Tag Archives: Institutional review board

Minimal risk and minimal experience: Can researchers competently navigate OHRP’s new risk categories?

human subjects

Photo via

By: Celia B. Fisher, Ph.D.

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.

Continue reading

Implications of Common Rule Changes for Minimal Risk and Expedited Review of Social & Behavioral Research


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.

Continue reading

Reducing Health Disparities and Enhancing the Responsible Conduct of Research Involving LGBT Youth

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.

Continue reading

Issues of Research Ethics in the Facebook ‘Mood Manipulation’ Study: The Importance of Multiple Perspectives


By: Michelle Broaddus, Ph.D.

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.

Continue reading

Issues of Research Ethics in the Facebook ‘Mood Manipulation’ Study: The Importance of Multiple Perspectives (full text)


By: Michelle Broaddus, Ph.D.

A recent paper published in the Proceedings of the National Academy of Sciences describes a mood manipulation experiment conducted by Facebook scientists during one week in 2012 that suggests evidence of “emotional contagion,” or the spread of positive and negative affect between people. The backlash to this publication has been significant. As two examples, Slate.com published a piece entitled “Facebook’s Unethical Experiment: It intentionally manipulated users’ emotions without their knowledge” and The Atlantic’s piece, “Even the Editor of Facebook’s Mood Study Thought It Was Creepy.”

Continue reading

Clinical trials can & should be designed to include people with disabilities

Clinical trials tend to exclude vulnerable populations, such as people with disabilities. Speaking to Joshua Howgego of SciDev.net, Dr. Celia B. Fisher, Director of the Center for Ethics Education, explained that clinical trials can — and should — be designed to include people with disabilities.

Continue reading

Improved Regulations to Protect Human Research Subjects Would Reduce Burden on IRBs While Better Protecting Study Participants


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.

Continue reading