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.

Best intentions, worst outcomes: Ethical and legal challenges for international research involving sex workers

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Central America hosts a thriving sex work industry that is a key source and transit region for sex trafficking and undocumented migrants engaged in sex work. Sex workers – particularly those who are migrant – are at high risk for HIV and other sexually transmitted infections as well as physical abuse and in some cases murder. However, the existing network of international, national, and local criminal and human rights policies applicable to sex workers can be confusing and contradictory, not only in the context of access to sexual health preventions and interventions, but also for investigators seeking to conduct that can lead to effective sexual health services.

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Fisher describes innovative approach to research involving vulnerable adolescents at OHRP conference

 

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Fordham University Center for Ethics Education Director and Marie Ward Doty University Chair in Ethics Dr. Celia B. Fisher gave the keynote address this morning at an Office for Human Research Protections (OHRP) conference, entitled “Vulnerable, Marginalized and At-Risk Participants in Research.”

In this address, Fisher describes her innovative approach to giving vulnerable adolescents and their families a voice in ensuring the responsible conduct of research. Her work illuminates the importance of fitting research ethics protections to the real world lives of LGBT teens, pediatric cancer patients, and ethnic minority youth in ways that reflect their values and merit their trust.

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Predatory Publishers: a $75 million-a-year business that can exacerbate health disparities

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A  longitudinal study published yesterday indicates that predatory publishing is big business, bringing in $75 million in 2014 alone by publishing nearly half a million articles.

Researchers in Finland conducted the first comprehensive study of predatory publishers, examining the e-business aspect as well as the inadequate peer-review process. They found that predatory journals have rapidly increased their publication volumes from 53,000 in 2010 to an estimated 420,000 articles in 2014, published by around 8,000 active journals.

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Dr. Elizabeth Yuko appointed to international bioethics advisory board

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Fordham University Center for Ethics Education bioethicist Dr. Elizabeth Yuko has been appointed to the Advisory Board of the Global Bioethics Initiative (GBI), an independent, non-profit organization dedicated to improving quality of life in vulnerable populations globally, through research, education and policy change recommendations.

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Humanitarian intervention: what are the ethical challenges facing aid workers, and how should they be addressed?

Dr. Ramin Asgary, M.D., M.P.H.
Ramin Asgary, M.D., M.P.H.

By: Elizabeth Yuko, Ph.D.

Recent natural disasters such as Hurricane Katrina, the earthquake in Haiti, and the tsunami in Southeast Asia and the Arab Spring resulted in an increase in short-term medical volunteerism. This type of medical practice raises many ethical issues for both the medical practitioners and their institutions. Dr. Ramin Asgary, Assistant Professor in New York University’s Department of Medicine, has experienced these ethical issues from two perspectives: as a physician working abroad in humanitarian settings, and as an academic examining the ethics of short-term medical volunteerism, and aid workers in general. Continue reading “Humanitarian intervention: what are the ethical challenges facing aid workers, and how should they be addressed?”

The Fallen Children: has the Christian narrative failed foster care?

By: Kate Smoot

Photo courtesy http://thegentreport.blogspot.com/2012/10/juvenile-delinquency-age-of-majority.html
Image via http://thegentreport.blogspot.com/2012/10/juvenile-delinquency-age-of-majority.html

Justice is notoriously difficult to get right.  Often, injustice prevails through simple ignorance or willful blindness.  Even the best-laid plans may go horrifically awry through inadequate attention to complex social realities. In a course entitled “Health Disparities and Social Inequalities” taught by Dr. Celia B. Fisher at Fordham University, we utilize current social research to link theoretical frameworks with careful attention to context.   In one study, “Pathways to Prison: Life Histories of Former Clients of the Child Welfare and Juvenile Justice Systems,” imprisoned adults were invited to tell their own stories, addressing their own understandings of justice, agency, and responsibility.

Continue reading “The Fallen Children: has the Christian narrative failed foster care?”