If you’re just joining us, this post serves as third in a series discussing the ANPRM for proposed changes to the Common Rule. I had the opportunity to interview John Stillman, Director of the Institutional Review Board at the University of Utah to get some insight into what some of the proposed changes may mean.
One of the proposed changes in the ANPRM that could have a potentially significant impact on the research community is the notion that written informed consent is required for biospecimen research, even when the specimen is de-identified.
Here’s a hypothetical that may be useful in illustrating what informed consent for biospecimen research looks like right now – before the proposed changes. Say a woman has a mastectomy and gives informed consent to some kind of research (breast cancer research, for example) involving the removed breast tissue. Years later, for a totally separate research study, researchers could then de-identify the tissue (by removing any associated potentially identifiable information including the patient’s name, geographic location, date of birth, telephone number, social security number, etc.) and then use that same sample for research that the patient did not provide informed consent to. Under the proposed change, research of the patient’s de-identified tissue would not be permitted without the patient’s informed consent. Instead, the ANPRM contemplates that the patient would provide more general informed consent at the outset, which would presumably authorize any future research, whether de-identified or not.
When I discussed this proposed change with John, he acknowledged that many individuals have expressed concern about the use of de-identified samples without consent, but he is not sure that this proposed change actually resolves the concern.
More specifically, while the proposal sounds well and good at first glance, query what this type of informed consent would even look like? John says that one possibility is that researchers would essentially be requesting consent from every patient at the door when they walk into the hospital for care. What kind of meaningful consent can actually be gained at that time from asking “may we use tissue for future research?” Another possibility is a specific document where patients could check what types of research they would and would not consent to, which would likely be hugely complex. So although the concern of the use of de-identified samples without consent is recognized, it seems unlikely that this proposal adequately presents a solution.
If you have any thoughts on this, feel free to discuss in the comments below, or submit a comment to HHS. The comment period for the ANPRM closes on October 26, 2011.
In the final two parts of this series, we will discuss the proposal to standardize informed consent and to create categories of research that are excused or exempt from IRB oversight.
– Kim Child