Table 2.
Example metrics and assessments to evaluate common IACUC functions
IACUC function | Function component | Metric | Assessment | Committee type evaluated | Reference |
Protocol Review | Participation | Member participation during protocol reviews | Incidence or frequency of feedback by individual or member category (chair, scientist, nonscientist, veterinarian, nonaffiliated) | IRB | Candilis, P.J., and colleagues 20129 |
IACUC | Silverman J., and colleagues 201551 | ||||
Quality of member participation during protocol reviews | Transcribe and code discussion topics presented during review | IACUC | Houde L., and colleagues 200323 | ||
IACUC | Silverman J., and colleagues 201551 | ||||
Audit protocol review comments based on protocol form sections | IACUC | Dresser R. 198913 | |||
Process | IACUC member satisfaction with review process | Survey or interview IACUC members | IACUC | Silverman J., and colleagues 201248 | |
Researcher satisfaction with review process | Survey researchers | IACUC | Norton J.N., and colleagues 201736 | ||
Days under each phase/type of review process | IRB | Varley P.R., and colleagues 201660 | |||
IACUC member views on the committee's ethical framework | Survey IACUC members | IACUC | Houde L., and colleagues 200924 | ||
Duration | Factors affecting duration of protocol review process | Study characteristics impacting review time | IRB | Caligiuri M., and colleagues 20178 | |
Impact of regulatory support personnel on review time | IRB | Desai, P., and colleagues 201712 | |||
Time to approve based on funding source, procedure invasiveness | IRB | Hall D.E., and colleagues 201520 | |||
Outcomes | Protocol review outcomes | Protocol review outcomes, type of protocols, category of invasiveness | IACUC | Houde L., and colleagues 200323 | |
Frequency of protocols approved without revisions, protocols requiring revisions, protocols rejected | IRB | Abdel-Aal, W. and colleagues 20134 | |||
Volume | Number of protocols reviewed | Total number of protocols reviewed per meeting, per year | AEC | Schuppli C.A. and Fraser D. 200746 | |
Reviewer workload | Frequency each member or member category is assigned designated or primary reviewer | AEC | Schuppli C.A. and Fraser D. 200746 | ||
Concurrent Factors | Protocol review time occupied with ancillary review | Incidence and duration reviews are held for ancillary purposes (for example, radiation safety review, biosafety review, scientific review) | IRB | Caligiuri M., and colleagues 20178 | |
Continuing Reviews | Lapse in performing continuing reviews | Incidence or frequency of completed continuing reviews compared with lapses in continuing reviews | IACUC | Tsan M.F., and colleagues 201654 | |
Workload associated with continuing review | % protocols undergoing continuing review/year | IRB | VandenBosch T.M and Maio T.M. 201158 | ||
Outcomes of continuing reviews | Incidence and frequency of noncompliance findings during routine continuing review | IACUC | Vanderford D.A., and colleagues 201559 | ||
Semiannual Inspections | Inspection Process | IACUC member satisfaction with inspection process | Survey or interview IACUC members | IACUC | Borkowski G., and colleagues 19977 |
Researcher satisfaction with program oversight | Survey animal-user population | IACUC | Norton J.N., and colleagues 201736 | ||
Program Review | Program Review Process | IACUC member satisfaction with program oversight | Survey or interview IACUC members | IACUC | Borkowski G., and colleagues 19977 |
Solicit feedback from core campus services | IACUC | McEntee H.I. and Sandgren E.P. 200732 | |||
Training Process | IACUC member satisfaction with continuing education | Survey IACUC members | IRB | Feldman J.A. and Rebholz C.M. 200916 | |
Researcher compliance with training expectations | Number of personnel without initial training, lapse in continuing training | IRB | Tsan M.F., and colleagues 201355 | ||
Researcher satisfaction of training programs | Survey animal use population | IACUC | Ingham K.M., and colleagues 200028 | ||
Outcomes | Deficiencies | Number of policies and procedural issues discussed | IBC | Dutton D.B. and Hochheimer J.L. 198215 | |
Regulatory Burden | Perception of burden among IACUC processes | Survey animal-user population | IACUC | Norton J.N., and colleagues 201736 | |
Investigate Concerns | Methods to report concerns | Methods in place to report concerns | Survey IACUC members | IACUC | Borkowski G., and colleagues 19977 |
Investigation Process | Volume | Number and reason for protocol suspensions/terminations | IRB | Tsan M.F., and colleagues 201355 | |
IACUC Administration | Personnel workload | Number of protocols per IACUC Administrator FTE | IRB | Caligiuri M., and colleagues 20178 | |
Quality Improvement | Success of Interventions | Researcher perception of interventions made by IACUC | Resurvey animal-user population | IACUC | Ingham, K.M. 200327 |
While some assessment tools listed here have been used in studies directly evaluating IACUC functions, additional tools which have been used to evaluate similar functions of IRBs and IBCs are also included.