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.

“She Can’t Help The Choices She Makes”

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STUDENT VOICES | CHYNN PRIZE FIRST-PLACE WINNER

By Madeleine Cardona

I will never forget the day my mother got diagnosed. I could swear that just yesterday I was thirteen years old waiting anxiously to be called in from the waiting room of some fancy New York State doctor’s office. I was young, but I had some idea of what was going on. I knew my parents and I were there because they were going through a divorce and fighting for custody of me. What I did not know was that we were about to endure a court-ordered psychiatric evaluation and that the results were going to change my life forever.

“Madeleine, your mom is very sick,” the psychiatrist attempted to explain to me. I did not understand. I did not know a sick person could look perfectly healthy. “It’s not a physical sickness, it’s in her head. She has a mental disorder called Paranoid Schizophrenia.” She went on using big words to explain how my mother’s brain “wasn’t like other people’s brains.” I sat there listening closely, hanging on every word the woman was saying to me. “She can’t help the choices that she makes, it’s not her fault that she is the way that she is. She needs help.” Every day since that day in the doctor’s office, that remark replays in my head over and over. “She can’t help the choices she makes.”

That is what gave me the most trouble. I sat around for years and years watching the choices that my mother was making, unable to intervene. If she cannot help the choices she makes, why could my dad or my mother’s other family not make the choices for her? Why could nobody make her take medication? I eventually learned that it was because my mother was sick, but “not sick enough.” The court ruled in favor of autonomy and said that my mother still had the right to make her own medical decisions. According to them she was functional and was not posing an immediate danger to herself or others. I understand autonomy. Autonomy is defined as “a principle in which a person should respect the rights of other individuals to freely determine their own choices and decisions” (Jonas). I understand how important free will and the ability to make choices about your own body are. It is hard for me, however, to understand how you can continue to honor a person’s right to make their own decisions, when every decision they make is only hurting them. It is hard to sit there, as a loved one, and not want to just make them take the medication they need to get better, or force them participate in that research study that just might help.

Continue reading ““She Can’t Help The Choices She Makes””

‘Goodness of Fit Ethics’ to Promote Health Research for LGBT Youth

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This past November, Public Responsibility in Medicine and Research (PRIM&R), a non-profit organization dedicated to the study and advancement of the highest ethical standards in the conduct of research, held its annual Advancing Ethical Research (AER) Conference featuring Dr. Celia B. Fisher, Director of the Center for Ethics Education and HIV and Drug Abuse Prevention Research Ethics Training Institute at Fordham University. She, along with Janet L. Brody, PhD and Eric Kodish, MD, were panelists on Panel III: Research With Children and Adolescents: Who and How Is the Decision Made to Participate?

Discussing her NIH-funded research on ethical issues in research involving LGBT youth, Dr. Fisher discussed the “interfamilial, regulatory and ethical tensions” that emerge in HIV prevention studies striving to recruit sexual and gender minority adolescents under 18 years of age.

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TEDxFordhamUniversity: Lesson in Bioethics Given by Golden Girls | Dr. Elizabeth Yuko

As one of the most groundbreaking sitcoms of all time, The Golden Girls introduced a range of bioethical issues on the show regarding medicine, the human body and women’s health.

In this TEDx Talk, Dr. Elizabeth Yuko, a Fordham University Center for Ethics Education  fellow and adjunct professor, discusses how influential Golden Girls was, and still is, as a lens for the study of bioethics and its principles using examples from the show’s most notable episodes.

Watch below:

Dr. Elizabeth Yuko is also the Health Editor at SheKnows Media, a women’s lifestyle digital media company operating SheKnows.com. BlogHer.com. HelloFlo.com and STYLECASTER.com. Please visit her website and Twitter page for more information.

‘One uterus bridging three generations of a family’: Woman who received her mother’s transplanted womb gives birth

Photo via freedigitalphotos.net
Photo via freedigitalphotos.net

By: Elizabeth Yuko, Ph.D.

The fourth baby born via a transplanted uterus isn’t just a medical success story – it bridges three generations of a family.

A woman in Sweden who lost her own uterus to cancer in her 20s has given birth to a healthy baby boy after receiving a transplanted womb donated by her mother.

Continue reading “‘One uterus bridging three generations of a family’: Woman who received her mother’s transplanted womb gives birth”

What Mad Men’s Betty Draper-Francis Can Teach Us About Paternalism in Medicine

January Jones as Betty Draper-Francis on AMC's Mad Men.
January Jones as Betty Draper-Francis on AMC’s Mad Men.

By: Elizabeth Yuko, Ph.D.

Warning: spoilers ahead.

The penultimate episode of AMC’s Mad Men provided an all-too-familiar portrayal of the paternalistic nature of medicine via the handling of Betty Draper-Francis’s diagnosis of lung cancer. While the episode takes place in 1970 and there has since been a gradual shift to a more patient-centered approach in medicine, it offers a glimpse into power imbalances in medical care that still can occur today.

When Betty’s new classmates bring her to the emergency room, the first words out of the doctor’s mouth are “Mrs. Francis, is it possible to get your husband down here?” Betty assumes it is for the purpose of driving her home, but the doctor assures her that it is, in fact, for the purpose of explaining her condition to her husband, Henry, either prior to or at the same time he discloses the diagnosis to Betty.

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Fordham RETI Santander Universities Fellow Tackles HIV Prevention in India through Research & Clinical Practice

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Dr. Arunansu Talukdar

Fordham University HIV and Drug Abuse Prevention Research Ethics Training Institute (RETI) Fellow Dr. Arunansu Talukdar is not just conducting research on HIV prevention – as a physician, he is practicing it as well.

Talukdar is a member of the fourth cohort of RETI fellows, and was the 2014 recipient of the Fordham University Center for Ethics Education / Santander Universities International Scholarship, which covers the cost of his travel to Fordham for two consecutive summer training institutes, as well as the cost of his mentored research project (MRP). His MRP examines voluntariness of consent to research involving women participating at a clinic-based HIV intervention trial in Kolkata, India.

Continue reading “Fordham RETI Santander Universities Fellow Tackles HIV Prevention in India through Research & Clinical Practice”