or the proposed change poses an increased risk or there is a
change in the risk or safety information to participants that significantly affect the nature of the study. Examples of revisions that would require full
board review may include one or more of the following:
                Addition of a new risk, serious unexpected adverse event, safety information or other risks to the protocol, Investigator
                     Brochure, packet insert or consent documents
                Investigational Brochures, protocols, or package inserts with updated risk or safety information that is not already in the consent
                     and, if multiple studies are using the drug, that does pertain to this study
                Changes to the consent or Investigator Brochure that are more than administrative changes
                Broadening the range of inclusion criteria
                Narrowing the range of exclusion criteria
                Alteration in the dosage or route of administration of an administered drug
                Substantially extending the duration of exposure to the test material or intervention
                Deletion of laboratory tests, monitoring procedures, or study visits directed at the collection of information for safety evaluations
                Changes that, in the opinion of the IRB Chair or his/her designee, do not meet the criteria or intent of a “minor” modification

                       Submission Requirements for Full Board Review: Collate all copies
                                                              Number of copies to submit: M1, PH1 & B3: 3 copies; MP2 & MP4: 19 copies
Amendment Form                                                With original signatures
                                        Currently
          Amended Item                  Approved                  Amended Version
                                         Version
                                         3 copies             M1, PH1 & B3: 3 copies; MP2 & MP4: 19 copies
Advertising Materials & items
                                                              Highlight all changes on all copies
given to participants (eg, diaries)
                                                              2 clean copies (unhighlighted) for IRB approval stamp
                                         3 copies             3 copies with all changes highlighted on all copies.
Protocol Revisions                                            3 copies of a “Summary of Changes” from sponsor or PI (if applicable). The
                                                               summary should include the specific page number of the revisions.
                                         3 copies             M1, PH1 & B3: 3 copies; MP2 & MP4: 19 copies
Consent, Assent, Information                                  Please update the footer with the revised date
Sheets                                                        Highlight all changes on all copies
                                                              2 clean (unhighlighted) copies for IRB approval stamp
                                         3 copies             3 copies of the signed HIPAA Summary Form with all changes highlighted.
                                                              3 copies of the HIPAA Authorization Form (if not part of the consent document) with
HIPAA Forms                                                    all changes highlighted on all copies.
                                                              2 clean (unhighlighted) copies of the HIPAA Authorization Form (if not part of the
                                                               consent document)
Drug Brochure / Package Insert           3 copies             3 copies of the revised version with all changes highlighted on all copies.
                                         3 copies             3 copies of each item (including a cover memo, if applicable) with all changes
Other
                                                               highlighted on all copies.

     Forms can be double-sided for submission, except for the two clean copies of the revised consent; these must be single sided.
                                                                                    Institutional Review Board
                                                                                    87 E. Canfield, Second Floor              (313) 993-7122 Fax
                                                                                    Detroit, MI 48201                         (313) 577-1628 Office
                                                                                    www.irb.wayne.edu



                              Full Board Medical/Behavioral Amendment Form


           All IRB submission forms must be the current form date (down load from http://irb.wayne.edu/forms-requirements-categories.php) and
            typed or computer generated.
           *Forward your @wayne.edu e-mail to your @med.wayne.edu, @karmanos.org, etc. e-mail in order to receive important e-mail
            communications regarding your study if you do not access your @wayne.edu e-mail OR go to Pipeline and enter the e-mail account that
            you wish to use. Non-WSU employees, please enter your e-mail. An e-mail address is required.
           On original form only: Submit with original signatures—no faxed or copies of signatures.
           Please submit this number of copies of this form: M1, PH1 & B3: 3 copies; MP2 & MP4: 19 copies
           The IRB committee deadlines are at: http://irb.wayne.edu/meetings-deadlines.php
           Please call us if you have any questions along the way: (313) 577-1628

Section A: Principal Investigator (PI)
 1.        Name of PI                                                                          Department
 2.        PI’s SIGNATURE                                                                      Fax

 3.        Address                                                                             Pager

                                                                                               *E-Mail
                                                                                               Telephone
 4.        Form Completed By                                                                   Date
           Telephone                                                                           *E-mail
           Name of Faculty                    N/A                                              *E-mail
           Sponsor/Supervisor


Section B: Protocol Information
 5. Coeus Number
 6. IRB Protocol Number
           (ex.######MP2E)
 7.        Current Project Title

