Justice and the Human Development Approach to International Research

This chapter articulates and defends the human development approach to international research. This approach extends into the international context the egalitarian research imperative outlined in chapter 4, the integrative approach to research risk in chapter 6, and the non-paternalistic approach to research oversight in chapter 7. In this approach, requirements related to responsiveness to host community health needs, the standard of care, and post-trial access to study interventions are grounded in requirements of justice and the egalitarian research imperative. The result is a unified foundation for both domestic and international research ethics that treats research as a social undertaking, recognizes justice as the first virtue of social institutions, and gives moral force to the imperative to generate the information needed to improve the ability of social institutions to advance the common good.

改變“14天規則”：生命倫理學與公眾參與的再平衡

LANGUAGE NOTE | Document text in Chinese; abstract also in English. This article argues that the ISSCR's changes to the 14-day rule should be welcomed. In the future of human embryo research oversight in China, bioethics and public engagement should be fully balanced. This is essential to safeguard the public's trust in science.

International Coordination of Research Ethics Review: An Adequacy Model

International direct-to-participant (DTP) genomics research involves the use of mobile technology to recruit, consent, and study participants remotely. This model can facilitate research across broad geographies and many countries, but must also comply with the norms of multiple recruitment jurisdictions, with each jurisdiction typically requiring at least one local research ethics review. Each additional research ethics review increases bureaucratic hurdles without necessarily strengthening the protection of participants’ rights and interests. For DTP genomic research, obtaining a review may in fact be impossible in the absence of a local research partner. This paper proposes an “adequacy” approach, inspired by data protection law, to coordinate the regulation and oversight of international DTP genomics research. This involves one country voluntarily assessing whether another country’s research ethics reviews are equivalent to its own, in terms of objectives and effectiveness. Ethics-approved projects led by researchers from countries recognized as adequate are deemed to comply with local norms, eliminating the need for a duplicative local review. Adequacy preserves the sovereignty of countries to determine their own regulatory aims and which other countries to trust. It therefore provides a voluntary, incremental path towards greater global coordination of health research oversight.

Independent Review, Data Safety Monitoring, and Research Oversight

Independent review, data monitoring, and general oversight of human subjects research provide systematic mechanisms for ensuring that investigators implement best practices to minimize risks, maximize benefits, and ensure justice in the conduct of research. This chapter describes how successful partnerships between research teams and oversight groups have focused on the shared goals and commitments of the research enterprise and how each constitutive piece combines with structure, function, and purpose to facilitate the conduct of ethical research. The author argues that collaborative work toward ensuring not just fidelity to rules and regulations but also attention to the underlying ethical foundations for these mechanisms will foster meaningful conversations about how to ensure high-quality research that places the safety of human subjects at its core.

The Commitment to Science

The association of medicine with science is at the core of the profession’s expertise. This chapter explains that doctors are duty-bound to base their diagnoses and treatment decisions on scientific evidence because patients rely on that commitment when seeking treatment and advice. Thus, the commitment to science is a core duty of medical ethics. The chapter argues that doctors should be committed to advancing biomedical knowledge and supporting medicine’s research agenda. In that light, the chapter opposes two widely accepted views. One is the World Medical Association’s position that physicians should focus exclusively on the good of their individual patient. The other is the US Common Rule’s distinction between clinical innovation and research, which has the effect of driving a wedge between medical ethics and research ethics. The chapter also addresses challenging issues of how human subject research should be conducted, research oversight, consent, vulnerable subjects, and placebo studies.

Institutional Animal Care and Use Committee Postapproval Monitoring Programs: A Proposed Comprehensive Classification Scheme

Introduced over 20 y ago, IACUCs undertaking postapproval monitoring (PAM) of animal research procedures as a means to ensure researcher compliance is now widely used as an oversight tool in laboratory animal research. Through a literature review evaluating the history of PAM in the United States, discussions of controversy surrounding PAM activities, and reflections on how PAM activities are described within the IACUC community, we present an up-to-date and comprehensive classification system for PAM program methodologies that could serve to standardize how such activities are characterized in IACUC policies, communicated to research staff, used in training programs, implemented for the desired impact by individuals involved in animal research oversight, and referenced by regulatory agencies.

Regulatory flexibility for COVID-19 research

Clinical research is critical to combatting COVID-19, but regulatory requirements for human subjects protection may sometimes pose a challenge in pandemic circumstances. Although regulators have offered some helpful guidance for research during the pandemic, we identify further compliance challenges regarding institutional review board (IRB) review and approval, informed consent, emergency research, and research involving incarcerated people. Our proposals for regulatory flexibility in these areas seek to satisfy the goals of protecting participants and promoting the development of high-quality evidence to improve patient care. These recommendations may have relevance beyond the COVID-19 pandemic to enhance the efficiency of research oversight and participant protection more broadly.

The cancer care network clinical trials program: Rising from the camp fire ashes.

168 Background: The UC Davis Health Cancer Care Network (CCN) in Sacramento improves quality through partnerships with community cancer centers and the UC Davis Comprehensive Cancer Center (UCDCCC). The UCDCCC, as an NCI Lead Academic Participating Site (LAPS) grant recipient, lists Adventist Health Rideout Cancer Center (RCC) in Marysville (42 miles north of Sacramento) as a component. The Adventist Health Feather River Cancer Center (FRCC) and the town of Paradise were devastated by the 2018 Camp Fire, forcing FRCC’s relocation to the city of Chico (49 miles north of Marysville). FRCC was forced to disband its local IRB and unable to continue clinical trials research operations during the aftermath of this natural disaster. The CCN established an affiliation with the FRCC in April 2019. Future plans include establishing an IRB agreement and adding FRCC as a LAPS component. The CCN identified strategies to facilitate the participation of FRCC patients in clinical trials. Methods: The CCN identified 13 NCTN clinical trials with 34 enrolled patients that were in need of appropriate research oversight. Four of these trials were previously never activated at the UCDCCC or its affiliates. CCN staff engaged leaders at the various institutions involved: Quality Assurance (QA) Managers at each NCTN research base, the CIRB, the local IRB, the CTSU, and other leaders within UC Davis and Adventist Health. Results: Stakeholders acknowledged the unusual and urgent nature of our requests and questions, while contributing to the development of a plan allowing patients to continue clinical trial participation. QA managers approved a plan transferring patients to the RCC, allowing research staff to collect and submit data while patients continue receiving care closer to home. Together we developed a notification letter to inform patients of this plan. Conclusions: The relocation of facilities and patients brought rare challenges while conducting clinical research in rural communities. We learned that the cooperation and flexibility of all parties involved was crucial in supporting the continued care for FRCC's clinical trial patients and research contributions.

Ongoing Consent in Situations of Cognitive Vulnerability

This chapter explores ethical issues in obtaining ongoing consent for clinical research involving cognitively vulnerable patient populations. Stakeholders in these challenges include researchers, sponsors, study participants, caregivers and other legally authorized representatives, and research oversight boards. First, this chapter examines existing conceptual frameworks and proposed safeguards for the protection of cognitively vulnerable research participants, including double consent, proxy consent with participant assent, advance consent, and process consent. This chapter then proposes an inclusionary approach to obtaining ongoing consent to research participation when cognition could fluctuate over the course of research participation. Proposed safeguards and modifications to the consent process should address duration of research participation, the nature and timing of research-related risks, expected and unexpected fluctuations in decision-making capacity, and the process of exiting a clinical trial. The proposed framework is then applied to the specific context of implanted neural device trials, with special attention to considerations for device explant.