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The U.S. Department of Health and Human Services has announced proposed revisions to modernize federal regulations governing the protection of research participants’ rights and welfare. The newly proposed regulations have many positive features that will improve the informed consent process through transparency and stricter requirements to protect participant privacy and enhance informed consent.
Posted in Fordham University HIV and Drug Abuse Prevention Research Ethics Training Institute, In the News
Tagged benign interventions, Celia B. Fisher, Common Rule, ethics training, Fordham University HIV and Drug Abuse Prevention Research Ethics Training Institute, HHS, Human subjects protections, Human subjects research, Institutional review board, IRB, Minimal risk, OHRP, Research Ethics, social and behavioral research, training
For the first time in 20 years the U.S. Department of Health and Human Services has proposed changes to Federal Regulations governing protections for people who participate in research. Any changes will have a substantial impact on the conduct and Institutional Review Board (IRB) approval of social-behavioral research–especially in terms of how IRBs will interpret criteria for “minimal risk” research and expedited review.
At the recent 2014 PRIM&R Advancing Ethical Research conference, Dr. Celia B. Fisher, Director of Fordham’s Center for Ethics Education and a member of the National Research Council’s Committee on Revisions to the Common Rule for Social & Behavioral Science, explained the Committee’s recommendations for regulatory change and its impact on SBR and research involving children and other “vulnerable” populations. Dr. Fisher’s PRIM&R presentation is available for download here.
Posted in Contemporary Ethical Issues, Evidence-Based Ethics
Tagged AER2014, behavioral sciences, Celia B. Fisher, Common Rule, Fordham University, Human subjects protections, Human subjects research, Institutional review board, Minimal risk, National Research Council, PRIM&R, social sciences, Society for Research in Child Development
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There has been a recent increase in public attention to health disparities in the incidence and treatment of suicide, substance abuse and sexual health risks among lesbian, gay, bisexual, and transgender youth (LGBTY). Although there is clearly a need for prevention and treatment programs for LGBTY under the age of 18, few such programs exist, due in substantial part to limited research knowledge. Fordham University Center for Ethics Education Director Dr. Celia B. Fisher and Fordham HIV and Drug Abuse Prevention Research Ethics Training Institute faculty member Dr. Brian Mustanski address this issue in a recent article in The Hastings Center Report.
Posted in Bioethics, Contemporary Ethical Issues, Evidence-Based Ethics, Fordham University HIV and Drug Abuse Prevention Research Ethics Training Institute
Tagged Adolescents, bisexual, Brian Mustanski, Celia Fisher, Children's Research, Fordham University, Fordham University HIV and Drug Abuse Prevention Research Ethics Training Institute, gay, Health disparities, Institutional review board, lesbian, LGBT, LGBT Ethics, Northwestern University, Research Ethics, Responsible conduct of research, The Hastings Center Report, Transgender, waivers of permission, youth
A new study using Facebook data to study “emotional contagion,” and the ensuing backlash of its publication offers the opportunity to examine several ethical principles in research. One of the pillars of ethically conducted research is balancing the risks to the individual participants against the potential benefits to society or scientific knowledge. While the study’s effects were quite small, the authors argue that “given the massive scale of social networks such as Facebook, even small effects can have large aggregated consequences.” However, participants were not allowed to give informed consent, which constitutes a risk of the research and the major source of the backlash.
Posted in Contemporary Ethical Issues, Fordham University HIV and Drug Abuse Prevention Research Ethics Training Institute
Tagged American Psychological Association, Deception research, Emotional contagion, Facebook, Fordham University HIV and Drug Abuse Prevention Research Ethics Training Institute, Informed consent, Institutional review board, IRB, Michelle Broaddus, Minimal risk, Mood manipulation, Proceedings of the National Academy of Sciences, Research Ethics, Slate, Social Media, The Atlantic
Proposed updates to federal regulations that protect human research subjects need additional clarification when applied to the social and behavioral sciences, says a new report from the National Research Council. Fordham University Center for Ethics Education Director Dr. Celia B. Fisher was a member of the committee and an author of the report.
Posted in Bioethics, Evidence-Based Ethics
Tagged Advance Notice of Proposed Rulemaking, Celia B. Fisher, Center for Ethics Education, Common Rule, Department of Health and Human Services, Fordham University, Human research subjects, Human subjects protections, Institutional review board, IRB, National Academy of Sciences, Research Ethics, Social behavioral research
