Returning Clinically Relevant Research Results to Participants: Guidelines for Investigators and the IRB.

In 2019, the revised Common Rule required informed consent documents for research to include a statement about whether clinically relevant research results would be returned to research participants. While there are national discussions regarding the return of results, these do not provide specific guidance about how institutional review boards (IRBs) should address this issue. Through a year-long process involving IRB staff and leadership, science and bioethics faculty members, community IRB members, and others, Indiana University's human research protection program created a framework that offers a clear categorization of types of results for researchers to consider returning, provides language for informed consent documents, and describes an active but intentionally limited role for the IRB. In this article, we describe this framework and its rationale as a model for other universities and, more generally, as a model for balancing the need to protect human subjects with efforts to limit the burdens on researchers and the IRB.

Refuge-yeah or refuge-nah? Predicting locations of forest resistance and recruitment in a fiery world.

Climate warming, land use change, and altered fire regimes are driving ecological transformations that can have critical effects on Earth's biota. Fire refugia-locations that are burned less frequently or severely than their surroundings-may act as sites of relative stability during this period of rapid change by being resistant to fire and supporting post-fire recovery in adjacent areas. Because of their value to forest ecosystem persistence, there is an urgent need to anticipate where refugia are most likely to be found and where they align with environmental conditions that support post-fire tree recruitment. Using biophysical predictors and patterns of burn severity from 1180 recent fire events, we mapped the locations of potential fire refugia across upland conifer forests in the southwestern United States (US) (99,428 km2 of forest area), a region that is highly vulnerable to fire-driven transformation. We found that low pre-fire forest cover, flat slopes or topographic concavities, moderate weather conditions, spring-season burning, and areas affected by low- to moderate-severity fire within the previous 15 years were most commonly associated with refugia. Based on current (i.e., 2021) conditions, we predicted that 67.6% and 18.1% of conifer forests in our study area would contain refugia under moderate and extreme fire weather, respectively. However, potential refugia were 36.4% (moderate weather) and 31.2% (extreme weather) more common across forests that experienced recent fires, supporting the increased use of prescribed and resource objective fires during moderate weather conditions to promote fire-resistant landscapes. When overlaid with models of tree recruitment, 23.2% (moderate weather) and 6.4% (extreme weather) of forests were classified as refugia with a high potential to support post-fire recruitment in the surrounding landscape. These locations may be disproportionately valuable for ecosystem sustainability, providing habitat for fire-sensitive species and maintaining forest persistence in an increasingly fire-prone world.

Collecting Biospecimens and Obtaining Biobank Consent From Patients in an Academic Health Care Setting: Practical and Ethical Considerations.

Academic health centers and health systems increasingly ask patients to enroll in research biobanks as part of standard care, raising important practical and ethical questions for integrating biobank consent processes into health care settings. This article aims to assist academic health centers and health systems considering implementing these integrated consent processes by outlining the 5 main issues-and the key practical and ethical considerations for each issue-that Indiana University Health and the Indiana Biobank faced when integrating biobank consent into their health system, as well as the key obstacles encountered. The 5 main issues to consider include the specimen to collect (leftover, new collection, or add-ons to clinical tests), whether to use opt-in or opt-out consent, where to approach patients, how to effectively use digital tools for consent, and how to appropriately simplify consent information.

Anticipatory Waivers of Consent for Pediatric Biobanking.

As pediatric biobank research grows, additional guidance will be needed about whether researchers should always obtain consent from participants when they reach the legal age of majority. Biobanks struggle with a range of practical and ethical issues related to this question. We propose a framework for the use of anticipatory waivers of consent that is empirically rooted in research that shows that children and adolescents are often developmentally capable of meaningful deliberation about the risks and benefits of participation in research. Accordingly, bright-line legal concepts of majority or competency do not accurately capture the emerging capacity for autonomous decision-making of many pediatric research participants and unnecessarily complicate the issues about contacting participants at the age of majority to obtain consent for the continued or first use of their biospecimens that were obtained during childhood. We believe the proposed framework provides an ethically sound balance between the concern for potential exploitation of vulnerable populations, the impetus for the federal regulations governing research with children, and the need to conduct valuable research in the age of genomic medicine.

Visions of Restoration in Fire-Adapted Forest Landscapes: Lessons from the Collaborative Forest Landscape Restoration Program.

Collaborative approaches to natural resource management are becoming increasingly common on public lands. Negotiating a shared vision for desired conditions is a fundamental task of collaboration and serves as a foundation for developing management objectives and monitoring strategies. We explore the complex socio-ecological processes involved in developing a shared vision for collaborative restoration of fire-adapted forest landscapes. To understand participant perspectives and experiences, we analyzed interviews with 86 respondents from six collaboratives in the western U.S., part of the Collaborative Forest Landscape Restoration Program established to encourage collaborative, science-based restoration on U.S. Forest Service lands. Although forest landscapes and group characteristics vary considerably, collaboratives faced common challenges to developing a shared vision for desired conditions. Three broad categories of challenges emerged: meeting multiple objectives, collaborative capacity and trust, and integrating ecological science and social values in decision-making. Collaborative groups also used common strategies to address these challenges, including some that addressed multiple challenges. These included use of issue-based recommendations, field visits, and landscape-level analysis; obtaining support from local agency leadership, engaging facilitators, and working in smaller groups (sub-groups); and science engagement. Increased understanding of the challenges to, and strategies for, developing a shared vision of desired conditions is critical if other collaboratives are to learn from these efforts.