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NEW STUDY REVIEWER CHECKLIST Full Board

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					    203-A                         NEW STUDY REVIEWER CHECKLIST                                  IRB #: ________________
                                                                                                    PI:________________
                                            Full Board
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?
               Does this study meet the definition of human subject research?


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 this an investigator-initiated study?
               Is a valid IND or IDE present (letter from FDA or sponsor)? If exemption is appropriate, refer to new
                 project application supplemental IND/IDE sheets and provide exemption criteria #_______________
               Do you concur with PI's assessment of the IND/IDE justification? If not, state reasons:

               ___________________________________________________________________________________
               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?
               Is the inclusion/exclusion criteria clearly stated?
               Is the importance of expected knowledge justified?
               Is there genetic testing / tissue repository involvement?
               If applicable, is the status of drug; dosage & route of administration, & risks included in protocol?
               Is the plan to control the storage & dispensation of the investigational article adequate?
               If applicable: are surveys / questionnaires included?
                                                                              .


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    203-A                         NEW STUDY REVIEWER CHECKLIST                                IRB #: ________________
                                                                                                  PI:________________
                                            Full Board
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)
                               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.
                      Are there any protected groups or special classes excluded and if so, are the exclusions
                        scientifically supported and appropriate?


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?




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    203-A                         NEW STUDY REVIEWER CHECKLIST                                   IRB #: ________________
                                                                                                     PI:________________
                                            Full Board
               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 qualfies for waiver of consent, refer to the Waiver of Consent Criteria Sheet)

Y     N        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
                       Signature & date lines for the witness to the participant's signature
                       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
                      Written consent summary embodies basic & required additional elements


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    203-A                         NEW STUDY REVIEWER CHECKLIST                                  IRB #: ________________
                                                                                                    PI:________________
                                            Full Board
                      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:

               Will legally effective informed consent be 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?
               Will consent information be 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?


               FREQUENCY OF IRB REVIEW

                 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        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: _________________________



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203-A                         NEW STUDY REVIEWER CHECKLIST   IRB #: ________________
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203-A                         NEW STUDY REVIEWER CHECKLIST   IRB #: ________________
                                                                 PI:________________
                                        Full Board




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203-A                         NEW STUDY REVIEWER CHECKLIST   IRB #: ________________
                                                                 PI:________________
                                        Full Board




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     203-A                         NEW STUDY REVIEWER CHECKLIST   IRB #: ________________
                                                                      PI:________________
                                             Full Board




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