It’s becoming increasingly rare for us to transmit large chunks of information via pages and pages of printed text. One notable exception is the documenting of informed consent for research. While the research community continues to explore ways to make informed consent forms and processes easier for subjects to understand, relatively long and complex research consent forms […]

Researchers and IRB members are aware of the need to ensure study populations reflect the community. Careful attention to enrollment helps ensure  study results are valid and generalizable, and allows the IRB to determine that subject selection is equitable (which is one of the criteria for approval). A recent New York Times article addressed the […]

Can investigators also be research subjects in their own studies? Science Magazine recently published a piece discussing the regulatory and ethical issues about researchers doing their research on themselves. As the piece points out, self-experimentation can lead to results that are life changing, for better or worse – two scientists went on to win Nobel […]

Research subjects provide a tremendous service to subjects, at a sometimes not-negligible cost, in terms of time and inconvenience (and potentially needlesticks, radiation exposure, etc.) to them. Some research procedures may yield information important to the participant’s health, or that could minimize that person having to have the same procedures done as part of their regular […]

IRB members, we know you have that Tuesday afternoon meeting time noted on your calendars – in ink. Another important meeting-related time to keep in mind, however, is “noon Monday.” That’s the deadline we ask you to meet in reviewing your assignments and having your comments and contingencies entered into CLARA. Having them done relatively […]

Some new study submissions, in addition to all the usual material, include something called a pregnant partner consent form. These forms are intended to be used if the female partner of a study subject becomes pregnant during the subject’s participation in a clinical trial. They allow sponsors to collect information about the pregnancy and its […]

When approving research, the IRB has to find that research risks are minimized by using procedures consistent with sound research design. One consideration in that determination is whether adequate resources are available to safely carry out research procedures and to protect data confidentiality. The resources of interest to the IRB can include adequate space and […]

Who, exactly, needs to be in attendance for us to be able to actually hold an IRB meeting? The regulation describing IRB membership, 45 CFR 46.107, is arguably somewhat non-specific. It requires an IRB to have at least 5 members. We have substantially more than 5 members on each committee roster, which is appropriate for a board that reviews […]

Community involvement has long been a concern in research. The Belmont Report mentions “justice” as one of its basic priniciples. Justice, in this context, refers to ensuring the burdens and benefits of research are equitably distributed. More recently, the issue of community based participatory research has come to the fore. This type of research brings community […]

A recent post on the PRIM&R blog Ampersand drew our attention to the issue of using social media to recruit research subjects. A Harvard-based working group recently published an open access guidance document titled, “The Use of Social Media in Recruitment to Research: A Guide for Investigators and IRBs.”  The guidance document, though fairly long, […]