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CONTINUING REVIEW REVIEWER CHECKLIST Full Board Expedited

VIEWS: 12 PAGES: 8

									    203-H                                       CONTINUING REVIEW                                  IRB #: ______________
                                                REVIEWER CHECKLIST                                     PI:______________
                                                Full Board / Expedited
Y     N       GENERAL ISSUES

              If this study involves the VA, do you concur with the VA review determination?

              Does the IRB have adequate expertise to review?
              Is outside consultation required?

              EXPEDITED REVIEW CRITERIA

Y     N       If any of the following are answered 'yes', the study qualifies for review by the expedited
                review process
                     Is the research permanently closed to new enrollment; have all participants completed all
                       research-related interventions; and does the project remain open for long-term follow-up?
                     Have no participants been enrolled and no additional risks been identified?
                     Are the research activities limited to data analysis only?
                     Has the IRB determined & documented at a convened meeting that the research involves no
                       more than minimal risk & no additional risks have been identified?

                     Definition of minimal risk: the probability and magnitude of harm or discomfort anticipated in
                      the research are not greater in and of themselves than those ordinarily encountered in daily life
                       or during the performance of routine physical or psychological examinations or tests.


Y     N       APPLICATION ISSUES

              Are investigators sufficiently qualified to conduct this research?
              Is there adequate number of qualified staff to conduct research?
              Do potential conflicts of interest exist?/Are any conflicts of interest disclosed?
              Are there conflicts of interest that require resolution? If yes, explain:

              __________________________________________________________________________________
              Is a valid IND or IDE present (letter from FDA or sponsor)?
              Study Sites: are facilities adequate?
              Is additional committee review required (e.g.Radiation Safety, Biosafety)?


Y     N       SCIENTIFIC / SCHOLARLY REVIEW ISSUES

              Is the hypothesis statement / research question / purpose clearly stated?
              Is the correct sample size/power calculation provided?
              Is the statistical analysis appropriate?
              Does the protocol provide adequate information to obtain research data/results?
              Are there patient safety issues that require resolution? If yes, explain:__________________________

              ____________________________________________________________________________________


Y     N       PROTOCOL ISSUES

              Is there sufficient time for investigator to conduct & complete the study?
              Is study a multisite study where the PI is the lead investigator?
                If yes, is the management of unanticipated problems, interim study results, & modifications adequate?
              Are the research procedures justified?
              Is the protocol consistent with the grant or sponsor's document?

    Continuing Review Reviewer Checklist
    Version Date: 11/01/2006                                  1
    203-H                                       CONTINUING REVIEW                                IRB #: ______________
                                                REVIEWER CHECKLIST                                   PI:______________
                                                Full Board / Expedited
              Is the inclusion/exclusion criteria clearly stated?
              Is the importance of expedted knowledge justified?
              Is there genetic testing / tissue repository involvement?
              If applicable, is the status of drug; dosage & route of administration, & risks included in protocol?
              If applicable: are surveys / questionnaires included?

Y     N             Study Population:

                    Is there an adequate number of participants/controls to obtain results?
                    Is selection equitable, taking into account the following:
                            Purpose of the study
                            Setting in which study will be conducted
                            Inclusion/Exclusion criteria
                            Potential for coercion or undue influence
                            Recruitment & enrollment procedures
                            Influence of payments to participants
                            VA Research: non-veterans should be allowed to be entered only when there are
                              insufficient veterans available to complete the study

Y     N
                    Are adequate medical or psychological resources available if required as a consequence of study?
                    Are protected groups involved?
                     If yes, are additional safeguards in place to protect their rights & welfare?
                            Pregnant women, fetuses (refer to additional review checklist & VA checklist if applicable)
                            Prisoners (refer to additional review checklist) If yes, study must be reviewed by full board.
                            Children (refer to additional review checklist)
                            Neonates (refer to additional review checklist)
                    Does the research involve in vitro fertilization? If so, cannot be approved if there is VA involvement.

Y     N             Risks: (physical, psychological, legal, economic, social)

                    Are procedures consistent with sound research design (i.e., they do not expose participants to
                     unnecessary risks)?
                    When appropriate, are procedures being used that are already being performed for diagnostic or
                       treatment purposes?
                    Are risks reasonable in relationship to potential benefits (if any) and the importance of knowledge
                       that might be expected to result?
                    If study is more than minimal risk, is there an adequate plan in place for monitoring data?
                    If plan is inadequate, state reasons: __________________________________________________

                    ________________________________________________________________________________

Y     N             Confidentiality

                    Are there adequate provisions to protect the privacy of participants & maintain confidentiality
                      of data?
                    Is a certificate of confidentiality required?


Y     N       PRIVACY BOARD ISSUES

              Is the appropriate authorization form being utilized; is the information complete?
              Are additional Privacy Forms required?


    Continuing Review Reviewer Checklist
    Version Date: 11/01/2006                                 2
    203-H                                        CONTINUING REVIEW                                 IRB #: ______________
                                                 REVIEWER CHECKLIST                                    PI:______________
                                                 Full Board / Expedited

              CONSENT DOCUMENT ISSUES

              (If this study involves the VA, VA Form 10-1086 must be used. Also refer to the VA Research
                Reviewer Checklist for additional criteria)
              (If this study qualifies for a waiver of consent, refer to the Waiver of Consent Criteria Sheet)
Y     N
              Is the current consent document still adequate and complete?

