Are NCI Cancer Centers Providing Adolescents and Young Adults With Cancer Focused Clinical Services? A National Survey.

BACKGROUND: This study sought to evaluate the current services and delivery models of adolescent and young adult oncology (AYAO)-specific programs at NCI-designated Cancer Centers (NCI-CCs). PATIENTS AND METHODS: NCI, academic, and community cancer centers were electronically sent surveys from October to December 2020 and administered via REDCap. RESULTS: Survey responses were received from 50 of 64 (78%) NCI-CCs, primarily completed by pediatric oncologists (53%), adult oncologists (11%), and social workers (11%). Half (51%) reported an existing AYAO program, with most (66%) started within the past 5 years. Although most programs combined medical and pediatric oncology (59%), 24% were embedded within pediatrics alone. Most programs saw patients aged 15 (55%) to 39 years (66%) mainly via outpatient clinic consultation (93%). Most centers reported access to a range of medical oncology and supportive services, but dedicated services specifically for adolescent and young adults (AYAs) were available at a much lower extent, such as social work (98% vs 58%) and psychology (95% vs 54%). Although fertility preservation was offered by all programs (100%), only two-thirds of NCI centers (64%) reported providing sexual health services to AYAs. Most NCI-CCs (98%) were affiliated with a research consortium, and a lesser extent (73%) reported collaboration between adult and pediatric researchers. Nearly two-thirds (60%) reported that AYA oncology care was important/very important to their respective institution and reported providing good/excellent care to AYAs with cancer (59%), but to a lesser extent reported good/excellent research (36%), sexual health (23%), and education of staff (21%). CONCLUSIONS: Results of this first-ever national survey to assess AYAO programs showed that only half of NCI-CCs report having a dedicated AYAO program, and that areas of improvement include staff education, research, and sexual health services for patients.

Addressing risks to advance mental health research.

IMPORTANCE: Risk communication and management are essential to the ethical conduct of research, yet addressing risks may be time consuming for investigators and institutional review boards may reject study designs that seem too risky. This can discourage needed research, particularly in higher-risk protocols or those enrolling potentially vulnerable individuals, such as those with some level of suicidality. Improved mechanisms for addressing research risks may facilitate much needed psychiatric research. OBJECTIVE: To provide mental health researchers with practical approaches to (1) identify and define various intrinsic research risks, (2) communicate these risks to others (eg, potential participants, regulatory bodies, and society), (3) manage these risks during the course of a study, and (4) justify the risks. EVIDENCE REVIEW: As part of a National Institute of Mental Health-funded scientific meeting series, a public conference and a closed-session expert panel meeting were held on managing and disclosing risks in mental health clinical trials. The expert panel reviewed the literature with a focus on empirical studies and developed recommendations for best practices and further research on managing and disclosing risks in mental health clinical trials. No institutional review board-review was required because there were no human subjects. FINDINGS: Challenges, current data, practical strategies, and topics for future research are addressed for each of 4 key areas pertaining to management and disclosure of risks in clinical trials: identifying and defining risks, communicating risks, managing risks during studies, and justifying research risks. CONCLUSIONS AND RELEVANCE: Empirical data on risk communication, managing risks, and the benefits of research can support the ethical conduct of mental health research and may help investigators better conceptualize and confront risks and to gain institutional review board-approval.

Ethics in Psychiatric Research: A Review of 25 Years of NIH-funded Empirical Research Projects.

BACKGROUND: This paper reviews the past 25 years of empirical research funded by the National Institutes of Health (NIH) on matters of ethics in psychiatric research. METHODS: Using the NIH RePORTER and Medline databases, we identified 43 grants and 77 publications that involved the empirical study of a matter of ethics in research involving mental health service users. RESULTS: These articles provide original and useful information on important topics, most especially the capacity to consent and the voluntariness of consent. For example, participants who share a diagnosis vary widely in levels of cognitive impairment that correlate with decisional capacity, and capacity to consent can be enhanced easily using iterative consent processes. Few articles address matters of justice or benefits in research, particularly from the perspectives of participants. No articles address matters of privacy, confidentiality, or researcher professionalism. CONCLUSIONS: Despite the usefulness of data from the studies conducted to date, current research on research ethics in psychiatry does not adequately address the concerns of service users as expressed in recent publications.

Ethical issues in mental health research: the case for community engagement.

PURPOSE OF REVIEW: To describe community-engaged research (CEnR) and how it may improve the quality of a research study while addressing ethical concerns that communities may have with mental health and substance abuse research. This article includes a review of the literature as well as recommendations from an expert panel convened with funding from the US National Institute of Mental Health. RECENT FINDINGS: CEnR represents a broad spectrum of practices, including representation on institutional ethics committees, attitude research with individuals from the study population, engaging community advisory boards, forming research partnerships with community organizations, and including community members as co-investigators. SUMMARY: CEnR poses some challenges; for example, it requires funding and training for researchers and community members. However, it offers many benefits to researchers and communities, and some form of CEnR is appropriate and feasible in nearly every study involving human participants.