Tuesday, August 2, 2011

Will ANPRM Limit the Use of Published Data?

Despite the ANPRM's general goal of "reducing burden, delay, and ambiguity for investigators," the proposed policy for the re-use of pre-existing data threatens to increase all of those by expanding the current definition of human subjects research.

The present Common Rule states that "Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects." So if a data set has been stripped of its identifiers, it is no longer subject to regulation, no matter the circumstances in which the data were first collected.

The ANPRM proposes changing this so that some information that is not individually identifiable would be covered by the Common Rule:
With regard to the researchers’ use of pre-existing data (i.e. data that were previously collected for purposes other than the currently proposed research study):

a. If the data was originally collected for non-research purposes, then, as is currently the rule, written consent would only be required if the researcher obtains information that identifies the subjects. There would accordingly be no change in the current ability of researchers to conduct such research using de-identified data or a limited data set, as such terms are used in the HIPAA Rules (see Section V), without obtaining consent.

b. If the data was originally collected for research purposes, then consent would be required regardless of whether the researcher obtains identifiers. Note that this would be a change with regard to the current interpretation of the Common Rule in the case where the researcher does not obtain any identifiers. That is, the allowable current practice of telling the subjects, during the initial research consent, that the data they are providing will be used for one purpose, and then after stripping identifiers, allowing it to be used for a new purpose to which the subjects never consented, would not be allowed. (44519, emphases in original.)

The next several paragraphs of the ANPRM claim that this would not hinder research much, because "in most instances, the consent requirements described above would have been met at the time that the biospecimens or data were initially collected, when the subject would have signed a standard, brief general consent form allowing for broad, future research. This brief consent could be broad enough to cover all data and biospecimens to be collected related to a particular set of encounters with an institution (e.g. hospitalization) or to any data or biospecimens to be collected at anytime by the institution."

This is less than reassuring, since it suggests that this proposal was written for hospital-based research research with biospecimens. My sense is that it would be easier to secure "standard, brief general consent form[s] allowing for broad, future research" for such research than it would be for the more diffuse world of survey data, especially since the ANPRM itself stresses that "oral consent without written documentation would continue to be acceptable for many research studies involving educational tests, surveys, focus groups, interviews, and similar procedures."

So I am struggling to understand what the proposal on pre-existing data would mean for social research.

Let's say I read a study that finds that "Researchers who perceive that they are being unfairly treated are less likely to report engaging in 'ideal' behaviors and more likely to report misbehavior and misconduct." Could I even report this finding, and some of the numbers behind it, without first determining if the initial research consent warned participants about snarky bloggers?

For that matter, could even qualitative information be subject to the rule? If a researcher interviews someone for a book and quotes him, can other authors not use the quotation for their own projects?

Can someone help me here?


The relevant ANPRM questions read as follows:

Question 45: Under what circumstances should future research use of data initially collected for non- research purposes require informed consent? Should consent requirements vary based on the likelihood of identifying a research subject? Are there other circumstances in which it should not be necessary to obtain additional consent for the research use of currently available data that were collected for a purpose other than the currently proposed research?

Question 46: Under what circumstances should unanticipated future analysis of data that were collected for a different research purpose be permitted without consent? Should consent requirements vary based on the likelihood of identifying a research subject?

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