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Table 1 Ethical principles and benchmarks for ethically credible partnerships between ahcs and industry Principles Benchmarks Academic freedom 1. Promote investigator-initiated science and protect the ability to attract and maintain federal research support 2.
In contrast with the principles, benchmarks are more concrete and intended to be framed as actionable steps that an organization could use to determine whether or not the principle was being satisfied.
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Developing and vetting the principles and benchmarks Following the scoping exercise, all items were transformed into an initial set of 60 benchmarks which we then separated into categories based on relatedness amongst their content.
We shared the ethics principles and benchmarks with RI leadership in a focus group setting before finalizing a document consisting of 9 principles and 23 benchmarks.
The combined document of principles and benchmarks constituted the ethics framework for our review.
Our process for creating the principles and benchmarks of ethically-credible AHCIPs involved the reviewing key partnership documents; reviewing the relevant academic literature; scoping the issues; and developing and vetting the draft Principles and Benchmarks before producing a final document.
The resulting principles and benchmarks may be seen as the outcome of a process which sought to be exhaustive and comprehensive in its criteria for ethically credible AHCIPs.
Some commentary on the nature of the Regenstrief AHCIP has been recounted elsewhere which gives an account for how the Principles and Benchmarks were applied [22, 35].
Additionally, the principles and benchmarks were readily adaptable to the interview guide we used in a focus group early in the vetting process.
For instance, while some principles and benchmarks were not fully met by the RI AHCIP, we made specific recommendations that, if followed, could assist RI in meeting or exceeding the benchmarks in the future.
Similarly, Emanuel et al. developed an ethics framework that combines principles and benchmarks to assess the ethical acceptability of clinical trials in developing countries [30], an approach also embraced by others [34].
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