Tag: therapeutic research

Bioethics Blogs

Charlie Gard: Three Issues That Did Not Make Social Media

by Ann Mongoven, Ph.D., MPH

All hearts go out to the Gard family in this time of grief for their son, Charlie.

The legal wrangling over Charlie’s care became a political football–unfortunately, about many things having little to do with Charlie.

Despite the involvement of Pope Francis, this was not a case about abortion rights or the sanctity of human life. Catholic tradition warns both that quality-of-life arguments can dehumanize the disabled, and that unduly burdensome medical care can become assaultive. There is no “Catholic” view of the case, and Catholic moral theologians disagree about it.

Despite the involvement of Donald Trump, this was not a case about the relative merits of the U.K. National Health Service (NHS) versus other health systems. It was not a case of utilitarian ethics pitted against duty-based ethics or love. The NHS provided extremely expensive intensive care for Charlie for most of his life, and British courts governed cases related to his care solely by a “best interest of the child” standard– amidst heated disagreement between Charlie’s parents and doctors about his interests. The European Court of Human Rights backed the British court decision.

The case did address questions about who should decide when parents and doctors disagree about a child’s medical interest. But contrary to some portrayals in the American press, it neither changed conventional parameters for addressing those questions, nor exposed major differences in legal reasoning used to address them in the U.K. and the U.S.  Both countries appeal to “best interest” standards for resolution, and both reject an absolutist interpretation of parental rights.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics Blogs

Five reasons we should embrace gene-editing research on human embryos

Future people would be grateful if their disease is cured, rather than being replaced by a different healthier or non-disabled person. sabianmaggy/Flickr, CC BY-SA

Scientists from around the world are meeting in Washington this week to debate how best to proceed with research into gene-editing technology.

Gene editing is a new precise form of genetic engineering. It uses enzymes from bacteria to locate genes within DNA and delete or replace them. In early 2015, Chinese scientists used it to modify human embryos as a first step towards preventing the genetic transmission of a blood disease.

Many people, including scientists, are worried about creating genetically modified humans. They’re worried about numerous things: genetic mistakes being passed on to the next generation; the creation of designer babies who are more intelligent, more beautiful or more athletic; and the possibility of causing severe growth abnormalities or cancer.

While these are valid concerns, they don’t justify a ban on research. Indeed, such research is a moral imperative for five reasons.

1. Curing genetic diseases

Gene editing could be used to cure genetic diseases such cystic fibrosis or thalassaemia (the blood disease that the Chinese researchers were working to eliminate). At present, there are no cures for such diseases.

Detractors say selection of healthy embryos or fetuses via genetic testing is preferable. But such genetic tests require abortion or embryo destruction, which is also objectionable to some people.

Gene-edited embryonic stem cell lines that cause or protect against disease could help us understand the origins of disease.
Image Editor/Flickr, CC BY-NC-ND

What’s more, genetic selection doesn’t benefit patients – it’s not a cure.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics Blogs

Remembering Felix A. Gyi: A wise, generous, and kind leader

Felix A. Khin-Maung-Gyi, PharmD, MBA, CIP, RAC, an active and valued leader in the field of human subjects protections and proud family man, passed away on October 2, 2014.

A pharmacist by training, Dr. Gyi received a bachelor’s degree in pharmacy from the University of Maryland School of Pharmacy in 1983, and went on to receive his doctorate in the subject from Duquesne University in 1986. He also obtained a master’s in business administration from Loyola University Maryland (The Baltimore Sun).

Among his many accomplishments, Dr. Gyi founded Chesapeake Research Review LLC, an independent IRB, in 1993, and served as its CEO for more than 20 years. During his time at Chesapeake IRB, Dr. Gyi helped raise important questions about the growing role of central IRBs.

Dr. Gyi was also instrumental in the creation of the Certified IRB Professional (CIP®) credential. Gary Chadwick, PharmD, MPH, another of the credential’s founders, spoke to Dr. Gyi’s contributions: “He was one of the first persons I tapped to get the CIP credential off the ground back in 1999. I saw firsthand his dedication and extensive knowledge, which, when put with his easy going nature and great sense of humor and fun, produced outstanding results and spurred others to excel.”

Dr. Gyi also served alongside Gary Chadwick, Susan Delano, Marianne Elliot, Nancy Hibser, Moira Keane, Susan Kornetsky, Peter Marshall, Daniel Nelson, and Lucy Pearson as inaugural members of the Council for Certification of IRB Professionals. Ms. Delano reflected: “He could always be relied on for his sound judgment and in-depth knowledge of the complex regulations and guidance governing research involving human subjects.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics Blogs

Consent Comprehension

Chaisson, L. H., Kass, N. E., Chengeta, B., Mathebula, U., & Samandari, T. (2011). Repeated assessments of informed consent comprehension among HIV-infected participants of a three-year clinical trial in Botswana. PloS one,6(10), e22696.
informed consent, consent comprehension, risks & benefitsHIVSTIsBotswana, ethics questionnaire

Miller, C. K., O’Donnell, D. C., Searight, H. R., & Barbarash, R. A. (1996). The Deaconess Informed Consent Comprehension Test: an assessment tool for clinical research subjects. Pharmacotherapy: The Journal of Human Pharmacology and Drug Therapy, 16(5), 872-878.
informed consentquality of informed consent, consent comprehension, clinical trial, ethics questionnaire

Wirshing, D. A., Wirshing, W. C., Marder, S. R., Liberman, R. P., & Mintz, J. (1998). Informed consent: assessment of comprehension. American Journal of Psychiatry, 155(11), 1508-1511.
informed consentpsychiatry, consent comprehension, ethics questionnaire

Wolthers, O. D. (2006). A questionnaire on factors influencing children’s assent and dissent to non-therapeutic research. Journal of medical ethics, 32(5), 292-297.
childrenchild assentinformed consentvoluntarinessadolescents, consent comprehension, ethics questionnaire

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics Blogs

Child assent

Kimberly, M. B., Hoehn, K. S., Feudtner, C., Nelson, R. M., & Schreiner, M. (2006). Variation in standards of research compensation and child assent practices: a comparison of 69 institutional review board–approved informed permission and assent forms for 3 multicenter pediatric clinical trials. Pediatrics, 117(5), 1706-1711.
informed consentchildrenguardian permission, child assent, clinical trialincentives, ethics vignette

Miller, V. A., Reynolds, W. W., & Nelson, R. M. (2008). Parent–Child Roles in Decision Making About Medical Research. Ethics & Behavior, 18(2-3), 161-181.
informed consentchildren, child assent, guardian permission, participant perspectives, ethics interview

O’Lonergan, T. A., & Forster-Harwood, J. E. (2011). Novel approach to parental permission and child assent for research: Improving comprehension. Pediatrics, 127(5), 917-924.
informed consentchildren, child assent, guardian permission, multimedia, ethics questionnaire

Wolthers, O. D. (2006). A questionnaire on factors influencing children’s assent and dissent to non-therapeutic research. Journal of medical ethics, 32(5), 292-297.
children, child assent, informed consentvoluntarinessadolescents, consent comprehension, ethics questionnaire

 

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.