Perceptions of Molecular HIV Surveillance Among Men Who Have Sex with Men in the United States.

Expanding HIV cluster detection using molecular HIV surveillance (MHS) raises ethical and social concerns, which may impede HIV outbreak detection and response as well as deter people living with HIV from seeking care. This underscores the need for effective communication strategies. We examined two methods for explaining MHS among men who have sex with men (MSM) living with HIV and at-risk without HIV in the United States.

Brief Report: Challenges in Obtaining the Informed Perspectives of Stakeholders Regarding HIV Molecular Epidemiology.

Background: HIV molecular epidemiology (HIV-ME) is now being used in a variety of ways, including molecular HIV surveillance to help identify and respond to emerging HIV transmission clusters as specified in the Ending the HIV Epidemic in the U.S. initiative.

Patients' Reactions to Letters Communicating Collateral Findings of Pragmatic Clinical Trials: a National Web-Based Survey.

Background: Collateral findings in pragmatic clinical trials are findings that may have implications for patients' health but were not generated to address a trial's primary research questions. It is uncertain how best to communicate these collateral findings to patients.

Objectives: To determine how reactions to a letter communicating collateral findings relate to who signed the letter, the type of finding, or whether the letter specified that the finding arose from a pragmatic clinical trial.

Challenges to Building a Gene Variant Commons to Assess Hereditary Cancer Risk: Results of a Modified Policy Delphi Panel Deliberation.

Understanding the clinical significance of variants associated with hereditary cancer risk requires access to a pooled data resource or network of resources-a "cancer gene variant commons"-incorporating representative, well-characterized genetic data, metadata, and, for some purposes, pathways to case-level data. Several initiatives have invested significant resources into collecting and sharing cancer gene variant data, but further progress hinges on identifying and addressing unresolved policy issues. This commentary provides insights from a modified policy Delphi process involving experts from a range of stakeholder groups involved in the data-sharing ecosystem.

A scoping review of genetics and genomics research ethics policies and guidelines for Africa.

Background: Genetics and genomics research (GGR) is increasingly being conducted around the world; yet, researchers and research oversight entities in many countries have struggled with ethical challenges. A range of ethics and regulatory issues need to be addressed through comprehensive policy frameworks that integrate with local environments. While important efforts have been made to enhance understanding and awareness of ethical dimensions of GGR in Africa, including through the H3Africa initiative, there remains a need for in-depth policy review, at a country-level, to inform and stimulate local policy development and revision on the continent.

Stakeholder perspectives regarding pragmatic clinical trial collateral findings.

Context: Pragmatic clinical trials (PCTs), which are becoming widespread since they are relatively inexpensive and offer important benefits for healthcare decision-making, can also present practical, ethical, and legal challenges. One such challenge involves managing "pragmatic clinical trial collateral findings" (PCT-CFs), or information emerging in a PCT that is unrelated to the primary research question(s), yet may have implications for individual patients, clinicians, or health care systems from whom or within which data were collected. The expansion of PCTs makes it likely healthcare systems will increasingly encounter PCT-CFs, yet little guidance exists regarding their appropriate management.

Patients' Views About the Disclosure of Collateral Findings in Pragmatic Clinical Trials: a Focus Group Study.

Background: Pragmatic clinical trials (PCTs) are increasingly being conducted to efficiently generate evidence to inform healthcare decision-making. Despite their growing acceptance, PCTs may involve a variety of ethical issues, including the management of pragmatic clinical trial-collateral findings (PCT-CFs), that is, information that emerges in PCTs that is unrelated to the primary research questions but may have implications for patients, clinicians, and health systems.

Objective: We sought to understand patients' views about PCT-CF disclosure, including how, by whom, and the nature and extent of information provided.

Early experiences of independent advocates for potential HIV+ recipients of HIV+ donor organ transplants.

Background: HIV+ to HIV+ solid organ transplants in the United States are now legally permitted. Currently, these transplants must adhere to the HIV Organ Policy Equity (HOPE) Act Safeguards and Research Criteria that require the provision of an independent recipient advocate, a novel requirement for solid organ transplant programs. The objective of this study was to understand the experiences of the first advocates serving in this role.

The Role of Participants in a Medical Information Commons.

