New IRB Regulations Could Be Really Stupid

And they will make microbiological research much harder.

For those who don’t know what an IRB is (a perfectly reasonable state of affairs), it stands for Institutional Review Board, and it is the entity (actually, entities plural–most universities and large research groups have them) that approves human subjects research (in English, doing stuff to people). Basically, when it comes to research, all of Gaul human subjects research can be divided into three parts:

  1.  IRB approval required.  The IRB must determine that the research doesn’t violate human subjects research standards, including issues of privacy.
  2. Human subjects exempt.  Here, the IRB states that the research doesn’t require an examination by the IRB.  That is, an examination of the study design provided by the researcher indicates no human subjects research issues could arise.
  3. IRB approval not required.

For a lot of micriobiological research, especially population genetics and basic epidemiology, a lot of research is human subjects exempt as it uses ‘laboratory bycatch.’ This includes getting all blood or urine samples of a particular organism from a hospital or all drug-resistant bacterial isolates. We often don’t care–and don’t really want to know–who had what infection. In other words, there is no identifying information about the patient, so researchers can easily acquire the isolates.

Well, there are proposed changes to the Common Rule which governs human subjects research, and, as best as I can tell, they would essentially eliminate the ability to gather this microbiological bycatch (p. 53965; boldface mine):

A majority of commenters opposed the suggestion that there be consent requirements for the research use of non-identifiable biospecimens collected for purposes other than the current research study…

Commenters to the 2011 ANPRM were mostly concerned with the cost and burden that would be imposed by the requirement to obtain consent for future research use of all biospecimens, regardless of identifiability.

Commenters anticipated these costs to include obtaining consent from participants and the administrative efforts required to keep track of the consent status of biospecimens. Most commenters did not provide detailed cost estimates with their comments; data are specifically requested in response to this NPRM. In addition, estimates of the type and number of studies that could not be pursued using existing samples and data because of the absence of sufficient consent are requested. Comment is also sought on the value to the public and research participants of being asked their permission for research use of their data and biospecimens.

While consideration was given to the opposition expressed by ANPRM commenters of a consent requirement for secondary research use of non- identified biospecimens, the NPRM proposes to require that consent be obtained for the research use of non- identified biospecimens, but to allow for that consent to be broad. Thus, while consent would be required for the research use of non-identified biospecimens, one would not have to obtain study-specific consent for the research use of those biospecimens, drastically reducing the burden imposed by this new requirement.

As best as I can determine, this means that microbiological bycatch would be dead: all microbiological lab samples would have to receive written consent from patients even if there were no way for a researcher to trace back the samples to the patient. Likewise, any researcher who wanted to collect simple antibiotic resistance information apart from patients (what drugs are bacteria resistant to?) would also appear to be limited by this requirement.

This is what happens when one writes ‘one size fits all’ regulations. This is a ‘human-centric’ document, as the words “viral” and “bacterial” are only mentioned to describe sample types (i.e., there’s no discussion of potential implications), while microbiological doesn’t appear at all. I realize people’s legitimate concerns about their genomes and other related materials being misused. But, in case you haven’t noticed, we are facing some very serious infectious disease crises, and making it harder for microbiologists to do their work isn’t helping.

These proposed changes also need to be discussed in the content of microbiological research. We don’t want to damage our ability to conduct research related to pathogens or antibiotic resistant microbes.

Aside: Government surveillance efforts are not regulated by the Common Rule.

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2 Responses to New IRB Regulations Could Be Really Stupid

  1. David Taylor, MD says:

    Mike: I think you read the proposed changes incorrectly. As I understand it, the requirement would be to obtain consent at the time biosamples are collected — consent to use that material in some research, some time, some where. Consent would not be required for the use of those biosamples in subsequent research — no “study specific” consent would be required.

  2. Lorax says:

    I agree with David, this appears to be no different than patients who donate waste tissue from biopsies and surgeries for research purposes. I use these materials and use a generic IRB approval for use of human tissue.

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