 8.        Is this research being conducted at the VAMC?                     Yes (Please attach VA CIC approval memo)
                                                                             No
 9.        Expiration Date
 10.       Is this protocol closed to recruitment?                           Yes
                                                                             No
 11.       Is WSU the Coordinating Center for this study?
                Yes        No If adding or deleting centers, submit a Coordinating Center Form: http://irb.wayne.edu/forms-requirements-categories.php

 12.       Indicate the number of local participants consented to
           date at WSU.
 13.       Current Source of Funding


Full Board Amendment Form                                                     Page 1                                                       Revised 02/12
 14.   Amendment originates from:                                       Sponsor
                                                                        Principal Investigator


Section C: Proposed Amendments

 15.
       Recruiting Materials and Documents Given to Participants
       (Check all that apply and provide the requested information. Inadequate responses may significantly delay the review process )
       Please Note: If using the Internet for advertising, please complete Appendix B.


           Advertisement        New        Revised   State location of posting and/or
                                                     name of radio station or newspaper.

           Notice/Flyer         New        Revised   State location of posting.


            Participant         New        Revised   State to whom and the means by
       information,                                  which the information, brochure, or
       brochure, pamphlet                            pamphlet will be distributed.
           Press release        New        Revised   State name of radio or TV station,
                                                     etc.

       State reason for the revision(s):
 16.                                                     Administrative / editorial
       Protocol Revisions                                Study Design
       (Check all that apply and completely              Enrollment criteria (e.g., inclusion/exclusion criteria)
       answer the following questions.                   Addition of vulnerable participants (prisoners, cognitively impaired, minors, etc.)*
       Inadequate responses may significantly          *Must submit appropriate vulnerable groups Appendix
       delay the review process)                         Change in treatment
                                                         Data collection methods and/or instruments
       You may need to submit an Appendix if             Telephone script
       changes are made from the originally
                                                         Risks and/or Benefits
       approved version of the protocol. For
       example, if you add another or new blood          Change in protocol title- provide new title:
       draw, submit Appendix F; add another or           Change in accrual
       new radiation test, submit Appendix G.            Change in site/additional site-- location:
                                                         If adding DMC, KCI, or VA for first time, please attach the approval letter.
       See below and website for all of the              Change in site/additional international site-- submit Appendix A and contact the
       Appendixes: http://irb.wayne.edu/forms-           export control office: http://research.wayne.edu/export-control/
       requirements-categories.php
                                                         Other (Explain):
                                                     If any box is checked, please fill in all other sections below




Full Board Amendment Form                                                Page 2                                                        Revised 02/12
       Please indicate the Appendixes that you               Appendix A - International Research
       are attaching:                                        Appendix B - Internet Use in Research
                                                             Appendix C - Children as Research Participants
                                                             Appendix D - Cognitively Impaired or Mentally Disabled Research Participants
                                                             Appendix E - Prisoners as Research Participants
                                                             Appendix F - Use of Drugs, Biologic Agents, or Devices
                                                             Appendix G - Imaging/Diagnostic Radiation
                                                             Appendix H - The Use of Biological Specimens
                                                             Appendix I - Research Funded by a Component of the Department of Defense
                                                             (DoD)
                                                             Appendix J - Studies Conducted at or by the VA
                                                             Appendix K - Pregnancy, Fetuses, Neonates

       State reason for the revision:

       If adding vulnerable participants: provide                                                                       N/A
       specific justification for their inclusion.
       State how this revision will change the
       study:
       State how this change may affect risks to
       participants:
       State what safeguards will be
       implemented to protect study participants
       from additional risks:
       State how this amendment will affect
       currently enrolled study participants:
       State if the proposed change affects            Yes        No
       privacy or confidentiality:
          If yes, please explain how:
       Provide references to support this
       revision, if applicable:
 17.
       Consent, Assent Forms or                                                            New                     Revised
                                                       Consent Forms
       Information Sheets
              Check all that apply.                   Assent Forms                        New                     Revised
              See directions for the # of copies
               to attach.
                                                       Oral Assent Script                  New                     Revised
              Highlight the changes on all of the
               copies.
              Please update the date on the           Addendum to Consents                New                     Revised
               footer.
                                                       Information Sheets                  New                     Revised


       Provide a narrative description and
       justification of the proposed changes to
       the Consent, Assent Forms and/or
       Information Sheet:
       Parental Consent Forms: Will both               Yes        No
       parents be asked to sign the consent
       form? http://irb.wayne.edu/policies/08-02-
       vulnerable-participants-children-03-07-11.pdf


Full Board Amendment Form                                              Page 3                                                 Revised 02/12
         If no, please provide justification and
      state current risk level (1,2, or 3):

      State if the proposed change affects              Yes        No
      previously enrolled participants:

      Will currently enrolled participants be           Yes        No
      notified of this change?

