Award for Excellence in Human Research Protection
Best Practice Award questions
Q.1. Practice: What is the best practice for which you are applying for the Award? Please describe it in relevant detail (e.g., purpose, objectives, methods, monitoring). If applicable, provide flowcharts, diagrams, etc. Note the institutions at which it is being used currently.
Q.2. Genesis: What was the genesis of the practice? Please describe briefly any events that led to the redesign of an existing or the establishment of this new practice. For example: Was the need for the practice identified by compliance self-assessment or continuous quality improvement (CQI) activities? If so, describe briefly the QI activity that identified the need to redesign an existing or to establish this new practice.
Q.3. Experience: When was this redesigned or new practice first established, introduced, or implemented? If the practice has evolved over time, e.g., as a result of QI activities, please state the month and year the practice was first introduced. How successfully has the practice been implemented?
Q.4. Compliance: What human research protection regulations, accreditation standards, or institutional policies does the practice satisfy or address? Specify them by source and reference number, if any, and describe them briefly. Describe how the practice is consistent with these regulations, etc, and their intent. If the practice exceeds minimum regulatory requirements, describe in what ways.
Q.5. Protection of human subjects: How does the practice achieve or contribute toward the achievement of the protection of human subjects? To the extent applicable, document how it demonstrates a commitment by the institution to creating and/or maintaining a culture that exemplifies the central principles of humanity as a fundamental element of the research enterprise and to the welfare of research subjects, patients, and people.
Q.6. Monitoring and evaluation/outcomes: What monitoring and/or evaluation is ongoing and/or has been completed to demonstrate the practice's effectiveness (including its sustainability) and/or its efficiency (including costs and burdens placed on research participants) compared to other effective practices? If the institution monitors or evaluates the practice periodically, specify how often. Describe who performed the evaluation, methods, results to date (i.e., in the last 5 years), and any changes to the practice stemming from monitoring its cost and/or effectiveness (in terms of achieving the practice's objectives and the protection of human subjects). What comparative (benchmarking) assessments have been conducted that suggest the practice is a "best practice?" If benchmarked, describe who conducted the assessment, assessment methods, results, and any changes to the practice consequently. Describe the evidence that the practice actually assures or improves the protection of human subjects.
Q.7. Innovation: In what ways, if any, is the practice innovative? For example, does the practice focus attention on a protection that is generally not undertaken? Does it provide a novel way of meeting an accepted requirement?
Q.8. Replicability: What types of institutions could adopt or adapt this practice? How adoptable or adaptable is it by these institutions? Describe what efforts, if any, are being or have been made to disseminate the practice and/or to provide technical assistance to other institutions interested in adopting or adapting it. If applicable, describe the required circumstances (e.g., institutional environment) and personnel, financial, and other resources necessary to replicate (i.e., plan, establish, implement, and monitor) the practice at another institution.
Q.9. Justification for award: Why should this practice receive an Award of excellence and be judged a 'best' practice? How does it demonstrate leadership by example? Summarize the main points made above. Add any others necessary to convince judges that this practice should receive this year's Award.
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