by Meryn Robinson, Educational Program Intern
When reviewing a study that sought to investigate how sex offenders used networked technologies and communications for human trafficking, Hila Berger, MPH, CIP, and her colleagues on the IRB at Montclair State University faced a unique challenge: balancing protections for the study’s subjects—sex offenders—against protections for potential victims. The potential for subjects to incriminate themselves and potential legal obligations related to information disclosed during the research further complicated the protocol review. To overcome these challenges, the IRB and legal counsel worked together to implement additional protections for the group.
by Holly Fernandez Lynch, JD, MBioethics, Executive Director of the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics
The current framework for the regulation of human subjects research emerged largely in reaction to the horrors of Nazi human experimentation, revealed at the Nuremburg trials, and the US Public Health Service Syphilis Study at Tuskegee, conducted by US government researchers from 1932 to 1972. This [...] Read more
by Avery Avrakotos, Education and Policy Manager
PRIM&R has long been committed to the protection of the rights and welfare of human subjects, and strongly believes that informed consent is an essential mechanism for providing potential subjects with the information they need to make considered, autonomous decisions about research participation.
In July, the US Food and Drug Administration (FDA) announced it [...] Read more
by Betty Kalama, Senior Community Facilitator at the Kenya Medical Research Institute Wellcome Trust Research Programme
As a community facilitator within the Kenya Medical Research Institute (KEMRI)-Wellcome Trust Research Programme, my primary responsibility is supporting community engagement. From workshops for community members to staff training sessions on research ethics and communication skills, I work frequently with researchers and community members to strengthen the relationship between the programme and the community. In addition, I participate as a member of the Consent and Communication Committee, which aims to support ethical research by advising on locally appropriate strategies for communicating with participants and the wider community about research.
Given my professional responsibilities, I was very [...] Read more
We all know that designing a mechanism for obtaining valid informed consent is a perennial challenge, but it seems to be receiving special and renewed interest lately.
The United States Food and Drug Administration (FDA) recently released a draft guidance, Informed Consent Information Sheet: Guidance for IRBs, Clinical Investigators, and Sponsors, for public comment. The draft is intended to replace the FDA’s previous, and much briefer, guidance on informed consent, which dates from 1998. Throughout the new draft guidance, the FDA emphasizes that informed consent involves more than a form, and encourages investigators, IRBs, [...] Read more