TAG ARCHIVES FOR webinar

26
Apr2018

The Guide for the Care and Use of Laboratory Animals and the Animal Welfare Act Regulations describe rules and best practices for animal care and use professionals to follow in order to ensure high welfare standards are upheld for animals used in research. When an IACUC finds something that diverges from these regulations and standards, it can be a challenge to know whether and where to report the issue. To complicate matters, OLAW and USDA APHIS use differing terminology to describe these occurrences, and have different requirements for reporting. A solid, systematic framework for understanding, sorting, and managing “exceptions” and “departures” can help IACUC administrators more effectively sort through complex issues of compliance. Read more

26
Mar2018

Research conducted in international settings poses particular challenges for the reviewing IRB, as it must possess adequate knowledge of laws and regulations in the country where the research is taking place, and be sensitive to the area’s cultural norms, in order to appropriately evaluate the study. Social, behavioral, and educational research (SBER) in particular may involve the study of stigmatized health conditions or behaviors, and may require the recruitment of marginalized populations and minors. Conducting research on these topics is important, but it is equally essential that IRBs and researchers mitigate the risk of social consequences that might result from subjects’ participation in the study, such as rejection in their communities or conflict within their families. The regulations regarding human subjects protections vary greatly between countries as well, which can lead to additional difficulties for IRBs. Read more

9
Mar2018

When research subjects’ capacity to consent is absent, diminished, or fluctuating, additional consent enhancements, safeguards, and support may be required by the IRB. AAHRPP Standard II-4 requires IRBs to provide additional protections for vulnerable subjects in research, including policies and procedures to protect subjects whose capacity to consent is potentially absent, diminished, or fluctuating. The regulations, however, are generally silent on the specifics of these additional protections. Read more

15
Feb2018

Suicide is an urgent and growing public health crisis. It was the tenth leading cause of death in the United States in 2015, with over 44,000 deaths, according to the CDC. Studying suicide, and including suicidal or potentially suicidal individuals in clinical research, is an important way to gain valuable data that can advance prevention efforts. Researchers and IRBs may tend to exclude suicidal individuals from research in order to avoid potential risks; however, in order for the research to be scientifically and clinically valuable, it is important that suicidal individuals are not excluded from research unnecessarily. Read more

5
Feb2018

The potential benefits of data sharing for secondary research purposes are well recognized, but certain ethical barriers must be addressed before these benefits can be fully realized. American Indian and Alaska Native (AI/AN) individuals and tribes that participate in research are often interested in sharing their data when doing so will help answer important questions or contribute to improved population health outcomes, and when appropriate protections are in place. While perspectives on data sharing agreements and processes can vary among AI/AN individuals and tribes, some views are consistent and much can be learned by examining how specific studies have navigated data sharing in ways that both respect tribal sovereignty and meet the overall study goals. What best practices, lessons, and examples exist for IRBs, researchers, and funders who wish to include a data sharing component in research with AI/AN individuals and tribes? Read more

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