Researchers have used the 2018 public health surveillance exception to the Common Rule for the first time during the COVID-19 pandemic.
“The exception basically said when you’re collecting specimens or data for public health surveillance purposes that it will be exempt this from the Common Rule requirement, and it would not be considered research,” says Mary Catherine Beach, MD, MPH, co-chair of IRB3 and professor of medicine at Johns Hopkins University. Beach also is core faculty in the Berman Institute of Bioethics. “Therefore, all the protections that we would have in place for research projects may not be in place for samples collected under a public health surveillance protocol.”
In the early weeks of the pandemic, researchers might have overused this exception. Federal agencies approved some protocols involving lines of genetic materials with explicit research purposes, even if these were secondary to the public health surveillance purpose, Beach notes.
“It was something you would never allow a study to do without an informed consent, in normal circumstances, and these were not the reason the public health surveillance exception was written,” she says.
For example, investigators for one study collected nasal swabs, blood, and feces from children and their caregivers, and the families mailed these in. A secondary plan to use genetic information and make that publicly available was sponsored by the National Institutes of Health, Beach says.
“Another study, sponsored by the Centers for Disease Control and Prevention, involved collecting nasal swabs from healthcare providers to create some cell lines,” she adds.
These data could be identifiable later, and the plans to use them for research were established in the beginning.
“If you’re collecting that much material from somebody, it’s not that hard to collect a consent form,” Beach says.
Obtain Consent When Possible
Johns Hopkins University has a policy that all public health surveillance efforts must be reviewed by the IRB to determine whether they also might involve research and require informed consent. In some cases, the IRB decided COVID-19 public health surveillance projects were human subject research studies and could not continue without informed consent, Beach says.
“A signed consent form didn’t seem prohibitive,” she adds.
Several institutions allowed these types of projects to continue without informed consent. There might have been cases in which these surveillance projects were approved administratively by an IRB office without coming before a convened board, Beach says.
An IRB’s goal should be for researchers obtain informed consent when it is possible and is desirable from a human research protection perspective.
“I guess it’s possible for researchers, who decide to use public health surveillance specimens for a later research study, to go back to the IRB for review and ask for a consent waiver to use with the specimens that were collected without informed consent,” Beach explains.
For example, if an IRB sees a protocol that uses previously collected biological COVID-19 samples, then the IRB could consider waiving consent according to appropriate criteria. The IRB might say this study qualifies for a waiver of informed consent as it will not violate anyone’s rights and the research is important, she adds.
If a public health surveillance project is not intended to be used in a research study, then it would meet the exception criteria, even if specimens were to be stored in a biobank and later used in research, Beach says. But in many cases, the scientists collecting the samples know in advance they also will be used for research.
“In that case, the research project should undergo IRB review and be considered as a research project,” Beach says. “There is confusion about whether the samples collected for surveillance can be used for research purposes. It’s our view that any research study involving biobank samples should undergo regulatory and ethics review through the IRB, even if it’s not possible for them to obtain consent.” In those cases, a waiver of consent is possible.
Mainly, the IRB is concerned with a situation in which samples are collected prospectively with some intention of being used in a research study, and the investigators could fairly easily obtain informed consent but choose not to do so. “You should get consent for that kind of research even if we’re in a public health emergency,” she explains. “The only things allowed under the public health exclusion are those immediately necessary to solve public health problems. If we allow people to do projects on samples collected under public health surveillance, then researchers can bypass all research protections.”
IRBs should tell researchers if they are conducting public health surveillance and believe they might use the samples for research, then they should obtain informed consent up front. “You may be able to collect a sample for public health surveillance purposes, but know that people may not want you to store it for future research,” Beach says. “Some examples are creating cell lines with genetic material from participants, without consent, or making genetic analyses publicly available.”
These uses can pose a risk to participants through the potential violation of privacy and their rights when that was not the purpose for donating their sample. “Part of the reason there has been a pushback on IRB review is because people feel the process is unduly burdensome, administratively,” she notes. “In a pandemic, IRBs have a responsibility to mobilize quickly and do quick turnaround on protocols.”
This way, investigators know the IRB will not hold up emergency research and create more burdens. “We met daily during the beginning of the pandemic to address these issues, and there shouldn’t be any delay in any protocol as a result of our actions,” Beach says.