Research Ethics Roundup: Proposed changes to the Helsinki Declaration, considering gene patents, and more

It’s been a busy two weeks in the research world and we have the articles to prove it. Read on to learn about some of the current issues that are impacting research from court deliberations on gene patents and oral history research to revelations about the regulatory and ethical failures of a study involving premature infants.


Supreme Court considers gene patents: The US Supreme Court is considering a case challenging the patents issued to Myriad Genetics for isolating genes that indicate a hereditary link to ovarian and breast cancer. The Court must balance the need for maintaining incentives to conduct scientific research with the need to curb monopolization of research in a particular area.

Study of babies did not disclose risks, US finds: The New York Times reports that the Office for Human Research Protections (OHRP) found that the University of Alabama at Birmingham failed to properly disclose risks of a study on oxygen levels for extremely premature infants. OHRP stated that risks of eye disease, blindness, and death were not properly communicated to the parents of the subjects. The NIH-funded multisite study, which was conducted by twenty three institutions, took place between 2004 and 2009.

Public consultation opens on WMA Helsinki Declaration: A draft revision of the Declaration of Helsinki is now available for public comment through the middle of June. Proposed changes include additional protections for vulnerable groups; more quality and transparency in the functioning of research ethics committees; and a more systematic approach to the use of placebos. Additionally, the issue of compensation of study participants will be addressed for the first time.


Human genome, then and now: National Human Genome Research Institute director Eric D. Green reflects on the game changers that have resulted from the completion of the Human Genome Project, which is celebrating its tenth anniversary this month.  Green cites rapidly declining costs for genome sequence testing and the ability to trace disease outbreaks in a matter of hours as examples of the program’s success.

Court rejects appeal over secret IRA tapes at Boston College: The US Supreme Court declined to hear an appeal of a lower court ruling that forces Boston College’s Belfast Project, an oral history initiative, to turn over recordings of interviews conducted with a deceased, convicted Irish Republican Army car bomber. Boston College argued that by doing so, the identities of the other participants would be revealed, thus putting their lives in danger. The US government had subpoenaed the recordings pursuant to a treaty with the United Kingdom, which requires both countries to aid one another’s criminal investigations.