Wednesday, September 29, 2010

OHRP Issues Guidance on Withdrawal

On September 21, OHRP posted new "Guidance on Withdrawal of Subjects from Research: Data Retention and Other Related Issues." The document makes it clear that if a research participant in a social science study wishes to withdraw, the researcher is not obliged under federal regulations to throw out information that has already been collected:

May an investigator retain and analyze already collected data about a subject who withdraws from the research or whose participation is terminated by the investigator?

OHRP interprets the HHS regulations at 45 CFR part 46 as allowing investigators to retain and analyze already collected data relating to any subject who chooses to withdraw from a research study or whose participation is terminated by an investigator without regard to the subject's consent, provided such analysis falls within the scope of the analysis described in the IRB-approved protocol. This is the case even if that data includes identifiable private information about the subject.

Of course, in some cases, researchers may still choose to discard such data:

For research not subject to regulation and review by FDA, investigators, in consultation with the funding agency, certainly can choose to honor a research subject's request that the investigator destroy the subject's data or that the investigator exclude the subject's data from any analysis. Nothing in this document is intended to discourage such a practice. For example, an investigator studying social networks in a community may agree to omit all of the data they have collected from a subject of the study at the request of that subject.

(The clause about the FDA is due to the FDA's concern that withdrawals can skew the findings of clinical trials.)

This guidance strikes me as helpful. When reading sample consent forms, e.g., Cornell's, I am often left wondering what is meant by the boilerplate, "you are free to withdraw at any time," especially when it comes to interviews. If a researcher does a great interview and writes a dissertation chapter around it, can the narrator show up at the dissertation defense and pull the information? (This is apparently the case with undergraduate research at Bard College.)

Fortunately, OHRP says no.


Anonymous said...

Thanks for this. Someone in my dept is facing this problem, and it seems that in the UK participants can withdraw and have the data collected on them also withdrawn and destroyed *at any time* in the process, even as the book manuscript is going off to print. It looks like this is not the case here in the States, though this seems to apply mostly to medical and health data. Do you know if there are any cases of this being tested or challenged in regards to a social science research project?

Zachary M. Schrag said...

I'm sorry to learn of the situation in the UK, and I hope someone brings the US decision to authorities there.

I am not aware of specific cases in the US, nor of other policies as disruptive to research as those at Bard .