Exempting low-risk health and medical research from ethics reviews: comparing Australia, the United Kingdom, the United States and the Netherlands.

BACKGROUND: Disproportionate regulation of health and medical research contributes to research waste. Better understanding of exemptions of research from ethics review in different jurisdictions may help to guide modification of review processes and reduce research waste. Our aim was to identify examples of low-risk human health and medical research exempt from ethics reviews in Australia, the United Kingdom, the United States and the Netherlands. METHODS: We examined documents providing national guidance on research ethics in each country, including those authored by the National Health and Medical Research Council (Australia), National Health Service (United Kingdom), the Office for Human Research Protections (United States) and the Central Committee on Research Involving Humans (the Netherlands). Examples and types of research projects exempt from ethics reviews were identified, and similar examples and types were grouped together. RESULTS: Nine categories of research were exempt from ethics reviews across the four countries; these were existing data or specimen, questionnaire or survey, interview, post-marketing study, evaluation of public benefit or service programme, randomised controlled trials, research with staff in their professional role, audit and service evaluation, and other exemptions. Existing non-identifiable data and specimens were exempt in all countries. Four categories - evaluation of public benefit or service programme, randomised controlled trials, research with staff in their professional role, and audit and service evaluation - were exempted by one country each. The remaining categories were exempted by two or three countries. CONCLUSIONS: Examples and types of research exempt from research ethics reviews varied considerably. Given the considerable costs and burdens on researchers and ethics committees, it would be worthwhile to develop and provide clearer guidance on exemptions, illustrated with examples, with transparent underpinning rationales.

First meeting in Asia of the Asia Pacific Research Integrity network.

In 2017, the University of Hong Kong and the University of California San Diego co-hosted the first Asian meeting of the recently formed Asia Pacific Research Integrity (APRI) network in Hong Kong. Aligned with planning meetings in 2015 and 2016 funded in part by the US Office of Research Integrity (ORI), the Hong Kong meeting was designed by a multi-national planning committee to address pressing challenges in research integrity: improving multi-national communication; exchanging information on managing misconduct investigations; and sharing best practices to promote research integrity. To create a sustainable, robust international partnership to promote research integrity in the region, the purpose of this 2017 meeting was to foster multi-national awareness, understanding, and opportunities for collaboration. The meeting was defined by four objectives that emerged from the previous meetings: (1) Articulate differences as well as areas of common ground; (2) Identify best or recommended practices; (3) Identify opportunities for research or collaboration; and (4) Set an APRI network agenda for coming years. The key anticipated outcome was to advance the conversation surrounding research integrity among academic institutions and regulators in Asian and Pacific Rim nations. This outcome was evidenced by meeting participation, participant satisfaction, and articulation of next steps for the APRI network.

The research subject advocate at the University of Hawai'i Clinical Research Center: an added resource for protection of human subjects.

In early 2001 the National Institutes of Health (NIH) created the Research Subject Advocate (RSA) position as an additional resource for human subjects protection at NIH-funded Clinical Research Centers (CRCs) to enhance the protection of human subjects participating in clinical research studies. The purpose of this article is to describe the RSA position in the context of clinical research, with a particular emphasis upon the role of the RSA in one of the five CRCs funded by the NIH Research Centers in Minority Institutions (RCMI) program. Through participation in protocol development, informed consent procedures, study implementation and follow-up with adverse events, the RSA works closely with research investigators and their staff to protect study participants. The RSA also conducts workshops, training and education sessions, and consultation with investigators to foster enhanced communication and adherence to ethical standards and safety regulations. Although it is too early to provide substantive evidence of positive outcomes, this article seeks to illuminate the value of the RSA position in ensuring that safety of research participants is accorded the highest priority at CRCs. Based upon initial results, we conclude that the RSA is an effective mechanism for achieving the NIH's goal of maintaining the utmost scrutiny of protocols involving human subjects.

Use of provider delivered complementary and alternative therapies in Hawai'i: results of the Hawai'i Health Survey.

BACKGROUND: Provider delivered complementary and alternative medicine (CAM) is used increasingly as a treatment option. Nevertheless, data related to the prevalence of provider delivered CAM (or PDCAM) use in diverse racial and ethnic populations is limited. The purpose of this investigation was to describe the use of provider delivered CAM in Hawaiian, Asian, and other Pacific Island populations in Hawai'i. The investigation was undertaken to test the hypothesis that a significant difference existed in the use of provider delivered CAM in Hawai'i because of the cultural diversity existing within the population. METHODS: The data were collected through the Hawai'i Health Survey (HHS). The HHS was administered by telephone among 5,000 stratified, randomly selected households, representing each of the Hawaiian Islands. Data were collected on all members of sample households. The sample population was statistically adjusted to represent the population of Hawai'i. RESULTS: Several factors emerged that may indicate increased use of provider delivered CAM. Most provider delivered CAM users are more educated, have incomes 200% or more above the poverty line, and reported either good or very good health status. Among respondents with poor health status, 60.4% have used provider delivered CAM. Those with a body mass index indicating that they were overweight also reported a high level of provider delivered CAM use (51.4%). Similar percentages of both women and men use provider delivered CAM, while the youngest and oldest respondents reported the least use of provider delivered CAM. Whites (60.0%) and Koreans (56.6%) reported the highest percentage of use of provider delivered CAM, while African Americans (35.5%) and Filipinos (37. 1%) reported the lowest percentage. The majority of people without health insurance report provider delivered CAM use (53. 7%). The highest portion of people who have usedanyalternative health care service is found among those whose pain severely interferes with normal work (78.3%). CONCLUSIONS The use of provider delivered CAM was found to be significantly greater in Hawaii compared with the mainland. Our results suggest the need for additional investigation of provider delivered CAM use in specific ethnic subpopulations.

