Fordham University’s Dr. Celia Fisher Discusses What the Revised Common Rule Means for Informed Consent in Medical Ethics Advisor

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The Federal Policy for the Protection of Human Subjects, or the Common Rule was revised earlier this year and is set to be effective on January 19th, 2018. The Common Rule was created in 1991 to “better protect human subjects involved in research, while facilitating valuable research and reducing burden, delay, and ambiguity for investigators.” Departments and agencies including, but not limited to, the Department of Homeland Security, the Department of Health and Human Services and the National Science Foundation made these revisions in an effort to “modernize, simplify, and enhance the current system of oversight.”

In this year’s October issue of Medical Ethics Advisor, Dr. Celia Fisher, Director of Fordham University’s Center for Ethics Education and HIV and Drug Abuse Prevention Research Ethics Training Institute, discusses two significant ways the revised Common Rule will change informed consent practices in research, and critical ethical questions to consider about these changes.

According to Dr. Fisher, the first change, stating that investigators are permitted to obtain broad consent from participants for future use of identifiable biospecimens by the original investigator or other investigators, “increases the ability of scientists to combine large data sets to explore important medical questions.” However, she says, “it is unclear whether hacking or the use of the identifiable information…will pose a social or economic risk to participants.” Dr. Fisher continues that it could be additionally problematic if “identifiable data is used to inform policies that promote medical discrimination of already vulnerable groups” without the research participants understanding how their data will be used in the future.

The second revision of the Common Rule that will impact informed consent practices states that investigators are required to give prospective participants a brief summary of “key points” that a reasonable person would want to know to make an informed choice. Dr. Fisher notes that this revision “can be an advantage over the current risk-averse legal language in informed consent materials,” but the revision does not state who will be deciding what the key points are which could be potentially problematic considering participants, investigators and IRB members may have different ideas of what “important information” is.

To read the full article and October’s Issue of Medical Ethics Advisor, please visit their website here. To subscribe to the journal, please visit AHC Media.

Dr. Celia Fisher is the Mary Ward Doty University Chair in Ethics at Fordham University, a professor of Psychology and the director of Fordham University HIV and Drug Abuse Prevention Research Ethics Training Institute. In addition to chairing the 2002 revision of the American Psychological Association’s Ethics Code, Fisher’s Decoding the Ethics Code: A Practical Guide for Psychologists is now in its fourth edition from Sage Publications.  Please visit her webpage for more information about her work, as well as the Fordham University Center for Ethics Education Research page.

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

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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.

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

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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.

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

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For more information, please visit & “like” RELAY: Resources & Education for LGBT & Allied Youth: www.facebook.com/lgbtrelay

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.

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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.

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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.”

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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.

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