TAG ARCHIVES FOR sber

5
Aug2019

Enthusiasm for data sharing and research transparency has grown across the social sciences. This newer scholarly imperative has begun to overlap with the long-standing mandate to minimize risks for human subjects in research. IRBs play a crucial role in this realm, as the IRB’s recommendations on a social science research protocol will often determine whether or not the data obtained through the study may be shared in the future. IRBs are tasked with assisting and educating social scientists to include the appropriate elements, language, and procedures in their protocol materials in order for researchers to approach data sharing in an ethical and responsible manner. Read more

19
Jun2019

There’s a growing trend in Social, Behavioral, and Education Research (SBER)–machine learning–in which investigators often request to obtain, through direct interaction and intervention, various sets of data on human subjects, including their physiological (i.e., data obtained from either invasive or non-invasive means) and/or biometric data (e.g., audio/visual recordings). The research as originally conceived may or may not have been considered human subjects research, but its ultimate purpose is to teach machines how to think, draw conclusions, and process information in much the same way humans do. Read more

13
Jun2019

In April, the Food and Drug Administration (FDA) issued a discussion paper, "Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD).” The paper represents FDA’s response to the growing number of medical device manufacturers who are utilizing artificial intelligence and machine learning technologies to continuously improve their products. On June 3, PRIM&R submitted comments in response to the discussion paper, thanking the FDA for their consideration of the public health implications of the use of these technologies, but also cautioning that any new regulatory approach in this area must address the protection of individuals whose personal information and data are being used in the creation and ongoing testing of these technologies. Read more

30
Oct2018

I am thrilled to attend my second PRIM&R Advancing Ethical Research Conference (AER18) and to share my experiences as a Blog Squad member! With so many recent and forthcoming regulatory changes—the revised Common Rule, NIH single IRB of record mandate, and the EU General Data Protection Regulation (GDPR), just to name a few—this is an exciting time for the human research projections community, and I am delighted to explore these topics with you! 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