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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 _ 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
"CONTINUING REVIEW REVIEWER CHECKLIST Full Board Expedited"