Widening the Pool: Open and Inclusive Grant Competitions: Lessons Learned From the Social Innovation Fund

Offers guidance on implementing transparent and competitive grantmaking processes as required by the Social Innovation Fund, including the benefits of transparency, key design considerations such as clear criteria, and examples of open processes

Counting Is Not Enough: Investing in Qualitative Case Reviews for Practice Improvement in Child Welfare

Outlines the value of quality case service reviews in child welfare systems, requirements for building and sustaining a robust process and adapting it under limited state budgets, and recommendations for jurisdictions, initiators, and national leadership

Deregulation Using Stealth “Science” Strategies

In this Article, we explore the “stealth” use of science by the Executive Branch to advance deregulation and highlight the limited, existing legal and institutional constraints in place to discipline and discourage these practices. Political appointees have employed dozens of strategies over the years, in both Democratic and Republican administrations, to manipulate science in ends-oriented ways that advance the goal of deregulation. Despite this bald manipulation of science, however, the officials frequently present these strategies as necessary to bring “sound science” to bear on regulatory decisions. To begin to address this problem, it is important to reconceptualize how the administrative state addresses science-intensive decisions. Rather than allow agencies and the White House to operate as a cohesive unit, institutional bounds should be drawn around the scientific expertise lodged within the agencies. We propose that the background scientific work prepared by agency staff should be firewalled from the evaluative, policymaking input of the remaining officials, including politically appointed officials, in the agency

HREC members\u27 personal values influence decision making in contentious cases

This article identifies 14 contentious issues faced by Human Research Ethics Committees (HRECs). The authors argue that HREC members will respond variably to these issues based on their own fundamental values and worldview. In particular, we propose that personal interpretations of current ethics regulations and HREC members’ attitudes to consequentialism, Kantianism, and utilitarianism in some cases affect their responses to contentious research issues. We seek to promote understanding of how personal and professional back­grounds of HREC reviewers influence their approaches to value-laden issues embedded in ethics applications. Taking the form of a literature review, our con­tribution highlights the need for further exploration of how HREC members make decisions, and what factors influence the outcomes of ethics applications

The South African Regulatory System: Past, Present, and Future

The drive for improved regulatory systems and the establishment of a more effective regulatory framework in South Africa has been evident for the past two decades but despite political intentions and legislative revisions success has been limited to date. Efforts to address the increasing volume of applications that have been received have to date failed and resources have been stretched to capacity resulting in the development of a significant backlog and extended timelines for product registration. The promulgation of the recently amended Medicines and Related Substance Act of 1965 triggered the establishment of the South African Health Products Regulatory Authority (SAHPRA) as a separate juristic person outside of the National Department of Health to replace the former medicine regulatory authority the Medicines Control Council (MCC). The aim of this review is to provide the historical context supporting the new regulatory environment in South Africa and the transition from the MCC to SAHPRA. Key recommendations to SAHPRA to ensure the full potential of the new regulatory environment in South Africa include: establishing a quality management system to safeguard accountability, consistency and transparency and to streamline the implementation of good review practices including quality decisionmaking practices and benefit-risk assessment; the measurement and monitoring of regulatory performance, targets for overall approval time and key review milestones to instill a culture of accurate metrics collection and measurement of key performance indicators and their continuous improvement and the employment of a risk-based approach to the evaluation of medical products and codify the use of facilitated regulatory pathways in policy and culture. The application of a risk-based approach to regulatory review commensurate with a product’s risk to patients will facilitate the application of increased resources for pharmacovigilance activities and to support the reliance and recognition of reference agencies.Peer reviewe