From an IRB and research ethics perspective, when are historical wrongdoings truly in the past? Today’s IRB and human research protection regulations are the result of public outrage over historic experiments that hurt and even killed people in Nazi Germany and the U.S. in the mid-20th century. But as the global research community has enacted safeguards against exploitation of research volunteers and generations of IRBs work hard to protect study volunteers and reassure the public that they won’t condone unethical research, sometimes additional old wrongs are uncovered.
After nine months and reviewing 125,000 pages of records, the Presidential Commission for the Study of Bioethical Issues found that the Guatemalan studies of sexually transmitted diseases were “ethically impossible.”
Both Johns Hopkins University and the Rockefeller Foundation recently issued statements saying that while they condemn the Guatemalan studies that harmed hundreds of people, their institutions were not involved or responsible for those studies.
IRBs spend considerable time poring over informed consent documents and learning all they can about a study’s informed consent process. But how do these IRB discussions and changes translate into a living informed consent process after the study is approved?
IRBs need to be reminded how even the smallest of studies based on bad science or being performed by an unethical researcher can have long-lasting dangers and impact on society, a regulatory coordinator says.
The use of digital storytelling and social media to engage a vulnerable population is part of the research frontier that is possible because of technology. It might change the way IRBs view human research, and it might make investigators of community members, one socio-behavioral scientist says.