Sharing participant research data is critical to supporting reproducibility and collaboration in the scientific community, and leads to more reliable, effective results for research and eventual clinical application. But honesty and transparency are also critical when communicating to participants about these activities. Read more
On November 8, 2019, the National Institutes of Health (NIH) released its Draft NIH Policy for Data Management and Sharing and Supplement Draft Guidance as part of its continuing efforts to ensure public access to research the government conducts and pays for. Today, PRIM&R submitted comments applauding the NIH for taking steps to accelerate data sharing efforts while also offering a few constructive suggestions primarily centered around privacy and funding issues. The comment period closes today, and we encourage interested parties to consider submitting their own comments. Read more
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
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
For investigators, IRB members, and IRB staff alike, the revised Common Rule’s new exempt category at 45 CFR 46.104(d)(4)(iii) was a dream come true. The so-called HIPAA Exemption eliminates IRB review for research use of retrospectively or prospectively collected “identifiable health information when that use is regulated by the HIPAA Privacy Rule as health care operations, research, or for public health activities […].” Applying the HIPAA Exemption is not quite as simple as it might seem, though, as I learned at the 2018 Advancing Ethical Research Conference (AER18) session, appropriately titled “Just When You Thought You Understood the Health Insurance Portability and Accountability Act of 1996.” Read more
