-
For years, inmates of a Philadelphia city jail, known as Holmesburg Prison, participated in medical experiments. From the mid-1950s to 1974, when medical testing was banned, research, ranging from dermatological treatments to the effects of mind-altering drugs, was conducted at the jail.
-
The Partnership for Human Research Protection (PHRP) in Oakbrook Terrace, IL, recently announced the approval of final standards for a new accreditation program to safeguard the interests of human subjects participating in research efforts.
-
Except on the television drama ER, it rarely occurs, even at medical universities and affiliated hospitals, but occasionally an IRB may encounter a case where an investigator desires to have informed consent waived in order to conduct emergency medical research.
-
Inevitably, some investigators will not be compliant with the federal or state statutes and regulations, institutional rules, or IRB policies when conducting clinical research.
-
Recruiting students for research at universities and colleges is no longer as simple as having professors offer extra credit in exchange for participation. It has become an area that has created controversy within institutions and IRBs.
-
IRBs located in universities might find themselves inundated with low-risk protocols if they reviewed every single study proposed by college students working on their graduate papers. On the other hand, it would be poor policy and possibly provide risk to human subjects if these studies were routinely ignored.
-
One of the challenges in clinical trial operations is to recruit patients to participate. The Food and Drug Administration notes that recruitment methods and material also should be reviewed as a part of the IRB oversight function.
-
Nonaffiliated and nonscientist members of IRBs the so-called lay or community members say they need more introductory education and ongoing training to better meet the challenges of their roles.
-
College student populations may offer a plentiful and accessible source for human subjects research, but IRB and university research officials say that a variety of issues arise when students are used.
-
It started out a simple premise: protect patients privacy by securing their health information. But the Privacy Rule of the Health Insurance Portability and Accountability Act (HIPAA) is raising some concerns, not just among primary caregivers and treatment facilities.