Meaningful participant engagement has been identified as a key contributor to the success of efforts to share data via a "Medical Information Commons" (MIC). We present findings from expert stakeholder interviews aimed at understanding barriers to engagement and the appropriate role of MIC participants. Although most interviewees supported engagement, they distinguished between individual versus collective forms.

BRCA1/2 Variant Data-Sharing Practices.

Accessing BRCA1/2 data facilitates the detection of disease-associated variants, which is critical to informing clinical management of risks. BRCA1/2 data sharing is complex and many practices exist. We describe current BRCA1/2 data-sharing practices, in the United States and globally, and discuss obstacles and incentives to sharing, based on 28 interviews with personnel at U.

Importance of Participant-Centricity and Trust for a Sustainable Medical Information Commons.

Drawing on a landscape analysis of existing data-sharing initiatives, in-depth interviews with expert stakeholders, and public deliberations with community advisory panels across the U.S., we describe features of the evolving medical information commons (MIC).

What is a Medical Information Commons?

A 2011 National Academies of Sciences report called for an "Information Commons" and a "Knowledge Network" to revolutionize biomedical research and clinical care. We interviewed 41 expert stakeholders to examine governance, access, data collection, and privacy in the context of a medical information commons. Stakeholders' attitudes about MICs align with the NAS vision of an Information Commons; however, differences of opinion regarding clinical use and access warrant further research to explore policy and technological solutions.

Constraints on gene patent protection fuel secrecy concerns: a qualitative study.

Concern is mounting that innovators are responding to recent changes in patent eligibility by increasingly choosing to protect their discoveries as trade secrets. Due to the clandestine nature of trade secrets, it is impossible to quantify the extent to which innovators actually elect to protect their inventions as trade secrets rather than patents. Nevertheless, interest in each strategy may be gauged through qualitative means.

Comparison of Approaches for Notification and Authorization in Pragmatic Clinical Research Evaluating Commonly Used Medical Practices.

Background: For pragmatic clinical research comparing commonly used treatments, questions exist about if and how to notify participants about it and secure their authorization for participation.

Objective: To determine how patients react when they seek clinical care and encounter one of several different pragmatic clinical research studies.

Research Design: In an online survey using a between-subjects experimental design, respondents read and responded to 1 of 24 hypothetical research scenarios reflecting different types of studies and approaches to notification and authorization (eg, general notification, oral consent, written consent).

Sharing data under the 21st Century Cures Act.

On 13 December 2016, President Obama signed the 21st Century Cures Act ("the Act") into law. Many of its provisions support the creation of an "Information Commons," an ecosystem of separate but interconnected initiatives that facilitate open and responsible sharing of genomic and other data for research and clinical purposes. For example, the Act supports the National Institutes of Health in mandating data sharing, provides funding and guidance for the large national cohort program now known as All of Us, expresses congressional support for a global pediatric study network, and strengthens patient access to health information.

Patients' Views Concerning Research on Medical Practices: Implications for Consent.

Background: Comparative effectiveness research (CER) and pragmatic clinical trials commonly test interventions that are in routine use and pose minimal incremental risk or burdens to patients who participate in this research. The objective of this study was to elicit the range of patients' views and opinions regarding a variety of different types of research on usual medical practices, especially notification and authorization for them.

Methods: We conducted twelve focus groups with adults in five U.

Attitudes about regulation among direct-to-consumer genetic testing customers.

Introduction: The first regulatory rulings by the U.S. Food and Drug Administration on direct-to-consumer (DTC) genetic testing services are expected soon.

Public preferences regarding the return of individual genetic research results: findings from a qualitative focus group study.

Purpose: People are interested in receiving their individual research results in exchange for participating in genetic research. However, it is unclear whether the public understands the nature and limitations of these results and whether they would want information with unknown clinical utility.

Methods: We conducted 10 focus groups in three US cities to examine the types of results people would want and the perceived value of different types of individual research results.

Risky business: risk perception and the use of medical services among customers of DTC personal genetic testing.

Direct-to-consumer genetic testing has generated speculation about how customers will interpret results and how these interpretations will influence healthcare use and behavior; however, few empirical data on these topics exist. We conducted an online survey of DTC customers of 23andMe, deCODEme, and Navigenics to begin to address these questions. Random samples of U.