Aims & Scope

Ethics & Human Research (formerly IRB: Ethics & Human Research) aims to foster critical analysis of issues in science and health care that have implications for human biomedical and behavioral research. For example, in addition to covering topics related to informed consent for research, genetic research with human biospecimens, ethics committee review of research protocols, and research with children and other vulnerable populations, E&HR will publish work on rapid developments in science and medicine that bring new challenges to the ethical, regulatory, and policy frameworks that govern research with humans in the United States and elsewhere.

E&HR invites articles, commentaries, case studies, letters, and book reviews that address topics including, but not limited to,

  • review, approval, and oversight of human research by institutional review boards (IRBs), research ethics committees (RECs), and other oversight bodies (e.g., those of funders and regulators and those at the national and transnational levels);
  • regulatory and legal developments related to research with humans and to the privacy and confidentiality of their medical and other personal data;
  • informed consent for participation in research;
  • consent, privacy, and oversight issues related to research with human biospecimens and associated genetic and medical data;
  • research with organ donors, transplant organs, and transplant recipients;
  • research involving learning health care systems;
  • research with digital data from social media and other “big data” collections and platforms;
  • ethical issues surrounding novel trial designs, such as basket trials, umbrella trials or platform trials;
  • ethical issues in the testing and development of computational technologies from machine learning and artificial intelligence;
  • human research involving novel biotechnologies such as genome-editing techniques, cell-, gene-, and tissue-based interventions, and preventive and therapeutic neurological drug and device interventions;
  • research on nonhuman subjects and the ethical implications for the conduct and oversight of biomedical and behavioral human research and for the potential harms and benefits to people who participate in human research studies;
  • the implications of the quality and reporting of preclinical research involving animals and other models (e.g., in vitro assays, epidemiological studies, computer simulations) for the ethical translation of such research to human clinical trials;
  • the intersection of human research ethics with other lines of analysis and regulation in research (e.g., issues related to responsible research and innovation);
  • patient-centered research and community-based participatory research;
  • research with immigrants and with populations based on gender, socioeconomic class, race, and ethnicity, including with American Indians, Alaskan Natives, and other indigenous peoples and communities;
  • research with prisoners, children, pregnant women, and other individuals who may be considered vulnerable (e.g., individuals who are cognitively impaired, homeless, or have substance use disorders);
  • human research in low- and middle-income countries;
  • human research in refugee populations and among internally displaced people; and
  • human research in global health emergencies (e.g., natural disasters, war and other violent conflicts, infectious disease outbreaks).