The research subject advocate at minority Clinical Research Centers: an added resource for protection of human subjects.

In early 2001, the National Institutes of Health (NIH) created the research subject advocate (RSA) position as an additional resource for human subjects protection at NIH-funded Clinical Research Centers (CRCs) to enhance the protection of human participants in clinical research studies. We describe the RSA position in the context of clinical research, with a particular emphasis on the role of the RSA in two of the five CRCs funded by the NIH Research Centers in Minority Institutions (RCMI) program. Through participation in protocol development, informed consent procedures, study implementation and follow-up with adverse events, the RSA works closely with research investigators and their staff to protect study participants. The RSA also conducts workshops, training and education sessions, and consultation with investigators to foster enhanced communication and adherence to ethical standards and safety regulations. Although we cannot yet provide substantive evidence of positive outcomes, this article illuminates the value of the RSA position in ensuring that safety of research participants is accorded the highest priority at CRCs. On the basis of initial results, we conclude that the RSA is an effective mechanism for achieving the NIH goal of maintaining the utmost scrutiny of protocols involving human subjects.

Addressing oral health disparities in settings without a research-intensive dental school: collaborative strategies.

Research suggests that oral health is linked to systemic health, and those with poor oral health are potentially at greater risk for important diseases, including cardiovascular disease, stroke, diabetes mellitus, and adverse pregnancy outcomes. Asians and Pacific Islanders (APIs) in Hawaii have high rates of many such diseases. Studies in children in Hawaii have revealed disparities in dental health; for example, API children have significantly higher rates of cavities than other groups. Hence, conducting further study is vital in adults, particularly APIs, to assess oral health and its correlation to overall health outcomes. Given the lack of a dental school and the lack of fluoridated water in the state, the University of Hawaii's John A. Burns School of Medicine (ABSOM) has identified the need to assume a leadership role in creating effective community-based oral health research and treatment programs. With the support of the National Institute of Dental and Craniofacial Research, JABSOM fostered a collaborative relationship with the University of North Carolina at Chapel Hill School of Dentistry, a premiere research-intensive dental school, the Waimanalo Health Center, and the Hawaii State Department of Health. This partnership has worked together to implement a community-based approach to performing research designed to illuminate disparities and develop innovative strategies to promote oral health in Hawaii's diverse populations. We hope that this collaborative, culturally competent approach may serve as a model for use in other settings without a research-intensive dental school.

The relationship between ethnicity and obesity in Asian and Pacific Islander populations: a literature review.

The purpose of this literature review is to explore the potential relationship between ethnicity and obesity, and obesity-related risks, with a particular emphasis on disparities between Asian and Pacific Islander populations. We conducted a comprehensive search of available medical literature related to the rise of obesity in the United States, factors contributing to obesity, evidence-based clinical guidelines, and obesity and related risks as they occur in Hawaii. In conducting this search, we sought to illuminate obesity rates in Asians and Pacific Islanders in connection with various factors, such as diet and lifestyle, acculturation, and body image, as they occur in diverse cultural contexts. We found that the rates of obesity and related risks were highest in Native Hawaiians and Samoans. Based upon our review of the literature, we conclude that further research is necessary to address the relationship between ethnicity and obesity risk factors in Asian and Pacific Islander populations.

Partnering to harmonize IRBs for community-engaged research to reduce health disparities.

Emerging advances in health disparities research include controlled trials and comparative effectiveness studies that are frequently conducted at multiple community and academic sites. Review by different institutional review boards (IRBs) presents a major impediment to the timely and effective conduct of such research. When research involves minority and underserved communities as well as multiple geographic regions, institutional requirements and interpretation of ethical standards may vary substantially. Such variations can complicate the informed consent process and research protocol, and may undermine participant respect and trial quality. In addition, multiple IRB review can lead to unnecessary delays, jeopardizing funding and capacity to perform collaborative projects. In response to these issues, the Research Centers in Minority Institutions (RCMI) Translational Research Network (RTRN) is developing a community-partnered approach to streamlining IRB review across its consortium of 18 RCMI grantee institutions that will ensure compliance while enhancing the quality of health disparities research.