human subjects
Human Subjects
SACHRP Seeks Nominations for New Members
The Secretary’s Advisory Committee on Human Research Protections (SACHRP), the advisory body of the Office of Human Research Protections (OHRP), is seeking nominations to fill two spots that will become vacant in July 2015. The Committee provides guidance on matters “relating to the responsible conduct of research involving human subjects with particular emphasis on special populations such as neonates and children, prisoners, the decisionally impaired, pregnant women, embryos and fetuses, individuals and populations in international studies, populations in which there are individually identifiable samples, data or information; and investigator conflicts of interest.” Qualified candidates will possess expertise and experience in…
SACHRP Considers Consent in Low-Risk Online Studies
At its meeting on October 30, the Secretary’s Advisory Committee on Human Research Protections (SACHRP) heard a presentation from B.R. Simon Rosser, University of Minnesota School of Public Health, on “The Evolution of Consent in Low-Risk Studies: Lessons from Online Survey Research.” He suggested that SACHRP rethink how researchers handle informed consent for low-risk studies conducted over the internet.
OHRP Solicits Comments on Draft Guidance on Risk Disclosure in Research Evaluating Standards of Care
The Office of Human Research Protections (OHRP) has issued draft guidance on “Disclosing Reasonably Foreseeable Risks in Research Evaluating Standards of Care.” As more and more comparative effectiveness research is conducted to evaluate different treatments commonly used by medical practitioners (“standards of care”), the guidance is an attempt to assist researchers in determining how to disclose potential risks of the different treatments they are studying.