              Are all of the following required elements included in the consent document?
                     Statement that the study involves research
                     Statement that participation is voluntary
                     Explanation of the purposes of the research
                     Explanation of the expected duration of participation
                     Description of the procedures (coincides with protocol?)
                     Identification of any procedures that are experimental
                     Description of any reasonably forseeable risks or discomforts (coincides with protocol?)
                     Description of benefits (coincides with protocol?)
                     Disclosure of appropriate alternative procedures or courses of treatment
                     Statement that refusal to participate or discontinuation of participation will not result in penality or
                       loss of benefits to which the participant is otherwise entitled
                     Measures to maintain confidentiality
                     If applicable, statement that FDA may inspect records
                     For research involving more than minimal risk:
                              Explanation of compensation for injury & whether medical treatment is available for injury
                     Contact information for questions pertaining to the research, participant's rights, or research
                       related injury
                     Contact information for questions pertaining to the participant's rights


Y     N       Are the following additional elements necessary?
                    Approximate number of participants involved in the study
                    Statement that the procedure or test article may have unforeseeable risks
                    Statement regarding unforseeable risks as they pertain to pregnant women
                    Anticipated circumstances that may result in the participant's termination by the investigator
                    Additional costs to the participant
                    Consequences of a participant's decision to voluntarily withdraw
                    Procedures for orderly termination of participation
                    Statement of significant new findings

                     Is the information stated in the consent document consistent with the protocol?

              CONSENT DOCUMENTATION ISSUES

Y     N       If a long form is utilized, are the following items included?
                      Signature & date lines for the participart or legally authorized representative
                      Statement that indicates the participant will receive a copy of the consent document



Y     N       If a short form is utilized, are all of the following items included?
                     Statement that elements have been orally presented

    Continuing Review Reviewer Checklist
    Version Date: 11/01/2006                                   3
    203-H                                       CONTINUING REVIEW                                 IRB #: ______________
                                                REVIEWER CHECKLIST                                    PI:______________
                                                Full Board / Expedited
                     Written consent summary embodies basic & required additional elements
                     Witness present to oral presentation who, if necessary, is conversant in both English & language
                      of participant
                     Signature & date lines for participant or legally authorized representative
                     Signature & date lines for witness to sign both short form and copy of consent summary
                     Signature & date lines for person obtaining consent
                     Copy of signed & dated form will be given to participant or legally authorized representative
                     Copy of consent summary will be given to participant or representative



              CONSENT PROCESS ISSUES

              Pertains to consent from participants or their legally authorized representatives & assent from
Y     N        individuals unable to give consent:

              Has legally effective informed consent been obtained?
              Does consent process provide sufficient opportunity for participant to consider whether or not to
                participate?
              Is the possibility of coercion or undue influence minimized?
              Has consent information been communicated in language understandable to the participant?
              Is exculpatory language included in which it appears that the participant's legal rights have been
                waived - or - in which the participant has released the investigator, sponsor, institution or its agents
                from liability for negligence?


Y     N       Pertains to individuals who lack the ability to consent:

              Is there an adequate proposed plan for the assessment of the capacity to consent?
              If assent is required, is there an adequate plan?


              Have any significant modifications been made that will affect a participant's willingness to continue?
              Is there an indication of inconsistency or a concern that requires verification from other sources?


Y     N       FREQUENCY OF IRB REVIEW

              Are any of the following true?
                    There is a high degree of risk
                    The stage of the research is such that many of the risks are unknown
                    Procedures proposed have not previously been used in humans
                    More than minimal risk to vulnerable populations exist with no prospect of direct benefit
                    A high likelihood that participants will die due to the research procedures
                    Other: __________________________________________________________________________

              Should IRB review occur more frequently than annually? If yes, how often? ________________


      Signature of Reviewer: ______________________________________________________________________

      Date of Review: _________________________



    Continuing Review Reviewer Checklist
    Version Date: 11/01/2006                                  4
203-H                                  CONTINUING REVIEW        IRB #: ______________
                                       REVIEWER CHECKLIST           PI:______________
                                       Full Board / Expedited




Continuing Review Reviewer Checklist
Version Date: 11/01/2006                         5
    203-H                                  CONTINUING REVIEW        IRB #: ______________
                                           REVIEWER CHECKLIST           PI:______________
                                           Full Board / Expedited




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    Continuing Review Reviewer Checklist
    Version Date: 11/01/2006                         6
203-H                                  CONTINUING REVIEW        IRB #: ______________
                                       REVIEWER CHECKLIST           PI:______________
                                       Full Board / Expedited




Continuing Review Reviewer Checklist
Version Date: 11/01/2006                         7
203-H                                  CONTINUING REVIEW        IRB #: ______________
                                       REVIEWER CHECKLIST           PI:______________
                                       Full Board / Expedited




Continuing Review Reviewer Checklist
Version Date: 11/01/2006                         8

								
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