Global Ethics – Medical Ethics – Hospital Ethics Committees – Research Ethics – Public Health

Archive for the ‘Research Ethics’ Category

A recently published article in the Journal of Medical Ethics entitled “Through students’ eyes: ethical and professional issues identified by third-year medical students during clerkships”,  reported on the predominant ethical and professional issues cited by medical students.   Kaldjian and colleagues performed a content analysis of 272 Case Observation and Assessments written by  141 third-year medical students at the University of Iowa Carver College of Medicine.  Their analysis identified 35 subcategories of ethical and professional issues within the following 7 major domains: decisions regarding treatment (31.4%), communication (21.4%), professional duties (18.4%), justice (9.8%), student-specific issues (5.4%), quality of care (3.8%), and miscellaneous (9.8%).  Among the “decisions regarding treatment”, issues included “morality of providing treatment given poor quality of life”, “doctor wants intervention/test but patient or family does not”, and “problems surrounding surrogate decision making”.  Regarding Student Specific Issues, issues included “Learning on patients over their objections or without consent”, “asked to compromise my own ethical standards”, and “not being allowed to see a patient (because I am a student”.   Major Communication Issues included:  “breaking patient confidentiality”, “delivering bad news”, “deliberate lies and deception in context of medical care”.

This article contrasts with a previously article listing the ethical issues reported by medical students from the State University of New York Upstate Medical University:  Caldicott CV, Faber-Langendoen K.  Academic Medicine. 2005;80:866.  In this article, the most common issues were “deliberate lies or deceptions”, “patients’ right to refuse recommended treatment”, and “insistence on futile treatment”.

Researchers at the Group Health Research Institute and the University of Washington (UW) has published their study in which they discovered that peopled want to be informed and asked for their consent to share their coded, de-identified genetic information in a federal database.  This study, published in the September 2010 Journal of Empirical Research on Human Research Ethics (JERHRE), involved research participants who were enrolled in the longitudinal “Adult Changes in Thought” (ACT) study. When asked as to whether their genetic and medical record information could be shared in the database, 86 percent said “yes.”  Also, of the 365 ACT study participants who had agreed to let their genetic information be shared, 90 percent of participants said they thought it was important to have been asked for this consent – what researchers call “re-consent.”

Since 2008, the National Institutes of Health (NIH) has encouraged many studies to submit genetic information to the federal database of Genotypes and Phenotypes (dbGaP). The reason for this request is that genomic research on large numbers of people can yield insights that aren’t possible with smaller numbers.  For new studies that will enroll participants, informed consent for such data sharing in a national registry can be asked prospectively.  However,  for ongoing studies or completed studies in which biological samples or medical data had been collected previously for other purposes, the issue is whether retrospective or re-consent from the research participants is ethically necessary if the original informed consent did not address the issue of data sharing in a federal registry.

According to the federal regulations governing human research,  key issues for Institutional Review Boards (IRBs) that review such research to consider regarding a requirement for re-consent  is the risk level associating with such data sharing (i.e., risks due to a breach in the confidentiality of the data) and the practicableness of approaching research participants for their re-consent, which often be time consuming and expensive.   If the risks are minimal and re-consent is impracticable, then one can argue that the public good of data sharing in a federal repository outweighs the rights of individual participants to choose whether to participate.  IRBs will differ in their determinations based on their assessment of whether the data sharing represents minimal risk and the impracticableness of obtaining re-consent.  It is interesting to note that in the study published in the JERHRE journal, the participants in the  ACT study were receiving biennial examinations and hence, one could argue that it was not impracticable for the investigators to seek their re-consent.  However, for studies that had previously collected tissue samples and have been closed for years, one could argue that re-contact of the research participants would not be practicable.  Despite such uncertainty in the determining levels of risk and practicableness, one thing is certain, IRBs and investigators need to be mindful of recent high-profile legal cases that have highlighted the issue of consent and trust in research.  These include the Havasupai tribe vs. Arizona State University in which there were group harms; the Parents vs. the Texas health department, in which newborn blood samples were collected and stored without parental consent; and the the story of Henrietta Lacks (The Immortal Life of Henrietta Lacks), in which the highly profitable HeLa cell line was established without the consent of Ms. Lacks.

A recent study mapping the outsourcing of pharmaceutical pediatric research in developing countries has raised the concern of exploitation. The study performed by Duke investigators (Globalization of Pediatric Research: Analysis of Clinical Trials Completed for Pediatric Exclusivity) raises the concern that many of these trials are testing drugs that are unlikely to be reasonably available to the countries from where the research subjects are recruited. The study documented that more than one-third of the trials enrolled patients from a developing country and of these trials, more than one-third enrolled patients investigating cardiovascular and allergy/immunology diseases (e.g., atopic dermatitis and juvenile rheumatoid arthritis). To be sure, more than one-half of the trials involved studies of antiretroviral and antimalarial drugs, which address important health care needs of the developing countries. But a basic safeguard for the protection of potentially vulnerable populations is to test drugs first in populations that are less vulnerable, which would apply to the aforementioned cardiovascular and allergy/immunology diseases. Even if one wants to assume that parents gave volunatary informed consent for the enrollment of their children in research (a questionable reality), one needs to question the conclusions of institutional review boards (IRBs) that gave approval to the performance of these studies. Similar concerns have been raised in Chris MacDonald’s post on the Research Ethics Blog.