         If yes, state how and when this
      notification or re-consent process will be
      accomplished:
         If no, state the justification for why
      participants will not be consented:


      Waiver of Consent
      Is a waiver of consent now being                  Yes        No                                              N/A
      requested?
      (e.g., chart review, database analysis)
      See federal regulations 45 CFR 46.116(d)
      and 46.408(c)

            If yes:
           a.   Is the risk more than minimal?                                                          Yes   No

           b.   Will the waiver adversely affect the rights and welfare of the research participants?   Yes   No

           c.   Can the research be practicably carried out without the waiver?                         Yes   No

           d.   Will the participants be provided with additional pertinent information after           Yes   No   N/A
                participation, if appropriate?

           e.   Provide protocol-specific
                justification for requesting a
                waiver of consent:

           f.   Are you requesting a waiver of
                                                        Yes
                the requirement to obtain
                                                        No
                written documentation of the
                consent process? (Consent will
                be obtained, but there will be no
                signed form documenting
                consent)

                       If yes, provide a written
                       description of the
                       information to be
                       provided orally to
                       participants




Full Board Amendment Form                                                Page 4                                      Revised 02/12
 18.
       Health Insurance Portability                       HIPAA Summary Form (note, please turn in original signatures)
       and Accountability Act                             HIPAA Authorization Form
       (HIPAA)                                            Requesting a waiver of HIPAA Authorization.
       Check all that apply
       See directions for # of copies to attach
       Describe the proposed changes and
       provide justification:



 19.
       Drug Brochure / Package                            Investigator’s Drug Brochure
       Insert                                             Drug Package Insert
       Check all that apply
       See directions for # of copies to attach
       Provide a narrative description of the
       changes to the Drug Brochure/Package
       Insert
       If multiple studies are using this drug, does      Yes         No – this may be expeditable, see expedited              N/A
       the change apply to this study?                                     form.
       Does this change the overall risk/benefit          No          Increase           Decrease
       ratio from what it currently is?
       Attach the currently approved informed             Attached    (This is necessary for the reviewers to complete their review)
       consent
       Are these changes already in the consent?          Yes         No
       Will the proposed changes affect                   Yes         No
       previously enrolled participants?
       Will currently enrolled participants be            Yes         No
       notified of this change?
          If yes, how?


 20.                                                      Data Safety Monitoring Minutes/memos
       Other
                                                          Sponsor annual reports
       Check all that apply.                              Study off-hold
       See directions for # of copies to attach.          Study closed to accrual
                                                          Other
                                                          Study on-hold- DO NOT COMPLETE THIS FORM IF THE STUDY IS ON HOLD FOR
                                                       REASONS THAT MAY INCLUDE SAFETY, TOXICITY AND/OR EFFICACY- COMPLETE THE
                                                       UNEXPECTED PROBLEM FORM.

       Describe the proposed changes and
       provide justification:




Full Board Amendment Form                                               Page 5                                                         Revised 02/12
 21.
       Narrative Summary

       Please cut and paste response from Q#15 of Initial Protocol Summary form (if it has not previously been revised) OR attach a copy of
       the last approved version OR retype answers. Provide a complete and concise description of the protocol in non-technical language
       (lay terms). The completed summary should be 1-3 pages in length (absolute maximum 4 pages), with up to ¾ of a page allowed for
       the response to each question. If the narrative summary exceeds the allowed page length, one additional page can be added, but if it
       exceeds 4 pages, your submission will be returned to you. Please do not cut and paste text from the full protocol or refer to
       protocol page numbers. Literature citations should not be included in this section.

       a. Describe the background and rationale
          for the study:


       b. State the goals/aims/ hypothesis for
          the study:


       c. List inclusion criteria:



       d. List exclusion criteria:



       e. Describe the methods/ procedures of
          the study, including identification of
          those that are already being performed
          for diagnostic or treatment purposes


Renewing and Closing Your Study:
Just a reminder along the way that it is the PI’s responsibility to either submit a Continuation Form before the study
expires or to close the study before it expires by submitting a Closure Form at the end of the study. These forms are
located on the forms page of our website: http://irb.wayne.edu/




Full Board Amendment Form                                            Page 6                                                    Revised 02/12

								
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