“Can these data be used?” is a question the IRB finds itself considering every now and again. It usually comes up when there has been some kind of problem on a study — say, data were collected after continuing review expired, or before a complete consent process occurred.
The answer to this question, however, is much more nuanced than a straight “yes” or “no.” IRBs (and institutional officials, journal editors, research funders, and others) need to take several factors into account when considering this question, as described by three authors in a paper titled, “Ethical and Practical Concerns about IRB Restrictions on the Use of Research Data.” For example, what is the nature of the noncompliance that is leading the IRB to consider this question? Is disallowing the use of data an appropriate disincentive to flouting the rules? Is there a risk of bias in making these determinations, with the decision-maker potentially coming down harder on some investigators than others? Does an IRB have the authority at all to make these determinations? After all, the regulations say IRBs have the authority only to “approve, require modifications in (to secure approval), or disapprove all research activities” and to “suspend or terminate approval of research… .”
The article linked above discusses some of these issues and suggests guidance for making these determinations. Here’s the table referred to in the article.